G 2/08 Dosage regime [2010] OJ EPO 456

Some boards of appeal have considered recognising specific therapeutic uses as patentable in
principle to be problematic where they differ from the prior art merely in terms of the dosage
regimen. In G 2/08 (OJ 2010, 456), the Enlarged Board addressed this issue in detail.

With reference to the case law and the danger of a collision with Art. 52(4) EPC 1973,
decision T 584/97 denied patentability for a claim directed essentially to the administration of
nicotine in increasing doses. In T 317/95, T 56/97and T 4/98 (OJ 2002, 139) the issue was
discussed, with answers tending towards the negative, but ultimately left undecided. In all of
these cases, the grant of a patent would anyway have been refused on other grounds - i.e. lack
of novelty or inventive step - so that the outcome of a decision on this issue was immaterial (see
also T 1319/04, OJ 2009, 36)

In T 1319/04 (OJ 2009, 36), the board referred to the Enlarged Board of Appeal the question
whether medicaments for use in methods of treatment by therapy, where the only novel feature
was a dosage regime, are patentable under Art. 53(c) and 54(5) EPC. The Enlarged Board
answered in G 2/08 (OJ 2010, 456) as follows:

1. Art. 54(5) EPC does not exclude a medicament which is already used in the treatment of an
illness being patented for use in a different treatment by therapy of the same
illness. Art. 53(c) EPC, which lists as an exception to patentability 'methods for treatment of the
human body ... by therapy' is clear and unambiguous, and draws a borderline between
unallowable method claims directed to a therapeutic treatment on the one hand and allowable
claims to products for use in such methods on the other. The two concepts of a method of
treatment by therapy and of a product to be used in such a method are so close to each other,
that there is a considerable risk of confusion between them unless each is confined to its own
domain as allocated to it by the law. Art. 53(c), second sentence, EPC, is not therefore to be
interpreted narrowly; on the contrary, it is appropriate to give both provisions
(Art. 54(5) and Art. 53(c) EPC) the same weight and conclude that, in respect of claims
directed to therapy, method claims are absolutely forbidden in order to leave the physician free
to act unfettered, whereas product claims are allowable, provided their subject-matter is new
and inventive. By virtue of a legal fiction, Art. 54(4) and (5) EPC acknowledge the notional
novelty of substances or compositions even when they are already comprised in the state of the
art, provided they are claimed for a new use in a method which Art. 53(c) EPC excludes from
patent protection. The notional novelty, and thus, non-obviousness, if any, is not derived from
the substance or composition as such, but from its intended therapeutic
use. Art. 54(5) EPC refers to "any specific use" [emphasis added] and thus, in conjunction with
the stated intention of the legislator to maintain the status quo of the protection evolved in the
case law of the boards of appeal under G 5/83(OJ 1985, 64) in this respect, this use cannot
be ex officio limited to a new indication stricto sensu (approving T 1020/03, OJ 2007, 204).

2. The Enlarged Board went on to hold that such patenting is also not excluded where a dosage
regime is the only feature claimed which is not comprised in the state of the art. Given the
answer to the first question, and, since Art. 54(5) EPCmay be used in cases of the treatment of
the same illness, the "specific use" in the sense of that provision may reside in something other
than the treatment of a different illness, the Enlarged Board held that there is no reason to treat
a feature consisting in a new dosage regime of a known medicament differently from the one
given to any other specific use acknowledged in the case law. However, it stressed that the
whole body of jurisprudence relating to the assessment of novelty and inventive step also
applies. The jurisprudence on this continues to apply (see T 290/86; OJ 1992, 414; T 1020/03,
OJ 2007, 204; T 836/01; T 1074/06).

In T 1020/03 (OJ 2007, 204) a pure dosage regimen was for the first time recognised as not
excluded from patentability. The claims were directed to the use of insulin-like growth factor-I in
the preparation of a medicament for administering to a mammal in a specific discontinuous
administration pattern. In the headnote, the board stated that any use to which Art. 52(4) EPC,
first sentence, applies in circumstances where the composition has already been suggested for
some therapeutic use, allows a second medical use claim to the preparation of the composition
for that second medical use, irrespective of in what detail that use was specified, subject to the
use being novel and inventive. For the purposes of novelty also under Art. 54(5) EPC this
depends on whether use for therapy is novel, irrespective of the detail with which the therapy is
stated in the claim.

HTC v Apple [2013] EWCA Civ 451, [2013] RPC 30

HTC Europe Co. Ltd. V. Apple Inc. and Apple Inc. v. HTC Corporation, Court of Appeal,
London, UK, 3 May 2013, [2013] EWCA Civ 451

The Court of Appeal allowed in part Apple’s appeal of the decision of the Patents Court that one
of its patents was invalid.

The original trial before Mr Justice Floyd concerned four actions between HTC and Apple
regarding four patents owned by Apple. Following the judgment, HTC and Apple settled their
dispute and so HTC did not take part in the appeal.

The appeal only concerned the validity of two of the Apple patents, EP (UK) 2 098 948 (“the
‘948 Patent) and EP (UK) 1 964 022 (“the ‘022 Patent”). The ‘948 Patent relates to computer
devices with touch sensitive screens which are capable of responding to more than one touch at
a time and the ‘022 Patent relates to ways unlocking computer devices with touch sensitive
screens. The issues before the Court of Appeal were as follows:
==========

(i) Were claims 1 and 2 of the ‘948 Patent invalid because they related to computer programs as
such and so covered excluded subject matter;

(ii) Was claim 1 of the ‘948 Patent invalid for obviousness in light of the common general
knowledge; and

(iii) Were claims 5 and 17 of the ‘022 Patent invalid for obviousness in the light of the Neonode
mobile telephone.

The Court of Appeal held that claims 1 and 2 of the ‘948 Patent did not relate to computer
programs as such and so were not invalid for excluded subject matter. Lord Justice Kitchin held
that problem dealt with in the ‘948 Patent was essentially technical, that the solution lay with a
method concerned with the basic internal operation of the device and applied irrespective of the
software used and that there was a practical benefit of the invention in presenting a new and
improved interface to application programmers which made it easier to write application
software for a multi-touch device.

The Court of Appeal held the trial judge was correct in finding that claim 1 of ‘948 Patent was
invalid for obviousness in light of the common general knowledge. Lord Justice Kitchin noted
that the iPhone 1 was well known in the art at the relevant time and it made extensive use of
multi-touch functionality.

The Court Appeal dismissed Apple’s appeal in respect of claims 5 and 17 of the ‘022 Patent
being invalid for obviousness in the light of the Neonode, a mobile telephone launched in
Sweden in 2004. Lord Justice Kitchin held that the trial judge was entitled to find that it was
obvious to apply swipe-with-feedback to the unlocking of a plurality of applications.

Synthon v SmithKline [2005] UKHL 59, [2006] RPC 10

Summary
The House of Lords on Thursday unanimously allowed Synthon BV’s (“Synthon”) appeal for the
revocation of Smithkline Beecham plc’s (“SB”) patent for the methane sulfonate salt of
paroxetine. Heavily criticising the Court of Appeal’s judgment, Lord Hoffman, giving the principal
statement, found that on considering the concept of enabling disclosure in a patent specification
a clear distinction should be made between the “disclosure” element and the “enablement”
requirement. He further highlighted the fact that although for the purposes of assessing
disclosure “the prior inventor must be clearly shown to have planted his flag at the precise
destination before the patentee”[1] on considering “enablement”, particularly in cases
concerning complex technology, one should have regard to what an ordinary skilled man in the
art might consider trying in attempting to replicate the disclosed material.
Background

On 7 March 2001 Synthon commenced proceedings to have SB’s patent for crystalline
paroxetine methansulfonate (“PMS”) revoked on the ground that it was invalid for lack of
novelty, relying on their own earlier patent application and section 2(3) of the Patents Act 1977.
Section 2(3) provides that, for the purposes of novelty only, the state of the art may include
“matter contained in an application for another patent which was published on or after the
priority date of that invention, if … (a) that matter was contained in the application for that other
patent both as filed and as published; and (b) the priority date of that matter is earlier than that
of the invention”.

PMS is a salt of paroxetine, a drug that has been commonly used, in its hydrochloride
hemihydrate salt form, to treat depression and known commonly as Seroxat and Paxil. PMS has
properties making it more suitable for pharmaceutical use than the hydrochloride hemihydrate
form as it is more stable, less hygroscopic and much more soluble.

On 10 June 1997 Synthon filed an international application for a patent claiming a broad class of
sulfonic acid salts including PMS, which was specifically mentioned by way of an example. The
application was published on 17 December 1998.

On 6 October 1998 SB filed a document in the UK, giving it that priority date, and later filed a
patent application on 23 April 1999 for PMS based on that priority filing. It was the validity of this
patent that was in issue in the case.

The case went before Jacob J who on the 3 December 2002 revoked the patent. Jacob J
concluded that Synthon’s patent disclosed the existence of PMS in the crystalline form specified
in SB’s patent, that crystalline PMS was monomorphic (having only one possible crystalline
form) and that the ordinary skilled man in the art would be able to reproduce crystalline PMS as
claimed in SB’s patent.

SB appealed the decision.

Court of Appeal decision
On 25 June 2003 the Court of Appeal overturned Jacob J’s decision, Aldous LJ distinguishing
Synthon’s and SB’s disclosures: “the [SB patent] is directed at PMS, whereas the [Synthon
application] is directed at a large number of compounds both in the general statements and in
the preferred form. Second, the general statements as to how PMS can be obtained differ from
those relating to the compounds in the application. Third, the examples in the patent give
detailed instructions as to how crystalline PMS can be made, whereas the equivalent example
in the application does not work. Fourth, the patent claims a different crystalline form of PMS to
that described in the application”.[2]

On considering the expert evidence Aldous LJ added that “the crucial question was not whether
the skilled addressee would expect success, but whether the application made available PMS
as claimed … Once it had been established that [the PMS example in the Synthon application]
did not disclose a successful route to PMS as claimed in the patent, the skilled addressee might
have adopted obvious modifications. But such an approach is not permissible when considering
novelty” concluding that “the disclosure in the application does not make the PMS claimed …
available to the public”.[3]

The case was then referred by Synthon to the House of Lords.

House of Lords judgment

The House of Lords unanimously overturned the Court of Appeal’s verdict and revoked SB’s
patent. Lord Hoffman, giving the main judgment, heavily criticised the Court of Appeal’s
judgment.

Lord Hoffman’s principal criticism was of Aldous LJ’s lack of clarity and distinction between the
two requirements for anticipation “prior disclosure” and “enablement”. Making clear that the two
concepts should be considered separately, he briefly analysed the relevant case law noting that
although for the purposes of disclosure “the matter relied upon as prior art must disclose
subject-matter which, if performed, would necessarily result in an infringement of the
patent”[4] this does not hold when considering enablement. “Enablement means that the
ordinary skilled person would have been able to perform the invention which satisfies the
requirement of disclosure”[5]. The “person skilled in the art is assumed to be willing to make trial
and error experiments to get it to work.”[6] Therefore “once the meanings of the prior disclosure
and the patent have been determined, the disclosure is either of an invention which, if
performed, would infringe the patent, or it is not. The person skilled in the art has no further part
to play. For the purpose of enablement, however, the question is no longer what the skilled
person would think the disclosure meant but whether he would be able to work the invention
which the court has held it to disclose”.[7]

Lord Hoffman also added that he could see no reason why there should be any difference
between the test of enablement for the purposes of prior disclosure and that for the purpose of
sufficiency under section 72 of the Patents Act 1977.

In applying the facts of the case Lord Hoffman had no doubt that Synthon’s application
disclosed the existence of PMS crystals even though Synthon had mistakenly included an IR
spectrum differing from that indicated in SB’s patent, suggesting PMS to be polymorphic (having
more than one crystalline form). However, a variety of experiments conducted prior to the trial
suggested that PMS was monomorphic. This being the case Lord Hoffman considered that the
Judge at first instance had been right to disregard the IR spectrum and conclude that the PMS
monomorph had been disclosed by Synthon’s application. In that “the subject-matter described
was crystalline PMS and a skilled person who performed that invention, though he might, if he
had read the patent, think that he was not going to infringe it, would inevitably do
so.”[8] Whether the crystals could be made or not was a question of enablement.

For enablement the issue becomes whether in fact the ordinary skilled man in the art would
have been able to make crystalline PMS. Synthon had in their example unfortunately named a
solvent that was unsuitable for crystallisation. In the trial Judge’s opinion a skilled man would
have tried a different solvent, either from the range mentioned in the application or forming part
of his common general knowledge. Lord Hoffman could see no reason why this opinion of fact
should be interfered with.

On considering Aldous LJ’s four points on the two disclosures, above, Lord Hoffman believed
the first and fourth to be irrelevant. The idea of making crystalline PMS was clearly disclosed in
the application and PMS is in fact monomorphic. The second and third points were relevant to
enablement and not disclosure. Lord Hoffman further criticised Aldous LJ’s conclusion on the
expert evidence, above, for disregarding the Jacob J’s opinion that a skilled addressee would
have considered “obvious modifications”.

Pozzoli v BDMO [2007] EWCA Civ 588

The English Court of Appeal has used a recent judgment to restate the approach of the English
court towards the assessment of obviousness (the "Windsurfing" approach), and to comment on
technical prejudice arguments. An important practice point arises from the comments on
technical prejudice. In Pozzoli SPA v BDMO SA and Moulage Industriel de Perseigne SA, the
claimant's patent related to a form of packaging for compact discs. The Court of Appeal upheld
the first instance judgment that the patent was invalid for obviousness and that the accused
product fell outside the scope of the claims

Windsurfing elaborated, obviousness and technical prejudice (By Rowan Freeland)

The English Court of Appeal has used a recent judgment to restate the approach of the English
court towards the assessment of obviousness (the "Windsurfing" approach), and to comment on
technical prejudice arguments. An important practice point arises from the comments on
technical prejudice. In Pozzoli SPA v BDMO SA and Moulage Industriel de Perseigne SA, the
claimant's patent related to a form of packaging for compact discs. The Court of Appeal upheld
the first instance judgment that the patent was invalid for obviousness and that the accused
product fell outside the scope of the claims. Windsurfing reviewed and restated Lord Justice
Jacob (with whom the other two Lords Justice concurred) took the opportunity to restate the four
questions comprising the Windsurfing approach as follows: 1. a. identify the notional "person
skilled in the art" b. identify the relevant common general knowledge of that person 2. identify
the inventive concept of the claim in question or if that cannot readily be done, construe it 3.
identify what, if any, differences exist between the matter cited as forming part of the "state of
the art" and the inventive concept of the claim or the claim as construed 4. viewed without any
knowledge of the alleged invention as claimed, do those differences constitute steps which
would have been obvious to the person skilled in the art or do they require any degree of
invention? Step 1 used to come after step 2 in the original Windsurfing approach: but, as Jacob
LJ commented, "it is only through the eyes of the skilled man that one [can] properly understand
what such a man would understand the patentee to have meant and thereby set about
identifying the concept." Step 2 used simply to require the court to identify the inventive concept.
Jacob LJ commented: "In some cases the parties cannot agree on what the concept is. If one is
not careful such a disagreement can develop into an unnecessary satellite debate. In the end
what matters is/are the difference(s) between what is claimed and the prior art. It is those
differences which form the "step" to be considered at step 4. So if a disagreement about the
inventive concept of a claim starts getting too involved, the sensible way to proceed is to forget
it and simply to work on the features of the claim. In other cases, however, one need not get into
finer points of construction - even without them the concept is fairly apparent … In yet other
cases it is not even practical to try to identify a concept - a chemical class claim would often be
a good example of this. There is one other point to note. Identification of the concept is not the
place where one takes into account the prior art. You are not at this point asking what was new.
Of course the claim may identify that which was old (often by a pre characterising clause) and
what the patentee thinks is new (if there is characterising clause) but that does not matter at this
point." The Windsurfing approach was first expounded several years before the UK joined the
European patent system, and its appropriateness under the supposedly harmonised law of the
European Patent Convention has been the subject of debate from time to time. This decision
suggests that the Court of Appeal is not yet ready to depart from the Windsurfing approach.
Technial prejudice - real lions or paper tigers? Patentees frequently seek to defend their
inventions from a charge of obviousness by saying that, even if the skilled person might
conceive of the invention, he would reject the idea because he thought that it would not work for
some reason. Jacob LJ said that such technical prejudice arguments would only be capable of
succeeding if the information in the patent would enable the skilled person to overcome the
prejudice. He said: "Patentability [in the face of a technical prejudice] is justified because the
prior idea which was thought not to work must, as a piece of prior art, be taken as it would be
understood by the person skilled in the art. He will read it with the prejudice of such a person.
So that which forms part of the state of the art really consists of two things in combination, the
idea and the prejudice that it would not work or be impractical. A patentee who contributes
something new by showing that, contrary to the mistaken prejudice, the idea will work or is
practical has shown something new. He has shown that an apparent "lion in the path" is merely
a paper tiger. Then his contribution is novel and non obvious and he deserves his patent.
Where, however, the patentee merely patents an old idea thought not to work or to be practical
and does not explain how or why, contrary to the prejudice, […] it does work or is practical,
things are different. Then his patent contributes nothing to human knowledge and the patent
cannot be justified. This analysis does not require a different way of looking at the inventive
concept depending on whether or not the patentee has shown the prejudice is unjustified … It is
simply that in the former case the patentee has disclosed something novel and non obvious,
and in the latter not. The inventive concept is the essence of what is in the claim and not
dependent on any question about a prejudice being overcome." Practice points 1. when drafting
a patent, ask the inventor: "Is there any reason why people might think this invention would not
work? 2. always try to include examples or data which demonstrate that the invention does
work. Permission to appeal In England, an appeal may be brought only if the trial judge (or the
Court of Appeal itself) gives permission. This is intended to filter out appeals which are
hopeless. It has been suggested that this contravenes article 32 of the Trade Related Aspects
of Intellectual Property Rights agreement (TRIPs), which provides that "An opportunity for
judicial review of any decision to revoke or forfeit a patent shall be available." However, Jacob
LJ said that the decision whether to grant permission to appeal is indeed a "judicial review"
within the meaning of article 32: "It would be daft [for TRIPs] to require the grant of permission
to appeal in a case where a court of appeal had judicially determined that the appeal had no
prospects of success". French and German decisions In parallel proceedings in France, the
counterpart French patent was revoked for obviousness by the Tribunal de Grand Instance de
Rennes, which also held that the defendants' product fell outside the claims. Jacob LJ said that
he was reinforced in his decision by the decision of the French Court. However, the Landgericht
Düsseldorf has held that the counterpart German patent was infringed. Jacob LJ simply quoted
the relevant passage from the German judgment and said: "With respect I do not agree."
C-428/08 Monsanto Technology LLC, judgment of 6 July 2010 The Court specifies the scope of
the legal protection conferred on biotechnological inventions by a European patent: this can be
invoked only in relation to an invention which in fact performs the function for which it has been
patented. The company Monsanto has held a European patent since 1996 for a DNA sequence
which, inserted into the DNA of a soybean plant, makes it resistant to a powerful herbicide
frequently used in agriculture. This genetically modified soybean plant, known as "RR soybean",
is not on the other hand patented in Argentina, where it is cultivated on a large scale. In 2005
and 2006, European companies imported soy meal produced with Argentinian "RR soybean"
into the Netherlands. The Court of The Hague, before which Monsanto brought proceedings,
asked the Court of Justice whether the latter could invoke its European patent to prohibit the
marketing of this meal. The Court therefore specified the scope of the legal protection conferred
on biotechnological inventions by Directive 98/44/EC of 6 July 1998 and more specifically Article
9 of this Directive. It finds that these provisions make the protection provided for by a European
patent subject to the condition that the genetic invention contained in the patented product or
constituting that product in fact performs its function in this material. The protection granted in
this way is therefore not absolute. The Court adds that on this point, the Directive effects an
exhaustive harmonisation in the European Union, with the result that it precludes national
legislation offering absolute protection to a sequence of DNA as such, regardless of whether it
performs the specific function for which it was patented. Consequently, after having found that
the DNA sequence in question cannot perform its function when it is incorporated in dead
material, such as soy meal, the Court rules that Monsanto cannot obtain a ban on marketing soy
meal from Argentina, containing its biotechnological invention in residual state, on the basis of
the Directive.

Haberman v jackal
In terms of substantive patent law, 1999 was remarkable if only for the lack of any major
developments. I have set out in tables 1 and 2 below a summary of the High Court and Court of
Appeal decisions on the merits for 1999. There were no decisions on the merits handed down
by the Patents County Court.

I comment below on only two of them: the High Court decision in Haberman v Jackel1 on the
issue of commercial success and the Court of Appeal decision in United Wire v Screen Repair
Services2 on the issue of implied repair.

Although certainty can be considered a "good thing" insofar as it enables patent practitioners to
give clear advice to clients, there are nevertheless questions of substantive patent law on such
matters as construction and infringement and obviousness to name but two which are deserving
of review by the House of Lords. On construction and infringement, for instance, the issue as to
whether the approach set out in Catnic v Hill & Smith3 to the construction of a patent claim was
the correct approach under the Protocol to the Interpretation of Article 69 of the EPC was raised
in PLG v Ardon4. Millet LJ who gave the leading judgment in PLG concluded that Catnic was
otiose. Although Aldous LJ had been appointed to the Court of Appeal at the time of that appeal,
he was unable to sit on the appeal as he had decided PLG at first instance. He did however
have the opportunity to set the record straight in Kastner v Rizzla5where he decided that Millet
LJ's statements in PLG on Catnic were obiter dicta and therefore not binding on him and that
the approach set out in Catnic was the correct one to be adopted in order to comply with the
Protocol. Since then the lower courts (as well as Court of Appeal for that matter) have been
bound to follow Kastner. A review of the law on construction and infringement therefore awaits a
successful Petition to the House of Lords1*.
TABLES 1 AND 2
 In terms of procedural patent law, however, 1999 has been of considerable interest to patent
practitioners. Leaving aside the case law, one the most significant events of the year was the
coming into force of the new civil procedure rules (known as the CPR) on 26 April 1999. The
CPR are designed to make civil litigation in England & Wales cheaper and quicker, inter alia, by
giving to the Judges the power to manage cases in a proactive manner. Although competition
from not only the Patents County Court but also other European jurisdictions coupled with the
relative autonomy of the Patents Court had led the Patents Court Judges to begin the process
of case management ahead of their introduction, the CPR now provide them with the necessary
powers to cut the litigation cloth even better to suit the needs of each particular case.
Aside from the CPR, however, both the High Court and the Court of Appeal have handed down
some interesting decisions on various aspects of procedural patent law. I comment below on
those which I consider to be of particular importance to users of the English patent system,
namely: (1) summary judgment on construction and infringement; (2) the stay of English
proceedings pending the outcome of an EPO opposition; (3) the extent of the Court?s discretion
to refuse an amendment.

1999 Cases on Substantive Patent Law - Haberman v Jackel

Haberman is of interest mainly because it was one of the few recent cases in which "commercial
success" has been relied upon successfully to overcome an obviousness attack on the patent in
suit. In most cases, a plea of "commercial success" fails because either it is not established that
there is any relation between the invention and the increased sales of the commercial
embodiment of the invention or the commercial embodiment only represents one part of a
broader claim. In Molnlycke v Procter & Gamble6, the Court of Appeal relegated commercial
success to that of secondary evidence to be used only to test the primary evidence of the
properly qualified expert witnesses on the issue of obviousness.

In Haberman, the invention itself concerned a leak proof children's trainer cup. The Judge
approached the issue of obviousness on the basis of the widely used four part test set out
in Windsurfing v Tabour Marine7. He held that the question to be determined was whether,
without any knowledge of the alleged invention, the difference between it (being the use of a slit
valve to prevent leakage of fluid from the outlet of a training cup) and the prior art (being the
facts that teats from feeding bottles had been made drip resistant by incorporating slit valves in
the end and that it was a recognised problem that training cups were prone to leak) would have
been obvious to the skilled man or required a degree of invention. In gaining an insight into the
state of mind of the skilled man at the priority date, the Judge held that the following non-
exhaustive list of matters relating to commercial success would be relevant:
 What was the problem which the patented development addressed?
 How long had that problem existed? How significant was the problem seen to be?
 How widely known was the problem and how many were likely to be seeking a solution?
 What prior art would have been likely to be known to those expected to have involved in finding
a solution?
 What other solutions were put forward in the period leading up to the publication of the
patentee's development?
 To what extent were there factors which would have held back the exploitation of the solution
even if it was technically obvious?
 How well had the patentee?s development been received?
 To what extent could it be shown that the commercial success was due to the technical merits
of the developments?
On the facts, Laddie J held that the plea of "commercial success" was established and relying,
inter alia, on that finding further held that the invention was not obvious.
United Wire v Screen Repair Services
 United Wire is of interest because it is the first Court of Appeal decision under the Patents Act
1977 on the question of implied repair.

In United Wire, Aldous LJ, who gave the leading judgment, reviewed the authorities under the
1949 Patents Act and referred to the following comments of Lord Hoffman given in the Privy
Council decision in Canon v Green8 (a case which before the PC only concerned whether acts
of repair amounted to infringement of copyright):

"Their Lordships would observe that the concept of a licence namely something which makes an
action lawful which without it had been unlawful is not really applicable to the repair of a
patented article. Because repair is by definition something which does not amount to the
manufacture of the patented article, it is not an infringement of the monopoly conferred by the
patent. It cannot therefore be an unlawful act and needs no special licence to make it lawful,
unless as part of a general implied licence to use the patented product at all, which is
sometimes used to explain why mere user does not infringe the patentee's monopoly. But this is
perhaps better regarded as a consequence of the exhaustion of the patentee?s rights in respect
of the patented article when it is sold."

Aldous LJ held in United Wire that the concept of implied repair was not applicable to the law of
infringement as defined by the Patents Act 1977 and that when a patentee disposed of a
patented product, the owner did not have the right to manufacture a new product under the
guise of repair. In deciding whether a particular act constitutes the manufacture of the patented
product, Aldous LJ indicated (perhaps unsurprisingly) that account should be taken of (a) the
nature of the invention as specified in the claims and (b) what was done by the defendant.
On the facts, the Court of Appeal, overturning the finding of the Judge, held that the Defendants'
acts of reconditioning the Claimant's frames constituted the making of a product the subject of
the patent in suit and further that the Defendants had thereby infringed the patent in suit. The
Judge's finding of validity was upheld.

1999 Cases on Procedural Patent Law

Stay of UK proceedings pending the outcome of an EPO opposition
Up until about a year ago, it was generally accepted that the practice of the English Courts was
not to stay patent proceedings pending the outcome an EPO opposition. This practice, based on
the principle that "justice delayed is justice denied", was explained most recently by Aldous LJ
in Beloit v Valmet9:

"The fact that there may be proceedings both in national courts and before the EPO is inevitable
as patent rights, both under the Convention and under the Act, are national rights to be enforced
by the national courts with revocation and amendment being possible in both the national courts
and in certain circumstances before the EPO. That overlap can mean that there are parallel
proceedings in this country and the EPO with the potential for conflict. It is desirable for that to
be avoided. Therefore, the Patents Court will stay the English proceedings pending a final
resolution of the European proceedings, if they can be resolved quickly and a stay will not inflict
injustice on a party or be against the public interest. Unfortunately, that is not always possible as
resolution in opposition proceedings in the EPO takes from about 4-8 years."

Historically, the practice in most other European jurisdictions has been to accede to a request
for a stay at least unless the opposition can be shown to be weak.

In Smith and Nephew v 3M10 and then Bracco v General Hospital Corporation11, both patent
revocation actions, the defendants (i.e., the patentees) applied for and were granted a stay of
the proceedings pending the outcome of the corresponding EPO oppositions. In both cases, the
stay was granted only because the position of the petitioners (i.e., the prospective defendants to
prospective infringement actions) and the public interest (namely, the efficient disposal of
petitions for revocation) were satisfactorily protected. Thus, for instance, in Bracco, the stay was
granted on the basis of undertakings from the patentee (1) not to seek an injunction against the
petitioner and (2) to limit their claim to damages to a sum based on a reasonable licence fee.
Then, towards the end of last year, Aldous LJ handed the leading judgment in Kimberly-Clark v
Proctor & Gamble12. Although the appeal itself concerned the extent of the Court's discretion to
refuse an amendment, Aldous LJ stated in the course of his judgment that although the grant of
a stay was subject to a judicial determination of where the interests of justice lay, "the option to
stay the proceedings in [the UK] ... must be the preferred option when opposition proceedings
are before the EPO."

These comments of Aldous LJ would appear to indicate a relaxation of the previous practice on
the part of the Court of Appeal and indeed, in Bracco, leave to appeal having been given by the
Judge, the Court of Appeal at the end of January 2000 dismissed the petitioner's appeal against
the grant of the stay2*. Shortly after the Court of Appeal decision in BraccoLaddie J granted a
stay of a patent infringement action at the request of the defendant in Unilever v Frisa3*.
Although some patent practitioners view this development as a retrograde step, it still seems
highly likely given the current length of EPO oppositions that in those cases where the patent
represents a commercially important development and the patentee commences infringement
proceedings in England soon after the patent has been granted that the English Courts would
decide that justice would best be served by refusing to grant a stay. Indeed, shortly still after
Laddie J's decision in Unilever, he refused to grant a stay in another patent infringement
action, 3M v Rennicks. The factual position in 3M was far from from straightforward not least
because in the Opposition, a question of internal EPO procedure had been referred to the
Enlarged Board of Appeal. However, the main reason given by the Judge for the refusal to grant
the stay (at least until the outcome of the decision of the Enlarged Board) was the prospect that
a final decision by the EPO would not be rendered until after the expiry of the patent in suit
which would thereby have deprived 3M of the opportunity to seek an injunction.

The Extent of the Court's Discretion to Refuse an Amendment

Under the 1949 Patents Act, the Patents Court had a general discretion to refuse an
amendment to a UK patent over and above the statutory grounds set out in the 49 Act itself. In
practice, the exercise of that discretion meant that on an application to amend a patent so as to
validate an otherwise invalid claim, the patentee had to show through full disclosure of all
relevant matters that he had not behaved covetously (e.g., that he had not threatened an
infringer with an unamended patent after he knew or should have known of the need to amend
it). The authorities on the position under the 49 Act were reviewed and summarised by Aldous J
as he then was in Smith Kline and French Laboratories v Evans Medical13.

In a series of cases over the last few years, the Patents Court Judges had questioned the extent
to which under the Patents Act 1977 (unlike the 49 Act), at least in relation to a European
Patent, the Court still had a general discretion to refuse an amendment to an EP (UK) patent
over and above the statutory grounds set out in section 75 of the 77 Act namely, that the
proposed amendment must not add matter and nor extend the scope of protection14.
In Kimberly-Clark, the patent in suit was being opposed in the EPO by Proctor & Gamble and a
third party, amendments had been made in the course of that opposition which had been
allowed although their effect had been suspended because of an appeal and because whatever
amendments that were allowed by the EPO would be backdated to the date of grant of the
patent, any refusal to allow the same amendments in the UK proceedings would have been
rendered otiose.

At first instance, Laddie J had held that under the 77 Act the Court's discretion to refuse an
amendment was limited to the statutory grounds set out in section 75 and that the Court did not
have the power to refuse an amendment on the ground of covetous behaviour on the part of the
patentee. He justified his decision, inter alia, on the need for uniformity with the laws of other
European countries on amendment.

Laddie J's decision was overturned by the Court of Appeal. Aldous LJ who gave the leading
judgment in the Court of Appeal held that the position under 77 Act was the same as that under
the 49 Act for the following reasons: (1) the terms of the sections permitting amendment in both
Acts were strikingly similar; (2) section 75 of the 77 Act was concerned with post-grant
amendment whereas EPO oppositions were concerned with what was effectively a pre-grant
procedure; (3) section 75 was not one of the sections of the 77 Act which was to be construed
so as to accord with the corresponding provisions of the EPC and CPC; (4) nothing in the 77 Act
indicated an intention to restrict the Court's discretion so as to prevent covetous behaviour from
being a ground of refusal of an amendment; (5) section 75 applied to both national as well as
European patents and there was every reason to believe that Parliament had intended the
public to be protected from an abuse of monopoly of a national patent after the 77 Act as much
as before it.

In essence, Aldous LJ considered that the jurisdiction to amend under section 75 of the 77 Act
in English proceedings was not equivalent to the jurisdiction of the EPO to amend in opposition
proceedings and it was not therefore imperative that the same considerations were taken into
account in exercising the discretion to amend in each forum. As a purely practical matter,
Aldous LJ indicated strongly, as noted above, that the course of action which should have been
considered by the Judge (but which had not been) was whether to stay the English proceedings
pending the outcome of the EPO opposition.

Following the Court of Appeal decision in Kimberly-Clark, a patentee seeking an amendment of

their patent (whether a European or a domestic UK patent) will continue to be obliged to give full
disclosure and to justify to the Court any delay between becoming aware of the relevant piece of
prior and making the application to amend.

Summary Judgment on Construction and Infringement

In the mid-1980s, there were a series of striking out applications in patent actions all of which
were made on the ground that on the true construction of the patent there was no arguable case
of infringement. This culminated in the Court of Appeal decision in Strix v Otter15 overturning
the judgment of Aldous J (as he then was) striking out the action. Dillon LJ who gave the leading
judgment in the Court of Appeal, whilst recognising that it was in the public interest for
"hopeless" patent cases to be struck out, held that striking out applications were not permissible
where issues of fact required the conduct of a mini-trial on affidavit evidence. He went on to
explain that the difficulties on such applications brought in patent actions arose because the
construction of a patent whilst ultimately a question of law for the Court necessarily involved
evidence on the state of the art, the technical meaning ascribed to any terms of art used in the
claims and whether under the Catnic approach to purposive construction the variants had any
material effect on the way in which the invention worked and whether this would have been
obvious to a skilled man at the application date.. Interestingly, the patent in suit in Strix was
subsequently held to be valid and infringed (albeit by a different Judge to the one who had
heard and acceded to the striking out application at first instance). Since Strix, applications to
 strike out patent infringement actions have perhaps not surprisingly gone out of a fashion in the
UK.

In the US, by contrast, following the Supreme Court decision in Markman v Westview
Instruments Inc16, motions for summary judgment on the issue of construction and non-
infringement known as "Markman hearings" have become a normal part of US patent litigation
practice.

It is against this background then that the Patents Court and then shortly afterwards the Court of
Appeal were asked last summer in Monsanto v Merck17 to strike out certain pleaded allegations
of infringement on the basis that they disclosed no arguable case of infringement. The factual
background to the application is set out below.

The patent in suit concerned a class of pharmaceuticals known as NSAIDs. Claim 1 was
directed to the class itself and claim 20 was a Swiss style (second medical use) claim directed
to the medical use of that class to treat inflammation. Merck intended to launch a NSAID under
the name VIOXX which contained as its active ingredient a product known as MK-966 referred
to as the "keto form". In use, it was alleged by Monsanto that a substantial amount of the "enol"
and "enolate" forms would be produced in the human body. Monsanto also alleged that
substantial amounts of the "enol" and "enolate" forms were produced during the course of
manufacturing the "keto" form, a process which took place outside the UK.

Monsanto had 3 arguments on infringement based on these alleged facts: (1) that the "keto"
form fell within the scope of claim 1 and therefore the sale of VIOXX infringed the patent directly
under section 60(1)(a) of the 1977 Act; (2) the "enol" and "enolate" forms fell within the scope of
claim 1 and therefore (a) the sale of VIOXX infringed the patent indirectly under section 60(2) of
the 1977 Act (being the knowing supply of an essential element with directions); and (b) the
importation of VIOXX infringed the patent under section 60(1)(c) being a product obtained
directly from a process, the process being the Swiss style claim 20.

The question before the Court on the striking out application concerned Monsanto's last
infringement argument namely, whether the Court was in a position to conclude that claim 20 -
"The use of a compound of claim 1 for preparing a medicament for treating inflammation" -
should be construed in such a way as to exclude the use of the "enol" or "enolate" to form the
"keto" form for preparing the medicament.

Monsanto accepted that the "enol" and "enolate" forms were not present in VIOXX the active
ingredient imported into the UK, the active ingredient of which was in the "keto" form. The
application to strike out was heard on the assumptions that (1) the "keto" form did not fall within
the scope of claim 1, (2) the "enol" and "enolate" forms did fall within the scope of claim 1 and
(3) the "enol" and "enolate" forms were not present after administration but were present during
the production of the "keto" form abroad.

Pumfrey J, the Judge at first instance, decided that he was in a position to construe the claim as
contended by Merck having regard to the words of the claim and the specification. He stated in
the course of his Judgment that:

"It seems to me the crucial difference is actually between, on the one hand, the use of a
compound of claim 1 to prepare an active ingredient for use in preparing the medicament and
the use of an active ingredient to prepare the medicament. The latter is, in my judgment, what is
claimed."
The Court of Appeal overturned the Judge's decision and allowed the appeal. Aldous LJ who
gave the leading Judgment disagreed with the Judge's construction of the claim. He also cited
with approval the statements of Dillon LJ from the Court of Appeal decision in Strixregarding the
need for evidence on the issue purposive under Catnic and stated that the Dillon LJ's comments
made at that time of Strix under the Rules of the Supreme Court were equally apt nowadays
under the CPR.

As a post script, the same first instance Judge, Pumfrey J, held at trial that the patent was both
invalid and not infringed. On Monsanto's third infringement argument, the Judge held that on the
facts Monsanto had failed to establish that the "enolate" form was present in significant
quantities during the production of the "keto" form and that in any event the "enolate" salt itself
was not pharmaceutically acceptable (and thereby did not constitute a claim 1 compound..
Following the Court of Appeal decision in Monsanto, it seems that at least for the foreseeable
future, "Markman type" hearings will not become a feature of the UK's patent litigation practice.
US patent litigation practice is of course very different to that of the UK. One of the most striking
illustrations of the differences is the fact that in the US, patent actions are normally heard by a
jury and a technically unqualified Judge whereas in the UK they are heard by a technically
qualified Judge alone. As a result of these (fundamental) differences, procedures developed in
one jurisdiction are not necessarily appropriate in the other. That said, however, it would seem a
retrograde step especially given the objectives of the CPR if the Patent Court Judges did not
have the power to dispose at an early stage in the proceedings of arguments on construction
and infringement which are "hopeless" or at the very least fail what has sometimes been
referred to at least by some Judges as the "Judicial Laugh" test.

1* In UCC v BPCL, The House of Lords 7.1985 RPC 55

accepted the Defendant?s Petition against
the Court of Appeal decision on the ground
that Catnic was no longer good law but the
case was settled shortly afterwards.
2* 27 January 2000, unreported.
3* 3 February 2000, unreported.
1. 1999 RPC 683
2. 27 July 1999, unreported
3. 1982 RPC 183
4. 1995 RPC 287
5. 1995 RPC 585
6. 1994 RPC 49
8. 1997 RPC 728
9. 1997 RPC 489
10. 17 December 1998, unreported
11. 30 July 1999, unreported
12. 24 November 1999, unreported
13. 1989 FSR 561
14. Section 75 of the Patents Act 1977
15. 1991 RSR 354
16. 116 S. Ct. 1384, 38 USPQ2d 1461
(1996)
17. 5 May 1999 (High Court) and 23 July
1999 (Court of Appeal), both unreported.

C-34/10 Oliver Brüstle v Greenpeace eV, judgment of 18 October 2011

The use of human embryos for scientific research purposes is not patentable. A ‘human embryo’
within the meaning of Union law is any human ovum after fertilisation or any human ovum not
fertilised but which, through the effect of the technique used to obtain it, is capable of
commencing the process of development of a human being. Directive 98/44/EC on the legal
protection of biotechnological inventions lays down the principle that the human body, at the
various stages in its formation or development, cannot be patented. This is the case in particular
for the use of human embryos for industrial or commercial purposes, as expressly specified in
Article 6(2)(c) of the Directive. In the context of a dispute between Greenpeace and Mr Brüstle,
holder of a patent concerning neural precursor cells (i.e. immature body cells capable of forming
mature cells in the nervous system, as neurons), concerning the procedures used to produce
them from embryonic stem cells and concerning their use to treat neural defects, the
Bundesgerichthof asked the Court what is to be understood by ‘human embryo’ and by ‘use for
industrial or commercial purposes’, especially where the embryo is used for the purposes of
scientific research. Firstly, the Court starts by emphasising that it results from both the letter of
Article 6(2) of the Directive and its object and aim, that the concept of human embryo
constitutes an autonomous concept of Union law which must be interpreted in a uniform manner
throughout its territory. In fact, the lack of a uniform definition would create a risk of the authors
of certain biotechnological inventions being tempted to seek their patentability in the States
which have the most restrictive definition of the concept of embryo, such patentability being
prohibited in Member States with a wider concept, which would adversely affect the smooth
functioning of the internal market. The Court then points out that it has been asked for a legal
interpretation and that in this context it is not called upon to broach questions of a medical or
ethical nature. These preliminaries having been completed, it points out that the Directive seeks
to promote investment in the field of biotechnology, whilst specifying that the use of biological
material originating from humans must be consistent with regard for fundamental rights and, in
particular, the dignity of the person. It is from this perspective that the patentability of the human
body is prohibited. As a result of this, in its opinion, the concept of human embryo, within the
meaning of Article 6(2)(c) of the Directive, must be interpreted broadly as covering any cell
capable of commencing the process of development of a human being. This includes, on the
one hand, the human ovum as soon as fertilised and, on the other hand the non-fertilised
human ovum into which the nucleus from a mature human cell has been transplanted and a
non-fertilised human ovum whose division and further development have been stimulated by
parthenogenesis.

As regards, more precisely the stem cells obtained from a human embryo at the blastocyst
stage (an undifferentiated embryonic cell), as in the dispute in the main proceedings, it is for the
national court to ascertain, in the light of scientific developments, whether they comply with this
definition. Secondly, the Court, after having observed that the grant of a patent for an invention
implies, in principle, its industrial or commercial application, considers that the use of human
embryos for the purposes of research cannot be separated from the patent itself and the rights
attaching to it. It concludes from this that the exclusion of patentability concerning the human
embryo for industrial and commercial purposes provided for in Article 6(2)(c) of the Directive
also covers use for purposes of scientific research. Only use for therapeutic or diagnostic
purposes which is applied to the human embryo and is useful to it are patentable. Lastly, the
Court specifies that these same provisions exclude the patentability of an invention which does
not concern the use of human embryos as such, but a product whose production necessitates
the prior destruction of human embryos or their use as a base material. According to the Court,
this is the case in point, as it concerns an invention involving the production of neural precursor
cells, which presupposes the use of stem cells obtained from a human embryo at the blastocyst
stage, entailing the destruction of that embryo.

Merrell dow v hm Norton

Ratio: A patent for a substance which had been produced naturally before the application of the
process was invalid. The patent was invalidated after the discovery that the effect was produced
naturally from an acid metabolite. Patent infringement does not require that one should be
aware that one is infringing: ‘whether or not a person is working [an] . . invention is an objective
fact independent of what he knows or thinks about what he is doing . .’ Decisions of the Boards
of Appeal on provisions of the UK Act intended to implement corresponding provisions of the
EPC have ‘great persuasive authority’.

Lux traffic v pike signals

In Lux Traffic Controls Ltd v Pike Signals Ltd and Faronwise Ltd, Aldous J stated that:
There is a difference between circumstances where the public have an article in their
possession to handle, measure and test and where they can only look at it. What is made
available to the public will often differ in the circumstances. In the latter case it could be nothing
material; whereas in the former the public would have had the opportunity of a complete
examination

In other terms, novelty is destroyed by prior use of a product if analysis of the product using
available techniques shows the skilled person that it falls within the scope of the claims of the
subsequent application.

C-443/12 Actavis (12 december 2013);

The ECJ has answered the second of the questions referred by the High Court in a case where
there was a challenge to the validity of the grant of a second Supplementary Protection
Certificate. (Actavis Group PTC EHF and another v Sanofi and another C-443/12, 12 December
2013.)

Background
Article 3 of the Supplementary Protection Certificate (SPC) Regulation (1768/92/EC, now
replaced by 469/2009/EC) provides that a certificate shall be granted if, in the member state in
which the application for the certificate is submitted and at the date of that application:
 The product is protected by a basic patent in force (Article 3(a)).
 A valid authorisation to place the product on the market as a medicinal product has been
granted in accordance with Directive 2001/83/EEC or Directive 2001/82/EEC, as appropriate
(Article 3(b)).
 The product has not already been the subject of a certificate (Article 3(c)).
 The authorisation referred to in the second bullet point above is the first authorisation to
place the product on the market as a medicinal product (Article 3(d)).

Facts
Sanofi was the proprietor of European Patent (UK) No 0 454 511 (Patent), which covered an
antihypertensive drug known as irbesartan. The claims of the patent included a number of
claims to irbesartan combined with a generic type of other active ingredient; claim 20 was to
irbesartan combined with a diuretic. The Patent expired in March 2011. Sanofi obtained an SPC
for "[irbesartan] optionally in the form of one of its salts" (Irbesartan SPC) based on the Patent
and European marketing authorisations for irbesartan (marketed under the trade mark Aprovel).
The Irbesartan SPC expired on 14 August 2012.

Sanofi also obtained an SPC for "[irbesartan] optionally in the form of one of its salts and
hydrochlorothiazide" (Combination SPC) based on the Patent and European marketing
authorisations for a fixed-dose combination of irbesartan and the diuretic hydrochlorothiazide
(HCT) (marketed under the trade mark CoAprovel). The Combination SPC will expire on 14
October 2013. As the Patent and the Irbesartan SPC had both expired, Actavis intended to
market generic versions of both Aprovel and CoAprovel. It was common ground that the latter
would infringe the Combination SPC if the Combination SPC was valid. Actavis brought this
action to revoke the Combination SPC, contending that it was invalid.

Arnold J decided that it was necessary to refer questions relating to the interpretation of Articles
3(a), 3(c) and 3(d) of the SPC Regulation to the ECJ (see Legal update, High Court refers
questions on SPC regulation to ECJ). The following questions were referred:
"(1) What are the criteria for deciding whether "the product is protected by a basic patent in
force" in Article 3(a) of … Regulation No 469/2009?
(2) In a situation in which multiple products are protected by a basic patent in force, does
Regulation [No 469/2009], and in particular Article 3(c), preclude the proprietor of the patent
being issued a certificate for each of the products protected?"

Decision
The ECJ answered the referred questions as follows:
"In circumstances such as those in the main proceedings, where, on the basis of a patent
protecting an innovative active ingredient and a marketing authorisation for a medicinal product
containing that ingredient as the single active ingredient, the holder of that patent has already
obtained a supplementary protection certificate for that active ingredient entitling him to oppose
the use of that active ingredient, either alone or in combination with other active ingredients,
Article 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6
May 2009 concerning the supplementary protection certificate for medicinal products must be
interpreted as precluding that patent holder from obtaining – on the basis of that same patent
but a subsequent marketing authorisation for a different medicinal product containing that active
ingredient in conjunction with another active ingredient which is not protected as such by the
patent – a second supplementary protection certificate relating to that combination of active
ingredients."

This answer was based on the following reasoning.

Question 2
It was appropriate to consider the second question first.
The court had held that, where a 'product' within the meaning of Article 1 of the SPC Regulation
was protected by a number of basic patents in force, which might belong to different patent
holders and might be either patents for that product, patents for processes by which the product
was obtained or patents relating to an application of the product, under Article 3(c), each of
those patents may confer entitlement to an SPC but that only one certificate may be granted for
each basic patent. However, this case involved a situation in which the same patent protected a
number of products within the meaning of Article 3(a) of the SPC Regulation, thus raising a
different question, namely whether such a patent may permit its holder to obtain more than one
SPC.

It was possible, on the basis of a patent which protected several different 'products', to obtain
several SPCs in relation to each of those different products, provided, inter alia, that each of
those products is 'protected' as such by that 'basic patent' within the meaning of Article 3(a) in
conjunction with Article 1(b) and (c) of the SPC Regulation.

However, even if the condition laid down in Article 3(a) were satisfied, applying Article 3(c)
meant that the holder of a basic patent in force might not obtain a new SPC, potentially for a
longer period of protection, each time he placed on the market in a member state a medicinal
product containing both the principle active ingredient, protected as such by the holder's basic
patent and constituting the core inventive advance of that patent, and another active ingredient
which was not protected as such by that patent.

Under Article 5 of the SPC Regulation, an SPC granted in connection with a product conferred
upon the expiry of the basic patent, the same rights as were conferred by that patent in relation
to the product, within the limits of the protection conferred by the basic patent, as provided for in
Article 4 of the SPC Regulation. Therefore in this case, since it was common ground that during
the period in which the first SPC was valid, Sanofi was entitled to oppose, on the basis of its
basic patent, the use or certain uses of irbesartan in the form of a medicinal product consisting
of such a product or containing it, the SPC (now expired) granted for that product also conferred
on Sanofi the same rights for all uses of the product, as a medicinal product, which were
authorised before the expiry of that certificate.

Article 13 of the SPC Regulation dictates that, upon expiry of the initial SPC, the holder may no
longer use the basic patent on which the grant of the SPC was based to oppose the marketing
by third parties of the active ingredient which was the subject of the SPC. This means that, after
that date, third parties must be able to market not only medicinal products consisting of the
formerly protected active ingredient but also any medicinal product containing that active
ingredient in combination with another active ingredient that is not protected as such by the
basic patent or any other patent.

Moreover, given the second SPC granted in this case, it was possible, under the law of indirect
infringement, that an SPC relating to the irbesartan-hydrocholorothiazide combination might
permit the holder to oppose the marketing of a medicinal product containing the active
ingredient irbesartan, as a single active ingredient or in combination with another active
ingredient. In such a situation, the second SPC could in practice confer, albeit partially and
indirectly, further protection for irbesartan, extending de facto the protection it enjoyed as a
result of the grant of the first SPC relating to that active ingredient. This confirms that an SPC
such as the second SPC at issue in the main proceedings could not be issued. Given the
objective of the SPC Regulation, namely, to compensate the patent holder for the delay to the
commercial exploitation of his invention by providing him with an additional period of exclusivity,
the grant of the first SPC had already afforded the holder such compensation. The objective of
that Regulation was not to compensate the holder fully for the delay to the marketing of his
invention or to compensate for such delay in connection with the marketing of that invention in
all its possible forms, including in the form of combinations based on that active ingredient.

Question 1
In view of the answer to Question 2, there was no need to answer Question 1.

Comment
Once again, the ECJ has ducked giving general guidance on the interpretation of Article 3(a) of
the SPC Regulation. In the referring decision, Arnold J stated that he had to make the reference
"because the court did not answer the central question in the previous five references, and the
rulings it did make did not provide a clear test that could be applied to cases such as this". The
ECJ ruling is in accordance with the test suggested by Arnold J ("in the hope that it would assist
the ECJ to provide a clear answer this time") for determining what is a product "protected by"
the basic patent, but it does not state in specific terms that this the correct test. Expect more
SPC litigation.

Grimme Landmaschinenfabrik Gmbh & Co. KG v Derek Scott [2010] EWCA Civ 1110
In Grimme Maschinenfabrik GmbH & Co KG v Derek Scott (t/a Scotts Potato Machinery) [2010]
EWCA Civ 1110, Grimme’s patent related to a machine for sorting potatoes from the by-
products of the harvesting process, such as earth, stones and stalks. The significant part of
Claim 1, for the purpose of this dispute, was to a machine with a number of rollers arranged in
pairs on parallel that which rotated in opposite directions “characterised in that the roller bodies
comprise an elastically deformable shell part”.

Mr Scott sold a competing potato-separator called the “Evolution” which had steel rollers. He
separately sold rubber “spiral” rollers, which could be substituted for the metal rollers on the
Evolution machine.
Jacob LJ rejected Mr Scott’s submission that the supply of a complete machine with steel rollers
could not be the supply of a “means, relating to an essential element of the invention, for putting
the invention into effect”, because it was an entire unit capable of being used as supplied. The
fact that a steel-rollered machine, so long as it remained steel-rollered, did not infringe and was
capable of lawful use as a complete machine in that state was, in Jacob LJ’s view, irrelevant.
The requirements as to suitability and knowledge of intended use limited the scope of the
statutory tort in relation to such products and it was not a question of whether the product itself
was capable of lawful use without alteration, addition or adaptation. Furthermore, Jacob LJ held
that there was no reason why a device to which a part could be readily added to make it fall
within a claim should be a “means essential”, but a device from which a part could readily be
removed or replaced to make it fall within the claim should not be such a means.

As to what was needed to satisfy the requirements of knowledge and intention for contributory
infringement under Section 60(2), following KCI Licensing v Smith & Nephew [2010] FSR 740,
Jacob LJ held that it was clearly the intention of the person supplied and not of the supplier
himself that was key.

Accordingly, the Lords Justices upheld Floyd J’s decision that the machine and its rollers were
designed in order to enable the steel rollers to be replaced with rubber rollers and that, on the
evidence, Mr Scott knew (and it was obvious to a reasonable person in the circumstances) that
the machines were both suitable for running with at least two pairs of rubber rollers.

Schütz v Werit [2013] UKSC 16

Schütz (UK) Limited v Werit (UK) Limted, UK Supreme Court, 13 March 2013, [2013] UKSC
16

The UK Supreme Court today gave its judgment on the meaning of "makes" in section 60(1)(a)
of the Patents Act 1977 in relation to when replacing a consumable part may infringe. In doing
so, the Supreme Court reversed the decision of the Court of Appeal, reported here.
Lord Neuberger, in a unanimous decision of the Court, concluded:

78. Deciding whether a particular activity involves “making” the patented article involves, as
Lord Bingham said, an exercise in judgment, or, in Lord Hoffmann’s words, it is a matter of fact
and degree. In some such cases, one can say that the answer is clear; in other cases, one can
identify a single clinching factor. However, in this case, it appears to me that it is a classic
example of identifying the various factors which apply on the particular facts, and, after weighing
them all up, concluding, as a matter of judgment, whether the alleged infringer does or does not
“make” the patented article.

"In the present case, given that (a) the bottle (i) is a freestanding, replaceable component of the
patented article, (ii) has no connection with the claimed inventive concept, (iii) has a much
shorter life expectancy than the other, inventive, component, (iv) cannot be described as the
main component of the article, and (b) apart from replacing it, Delta does no additional work to
the article beyond routine repairs, I am of the view that, in carrying out this work, Delta does not
“make” the patented article."
The judgment also deals with a costs/damages provision of the UK Patent Act, section 68, but
as Werit's appeal was successful does not determine those issues.

G 1/07 Treatment by surgery (2011) oj epo 134

G 1/07 (OJ 2011, 134) marked an important turning point in the boards' case law on the
exclusion of surgical methods from patentability. Whilst the Enlarged Board endorsed the
existing basic approach to multi-step methods (see in this chapter I.B.4.3.1), it rejected the
practice followed by the EPO thus far of broadly construing interventions of a surgical nature. It
did not redefine the term "treatment by surgery", but indicated the direction in which it expected
future practice and case law to develop. According to G 1/07, the required new direction is that
the exclusion from patentability should not be applied to methods in respect of which the
interests of public health, of protection of patients and as a counterpart to that of the freedom of
the medical profession to apply the treatment of choice to their patients does not call for their
exclusion from patentability (see in this chapter I.B.4.3.3).

In G 1/07 the Enlarged Board upheld the principle confirmed in opinion G 1/04(OJ 2006, 334)
and underlying the whole body of practice and jurisprudence hitherto (see
e.g. T 820/92 (OJ 1995, 113)), that a method claim falls under the prohibition on patenting
methods for treatment by therapy or surgery now under Art. 53(c) EPCif it comprises or
encompasses at least one feature defining a physical activity or action that constitutes a
method step for treatment of a human or animal body by surgery or therapy. The principle is not
only formally justified by the fact that the exclusion under Art. 53(c) EPC does not contain any
limitation as to the defined methods being excluded only when claimed as such. More
importantly, it is also justified as to substance, i.e. it enables the legislative purpose served by
the exclusion to be achieved (see in this chapter I.B.4.1).

Treatment by surgery not limited to surgery for a therapeutic purpose

In G 1/07 (OJ 2011, 134) the Enlarged Board of Appeal concluded that neither the legal history
nor the object and purpose of the exclusions from patentability in Art. 53(c) EPC would justify a
limitation of the term "treatment by surgery" to curative surgery (overruling T 383/03). Such a
limitation would be contrary to the ordinary understanding of the word "surgery" as referring to
the nature of the treatment rather than its purpose, and contrary to the fact
that Art. 53(c) EPCdefines three separate alternative exclusions thereby suggesting that these
are not merely identical in scope. The Enlarged Board of Appeal observed in G 1/07 that the
comparison between T 383/03 and T 1172/03 showed how inconsistent the decisions to be
made could become if the term "treatment by surgery" was seen as limited to therapeutic
surgery only.

Towards a new concept of "treatment by surgery"

The Enlarged Board disapproved of the broad construction of interventions of a surgical nature
corresponding to the practice of the EPO, such as in decisions T 182/90 and T 35/99, namely
that all methods involving irreversible damage to or destruction of living cells or tissues of the
living body were regarded as non-insignificant interventions and thus as surgical treatments,
irrespective of the underlying mechanism of the intervention (e.g. mechanical, electrical,
thermal, chemical). This view was overly broad when considering today's technical reality. Thus
the definition given obiter dicta in G 1/04 that ""any physical intervention" on the human or
animal body…" is a method of surgery within the meaning of Art. 52(4) EPC 1973 appeared too
broad.

A narrower understanding of "treatment by surgery" was required. Any definition of the term
"treatment by surgery" must cover the kind of interventions which represent the core of the
medical profession's activities, i.e. the kind of interventions for which their members are
specifically trained and for which they assume particular responsibility. Such a narrower
understanding rules out uncritical methods involving only a minor invention and no substantial
health risks.
The Enlarged Board found itself unable to give a definition which would delimit the exact
boundaries of a new concept of treatment by surgery. The field of methods which potentially
involves surgical steps is vast, so that each category of class will have to be assessed on its
own merits.

However, the Enlarged Board indicated the direction it expected future practice and case law to
take, finding that the exclusion from patentability should not be applied to methods in respect of
which the interests of public health, of protection of patients and as a counterpart to that of the
freedom of the medical profession to apply the treatment of choice to their patients does not call
for their exclusion from patentability. It is for the departments of first instance and the boards to
define the boundaries of a more narrowly construed concept of "treatment by surgery", based
on the technical reality of the individual case under consideration.

The required medical expertise and the health risk involved may not be the only criteria which
may be used to determine that a claimed method actually is a "treatment by surgery" within the
meaning of Art. 53(c) EPC. It appears that what is to be understood by "surgery" in the medical
sense is to a large extent a matter of convention. Thus, in order to be surgical, it is not
necessary that the intervention be invasive or that tissues be penetrated (T 5/04). The scope of
what is surgery may change with time and with new technical developments emerging, as was
already acknowledged in decision T 182/90.

With regard to the facts of the case the Enlarged Board decided in G 1/07 that a claimed
imaging method, in which, when carried out, maintaining the life and health of the subject is
important and which comprises or encompasses an invasive step representing a substantial
physical intervention on the body which requires professional medical expertise to be carried out
and which entails a substantial health risk even when carried out with the required professional
care and expertise, is excluded from patentability as a method for treatment of the human or
animal body by surgery pursuant to Art. 53(c) EPC.

"Treatment by surgery" in the case law since G 1/07

a) Surgical nature of a method step
In T 992/03 of 4 November 2010, 129Xe gas was used as part of the claimed method. The board
observed that it was known that 129Xe could also be used as an anaesthetic, but found that this
was irrelevant in assessing whether the claimed methods should be excluded from patentability
under Art. 53(c) EPC. The Enlarged Board had clarified in G 1/07 that "there is an exclusion
from patentability as a surgical method only if the health risk is associated with the mode of
administration and not solely with the agent as such" and any anaesthetic effect of the 129Xe gas
thus did not fall under the exclusion.

The question to be decided in T 663/02 was whether the step of "injecting the magnetic
resonance contrast agent into a vein remote from the artery" had a surgical character.
Citing G 1/07, the board concluded that the fact that an intravenous injection of a magnetic
resonance contrast agent could be delegated by a physician to a qualified paramedical
professional indicated that such an injection may be considered as representing a minor routine
intervention which did not imply a substantial health risk when carried out with the required care
and skill. Such acts would be ruled out from the scope of the application of the exclusion clause
pursuant to Art. 53(c) EPC following the narrow understanding advocated by the Enlarged
Board of Appeal (G 1/04 and G 1/07). A possible way of assessing health risks is to use a risk
matrix permitting the levels of likelihood and health impact of a complication of a medical act
with regard to a large number of patients to be combined, so as to obtain statistical health risk
scores which may be used to decide what action should be taken.
In T 1075/06 the board held that venipuncture of blood donors and the extraction of blood from
a donor's body represent substantial physical interventions on the body which require
professional medical expertise to be carried out and which entail a substantial health risk even
when carried out with the required professional care and expertise. A method claim comprising
steps encompassing such procedures is a method for treatment of the human body by surgery.
Similarly, in T 1695/07 the board held that a blood manipulation process involving the
continuous removal of blood from a patient, its subsequent flowing through a circulating line of
an extracorporeal circuit and its re-delivery to the patient was a method of treatment of the
human body by surgery.

b) Surgical step part of claimed method?

In a series of decisions, the boards have considered whether particular surgical steps form part
of the claimed method or are simply preparatory measures which cannot be deemed such a
part. They have arrived at different conclusions.
In T 992/03 of 4 November 2010, methods were claimed for MR imaging the pulmonary and/or
cardiac vasculature of a subject, using dissolved-phase polarised 129Xe gas. The board stated
that whilst a skilled person would know that a MR imaging method was a rather complex
procedure requiring inter alia preparatory steps like positioning of a subject in the MR system,
delivering polarised 129Xe gas to the subject and initialising the MR system, these preparatory
steps did not form part of the contribution of the invention to the art. The method claims thus did
not comprise "an invasive step representing a substantial physical intervention on the body
which requires professional medical expertise to be carried out and which entails a substantial
health risk even when carried out with the required professional care" (G 1/07).

c) Apparatus claim – disguised method claim?

In T 1798/08, although all claims were directed to a visual prosthesis, i.e. an apparatus, they
were objected to by the opponent under Art. 53(c) EPC as relating to a surgical method. The
features "suitable to be located on the body of the user outside a wall of the sclera and attached
to the sclera" and "suitable to be located implanted in the eye behind the iris", the opponent
argued, related to a method for treatment of the human or animal body by surgery and thus
transformed the claim into a "disguised" method claim, even though it was notionally directed to
a device.

The board dismissed this objection. It observed that Art. 53(c), second
sentence, EPC specified that the provision did not apply to products. The claim category
"products" included apparatus. Accordingly, the provisions of Art. 53(c) EPC did not normally
apply to apparatus claims. The fact that some features of the claimed apparatus were
functionally defined in relation to the body of the patient did not, in itself, transform the
apparatus claim into a method claim (T 712/93, T 1695/07; see also T 1407/08).

Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents), House of
Lords, UK, 25 February 2009, Case No. [2009] UKHL 12, with thanks to Marc Döring and
Kevin Mooney, Simmons & Simmons

The Court of Appeal decision in Generics (UK) Limited v Lundbeck A/S followed Mr Justice
Kitchin's High Court judgment in May 2007. The case was subsequently appealed to the House
of Lords who gave their decision on 25 February 2009. The key issue for the Court of Appeal was
the extent of the monopoly given by a product claim in a patent. Kitchin J had extended the
application of the Biogen test for patentinsufficiency such that the scope of the monopoly for a
product claim could be severely reduced. Lundbeck's successful appeal, therefore, has significant
commercial implications for the pharmaceutical industry as a whole.

When is a product claim in a patent insufficient? By Kevin Mooney The Court of Appeal decision
in Generics (UK) Limited v Lundbeck A/S followed Mr Justice Kitchin's High Court judgment in
May 2007. The case was subsequently appealed to the House of Lords who gave their decision
on 25 February 2009. The key issue for the Court of Appeal was the extent of the monopoly
given by a product claim in a patent. Kitchin J had extended the application of the Biogen test
for patent insufficiency such that the scope of the monopoly for a product claim could be
severely reduced. Lundbeck's successful appeal, therefore, has significant commercial
implications for the pharmaceutical industry as a whole. The facts Lundbeck's patent for an
antidepressant drug, sold in the UK as citalopram, expired several years ago. Citalopram was
marketed as a racemic mixture and Lundbeck found a way to isolate the (+) enantiomer,
discovered that this was the effective enantiomer and applied for the patent which is the subject
of the current litigation. The claims in issue were for the (+) enantiomer itself and for a
pharmaceutical composition containing it. The High Court found these claims were invalid for
insufficiency. Kitchin J reasoned that since the existence of the (+) enantiomer was known as
part of the citalopram mixture and isolation of the separate enantiomers was known to be
desirable, Lundbeck's invention lay solely in the discovery of a way to make it. He concluded
that this should not entitle Lundbeck to a monopoly of every way of making it ie a product per se
claim. He applied the test set out by Lord Hoffmann in the House of Lords case, Biogen v
Medeva, that for sufficiency a disclosure should enable the full extent of the claim and not
merely a single example of something within the claim. In an interesting development, Lord
Hoffmann sat in on Lundbeck's appeal in order to consider the application of the Biogen test to
a product claim. The Court of Appeal Decision The court unanimously upheld Lundbeck's
appeal and found that the product claims were not invalid for insufficiency. A product claim is
sufficiently enabled if the specification discloses one way of making it. In the words of Lord
Hoffmann: "in an ordinary product claim, the product is the invention. It is sufficiently enabled if
the specification and common general knowledge enables the skilled person to make it. One
method is enough."

Lord Hoffmann confirmed that the Biogen test applied to a hybrid or "product by process" claim
such as that considered by the House of Lords in the Biogen case itself. The test could not be
extended to an ordinary product claim in which the product is not defined by a class of
processes of manufacture or is not simply a member of a large class. An inventor who finds a
way to make a new product is entitled to claim the product however made and however used,
even if the desirability of making it was known. The Court of Appeal also upheld Kitchin J in
holding that the product claims were novel and inventive. Comment This clear statement of the
law is good news for patentees and restores certainty over the extent of the monopoly provided
by a product claim. The Biogen test for insufficiency still exists but it only applies in the particular
circumstances such as those that arose in the Biogen case itself. The decision also confirms
that a claim to a single enantiomer is possible if all the normal criteria for patentability are
satisfied.

Kirin amgen
House of Lords Clarifies English Law on Patent Infringement In the most significant patent
decision in a number of decades the House of Lords in Kirin-Amgen has to some extent
rewritten the law on patent infringement. The House firmly aligned the English approach with
harmonisation of patent law throughout Europe, drawing a distinction between the European
and American approaches to analysis. While the test for infringement has been clarified, it
marks quite a change in emphasis and of necessity the issues to be considered in the test
involve difficult judgment calls. It will take some time to see how it is likely to be applied by the
courts in practice. Facts Kirin-Amgen Inc (Amgen) was the proprietor of a European patent
relating to the production of erythropoietin (EPO), a protein made in the kidney that increases
the body’s production of red blood cells. The discovery by Amgen of a method of making EPO
artificially for use as a drug was a significant advance in the treatment of anaemia, particularly
when associated with kidney failure. Amgen marketed it under the name Epogen and the patent
(which has subsequently expired) has been very profitable. The patent described a method of
making EPO by recombinant DNA technology and involved the introduction of an exogenous
DNA sequence (ie one originating from outside the cell) coding for EPO into a host cell. The
DNA sequence is the genetic code for the EPO protein which directs the cell to produce EPO.
The host cell containing the EPO DNA then “expressed” that gene, producing the EPO protein.
A dispute arose between Amgen and Transkaryotic Therapies Inc (TKT) and Hoechst Marion
Roussel (HMR). TKT, a US corporation, developed a method of making EPO by activating the
endogenous DNA sequence coding for EPO which existed in a human cell but which would not
ordinarily express it. TKT achieved expression by introducing the necessary control sequence
upstream of the EPO gene. TKT’s technique, known as homologous recombination, was not
known at the date of the patent in suit. HMR, a UK company, was proposing to import the EPO
produced by TKT into the UK. In summary, the Amgen EPO was made by adding the DNA
sequence to a host cell by genetic engineering (ie using DNA exogenous to the cell) and the
TKT EPO was made by a gene activation method in which the DNA was already present in the
cell (endogenous to it) and was simply switched on (though the DNA relating to the switch was
exogenous to the cell). The relevant claims of Amgen’s patent were for: (i) a DNA sequence for
use in securing the expression of EPO in a host cell (claim 1); (ii) EPO which was the product of
the expression of an exogenous DNA sequence (claim 19); and (iii) EPO which was the product
of the expression in a host cell of a DNA sequence according to claim 1 (claim 26). Because
TKT did not make any EPO in the UK, the alleged infringement was by importation: only claims
19 and 26 were therefore allegedly infringed. The trial judge, Neuberger J, found that claim 19
was invalid for insufficiency but that claim 26 was valid and infringed. The Court of Appeal held
that both these claims were valid, but that neither was infringed. Amgen appealed against the
decision that there was no infringement, while TKT and HMR appealed against the finding of
validity

Traditional approach of the English courts Until the Patents Act 1977, which gave effect to the
European Patent Convention (EPC), English statute law did not stipulate the extent of protection
conferred by a patent. The traditional English law rules of construction required the words and
grammar of a sentence to be given their “natural and ordinary meaning”, which was to be
adopted regardless of the context or background against which those words were used unless
they were ambiguous and capable of bearing more than one meaning. British courts gradually
moved away from these narrow rules of construction and, in Catnic Components Ltd v Hill &
Smith [1982] RPC 183 (a case decided under the pre-1977 law), Lord Diplock recognised that
the language used in a patent is sensitive to its context and held that a patent specification
should be given a purposive construction and not a purely literal one. As to inventions which
have an equivalent effect to the patent, the doctrine of infringement by use of the “pith and
marrow” of the invention was traditionally applied to prevent circumvention of the claims of the
patent by an immaterial variant. It was unclear whether the courts regarded this as a principle of
construction or as an extension of protection outside the claims, similar to the “doctrine of
equivalents” approach taken in the United States. In Catnic, Lord Diplock offered a new solution
and held that the relevant question is whether a person skilled in the area of work in which the
invention was intended to be used would understand that strict compliance with a descriptive
word or phrase appearing in the claim was intended by the patentee to be an essential
requirement of the invention. If so, any variant would fall outside the monopoly claimed, even
though it could have no material effect on the way the invention worked. The impact of
European Law The EPC deals expressly with the extent of protection granted by a patent. The
most important provision of the EPC for these purposes is Article 69, which applies to
infringement proceedings in the domestic courts of all Contracting States: “The extent of
protection conferred by a European patent or a European patent application shall be determined
by the terms of the claims. Nevertheless, the descriptions and drawings shall be used to
interpret the terms of the claims.” [emphasis added] Guidance as to the application of Article 69
is provided by the Protocol on the Interpretation of Article 69, which states that an approach
should be taken which lies between the purely literal construction of the patent claims and the
use of the claim only as a guideline. Both Article 69 and the Protocol are given effect in English
law. This requires a balance to be struck between a construction which gives: > fair protection to
the patentee and > a reasonable degree of certainty to third parties, who might wish to avoid
infringement. There has long been debate about whether the purposive approach set out in the
Catnic case is wholly in accordance with the approach set out in the Protocol. As a result there
has been some inconsistency in the UK courts’ approach to patent infringement. While the
courts have sometimes applied the test laid down in Article 69 interpreted in accordance with its
Protocol, the court has more often applied the principle of interpretation of patents outlined by
Hoffmann J (as he then was) in a three part test in Improver v Remington [1990] FSR 181, more
recently referred to as “the Protocol questions”. This test consists of a concise summary of Lord
Diplock’s guidance in the Catnic case and requires the court to ask itself the following three
questions: (1) does the variant (i.e. the feature of the alleged infringement that differs from the
feature claimed) have a material effect on the way the invention works? (2) would the fact that
the variant had no material effect have been obvious at the date of publication of the patent to a
reader skilled in the art? (3) would the reader skilled in the art nevertheless have understood
from the language of the patent that the patentee intended that strict compliance with the
primary meaning was an essential requirement of the invention? The correct test for patent
infringement The House of Lords held in Amgen that the correct approach to take is the test
based on Article 69 and its Protocol, the “bedrock” of patent construction and that the Protocol
Questions would only apply in special cases: “The determination of the extent of protection
conferred by a European patent is an examination in which there is only one compulsory
question, namely that set by article 69 and its Protocol: what would a person skilled in the art
have understood the patentee to have used

the language of the claim to mean? Everything else, including the [Protocol] questions, is only
guidance to a judge trying to answer that question. But there is no point in going through the
motions of answering the [Protocol] questions when you cannot sensibly do so until you have
construed the claim." [emphasis added] Explaining how this test should be applied, Lord
Hoffmann (who gave the principal opinion with which the rest of the House agreed) confirmed
that Lord Diplock’s purposive construction test in Catnic was consistent with the Protocol. The
Amgen question According to Amgen the key question is: what would the person skilled in the
art, reading the claims in context, have understood the patentee to mean by the language of the
claims? The test is an objective one: in other words what the patentee is understood to have
meant, rather than what the patentee actually meant or intended. The starting point is to identify
what the invention actually is. The patent is then to be construed as it would be understood by a
person skilled in the art. According to Amgen, the person skilled in the art will have: > the
common general knowledge of someone practising in the relevant field; and > a basic level of
knowledge of patentability – ie sufficient to appreciate that the patentee is trying to describe
something new and will be wanting to avoid a risk of invalidity (eg where a claim that is unclear)
or is trying to distinguish the invention over the prior art. The patent is not necessarily to be
given the widest possible construction in the light of the prior art, as it may be that the patentee
had particular reasons for including a limitation which are not known (for example to deal with
an issue raised in a patent office during prosecution). In contrast with the US, the prosecution or
file history relating to the progress of the patent through the patent office is not relevant to the
construction of the patent as granted. The language used will usually be of critical importance.
The House of Lords has brought construction of patents in line with that of other documents,
holding that patents must be construed in the light of their context and background (in line with
the West Bromwich case ([1998] 1WLR896)) and that “[the meaning of words] depends not only
upon the words the author has chosen but also upon the identity of the audience he is taken to
have been addressing and the knowledge and assumptions which one attributes to that
audience". This contrasts with the earlier approach of only looking beyond the words when there
was an ambiguity to resolve. Lord Hoffmann however recognised that there will be occasions
when it will be obvious to the skilled man that the patentee must in some respects have
departed from conventional use of language, or used words or phrases in his description that he
had not intended to be essential, but such occasions were not expected to occur very
frequently. No European doctrine of “equivalents” Lord Hoffmann gave a detailed account of the
law in relation to equivalents, which deals with cases where an infringer may use immaterial
variants to avoid the scope of the patent claims. The House firmly distinguished the European
approach from the US doctrine. This is an issue of some relevance in this case (as it often is) as
patent litigation has also been pending for some time between the parties in the US. The US
approach first gives the patent claims a literal interpretation and then determines the extent of
protection surrounding the claims. This is given effect by the doctrine of equivalents which in
effect extends protection to infringements which might be said to be “stealing the benefit” of the
invention by performing substantially the same function in substantially the same way to obtain
the same result. The effect of this is contained by file wrapper estoppel which essentially
prevents a patentee from claiming some protection that was given up during prosecution of the
patent. The House of Lords in Amgen confirmed that in England the claims have a central role
(and noted that that was now acknowledged in other European member states such as
Germany and the Netherlands where the claims had previously been regarded as a point of
departure). In England the claims are to be given a purposive construction, as they would be
understood by a person skilled in the art, but this does not equate to extension of protection
outside the claims. The Protocol or Improver Questions Significantly, the House drew a strong
distinction between the Protocol - which is universally applicable - and the Protocol questions
which, being merely “guidelines”, are more useful in some cases than in others. Lord Hoffmann
maintained that the Protocol questions can only usefully be answered once the claims of the
patent have been construed as required by

Article 69 and its Protocol. The Protocol questions which have been regularly regarded as the
key test for infringement are now considered to be relevant only in some cases, in particular in
relation to patents involving the use of figures, measurements and angles, or where there is an
argument that words may have an alternative looser meaning. They are unlikely to apply to
areas of new technology. Applying the law to the facts Applying these principles of patent
interpretation to the facts of the case, Lord Hoffmann considered that the relevant question was
whether the person skilled in the art would understand “host cell” to mean a cell which is host to
an exogenous DNA sequence which coded for EPO inserted into a cell. The alternative,
proffered by Amgen, was that it could include a sequence which is endogenous to the cell, like
the human EPO gene which expresses EPO through a method of gene activation, as long as
the cell is host to some exogenous DNA. The House held that the invention of the patent was a
particular method of producing EPO (by expression of exogenous DNA in a host cell) and not
simply the DNA sequence coding for DNA. On that basis, the person skilled in the art would not
understand the claim to cover an alternative method of producing EPO that was not known at
the time. In such circumstances, the Protocol questions were inappropriate and either caused
confusion or simply provided a formal justification for the conclusion which has already been
reached. Agreeing with the Court of Appeal decision, Lord Hoffmann held that the claims of
Amgen’s patent were insufficiently general to include TT’s new technology for making EPO. The
invalidity issue (1) “Product-by-process” claims While claim 1 of Amgen’s patent related to the
process for producing EPO, claim 26 related to EPO produced by way of the patented process.
Lord Hoffmann explained that the English practice of allowing a patent claim for a product
forming part of the state of the art, on the ground that it has been made by a new process, was
no longer necessary given that the EPC allows a patentee to rely directly on his process claim
to allege infringement of a product made by that process. The European Patent Office (“EPO”)
will only accept a claim to a product defined in terms of its process of manufacture when the
product is new in the sense of being different from any existing product in the state of the art but
where the difference cannot be described in physical or chemical terms. The House found that
claim 26 was anticipated and therefore invalid. (2) The EPO and the English courts Comments
made by the House also suggest it is encouraging the English courts to make findings
consistent with those of the EPO more often that has perhaps been the case. The House
indicated that it would be “unfortunate” if the English courts were to uphold the validity of a
patent which on identical facts would have been revoked in EPO opposition proceedings. It will
be interesting to see whether this marks a change in practice, with English courts striving to give
decisions on validity which are consistent with the approach of the EPO. In the past, the courts
have generally taken a notably independent line and on issues such as obviousness there has
been considerable scope for different results. However, in recent years, pressure to harmonise
further has grown, most notably in the area of software-related patents. (3) Sufficiency TKT and
HMR also appealed against the Court of Appeal’s rejection of their assertion that the
specification was insufficient to support claim 19. The Patents Act 1977 provides that a patent
may be revoked if the specification does not disclose the invention “clearly enough and
completely enough for it to be performed by a person skilled in the art”. Lord Hoffmann stated
that in order to decide whether the invention has been enabled, it is necessary to identify the
invention and decide what it claims to enable the skilled man to do. Claim 19 was held to be
insufficient, primarily because the test for distinguishing EPO falling within the claim was based
on molecular weight and was not capable of practical application. (Kirin Amgen Inc, Ortho
Biotech Inc and Ortho Biotech Products LP v Hoechst Marion Roussel Ltd, Hoechst Marion
Roussel Inc and Transkaryotic Therapies Inc [2004] UKHL 46, House of Lords (Lord Hoffmann,
Lord Hope of Craigenhead, Lord Rodger of Earlsferry, Lord Walker of Gestingthorpe, Lord
Brown of Eatonunder-Heywood), 21 October 2004)

g 3/07 computer programs 2011 oh epo 10

(see pdf)

Human Genome Sciences v Eli Lilly [2011] UKSC 51

In order to be patented, an invention must be “susceptible of industrial application”; this is provided
by Art 52(1) of the European Patent Convention (EPC) in relation to a European patent. It requires
merely that it can be made or used, in any kind of industry: Art 57 EPC. This provision has rarely
given rise to many issues of patentability; the standard example of an invention that would fall foul
of this provision is a perpetual motion machine. It all sounds pretty clear-cut.

This case was a rare one that turned on Art 52(1); specifically, it dealt with the industrial
applicability in the context of a patent for biological matter. HGS, the appellants, own a European
patent describing the amino-acid sequence for a protein called Neutrokine-a, along with the
nucleotide sequence coding for it, and some of its antibodies. Neutrokine-a is the member of a
particular class of proteins which are generally found to have certain biological and medicinal
properties. By extension, the patent made similar assertions about the properties of Neutrokine-
a in particular.
An opposition and appeal within the European Patent Office (EPO) led to its Technical Board of
Appeal (TBA – last three-letter abbreviation for now!) maintaining the patent. But Eli Lilly
simultaneously pursued parallel proceedings in the UK, seeking revocation of the patent on the
basis that the assertions as to the effects and functions of Neutrokine-a were speculative, and
merely presented the reader of the patent with a research project to go and try out. The High
Court agreed: the assertions about the properties of the protein and its antibodies were at “for too
high a level of generality to constitute a sound or concrete basis” for their use. The Court of
Appeal, in a judgment written by Lord Justice Jacob shortly before his retirement from the bench,
upheld Kitchin J’s first instance judgment. Lord Justice Jacob found that the English courts would
tend to follow any principle of law laid down by the TBA, but need not accord such considerable
respect to its findings on matters of fact and degree. He found that a judge who had the benefit
of fuller, cross-examined expert evidence before him might well accord greater weight to his own
evaluation than that of the TBA in such factual matters. Accordingly, the Court of Appeal held that
there was no difficulty in the fact that the High Court’s finding was at variance with that of the TBA.
The Supreme Court (see Lord Neuberger MR at §§83—95) agreed that the UK court was not
bound by the Board, and should not uncritically accept its conclusions. However, in cases where
the TBA had followed a consistent approach to an issue in several decisions, then that approach
should ordinarily be adopted by the national court (§87). The approach that the TBA had taken in
cases relevant to the facts at issue here was distilled into a series of statements listed by Lord
Neuberger at §§106ff. The Supreme Court held that Kitchin J, and by extension the Court of
Appeal, hadn’t been sufficiently faithful to the considered and consistent approach the TBA had
taken, leading to their finding that there was industrial applicability in HGS’s patent. Instead,
Kitchin J had applied too stringent a standard in seeking a confirmed use for the matter of the
patent, rather than true plausibility.

A further aspect of interest is the role of the interest groups who intervened. The policy reasons
seem to have been very important in the Supreme Court’s decision. The BioIndustry Association
intervened to the effect that the bioscience industry needed clarity, and needed to know exactly
at what stage in the research process they should file their patents. The BIA did not formally attach
to either party in the case, but made clear the outcome it desired (Lord Neuberger at §100). It
seems that the BIA’s submissions persuaded the Supreme Court, and at the very least they were
granted considerable respect. It will be interesting to see if such interventions by interest groups
become more common in IP cases of principle.

Stuart is the pupil at Three New Square, the specialist intellectual property chambers of Simon
Thorley QC. He is the chair of the Oxford International Intellectual Property Moot and
Conversazione.

rhone v yeda
Yeda v Rhone-Poulenc Rorer: Clarification of the law on inventorship and entitlement

Introduction
The recent House of Lords decision in Yeda v Rhone-Poulenc Rorer[1] provides a much awaited
and sensible clarification of the law on patent inventorship and entitlement. Over ruling the
approach of the Court of Appeal in Markem v Zipher[2], their Lordships unanimously held that
the Patents Act 1977 (the "Act") provides an exhaustive code for determining who is entitled to
the grant of a patent. This should bring to a close a particularly turbulent period for this aspect of
patent law.

The legislation
As the House of Lords noted in Yeda, the Act says that a patent or an application for a patent is
personal property. "The statute brings the property into existence, prescribes its incidents and
determines who shall be entitled to enjoy it"[3]. The rules for the grant of a patent are contained
in section 7:
"7. (1) Any person may make an application for a patent either alone or jointly with
another.
(2) A patent for an invention may be granted -
(a) primarily to the inventor or joint inventors
(b) in preference to the foregoing, to any person or persons who, by virtue of any enactment or
rule of law...or by virtue of an enforceable term of any agreement entered into with the inventors
before the making of the invention, was or were at the time of the making of the invention
entitled to the whole of the property in it (other than equitable interests) in the United Kingdom;
(c) in any event to the successor or successors in title of any person or persons mentioned in
paragraph (a) or (b) above or any person so mentioned and the successor or successors in title
of another person so mentioned; and to no other person.
(3) In this Act 'inventor' in relation to an invention means the actual deviser of the invention
and 'joint inventor' shall be construed accordingly.
(4) Except so far as the contrary is established, a person who makes an application for a
patent shall be taken to be the person who is entitled under subsection (2) above to be granted
a patent and two or more persons who make such an application jointly shall be taken to be the
persons so entitled."
The Act also contains procedural machinery for determining disputes over who is entitled to a
patent: section 8 applies to UK applications; section 12 applies to foreign and convention
applications (including European patent applications); and section 37 applies to granted UK and
European (UK) patents.

The Court of Appeal's approach

In Markem v Zipher, and again in Yeda, the Court of Appeal held that a party's entitlement to
apply for a patent pursuant to section 7 of the Act is, as such, irrelevant to whether or not it can
claim entitlement under sections 8, 12 and 37. Rather, the Court of Appeal considered that in
order to establish entitlement to an application or patent filed by a third party, the claimant had
to invoke some other rule of law, which gave him title, in whole or in part, to the defendant's
application or patent. This was a departure from the approach previously taken by the courts
when determining entitlement claims and presented multiple conceptual difficulties[4].

The correct approach to inventorship/entitlement claims

The House of Lords was clear in its opinion that the principle laid down in Markem v Zipher (and
applied by the Court of Appeal in Yeda) was wrong.
The Patents Act is an exhaustive code for determining entitlement
Lord Hoffmann considered the provisions of section 7 of the Act, noting in particular the
words "and no other person" at the end of section 7(2) and the definition of 'inventor' in section
7(3). He considered those sections "an exhaustive code for determining who is entitled to the
grant of a patent"[5]:
"The statute is the code for determining entitlement and there is nothing in the statute which
says that entitlement depends upon anything other than being the inventor. There is no
justification, in a dispute over who was the inventor, to import questions of whether one claimant
has some personal cause of action against the other."[6]
Similarly, Lord Walker of Gestingthorpe considered section 7 to "lay down requirements for
entitlement in terms that are both necessary and sufficient"[7].
The correct approach to inventorship/entitlement questions
Lord Hoffmann stated
"...the first step in any dispute over entitlement must be to decide who was the inventor or
inventors of the claimed invention. Only when that question has been decided can one consider
whether someone else may be entitled under paragraphs (b) or (c)". [8]
Lord Hoffmann noted that the inventor is defined in section 7(3) as "the actual deviser of the
invention":
"The word "actual" denotes a contrast with a deemed or pretended deviser of the invention; it
means, as Laddie J. said in University of Southampton's Applications [2005] RPC 220, 234, the
natural person who "came up with the inventive concept". It is not enough that someone
contributed to the claims, because they may include non-patentable integers derived from prior
art: see Henry Brothers (Magherafelt) Ltd v Ministry of Defence [1997] RPC 693, 706; [1999]
RPC 442. As Laddie J. said in the University of Southampton case, the "contribution must be to
the formulation of the inventive concept". Deciding upon inventorship will therefore involve
assessing the evidence adduced by the parties as to the nature of the inventive concept and
who contributed to it."[9]
In view of the above, the correct approach to any entitlement claim founded on a claim to
inventorship would appear to be as follows: first to identify the inventive concept(s) in question;
secondly to identify who came up with/contributed to the formulation of the inventive
concepts[10]; and thirdly to consider whether someone other than the inventor(s) may be entitled
under section 7(2)(b) or (c) of the Act (eg as the employer(s) of the inventor(s)).
It is noted that Laddie J.'s judgment in Southampton was subsequently reversed by the Court of
Appeal[11]. However, in Yeda, Lord Walker noted that before each tribunal Southampton had
turned on the different views as to what the inventive concepts were and who devised them,
rather than on any new principle said to have been introduced by Markem v Zipher.[12]
It is also worth noting that in many provisions of the Act 'invention' means patentable invention,
which inherently requires consideration of the validity of the patent. However, in the context of
the entitlement provisions, 'invention' refers to the inventive concept behind the patent or
application. [13]

Where the Court of Appeal went wrong

In Markem v Zipher, Jacob LJ introduced the Court of Appeal's discussion on entitlement with
the observation that "if A is to be entitled to a patent or part of a patent applied for by B, then
there must be some sort of link between the two". This is fundamental to the law of entitlement
and stems from the fact that the UK, like nearly all countries, operates on a first to file system. If
A makes an invention but does not apply for a patent and B independently comes up with the
same idea and applies first, A cannot complain or claim any part of B's patent. The
consequence of this, as Jacob LJ explained, is that
"...it is not enough for A to assert that the invention or concept (we use the expression loosely at
this stage) was known to its employees and that that itself gave A an entitlement to make an
application under s.7. What has to be shown is that A is entitled to B's application or part of it."
However, Jacob LJ continued as follows
"In the usual run of case, such an entitlement will arise by reason of the operation of some
independent rule of law, such as contract, breach of confidence or the like ... In the end the
question is always "who was to own the invention and the corresponding patent?" The question
is about "title" and that involves a question of legal rights."[14]
The House of Lords took issue with this reasoning. Lord Hoffman thought that the Court of
Appeal had confused the rules which go to the question of entitlement (which are "exhaustively
stated in section 7(1)") with the rules which go to the validity of a patent, which include that the
invention does not form part of the state of the art. He stated
"This rule of novelty is the only source, in English law, of the principle that if two people
independently make the same invention, the "first to file" is the one entitled to a patent. In article
60(2) of the European Patent Convention the rule is stated expressly in those terms. But the
important point is that the way this principle operates is not by supposing some meta-patent for
which the two inventors are in competition and which is awarded to the first to file. The inventor
first to file is the one entitled to a patent, not to the patent. The second to file is not entitled to a
patent because the invention he claims lacks novelty by virtue of section 2(3): see Synthon BV v
Smithkline Beecham plc [2005] UKHL 59."[15]
Lord Hoffmann continued
"...in proceedings in which neither side is challenging the validity of the patent, there is no
justification for requiring an applicant in a claim to entitlement to plead and prove allegations
which are relevant only to the question of validity"[16].
Lord Walker commented further on the relationship between breach of confidence and
entitlement:
"The misappropriation and misuse of confidential information which does not amount to an
invention may give rise to claims for an injunction and damages or an account of profits, but
cannot affect title to an invention. [In University of Southampton's Applications [2005] RPC 220]
the Court of Appeal rejected the notion (based on the Roman law doctrine of confusio) that
confidential information which eventually led to the making of a patentable invention (but was
not itself an invention) could affect entitlement to the invention. Where a patentable invention is
imparted in confidence (for instance, as part of a process of peer review) it does not amount to
publication since (in the hallowed words used by Bowen LJ in Humpherson v Syer (1887) 4
RPC 407, 413) the recipient of the information is not "free in law and equity to use it as he
pleased". If the recipient were to abuse the confidence and apply for a patent himself, his
application ought to fail, not because of breach of confidence as such, but for the simpler reason
that he was not the inventor - he was a pirate. In such a case the true inventor would, because
of the improper nature of the disclosure, have a six-month period of grace in which to make his
own application (section 2(4)(b) of the Act).[17]
In my opinion Jacob LJ's reference to the law of confidence as a typical example of a "rule of
law" operating under section 7(2)(b) to displace the claim of an inventor under section 7(2)(a)
does not really stand up to scrutiny. Breach of confidence may well be part of the narrative in
explaining why one person, rather than another, came to be the applicant for, or grantee of, a
patent. It may provide a period of grace in relation to publication. But it will not normally (and
Jacob LJ was speaking of "the usual run of case") operate under a rule of law to oust the
primary claim of the true inventor.[18]"
Lord Hoffmann and Lord Walker also took the opportunity to comment that in their opinions the
outcome in Markem v Zipher was the right one. Lord Hoffmann noted that Markem had claimed
to be entitled to the patent in suit on the ground that it used information which the listed inventor,
Mr McNestry, had obtained while working for them:
"But the Court of Appeal found that although that information may have contributed to the
claims, the inventive concept had been devised entirely by Mr McNestry while working for
Zipher.[19]
...[T]here appears to me to have been no room for dispute over who was the inventor. It was Mr
McNestry...Mr McNestry was not an employee of Markem at the time he made the invention. On
the contrary, he was an employe[e] of Zipher and they were entitled under section 39. There is
no rule by which a former employer can claim entitlement to an invention made after the
employee has left his employment simply because he has used the knowledge of prior art which
he gained with them and has included some of that prior art in his claims.[20]"

Conclusion
When considering any question of inventorship, or an entitlement claim based on a question of
inventorship, the correct approach is first to identify the inventive concept(s) in question; and
secondly to identify who "came up with"/"contributed to the formulation of" the inventive
concept(s).[21] This will involve assessing the evidence adduced by the parties as to the nature
of the inventive concept and who contributed to its formulation.[22] The third step (if in issue) is to
consider whether someone other than the true inventor(s) may be entitled under section 7(2)(b)
or (c) of the Act (eg as the employer(s) of the inventor(s)).
For an entitlement claim based on a claim to inventorship, breach of some other rule of law is no
pre-requisite for success.[23]

coco v clark
COCO V. A.N. CLARK (ENGINEERS) LTD [1969] RPC 41, High Court – Chancery (England) –
1 July 1968

FACTS
Coco was developing a motor-assisted cycle or moped. He entered into negotiations with AN
Clark to develop the moped and provided information to A.N. Clark about his moped. After some
time, A.N. Clark elected to not further develop the Coco moped and instead began to develop its
own moped.
Coco became suspicious that A.N. Clark was using some of his designs for the new moped. He
therefore applied for an injunction to stop A.N. Clark making or sell any moped using his
confidential information. A.N. Clark had just released its moped on the market while Coco had
stopped developing his moped.

ISSUES
Had Coco established a strong prima facie case that the information was confidential or that
there had been a breach of confidence?
Should an injunction be awarded to prevent the making and selling of the moped?

FINDING
Coco had failed to establish that the similarities between the two mopeds were achieved by the
use of information provided by him to A.N. Clark.
Also an injunction was not appropriate as the evidence for the case had not been properly
tested and Coco had not developed his own moped and therefore it did not need protection from
the sale of the rival moped.

QUOTE
Megarry J at page 47 said:
“In my judgment, three elements are normally required if, apart from contract, a case of breach
of confidence is to succeed.
First, the information must itself … have the necessary quality of confidence about it.
Secondly, that information must have been imparted in circumstances importing an obligation of
confidence.
Thirdly, there must be an unauthorised use of that information to the detriment of the party
communicating it.”

And at page 50 he said:

“If the duty is a duty not to use the information without consent, then it may be the proper
subject of an injunction to restrain its use, even if there is an offer to pay a reasonable sum for
that use.
If, on the other hand, the duty is merely a duty not to use the information without paying a
reasonable sum for it, then no such injunction should be granted.”
 IMPACT
When claiming that confidential information is being misused it is important to be able to clearly
identify the information and explain how it is being misused.
A Court may not order an injunction to prevent the use of confidential information if the plaintiff
is not themselves using that information.

This publication is intended to be a topical report on recent cases in the construction,

development and engineering industries. This publication is not intended to be a
substitute for professional advice, and no liability is accepted. This publication may be
reproduced with full acknowledgement.

actavis v eli lilly

The United Kingdom Supreme Court (UKSC) today handed down its judgment in the case
of Actavis UK Limited and others v Eli Lilly and Company ([2017] UKSC 48) that has
significantly changed the law of patent infringement in the UK.

Background
Lilly is the proprietor of a patent that claims the use of pemetrexed disodium in the manufacture
of a medicament for use in combination with vitamin B12 (and, optionally, folic acid) for the
treatment of cancer. Actavis sought declarations of non-infringement for its proposed products
which used (i) pemetrexed diacid, (ii) pemetrexed ditromethamine, or (iii) pemetrexed
dipotassium in place of pemetrexed disodium. Actavis sought such declaration in respect of the
UK, French, Spanish and Italian designations of Lilly's patent. The ability of the English courts to
grant such declarations in respect of the foreign designations had been confirmed earlier in this
action.

The High Court held that none of the Actavis products would directly or indirectly infringe the
patent in the UK, France, Italy and Spain. The Court of Appeal allowed Lilly's appeal in respect
of there being indirect infringement of the patent in each jurisdiction. Both parties were given
permission to appeal to the UKSC.

Judgment
The UKSC concluded that as a matter of ordinary language, it is clear that the only type of
pemetrexed compound to which the patent claims expressly extends is pemetrexed disodium.
The question that the UKSC then had to consider was how far one can go outside the wording
of a claim.

The UKSC reviewed the relevant case law of the UK and other Convention states. In relation to
the UK, those cases were the well-known cases of Catnic, Improver and Kirin-Amgen and the
Improver/Protocol questions that arose from those cases. The UKSC has stated that the
problem of infringement is best approached by addressing the following two issues:
1. Does the variant infringe any of the claims as a matter of normal interpretation; and, if not,
2. Does the variant nonetheless infringe because it varies from the invention in a way or ways
which is or are immaterial?

If the answer to either of those questions is "yes" then there is infringement, otherwise there is
not. The decision states that issue 1 self-evidently raises a question of interpretation, whereas
issue 2 raises a question which would normally have to be answered by reference to the facts
and expert evidence. The UKSC then criticises the approach taken in Catnic,
Improver and Kirin-Amgen for effectively conflating the two issues and indicates that
characterising the issue as a single question of interpretation is wrong in principle.
 The UKSC went on to explain that treating issue 2 as one of interpretation will lead to a risk of
wrong results in patent infringement cases and it will also lead to a risk of confusing the law
relating to interpretation of documents. Accordingly, issue 2 is said to involve not merely
identifying what the words in the claim would mean in their context to the notional addressee,
but also considering the extent, if any, to which the scope of protection afforded by the claim
should extend beyond that meaning.

Applying this new approach to the facts of this case, the UKSC confirmed that, in relation to the
first issue, there was no doubt that the Actavis products do not infringe the patent as in no
sensible way can pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium
be said to fall within the expression "pemetrexed disodium". However, it is the second issue that
posed more difficulties of principle to the UKSC namely, what is it that makes a variation
"immaterial"? While acknowledging that the Improver questions provided helpful assistance in
answering that question, the UKSC has undertaken a critical explanation of questions 1 and 3
but has also reformulated question 2.

In relation to the first Improver question, the UKSC has now said that the emphasis of that
question on how "the invention" works should involve the court focussing on "the problem
underlying the invention", "the inventive core" or "the inventive concept". Terms such as this will
be familiar to practitioners in other jurisdictions.

The UKSC found the second Improver question more problematic. Its view is that it places too
high a burden on the patentee to ask whether it would have been obvious that the variant had
no material effect on the way the invention works, given that it requires the addressee to figure
out for himself whether the variant would work. To overcome this problem, the UKSC has
determined that this question should be asked on the assumption that the notional addressee
knows that the variant works. This new question should also apply to variants which rely on, or
are based on, developments which have occurred since the priority date, even though the
notional addressee is treated as considering the second question as at the priority date.

In relation to the third Improver question, the UKSC was satisfied with that question as long as it
was properly applied. The court makes four points in relation to that. First, the "language of the
claim" does not exclude the specification and all the knowledge and expertise which the notional
addressee is assumed to have. Second, the fact that the language of the claim does not on any
sensible reading cover the variant is not enough to justify holding that the patentee does not
satisfy the third question. Third, it is appropriate to ask whether the component at issue is an
"essential" part of the invention, but that is not the same thing as asking if it is an "essential" part
of the overall product or process of which the inventive concept is a part. Fourth, when
considering a variant which would have been obvious at the date of infringement rather than at
the priority date, it is necessary to imbue the notional addressee with rather more information
than he might have had at the priority date.

In an attempt to assist with interpreting their judgment, the UKSC expressed their new questions
as follows:
 Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent,
does the variant achieve substantially the same result in substantially the same way as the
invention, i.e. the inventive concept revealed by the patent?
 Would it be obvious to the person skilled in the art, reading the patent at the priority date, but
knowing that the variant achieves substantially the same result as the invention, that it does so
in substantially the same way as the invention?
 Would such a reader of the patent have concluded that the patentee nonetheless intended that
strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential
requirement of the invention?

The impact of these new questions and the new approach to assessing infringement of patents
in the UK (and the consequences for the validity of those patents) will take time to become fully
appreciated.

Prosecution History
The UKSC was also asked to consider the use of the prosecution file when considering the
question of interpretation or infringement. It concluded that its current view was that such
reference to the file would only be appropriate where (a) the point at issue is truly unclear if one
confines oneself to the specification and claims of the patent, and the contents of the file
unambiguously resolve the point, or (b) it would be contrary to the public interest for the
contents of the file to be ignored.
In the present case, the UKSC did not consider that the file justified departing from its
conclusion that the Actavis products infringed Lilly's patent.

Foreign law
The UKSC had to address issues relating to infringement in France, Italy and Spain. Those
issues are to be the subject of a separate note.

Cases (d) C-443/12 Actavis (12 december 2013);

2017: (e) C-428/08 Monsanto [201
(a) G 2/08 Dosage regime [2010] OJ EPO
456; 2014:
(b) HTC v Apple [2013] EWCA Civ 451, (a) C-443/12 Actavis v Sanofi (12 December
[2013] RPC 30; 2013);
(c) Synthon v SmithKline [2005] UKHL 59, (b) Pozzoli v BDMA [2007] EWCA Civ. 588;
[2006] RPC 10; (c) Grimme Landmaschinenfabrik Gmbh &
(d) Pozzoli v BDMO [2007] EWCA Civ 588; Co. KG v Derek Scott [2010] EWCA Civ
(e) C-428/08 Monsanto [201 1110;
(d) Schütz v Werit [2013] UKSC 16;
2016: (e) G 1/07 Treatment by surgery (2011) oj
Haberman v jackal; Oliver brustle v epo 134
greenpeace; Merrell dow v hm norton;
Synthon v smithkline; Lux traffic v pike 2013:
signals haberman, generics v lundbeck,
kirin, synthon, g 3/07 computer programs
2015: 2011 oh epo 10
(a) G 2/08 Dosage regime [2010] OJ EPO
456; 2012:
(b) HTC v Apple [2013] EWCA Civ 451, kirin, synthon, human genome v eli lilly,
[2013] RPC 30; rhone v yeda, coco v clark
(c) Synthon v SmithKline [2005] UKHL 59,
[2006] RPC 10;
Question Topics
2017
1. Novelty, infringement, breach of
confidence
2. Grace period in europe, us, japan
3. Infringement, unjustified threats
4. Define terms: Restoration and
reinstatement; psa; intl and natl phase;
preliminary examination
5. Patentability of biotech subj matter
6. Claim construction (kirin-amgen); doctrine
of equivalents
7. Discuss significance of ff cases:
(a) G 2/08 Dosage regime [2010] OJ EPO
456;
(b) HTC v Apple [2013] EWCA Civ 451,
[2013] RPC 30;
(c) Synthon v SmithKline [2005] UKHL 59,
[2006] RPC 10;
(d) Pozzoli v BDMO [2007] EWCA Civ 588;
(e) C-428/08 Monsanto [201
2016:
1. patentability of software in europe and us;
alice v cls bank
2. Substantive exam; reinstatement; patent
infringement
3. Kirin-amgen; doctrine of equivalents
4. Biotech patents
5. Define terms: Restoration; psa; intl and
natl phase; sufficiency
6. Novelty; prior art
7. Confi info
8. Explain significance of Cases: haberman
v jackal; oliver brustle v greenpeace; merrell
dow v hm norton; synthon v smithkline; lux
traffic v pike signals
2015:
1. Patentability, ordre public, biotech
2. ??? Novelty, infringement
3. Evaluate Statement in atty-general v
guardian newspapers (no. 2)
4. Infringement, seeking patent office
opinion
5. Define: priority date and claim of priority,
psa, protected by patent in force (spc),
restoration and reinstatement and
resuscitation
6. Employee entitlement claim, ee
compensation claim
7. Us doctrine of equivalents- applicability in
europe (us v uk v germany)
8. (a) G 2/08 Dosage regime [2010] OJ
EPO 456;
(b) HTC v Apple [2013] EWCA Civ 451,
[2013] RPC 30;
(c) Synthon v SmithKline [2005] UKHL 59,
[2006] RPC 10;
(d) C-443/12 actavis (12 december 2013);
(e) C-428/08 Monsanto [201
2014:
1. Breach of confidence, entitlement
proceedings
2. Doc of eq. In us but not in uk
3. Groundless threat of p infringement,
patentability of biotech sm
4. Explain: added matter, psa, first
authorization (spc), pct natl phase
5. Patentability of comp prog inuk distinct
from epo
6. Prior art, novelty, inventive step
7. (a) C-443/12 Actavis v Sanofi (12
December 2013); (b) Pozzoli v BDMA
[2007] EWCA Civ. 588; (c) Grimme
Landmaschinenfabrik Gmbh & Co. KG v
Derek Scott [2010] EWCA Civ 1110; (d)
Schütz v Werit [2013] UKSC 16; (e) G 1/07
Treatment by surgery (2011) oj epo 134
2013:
1. ??? Breach of Confi
2. Contrary to public policy - wide ambit on
paper but narrow in practice
3. Same as 2
4. Discuss: added matter; employee
compensation; mosaicking; psa
5. Grace period harmonization - epo, japan,
us
6. Cases: haberman, generics v lundbeck,
kirin, synthon, g 3/07 computer programs
2011 oh epo 10
7. Novelty, inventive step, patentability
2012:
1. Computer prog
2. Patent inf
3. Inventive step in uk epo us japan
4. Cases: kirin, synthon, human genome v
eli lilly, rhone v yeda, coco v clark
5. Breach of confidence
6. Discuss: psa, added matter, sufficiency,
priority date
7. Patentability, entitlement to grant
8. Pct, global patent
2011:
1. Infringement, fto
2. Purpose of patent, licensing
3. Patent info resource for r&d
4. Patentable sm, dna patent
5. National security, patent infringement,
assignment
6. Pct
7. Ordre public, biotech
8. Discuss: psa, added matter, industrial
application