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IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION I. A. NO. _____ OF 2011 IN S.L.P. (C) NO.

20549/2009 IN THE MATTER OF: NOVARTIS AG VERSUS UNION OF INDIA & ORS. RESPONDENTS AND IN THE MATTER OF: SHAMNAD BASHEER INTERVENOR PETITIONER

WRITTEN SUBMISSIONS ON BEHALF OF THE INTERVENOR The intervenor seeks to assist the court in evolving a framework and a set of propositions for resolving patent disputes, particularly disputes around pharmaceutical patents and section 3(d). Being an academic, the interests of the intervenor lie in the robust development of sound patent jurisprudence for India that appropriately balances the competing interests of drug originators against that of generic companies and patients. I THE SECTION 3(d) STANDARD

Section 3(d) currently reads as under: 3. What are not inventions: The following are not inventions within the meaning of this Act. 1

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. In essence, section 3(d) stipulates that a new form of a known substance would be patentable only when the said new form demonstrates significantly enhanced efficacy when compared with the known substance.1 The key issues in interpreting the scope and ambit of section 3(d) are: 1. What does efficacy mean? 2. Does increased bioavailability qualify as enhanced efficacy? 3. What is the standard of proof required to establish efficacy? 4. When must proof of efficacy be produced? 5. What is the meaning of the term known substance under section 3(d)? A. Meaning of Efficacy

Section 3(d) of the Indian Patents Act, 1970. For an elaborate discussion of this provision, see Shamnad Basheer and Prashant Reddy, The Efficacy of Indian Patent Law: Ironing out the Creases in Section 3(d), Volume 5, Issue 2, Script-ed, August 2008.

The term efficacy is central to interpreting the scope and ambit of section 3(d). More specifically, the issue is whether or not efficacy ought to be interpreted narrowly to mean only therapeutic efficacy or whether it ought to be broadened out to include any kind of advantageous property attributable to the new form in question. The Madras High Court and held not that every efficacy meant only

therapeutic

efficacy

advantageous

property

claimed for the new drug derivative in question.2 The IPAB endorsed this interpretation. The intervenor submits that, based on the history of the section 3(d) and its current structure, this appears to be a correct reading of section 3(d). However, one important caveat needs to be borne in mind; section 3(d) is not limited to pharmaceutical technology alone. Rather, it applies also to chemicals (such as paints) and agrochemicals (such as pesticides), for which therapeutic efficacy cannot be an appropriate standard.3 A nuanced interpretation of efficacy would therefore suggest that it be defined in a technologically specific way i.e. while it would mean therapeutic efficacy in the pharmaceutical context, it would translate to an ability to destroy pests in a pesticide context. In other words, efficacy has to be construed in accordance with the predominant function/utility/purpose of the claimed substance/invention in question. This function is often adduced from the patent specification itself, where the alleged utility is cited. Such an interpretation to is in conformity neutral with patent prevailing standards patent in a jurisprudence in countries such as the US and EU which have been known
2

interpret

facially

Novartis AG & Anr. v. Union of India & Othrs., (2007) 4 MLJ 1153 at para 13 also available at <http://www.indiankanoon.org/doc/1111498/> (last visited 12 August, 2011).
3

Supra note 1 at internal page 244.

technologically specific way.4 The structure of section 3(d) as also its legislative history supports a narrow reading of the term efficacy. Illustratively, the Explanation to section 3(d) clearly states that all pharmaceutical derivatives would be considered the same substance, unless they differ significantly in properties with regard to efficacy. The above clause refers to only those properties that have some bearing on efficacy and not all properties. If "all properties" were to qualify, it would effectively render the term "efficacy" redundant. Had Parliament intended any property to qualify under section 3(d), the Explanation would simply have stated "unless they differ significantly in properties". And the main part of section 3(d) would have been rephrased as "the mere discovery of a new form of a known substance which does not result in the enhancement of the known "properties" of that substance." Therefore, not all advantageous properties of a new form (such as improved processability or flow characteristics, storage potential etc) ought to qualify under section 3(d), but only those properties that have some bearing on efficacy. Although this precise line of argument pointing to the phrase properties with regard to efficacy does not appear to have been explicitly made by either the Madras High Court or the IPAB to support their conclusion, it is one that compellingly supports a restrictive interpretation of the term efficacy.
See Dan L Burk and Mark A Lemley, Policy Levers in Patent Law 89 Va. L Rev. 1575, 1662 (2003). See Also Dan L Burk and Mark A Lemley, Is Patent Law Technology Specific? 17 Berkeley Tech. L.J. 1155, 1184 (2002).
4

This interpretation is further buttressed by the objectives of the Act, which suggests that section 3(d) was introduced to prevent evergreening.5 The Madras High Court states in this regard:6 We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent ever-greening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens Although the term ever-greening does not have a scientific definition as yet, it is widely understood to mean an inappropriate extension in patent monopoly which does not convert to a significant benefit for the patient.7 Put another way, it is a patenting strategy consisting of acquiring patents the on minor, of often trivial, modifications over of existing patented pharmaceutical products or processes in order to indirectly extend period patent protection previously compounds.8
See Transcript of Parliamentary Debate, March 22, 2005, where Shri Kurup makes a statement indicating that the section is being brought in to prevent evergreening. See also statements of Madras High Court in this regard.
5 6

Para 19 of the judgement.

'Ever-greening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rentearning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. T. A. Faunce & J. Lexchin, 'Linkage' pharmaceutical ever-greening in Canada and Australia, available at: < http://law.anu.edu.au/StaffUploads/236-Art%20ANZHP%20Linkage %20Evergreening.pdf> (last visited 31 August, 2011).
7 8

See Carlos Correa Guidelines for Examination of Pharmaceutical Patents, available at: <http://www.iprsonline.org/resources/docs/Correa_Patentability %20Guidelines.pdf> (last visited 31 August, 2011). See Also A. Kesselheim, Intellectual Property Policy in the Pharmaceutical Sciences: The Effect of Inappropriate Patents and Market Exclusivity Extensions on the Health Care System, available at: <http://www.aapsj.org/view.asp?art=aapsj0903033> (last

B.

Exploring the Contours of Therapeutic Efficacy

Sectlon 3(d)s lineage can perhaps be said to embody concepts of both patent law and drug regulatory norms. I will examine the patent concept linkage later while discussing the overall scheme of the Act and the links between Section 2(j), Section 2(ja) and Section 3. In terms of the link with drug regulatory concepts, it is important to note that section 3(d) borrows extensively from a EU drug regulatory directive. Article 10(2)(b) of Directive 2004/27/EC defines a generic medicinal product as: a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.

Given this history, there is a real danger in interpreting the provision in a strictly drug regulatory sense, which might prove problematic within a patent ecosystem. It is therefore submitted that the drug regulatory meaning must not be transposed wholly to the patent context, without suitable adaptation. For the purpose of these two
visited 31 August, 2011) patent ever-greening, is the patenting of nonessential features of products, including aspects of their formulation, their metabolites, or methods of administration.).

regimes are distinct. While the patent system is meant to grant protection to inventions that demonstrate technical/technological merit with a view to incentivizing innovation, a drug regulatory regime seeks to ensure that only safe and effective drugs are sold to consumers. Firstly, given that the intention behind section 3(d) appears to be to provide protection to those inventions providing a genuine advantage to patients (as opposed to ever-greened varieties), efficacy ought to be defined as any therapeutic advantage and not just efficacy as strictly understood in a drug regulatory sense. It is pertinent to note in this connection that under most drug regulatory regimes, the notion of efficacy is used quite distinctly from that of safety. It is a truism that almost all allopathic drugs are blessed with toxicity. A regulators job essentially entails a risk: benefit analysis i.e. determining whether or not the costs/risks of toxicity are clearly outweighed by the benefits offered by efficacy of the drug in question. In its review of a New Drug Application (NDA), the American Food and Drug Administration (FDA) considers inter alia [w]hether the drug is safe and effective in its proposed use, and whether the benefits of the drug outweigh the risks.9 Safety of a drug is assessed relative to risks and benefits.10 The intervenor therefore submits that the term efficacy under section 3(d) ought to be interpreted to mean any therapeutic advantage including one that flows from significantly reduced toxicity.
Susan Thaul, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, CONGRESSIONAL RESEARCH SERVICE, 5 (Jun., 2012), available at http://www.fas.org/sgp/crs/misc/R41983.pdf
9

See Cynthia Ho, From Conception to Commercial Success, in ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS 6,13(2011) (Although it would be optimal for all drugs to be completely safe, in most cases safety is assessed relative to risks and benefits.)
10

An Illustration The Orphan Drug Act, 1983 The Orphan Drug Act (ODA) is illustrative in this regard and could be used to delineate the contours of therapeutic advantage. The ODA was enacted by the US Congress to help incentivise the creation of what are known as orphan drugs i.e. any drug used to treat a rare disease or condition that affects fewer than 200,000 patients in the US or for which there is no reasonable expectation that the cost of developing the drug for a disease will be recovered from sales.11 Given that pharmaceutical companies generally shy away from research on orphan drugs, owing to the lack of large markets for such drugs, the ODA was brought into existence to grant additional incentives for creating such drugs to benefit minority patient populations. The incentive is in the form of a seven year marketing exclusivity to drug originators, so that they are able to recover their R&D costs and also make a healthy profit during this period of exclusive protection. Contrast this with regular data exclusivity regimes, which grant drug originators a period of exclusivity lasting only 5 years from the date of their approval. Further, such exclusivity is limited to preventing the use of and reliance upon data submitted by the drug originator to regulatory authorities, such that no follow-on drug manufacturers drug can be approved using this very same data during the time of protection. However, follow-on manufacturers are free to conduct their own clinical trials and procure drug marketing approval during this time period.12 On the other hand, the ODA which offers complete and absolute market exclusivity, independent of the clinical trial data that is
11

21 USC 360ee(b) (2) (1994).

Robert A. Bohrer and John T. Prince, A Tale of Two Proteins: The FDA's Uncertain Interpretation of the Orphan Drug Act, 12 Harv. J. L. & Tech. 365, 370 (1999).
12

submitted. In other words, the protection is against all follow-on drug manufacturers, who cannot enter the market, even if they repeat the clinical trials and are able to submit independently generated data.13 Complete market exclusivity, as opposed to mere data exclusivity, would mean that no follow-on manufacturer can make or sell a version containing the same active ingredient or claiming the same indication or use, even if they are able to generate their own data for the same. However, the issue of sameness has been a highly contentious one under the ODA. The FDA regulations on this count suggest that clinical superiority would render a structurally similar drug molecule different from the original drug entitled to orphan drug exclusivity.14 The regulations define a "clinically superior" drug as one that "is shown to provide a significant therapeutic advantage over and above that provided by an approved orphan drug . . . ." Therapeutic advantage, or clinical superiority15, can be shown in one of three ways: (1) greater effectiveness; (2) greater safety; or, (3) demonstration that the drug makes a major contribution to patient care in "unusual cases."16
13

Unlike other types of exclusivities for new drugs, the law provides complete market exclusivity for orphan drugs for a seven-year period, thereby preventing a competitor from entering the market, even if it were able to generate its own data. See Orphan Drug Act, 1983.
14

"With regard to macromolecular drugs, clinical superiority by itself will render a subsequent drug different." See Orphan Drug Regulations, 57 Fed. Reg. 62,076, 62,081 (1992) at 62,078. This "clinical differences" standard was based on the principle that the market exclusivity should not create a barrier to needed patient therapies. See Joseph A Levitt & John V Kelsey, The Orphan Drug Regulations and Related Issues 48 Food & Drug L.J. at 528-29. The terms therapeutic advantage and clinical superiority are interchangeable. Therapeutic advantage is demonstrated when clinical testing of a drug demonstrates it to be superior in an important dimension. See 21 C.F.R. . 316.3 (b) (3) (iii) (1999).
15 16

The FDA intends this to be "a narrow category," such as, for example, "the development of an oral dosage form where . . . only a parenteral dosage form" had existed previously.. See 21 C.F.R. .

It bears noting that the ODA norms above mentioned are not strictly regulatory in nature. Rather, they act as incentives for innovation in a manner similar to patents. Therefore these norms seem appropriate for providing guidance in a patentability context, such as in interpreting efficacy under section 3(d). However, a key limitation must be noted in this regard: In order to evaluate sameness under the ODA, one is always likely to have two drugs i.e. the drug which is protected for 7 years under the ODA and the new drug which is allegedly similar to the old known drug under protection. In a section 3(d) context however, the old substance against which the therapeutic advantage comparison is made, may not be a drug (as is the case with imatinib or imatinib mesylate in a form other than beta crystalline). Further, in some cases where patent applications are filed to claim new forms, such a new form may not be a fully developed drug at the time that the patent application is filed. In fact, in most cases, it is likely that the point of time at which a new form is claimed as a patent is prior in time to its being developed as a drug and submitted to the drug regulator for regulatory approval. It is therefore submitted that the standard of proof required to demonstrate significant therapeutic advantage cannot be as onerous as that expected for drug regulatory regimes such as the ODA, an aspect dealt with in a later section.

C.

Does increased bioavailability amount to significantly

316.3 (b) (3) (iii) (1999).

10

enhanced efficacy? It is humbly submitted that the short answer to this is this: it depends. As noted earlier, efficacy ought to be interpreted to mean a definite therapeutic advantage. As to whether or not a showing of increased bioavailability also converts to an added therapeutic advantage has to be assessed on a case-by-case basis; the answer cannot be a blanket yes or no.

Bioavailability means the rate and extent to which the active drug ingredient or active moiety is absorbed from a drug product and becomes available at the site of drug action.17 It is usually determined by measuring the concentration of a substance in biological fluids as a function of time, or by excretion of a substance as a function of time, or by acute pharmacology effect.18

Bioavailability in short relates to absorption. this aspect quite well.

The IPAB decision

reproduced a submission from one of the counsels that captured

The drug action process in the body was explained by Shri Parthasarathy, learned counsel appearing also on behalf of R 6 & R 7. Shri Parthasarathy explained that the drug action process which broadly be divided into three categories absorption, binding and response. The absorption related to the amount of active ingredient that had been absorbed by the body. However, this absorption did not automatically translate into therapeutic response. After the active ingredient was absorbed by the body, for it to act, it must bind with the relevant reception of the target cell. This binding was the crucial step that determined effect, where there were less
17

See 21 CFR Section 320.1(a). See 21CFR Sec 320.24.

18

11

number of receptor sites, increased availability of the active ingredient did not produce any therapeutic response. Therefore, binding and not absorption was the key to healing the disease. Subsequently, after the receptor- drug binding occurs, the subsequent response could be measured. The response was typically in the form of increase or decrease of some parameter (in this case the white blood cell count). Bio-availability was related to the absorption and not the binding stage of the drug action and therefore was not a measure of the efficacy of drug. 19

The intervenor wishes to adopt the above proposition, with the caveat that it is theoretically possible for increased bioavailability to result in increased enhanced efficacy in some cases. However, this must be independently established, without assuming that an increase in bioavailability automatically translates to enhanced efficacy.

Illustratively, in few cases, a new form with increased bio-availability might confer significant benefits in terms of reduced toxicity. Assume that the earlier known substance had to be administered at 10gm to be therapeutically effective, but that this 10 gm was significantly toxic to the patient. If the new form now enables 5 gm to deliver the same therapeutic impact with greatly reduced or no toxicity at all, this is a significant clinical advantage in so far as the patient is concerned. Such enhanced patient advantage ought to count as efficacy under section 3(d).20 It is pertinent to note in this regard that the regulations in relation to the ODA state that a diminution in adverse reactions may be sufficient to allow a finding of clinical superiority."21
Novartis AG v Union of India & Ors., Intellectual Property Appellate Board, M.P. Nos 1 to 5/2007 in TA/1 to 5/2007/PT/CH , M.P.No.33/2008 IN TA/1/2007/PT/CH, and TA/1 TO 5/2007/ PT/CH, at 51, June 26, 2009.
19 20

Supra note 1 at 243-244. Orphan Drug Regulations, 57 Fed. Reg. 62,078, See supra sub part Orphan

21

12

In other cases, it is possible that an increase in bio-availability does not convert to any significant therapeutic advantage at all.

In the specific facts of the case under dispute before this Honble Court, the Petitioner sought to establish that when compared with the Imatinib free base, the beta crystalline form demonstrates a 30% increase in bio-availability. However, this by itself does not demonstrate any therapeutic advantage in relation to the patient. Such advantage has to be independently established and has not been done in this case.

A commentator rightly notes: It is not the intent of a bio-availability study to demonstrate effectiveness, but to determine the rate and extent of absorption. If a drug product is not bio-available, it cannot be regarded as effective. However a determination that a drug product is bio-available is not in itself a determination of effectiveness.22

D.

Proving Efficacy

When it comes to evidentiary requirements, it is submitted that section 3(d) ought not to be interpreted in the same way as a regulatory standard. The drug innovation process could be broadly divided into two phases, namely drug discovery and drug development. Patents
Drug Act at 8-9. 22 42 FR 1640 (1977). Cf. Moffitt, Jane, Appropriateness of Bioavailability and Bioequivalency as Pre-Market Clearance Considerations, 34 Food Drug Cosm. L.J. 640 (1979).

13

are typically filed at the upstream drug discovery stage, when all that the applicant has is a potentially viable drug molecule. It is only later that the drug is developed and tested through a series of clinical trials and finally brought into the market after procuring regulatory approval. The time gap between discovering a drug molecule and developing it into a marketable drug can take several years. This is borne out by the present case itself, where the parent molecule (Imatinib) was first discovered in 1993, but the final regulatory approval for a drug based on this molecule issued only in the year 2001. Therefore, in many cases, it is unlikely that at the patenting (drug discovery) stage, the applicant would possess any clinical trial data at all. It would be irrational and even unethical to insist on clinical trial evidence only for the purpose of satisfying patentability requirements under section 3(d).23 For any such clinical trial testing would involve testing a less than optimal substance (the known substance) against its allegedly superior derivative. One might even argue that insisting on clinical trial type proof under section 3(d) would contravene the Helsinki Declaration, principle 21 of which states that trials and other experiments on humans can be performed only if the importance of the objective outweighs the inherent risks and burdens to the research subjects. threshold of section 3 (d) is unethical and unwarranted. One suggestion for the standard of proof could be as under: The applicant need not prove efficacy under section 3(d) as a matter of statistical certainty. Nor does the applicant have to provide actual evidence of trials in humans. Instead, the applicant has to demonstrate a reasonable correlation
23

Subjecting

human subjects to clinical trials for the sole purpose of crossing the

Supra note 1 at 255-256.

14

between the efficacy claimed and the data provided in support of this. Such reasonable evidence of the correlation can be established by relying on, inter alia, statistically relevant data documenting the activity of the new form and/or known substance, documentary evidence (e.g. articles in scientific journals), data generated using in vitro assays, or from testing in an animal model, other preclinical test data or any combination thereof.24

E.

When can proof of efficacy be submitted?

In so far as pharmaceutical patent applications were filed prior to the introduction of the 2005 Patent Amendments, the patent office must permit patent applicants an opportunity to file documentation/evidence in support of section 3(d) at the time that it reviews the application for the first time. This is only fair and just, as the patent applicant could not have known of the future existence of section 3(d) at the time of filing her patent application. However, in so far as applications filed after the coming into force of the Patents (Amendment) Act, 2005 are concerned, no such opportunity need be provided. In such cases, if the filed specification does not contain any evidence of increased efficacy, the patent office is entitled to reject the application.

F.

What is the known substance for the purpose of

section 3(d)? For an appropriate determination under section 3(d), the primary issue is: what is the known substance against which the enhanced efficacy comparison ought to be made? It is submitted that the standard for determining known substance
24

Supra note 1, at 256.

15

under section 3(d) ought to be the same as that used for determining novelty and anticipation under traditional patent law i.e. whether substance X that is claimed in a patent application is already part of the prior art and therefore anticipated? The test thus far employed in US and EU suggests that X is anticipated only if the prior art teaches a person skilled in the art to reproduce X without undue experimentation. In this regard, the intervenor wishes to draw the attention of the court to a British case, Synthon BV v. SmithKline Beecham.25 In Synthon, the appellant Synthon BV applied to revoke Smith Klines patent for a particular crystalline form of the blockbuster drug paroxetine, based on Synthon's own earlier patent application. Although Synthon was successful at the first instance, the court of appeals reversed the decision. Synthon accordingly appealed to the House of Lords. The leading opinion of the House of Lords was given by Lord Hoffman, who held that anticipation required proof of two distinct matters (1) the invention had been disclosed (2) the invention had been enabled viz. an ordinary skilled man would have been able to perform the disclosed invention if he attempted to do so by using the disclosed matter and common general knowledge. On the issue of enablement, Lord Hoffmann observed that enablement means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure. Enablement in the context of novelty, according to Lord Hoffman was the same as enablement for the purpose of determining sufficiency. It is important to note that disclosure and anticipation are distinct requirements, and proof needs to be submitted on both. In assessing disclosure, no aspect of trial or error is permitted. In
25

Synthon BV v. SmithKline Beecham plc [2006] RPC 10.

16

assessing whether or not the disclosure is enabled, a reasonable degree of experimentation can be expected and is permissible. Depending on the concept under consideration, the role of the skilled person is different. In assessing disclosure, the skilled person is attempting to discern what the author of the prior document art meant. In assessing enablement, the skilled person is not concerned with what the prior art may have meant, but rather, whether the invention disclosed by the prior art could be made to work. As such, disclosure is an inquiry as to construction. Enablement is an inquiry as to what the skilled man would or would not be able to achieve. The importance of the separation of these two concepts is evident particularly in cases of simple low-tech inventions, where a simple disclosure of an invention will probably be enough to enable it, but in cases of high-tech inventions, the basic assertion of the existence of an invention may disclose it, but it may well require additional detailed description to enable a skilled person to perform it.26

On the facts of the present case, it would appear based on the several admissions made by the Petitioner in various documents including its patent applications, (including wording such as preparation of salts known per se), the amorphous form of Imatinib Mesylate could be made by a person skilled in the art as on 2007 (the priority year of the application pertaining to the beta crystalline form) by referring to the disclosures in the 93 Zimmerman patent and the 1996 articles authored by Zimmerman and using common general knowledge.

See A Sharples and D Curley, Experimental Novelty: Synthon v. SmithKline Beecham, 28(5) E.I.P.R 308-311 (2006); See Also A. Batteson, Patents: Enabling Disclosures 28(2) E.I.P.R 28 (2006).
26

17

WRITTEN SUBMISSIONS ON BEHALF OF THE INTERVENOR (PART II)

II.

CONCEPTUALIZING SECTION 3(d): BUILDING A

BRIDGE?
18

While the intent behind Section 3(d) is laudable in that it seeks to impose a rigorous patentability threshold to prevent ever-greening (within the chemical arts) such that only truly meritorious inventions are granted patents, its execution leaves much to be desired. It is submitted that from an interpretative perspective, this Honble court is left with two broad choices:

1. To treat section 3(d) criterion as separate and distinct from traditional patentability criteria, such as novelty, inventive step and utility.

2. To create a bridge between section 3(d) and the traditional patent criteria, namely novelty, inventive step and utility. Under this approach, section 3(d) would be seen as a species of the general inventive step or non-obviousness test. In this sense, an invention that flunks the section 3(d) test would not amount to an invention within the meaning of section 2(j).

Each of these choices are explicated below.

A.

INDEPENDENT PATENT STANDARD UNDER SECTION 3(d)

This choice is easier to implement than its alternative, in that the patent office is at liberty to qualify an alleged invention as inventive, whilst at the same time holding that it flunks the 3(d) test. This is precisely what the IPAB did in the present case and the advantage is that one need not go out of the way to interpret 19

section 3(d) in consonance with other criteria. However, this choice might open India up to a potential TRIPS challenge. Article 27 of TRIPS reads as below: patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
27

One might argue that section 3(d) amounts to the imposition of a new patentability criteria i.e. a pharmaceutical derivative, which qualifies as an invention and is new, inventive and useful is now subjected to a further test, namely whether or not it satisfies the requirements of section 3(d). This therefore violates the mandate under TRIPS to grant patents to inventions that are new, inventive and useful.

However, one might counter this by suggesting that those claims falling within the scope of section 3(d) are not really inventions.

1.

The Invention Definition

Given that the term invention is not defined under TRIPS,


See also Panel Report on Canada- Patent Protection of Pharmaceutical Products, 17 March 2000, WT/DS114/R.
27

20

member states have some degree of flexibility in defining this term.

Practice of member states reveal that the term invention does not admit of a precise meaning. An English judgment is illustrative in this regard, where Peter Prescott J held as below:28

How, then, does the law define what is an 'invention'? The answer is that nobody has ever come up with a satisfactory, all-embracing definition and I do not suppose anybody will. By its very nature, therefore, the subject cannot be reduced to a precise verbal formula. It is, indeed, something of a moving target, because the progress of technology continues apace.

At best, the term could be understood to mean something having a technical or technological character of some sort.29 The fact that Article 27 uses this term in close conjunction with the phrase fields of technology makes this nexus even more evident. The Indian patent act also veers towards this suggestion by its use of the term technical advance in section 2(ja).
See Peter Prescott Js ruling in In the Matter of Patent Applications GB 0226884.3 and 0419317.3 by CFPH LLC, [2005] EWHC 1589 (Pat) available at <http://www.bailii.org/ew/cases/EWHC/Patents/2005/1589.html> (26 August 2005).. See also NRDC's Application [1961] RPC at 162, where their Honours said in relation to the term invention: To attempt to place upon the idea the fetters of an exact verbal formula could never have been sound 29 Comments made in relation to the 2000 European Patent Convention (EPC) revision are illustrative in this regard: Nevertheless, the point must be made that patent protection is reserved for creations in the technical field. This is now clearly expressed in the new wording of Article 52(1) EPC. In order to be patentable, the subject-matter claimed must therefore have a "technical character" or to be more precise - involve a "technical teaching", i.e. an instruction addressed to a skilled person as to how to solve a particular technical problem using particular technical means. It is on this understanding of the term "invention" that the patent granting practice of the EPO and the jurisprudence of the Boards of Appeal are based.
28

See Basic Proposal for the Revision of the European Patent Convention 13 October 2000. <http://patlaw-reform.european-patentoffice.org/epc2000/documents/mr/_pdf/em00002a.pdf>.

21

Peter Prescott J again tellingly notes: .If something is an invention we can call it "technology" for short.30

Owing to this definitional difficulty, most member states resort to a negative or exclusionary definition.31 Thus for example, in Europe, invention is defined to exclude the following: discoveries, scientific theories and mathematical methods; literary, dramatic, musical and artistic works, and any other aesthetic creations whatsoever; schemes, rules and methods for performing a mental act, playing a game or doing business, and programs for a computer; presentations of information; and methods of medical treatment.32

Indian law follows a similar format and section 3 excludes from the ambit of patent protection a diverse range of subject matter. It reads as below:

2.

What are not Inventions: Evaluating Section 3

The following are not inventions within the meaning of this Act, a. an invention which is frivolous or which claims anything obviously contrary to well established natural laws;
See CFPH LLC v Comptroller-General Marks [2005] EWHC 1589 (Pat), at para. 92.
30 31

of Patents,

Designs

and Trade

See NRDC (n 28) which states that in telling us about patentable inventions, the Patents Act 1977 does not try to define what is an 'invention'. Instead, it contains a list of things that are not inventions. Art 52(2) of the European Patent Convention, 1977 (hereafter EPC). See also Article 15 of the Andean Community law (Decision 486-Common Provisions on Industrial Property (14 September 2000), available at WIPO Collection of Laws for Electronic Access (CLEA) database) for a similar list of exclusions. <http://www.wipo.int/clea/en/index.jsp> (14 September 2005).
32

22

b. an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;] c. the mere discovery of a scientific principle or the formulation of an abstract theory [or discovery of any living thing or non-living substance occurring in nature;] d. the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation : For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;] e. a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; f. the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way; g. Omitted by Patents (Amdt.) Ad, 2002 h. a method of agriculture or horticulture; i. any process for the medicinal, surgical, curative, prophylactic 1[diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. j. plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; k. a mathematical or business method or a computer program per se or algorithms; l. a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematrographic works and television productions; m. a mere scheme or rule or method of performing mental act or method of playing game; n. a presentation of information; o. topography of integrated circuits; 23

p. an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

The Definitional Exclusions A careful evaluation of these various exclusions reveal a diversity of rationales underlying them. meaning of the term Some exclusions flow from the (hereafter definitional invention

exclusions). Thus, one might argue that the term invention connotes a man made creation within the technical or the technological field.

The exclusion of literary works (such as poems) under section 3(l) of the patents act comports well with this rationale. judge notes: Some kinds of ideas cannot be patented at all even if new and very ingenious. For example, you could not patent the plot of a detective story. It would not be considered to be an 'invention' under patent law.33. As an English

Similarly, a mere discovery of a scientific principle or a natural product (as excluded under section 3(c)) will fall outside the purview of the term invention. For one has not created or invented anything new by human intervention: but merely discovered something that was not known earlier.34 This is best expressed in the language of Lord Kenyon in Hornblower v Boulton35:
Peter Prescott Js ruling in In the Matter of Patent Applications GB 0226884.3 and 0419317.3 by CFPH LLC [2005] EWHC 1589 (Pat) available at <http://www.bailii.org/ew/cases/EWHC/Patents/2005/1589.html> (26 August 2005)
33

See Linda J. Demaine and Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, 55 Stan. L. Rev. 303, 373 (2002-03).
34 3 35

101 Eng. Rep. 1285

24

having now heard everything that can be said on the subject, I have no doubt in saying, that this is a patent for a manufacture, which I understand to be something made by the hands of man.36

And later, he states:

Courts in the United States, as well, have emphasized on the human intervention aspect of an invention. Illustratively, in Morton v New York Eye Infirmary37, the New York Circuit Court expressed the opinion that, In its naked ordinary sense, a discovery is not patentable. A discovery of a new principle, force, or law operating, or which can be made to operate, on matter, will not entitle the discoverer to a patent. It is only where the explorer has gone beyond the mere domain of discovery, and has laid hold of the new principle, force, or law, and connected it with some particular medium or mechanical contrivance by which, or through which, it acts on the material world, that he can secure the exclusive control of it under the patent laws. He then controls his discovery through the means by which he has brought it into practical action, or their equivalent, and only through them. It is then an invention, although it embraces a discovery. Sever the force or principle discovered from the means or mechanism through which he has brought it into the domain of invention, and it immediately falls out of that domain and eludes his grasp. It is then a naked discovery, and not an invention.38

Secondly, in order to constitute an invention, one might argue that the subject matter must necessarily be new, inventive and useful.

36

Id., at 1288. 5 Blatchf. 116, 17 F.Cas. 879 (1862)

37

Id., at 881. See also, Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 476 (1974) (stating that discovery is something less than invention)
38

25

The

Indian Patents Act explicitly

recognizes

this definitional

component and articulates it in section 2(j), which defines invention as a new product or process involving an inventive step and capable of industrial application.

Some of the section 3 exclusions draw from this definitional component and categorically exclude certain subject matter from the purview of patentable inventions.

Section 3(e) encapsulates such a rationale by suggesting that merely combining existing substances (when the combination does not yield a result greater than the sum total of the additions) is not patentable. It excludes a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. This is a kind of inventive step or non-obviousness test.

The Policy Based Exclusions The second broad category of section 3 exclusions are those that are made for policy reasons, whether explicit or implicit (hereafter policy based exclusions). The subject matter may be an invention from the definitional standpoint, having a significant nexus with technology and being new, inventive and useful. Yet, it may be denied patents for reasons of policy.

Section 3(b) is an excellent illustration of this, where subject matter is inventive, new and useful is still excluded since it is immoral in some way. This section excludes from patentability, an invention the primary or intended use or commercial exploitation of which 26

could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment. Examples might include a new and inventive device that aids in theft.

Similarly, section 3(i) excludes methods of medical treatment from the scope of patentability for policy reasons.39 Section 3(h) is also illustrative of this, where the act deems a new and inventive method of agriculture of a process of treatment to be a non invention and therefore not patentable.40.

This is a clear deeming provision under the law, where although technically the said subject matter may amount to an invention, the law deems them to be non inventions and therefore not patentable.

If section 3(d) is treated as separate and distinct from other patentability criteria and not a species of the inventive step test, then it qualifies as an exclusion made for policy reasons. The key question then is: to what extent can member states carve out exclusions from the term invention based on policy reasons?

Prima facie, TRIPS appears to carve out very specific cases where
3 39

This exception is not unique to India. Illustratively, Art. 53(c) of the European Patent Convention contains a similar exception. For a list of other countries with similar exceptions, see Richard Gold & Yann Joly, The Patent System and Research Freedom: A Comparative Study, in Exclusions from Patentability and Exceptions and Limitations to Patentees Rights , (Report prepared by Bentley et al. for WIPO Standing Committee on the Law of Patents, SCP/15/3, 2010), available at < http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3annex1.pdf>.
4 40

Indian Patent Act, 1970, S3(h) excludes from patentability, a method of agriculture or horticulture.

27

one might bring in a policy based exclusion. Article 27.2 and 27.3 3 states: 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

3.

Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

One might argue that any further policy exclusions are not sustainable under TRIPS. Therefore, a Section 3(d) type exclusion, if viewed as a policy based exclusion, might run foul of TRIPS. Panels are known to hew close to overly textual meanings of treaty terms41
41

See Petros C. Mavroidis (2009), Chapter 3 Licence to Adjudicate: A Critical Evaluation of the Work of the WTO Appellate Body So Far, in James C. Hartigan (ed.) Trade Disputes and the Dispute Settlement Understanding of the WTO: An Interdisciplinary Assessment (Frontiers of Economics and Globalization, Volume 6), Emerald Group Publishing Limited, pp.73-90 where he notes that WTO appellate body (AB) has traditionally followed an (overly) textualist interpretative approach. This attitude is probably consistent with the incentive structure of a risk

28

and if the term invention is understood to mean something of a technical or technological nature, then new forms of known chemical substances under section 3(d) would qualify as inventions within the meaning of TRIPS.

However, as one cannot predict with absolute certainty the outcome of a TRIPS challenge, given the fact that there is no consensus on what the term invention means. Suffice it to suggest that there is some risk of a TRIPS challenge and a finding of contravention, should section 3(d) be divorced from regular patentability criteria and be seen as an independent stand alone test for patentability.

It also bears noting that if this line of reasoning were adopted (namely that the only kind of policy based exclusions compatible with TRIPS are those that are explicitly carved out in Article 27.2 and 27.3), then 3(h) which excludes a method of agriculture from patentability may also be held to contravene TRIPS.

B.

THE

ALTERNATIVE:

BRIDGING

SECTION

3(d)

AND

INVENTIVE STEP

The second alternative is to interpret section 3(d) as nothing than a specific adaptation of the inventive step test to suit the specificities of chemicals/pharmaceuticals.

To this extent, it is seen as a species of the broader genus called


averse agent who can always turn back and request from its principals to write a more complete contract next time.

29

inventive step or non-obviousness. Such technologically specific applications of general patentability standards and the evolution of sector specific tests are common in leading patent jurisdictions such as the US. Within the chemical arts, courts in the US and EU have evolved a specific obviousness test that bears close similarly to section 3(d). Courts have held that structural similarities between a pharmaceutical substance that is sought to be patented and an earlier known substance trigger off a presumption of prima facie obviousness.42 This presumption can be dislodged only if the patent applicant demonstrates that the applied for substance exhibits unexpected or surprising results.
43

Although discount

unexpected advantages

results that

are

ordinarily mere

not

limited

to

therapeutic advantages alone,44 are

courts have been known to physical advantages.

Illustratively, in Pfizer v Apotex45, the CAFC (Court of Appeals for the Federal Circuit) strikes a distinction between therapeutic properties
In earlier cases, the presumption arose as soon as the structural similarity was established. In subsequent cases however (most notably Dillon), the court held that one must also demonstrate that there is some motivation to make the claimed structurally similar substance. See In Re Diane M. Dillon, 919 F.2d 688 (Fed. Cir. 1990).
42

43

For a recent application of the US standard, see Takeda v Alphapharm, 480 F.3d 1348 (Fed. Cir. 2007), where the court relied on two of its earlier decisions: In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990), which held that structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness. And In re Deuel (51 F.3d 1552, 1558 (Fed. Cir. 1995), where the court held that A known compound may suggest its homolog, analog, or isomer because such compounds often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. Id page 9. See Eli Lilly and Company v Premo Pharmaceutical Laboratories, Inc., 630 F.2d 120 (1980), where the court upheld the patentability of an oral antibiotic that was superior in terms of its mode of administration (it could be taken in tablet form, when compared with its predecessor that had to be taken intravenously). To this extent, the drug did not strictly exhibit increased therapeutic efficacy, but was a more advantageous dosage form/drug delivery mechanism.),
44 4 45

480 F.3d 1348 (2007)

30

and other properties (physical properties such as process-ability) of a pharmaceutical substance and appears to give the latter relatively much less weight while assessing non-obviousness. holds: Finally, we do not see the trial courts finding that amlodipine besylate had adequate physicochemical characteristics as sufficient to uphold the courts ultimate holding of unexpected superiority... At most, then, Pfizer engaged in routine, verification testing to optimize selection of one of several known and clearly suggested pharmaceutically-acceptable salts to ease its commercial manufacturing and marketing of the tablet form of the therapeutic amlodipine. Creating a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient . . . to enhance commercial opportunities . . . is universaland even common-sensical. A scholar notes in this regard: The Pfizer opinion repeatedly emphasized that the besylate part of the claimed compound was merely a drug delivery vehicle that did not improve amlodipines therapeutic effect. Because the Federal Circuit discounted the physical properties of improved stability and tablet processing, Pfizer was unable to rebut the prima facie case of obviousness based on the prior art.
46

The court

Therefore, one might argue that section 3(d) simply asks whether or not a structurally similar new form demonstrates unexpected properties (such properties relating specifically to efficacy).

To this extent, it is nothing more than a species of the overall inventive step test laid down in section 2(ja). One might also see it
See JM Mueller, Chemicals, Combinations, and Common Sense: How the Supreme Court's KSR Decision is Changing Federal Circuit Obviousness Determinations in Pharmaceutical and Biotechnology Cases 35(3) N. Ky. L. Rev. 281 (2008)
46

31

as a short cut for determining whether or not something is inventive.

A patent office faced with an alleged invention which potentially claims a new form of an existing substance would do well to therefore use section 3(d) as a short cut to determining inventive step. If the alleged new form fails the test of section 3(d), that is evidence enough of the fact that it is not inventive. To this extent, one would avoid the incongruous ruling such as the one handed down by the IPAB and potentially avoid a TRIPS challenge as well.

However, it bears noting that section 3(d) alone is not dispositive of the inventive step test. Rather, it might so happen that even despite the existence of significantly enhanced therapeutic efficacy, the new form was obvious to try with some reasonable expectation of success (it followed an obvious train of thought or came out of trial and error and fairly routine experimentation by the skilled person).

In such a case, the new form does not merit a patent, despite satisfying section 3(d).

In Pfizer vs Apotex, the court noted: Alternatively, we hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion. 32

patentability is not imparted where the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success. Merck, 874 F.2d at 809 (quoting In re Dow Chem. Co., 837 F.2d 469, 473 (Fed. Cir. 1988)). For these reasons, we hold that Apotex introduced clear and convincing evidence that a skilled artisan would have had a reasonable expectation of success with the besylate salt form of amlodipine at the time the invention was made.

In other words, after using section 3(d) as a short cut for determining whether or not a claimed new chemical form is inventive, the patent office would still need to subject the claimed form to the inventive step test in section 2(ja), which reads as below:

inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;

As I had noted earlier in an article47:

As can be seen from this definition, while the fundamental yardstick for measuring an inventive step remains that which is not obvious to a person skilled in the art, a requirement that the invention involve a technical advance or have an economic significance of some sort has been added. This change in the standard seems odd, given that the very purpose of the inventive step criterion is to determine whether an invention sufficiently advances the technical arts so as to warrant an exclusive right. This is
See Shamnad Basheer, Indias Tryst with TRIPS: The Patents (Amendment) Act, 2005, 1 Ind. J. L. Tech. 15 (2005).
47

33

no doubt achieved in an optimal manner by the simple test of whether the invention, though novel, is nonobvious to a person skilled in the art. .Contrary to suggestions by some commentators, the addition of technical advance or economic significance to the non obviousness test does not dilute the inventive step requirement..48 In other words, given that the term invention relates essentially to technological arts (as earlier discussed), any alleged invention that represents a sufficient leap from the prior art will ipso facto amount to a technical advance.

It bears noting that a determination of inventive step, considered as the key patentability filter, is prone to a high degree of fact specific assessment, and evaluative analysis, making for considerable variation in results.

WTO member states are free to devise appropriate standards and principles for determining inventive step, since the term is not defined under TRIPS. While some countries may opt for a lower threshold and permit a greater range of inventions to be patented, others may opt for a stricter standard. The Indian Patent Act 1970, premised on the Ayyangar Report in large part, arguably supports a much higher threshold, particularly for pharmaceutical technology, as made evident by section 3(d).

The Viagra example is illustrative in this regard. The chemical substance, Sildenafil Citrate, sold as Viagra by Pfizer, was the first effective oral treatment for MED (male erectile dysfunction), with up

48

Id., at 22.

34

to 82% of patients experiencing benefits.49 At the time of this pathbreaking discovery, Sildenafil Citrate was already a known substance and was being tested by Pfizer for its ability to cure angina (blood pressure) and a specific form of heart ailment. Upon discovering its potential new use as a cure for MED, Pfizer immediately filed a patent.50

The U.K. courts, however, invalidated the patent on the ground that the new use would have been obvious to a person skilled in the art. 51 The court based its reasoning on the ground that the prior art included an article by Rajfer et al. and published patents,52 that would have prompted the person skilled in the art to evaluate the possibility of using Sildenafil Citrate, for the treatment of MED.53 Famously, the court noted that it was worth a try.

49

See Darren R. Flower, Molecular Informatics: Sharpening Drug Designs Cutting Edge (2002), 17, available at http://www.rsc.org/ebooks/archive/free/bk9780854048168/bk978085404816800001.pdf.
50

Sildenafil Citrate essentially works by inhibiting an enzyme that retards the relaxation of the penile muscle. The relaxation of penile smooth muscle is traceable to chemicals called cyclic adenosine monophosphate or cAMP and cyclic guanosine monophosphate or cGMP. cGMP and cAMP are rendered ineffective by the action of a PDE enzyme. Viagra helps restore the potency of cGMP and cAMP by inhibiting the PDE enzyme with the help of certain other chemicals called PDE inhibitors.
51

See Lilly Icos Llc v. Pfizer Ltd [2002] EWCA Civ. 1 where the Court of Appeal in the U.K. upheld the High Court decision delivered by Laddie, J., in this regard (Pfizer Ltd v. Lilly Icos Llc [2000] EWHC Patents 49). Two earlier Pfizer patent applications, namely EP 0463 756 and EP 0526 004, referred to respectively as Bell I and Bell II, covered Sildenafil Citrate, along with a number of other chemicals, proposing their use for a number of medical applications, but not the treatment of MED specifically. However, these patents disclosed the use of Sildenafil Citrate as a PDE inhibitor for the treatment of such complaints as angina and hypertension.
52

53

See Lilly Icos Llc v. Pfizer Ltd. [2002] EWCA Civ. 1, 54 available at http://www.bailii.org/ew/cases/EWCA/Civ/2002/1.html (last visited Jan. 18, 2011) (citing the key prior art evidence as Rajfer J. et al., Nitric Oxide as a Mediator of Relaxation of the Corpus Cavernosum in Response to Nonadrenegic, Noncholinergic Neurotransmission, (1992) 326 NEW ENG. J. MED. 90).

35

However, the Federal Court of Appeals in Canada rejected the above line of reasoning and held that a mere worth a try possibility did not preclude inventiveness. Rather, the claimed invention would be obvious, only when the try was a matter of routine and required no significant thinking or effort.54

The divergent conclusions on obviousness discussed above stem not only from a differential subjective assessment of the same facts,55 but also due to a difference in legal standards. As can be seen from the above discussion, Canada preferred a lower non-obviousness or inventive step threshold that would have found in favour of the patentability of a larger number of inventions than the UK regime.56
54

Compare Pfizer Canada Inc. v. Apotex Inc. (F.C.A.), 2009 FCA 8, [2009] 4 F.C.R. 223, 28-31 available at http://reports.fja.gc.ca/eng/2009/2009fca8/2009fca8.html (last visited Jan. 18, 2011). (following the standard laid down by the Canadian Supreme Court in an earlier pharmaceutical case, Apotex Inc. v. Sanofi-Synthelabo Canada et al 2008 SCC 61), with Apotex Inc. v. Sanofi-Synthelabo Canada et al 2008 SCC 61 available at http://scc.lexum.umontreal.ca/en/2008/2008scc61/2008scc61.pdf (last visited Jan. 18, 2011), (holding that: For a finding that an invention was obvious to try, there must be evidence to convince a judge on a balance of probabilities that it was more or less self-evident to try to obtain the invention. Mere possibility that something might turn up is not enough.)

55

The US and other leading patent jurisdictions hold non-obviousness or inventive step to be a question of law, albeit one is that predicated heavily on underlying facts. See In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009) (Obviousness is a question of law based on underlying findings of fact.) See also Professor Chris Cotropia, KSR and the Line between Fact and Law, (May, 2007), available at http://www.patentlyo.com/patent/2007/05/ksr_and_the_lin.html (last visited Jan. 19, 2011) (Owing to the highly intensive fact specific nature of the enquiry and the subjectivity of the assessment, it is evident that courts may come to differing conclusions on the facts of the same case.)

56

See Pfizer Canada Inc. V. Apotex Inc., 2009 FCA 8, [2009] 4 F.C.R. 223, where the court noted: .the test applied by Mr. Justice Laddie appears to be met if the prior art indicates that something may work, and the motivation is such as to make this avenue worthwhile to pursue (Pfizer Ltd., at paragraph 107, as quoted at paragraph 42 above). As such, a solution may be worthwhile to pursue even though it is not obvious to try or in the words of Rothstein J. even though it is not more or less self-evident (Sanofi-Synthelabo, at paragraph 66). In my view, this approach which is based on the possibility that something might work, was expressly rejected by the Supreme Court in Sanofi-Synthelabo, at paragraph 66.

36

India is free to therefore devise her own standard for obviousness or inventive step without necessarily toeing the US, EU or any other country on this count.

C.

MAKING SENSE OF THE PATENT TERMINOLOGY

The Patent Act is creased in several parts, particularly in the aftermath of the 2005 amendments. Some of these creases can be ironed out by interpreting terms by drawing meaning from other provisions in the Act.

The Act uses the following terms: i) ii) iii) iv) v) vi) vii) invention product process substance entity pharmaceutical substance pharmaceutical product Product and process have fairly standard

Most patent regimes including TRIPS uses the terms: invention, product and process. connotation and are often used in contradistinction to each other57

The Indian Patent Act also uses these terms in the following sections:

See WIPO, Fields of Intellectual Property Protection, in WIPO: INTELLECTUAL PROPERTY HANDBOOK: POLICY, LAW & USE 16, 17 (Invention means a solution to a specific problem in the field of technology. An invention may relate to a product or a process.)
57

37

Section 2(j): "invention" means a new product or process involving an inventive step and capable of industrial application;

Section 48 stipulates that: .a patent granted under this Act shall confer upon the patentee (a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India: (b) where the subject matter of the patent is a process the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India:

Therefore the registrability of a patent and its rights really apply to only two broad categories: product and process. And one has to fit in all claimed subject matter within these terms. To this extent, terms such as substance, article,58 entity, etc., have to be read in conformity with these terms.

Section 3(d) outlines what is a patentable invention: any new form that demonstrates significantly enhanced efficacy is an invention and gets protection as a product. In other words, a new form qualifies as a patentable product (and a new substance) only when it demonstrates significantly enhanced efficacy. As to the kind of
58

See section 2(o) which defines "patented article" and "patented process" to mean respectively an article or process in respect of which a patent is in force;

38

protection that a product is entitled to, Merrel Dow vs Norton59 is illustrative:

The scope of the monopoly conferred by a product claim is defined by section 60(l)(a), which provides that where the invention is a product, a person infringes the patent if, without the consent of the proprietor, he "makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise." For this purpose it does not matter how the product is made or what form it takes. The monopoly covers every method of manufacture and every form which comes within the description in the claim.60

And later: It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context. ... It follows that if it can be shown that such physical entity (that is, a compound) is already in the state of the art (for example in the context of a particular activity), then a claim to the physical entity per se lacks novelty.61

Needless to add the very process of creating the new form may itself be patentable independently, if it is demonstrated to be new and inventive.

Whither Section 2(ta)?

59

[1995] UKHL 14. Id., at para 13. Decision G02/88 MOBIL/Friction reducing

60

Id., at para 14. (quoting additive [1990] EPOR 73)


61

39

The term pharmaceutical substance has been defined in section 2(ta) to mean: "pharmaceutical substance" means any new entity involving one or more inventive steps.

This is a rather curious definition, since the term does not find mention anywhere else in the Act. As noted in an earlier article:62

The term pharmaceutical substances has been rather strangely defined in section 2(1)(ta) as any new entity involving one or more inventive steps. Defined in such a broad way, one is forced to query: would a mobile phone that deploys advanced technology be a pharmaceutical substance if it is shown that such entity is new and involves one or more inventive steps? What is even more perplexing about this definition is the fact that the term pharmaceutical substance does not find mention anywhere else in the Patents Act.25 In the absence of such a term in the Act, one wonders why the legislature, in all its wisdom, did not see it fit to clarify this concept.63 It is pertinent to note in this regard that Section 92A, which deals with compulsory licenses in the context of exports to countries with minimal manufacturing capabilities, uses the term pharmaceutical products. However this term is used in a different sense than pharmaceutical substances, as is made evident by the fact that it is defined in section 92A itself. The absurd definition in section 2(1)(ta) cannot therefore apply to pharmaceutical products under section 92A. If one were keen on investing some meaning in this insertion of a term that finds no mention anywhere else in the act, one might argue that it offers some support for the proposition that section
See Shamnad Basheer, Indias Tryst with TRIPS: The Patents (Amendment) Act, 2005, 1 Ind. J. L. Tech. 15 (2005).
62 6 63

Id., at 23.

40

3(d) is a species of the inventive step test, as applied specifically to the pharmaceutical arts. The definition of pharmaceutical substance as a new entity involving one or more inventive steps essentially means that in order to constitute a new pharmaceutical substance, an allegedly new form must necessarily entail one or more inventive steps.

III.

INHERENT ANTICIPATION AND APPOINTMENT OF

EXPERT
The key issues are: 1. Was the beta crystalline version of imatinib mesylate

effectively enabled by the 1993 patent and subsequent literature that preceded the priority date of the 1998 patent application covering the beta crystalline version (the priority date for the 1998 application is 18 July, 1997) 2. Even if it was not enabled by the prior art, could the beta crystalline form have been said to be obvious to a skilled person from the prior art?

If the person skilled in the art attempting to produce imatinib mesylate (as per the disclosure in 1993 patent and other relevant prior art existing up to July 1997) would necessarily produce the beta crystalline version (since the compound naturally expresses itself in this form), then the beta crystal will be found to have been anticipated. Such a conclusion holds good even if such a skilled person obtaining the beta crystalline form is unable to characterize it as a beta crystalline form.

It is submitted that in such cases, the beta crystalline form is 41

anticipated under the doctrine of inherent anticipation, a doctrine explicated well in Schering Corp. v. Geneva Pharmaceuticals, Inc.64 In this case, Schering had a patent covering loratadine, an antihistamine marketed as Claratin. Schering subsequently filed a second patent on descarboethoxyloratadine (DCL) that is naturally produced by the human body as a metabolite of loratadine.65 Notwithstanding the lack of any prior art teaching of DCL, or any other metabolite of loratadine, the Court held that Scherings prior art patent claiming loratadine inherently anticipated its subsequent patent. This is because DCL was necessarily and inevitably formed upon the metabolism of loratadine. Inherent anticipation does not require that the inherent feature be appreciated or recognized at the time of the earlier patent, as long as the disclosure is a "necessary and inevitable" consequence of the earlier invention.
66

Based on the above, if the beta crystalline version automatically results from the teachings of the prior art, it is anticipated, even if the skilled person is unable to identify or characterize it.

Conversely, if the beta crystalline version does not automatically result from the teachings of the prior art, it cannot be held to be anticipated. However, it may still be held to be obvious to a person skilled in the art, in the light of prior art. In order to optimally resolve such complicated technical issues for the future, the intervenor requests that this Honble Court suggest
64

339 F.3d 1373, 1382 (Fed.Cir. 2003).

65

Id. at 1375. Supra note 38 at 1378-80

66

42

that lower courts and tribunals appoint independent experts under section 115 of the Patents Act. In the case at hand, such an expert could, at the very least, have been tasked with helping determining whether or not the prior art would have rendered Imatinib Mesylate inherent.

IV.

PATENTS, PUBLIC ORDER AND EXCESSIVE PRICING

The IPAB held that the beta crystalline form of imatinib mesylate was not eligible for a patent under section 3(b), since a drug corresponding to the patent had been priced excessively. Section 3(b) currently reads as under: 3. What are not inventions: The following are not inventions within the meaning of this Act (b) an invention the primary or intended use or commercial exploitation of which could be contrary to be public order or morality or which causes serious prejudice to human, animal, plant life or health or to the environment

According to the IPAB, the excessive price of Glivec would create public disorder and was therefore ineligible for a patent under section 3(b) of the Indian patents act. In the words of the IPAB But as per information furnished in its written counterargument by R 3 that when the Appellant was holding the right as EMR on GLEEVEC it used to charge Rs. 1, 20,000/- per month for a required dose of the drug from a cancer patient, not disputed by the Appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before 43

us, we observe that the Appellants alleged invention wont be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of section 3(d)of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things

It is submitted that this is a wrong legal proposition. Under current Indian patent law, the excessive price of a drug cannot be a ground for denying a patent to an invention underlying the said drug. The key issue at the time of granting a patent is whether the invention represents a good enough technical/scientific advance to merit a twenty year monopoly?

Any potential for patent abuse is redressable through a number of ex-post (prospective) mechanisms such as compulsory licensing and price control and ought not to factor in during the stage of grant of a patent, not least because very often, there is no product at the stage of grant of a patent.

Secondly, such an additional patentability criterion could fall foul of TRIPS. Under Article 27 of TRIPS, all inventions (barring those mentioned in paragraphs 2 and 3 of that Article) are patentable. Although the terms ordre public or morality are fairly subjective and dependent on the particular socio-cultural mores of a country at a given point in time,67 an exception based on public ordre and
67

Basheer, Purohit and Reddy, Patent Exclusions that Promote Public Health Objectives Report by Bentley et al Exclusions from Patentability and Exceptions and Limitations to Patentees Rights, WIPO Standing Committee on the Law of Patents, SCP/15/3, September 2010, available at < http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3annex1.pdf>.

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morality in Article 27.2 can be applied only when it is necessary to prevent the commercial exploitation of the invention.68 In other words, Article 27.2 of the TRIPS applies only if a prohibition against the commercial exploitation of the invention is necessary to protect ordre public or morality and only if the exclusion from patentability will likewise contribute to the protection of that ordre public or morality.69 This could suggest, as some have argued, that in order to justify a patent as immoral or against public order, one must first have a law which prevents the commercial exploitation of the particular product.70 Or one must at least show the existence of circumstances necessitating such a law or ban.71 Under such an interpretation, unless India bans the sale of Glivec or shows that Glivec is otherwise harmful, it cannot exclude a patent covering it on the grounds of public order or morality.

Thirdly, Article 27.2 appears to be predicated on a necessity test to assess whether protection of an overriding social interest is justified.72 Therefore, any measure taken is justified only if no
Patents: Ordre Public and Morality, Resource Book on TRIPS and Development, available at <http://www.iprsonline.org/unctadictsd/docs/RB2.5_Patents_2.5.3_update.pdf>.
68

69

Charles R. McManis, Patenting Genetic Products and Processes: A TRIPS Perspective, available at <http://law.wustl.edu/faculty_profiles/documents/Kieff/HGPIP/Final/GEN_50_CH5.p df> (citing Nuno Pires de Carvalho, The TRIPS Regime of Patent Rights 170-173 (2003)).
70

Nuno Pires De Carvalho, The TRIPS Regime of Patent Rights, 2nd edn. Kluwer Law International,Hague 2005 at 209.
71

Dan Leskien & Michael Flitner, Intellectual Property Rights and Plant Genetic Resources: Optionsfor a Sui Generis System (Issues in Genetic Resources No. 6 June 1997), In ternational Plant Genetic Resources Institute.
72

Though TRIPS constitutes the lex specialis for dealing with patent issues in the WTO framework, the GATT/WTO jurisprudence on Article XX of GATT is likely to play a role in the interpretation of the said Article. [Citing India- Patent Protection for Pharmaceutical and Agricultural Chemical Products case (WT/DS50)]. Article XX (a) and (b) of GATT have a similar structure to Article 27.2, and it is clear that,

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reasonable alternative is available to a Member. Here, as stated above, alternatives such as compulsory licensing, price control mechanisms are reasonably available. Hence in this case, one might argue that the conditions of Article 27.2 of TRIPS have not been satisfied.

For all the above reasons, it is submitted that the rejection of a patent based on excessive price of the final patent product has no basis in Indian patent law.

for the purposes of these provisions, exclusions must be objectively justified. [GATT Analytical Index, Vol. I, p. 518 et seq.]. Applying principles of the GATT that interpret similar provisions in Article XX, the necessity test must be applied to determine whether a) it is necessary to public morals, and b) that it is necessary to protect human, animal or plant life.

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