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PATENT CASE LAWS IN INDIA

INDIAN IP LAWS Patent Case Laws:

PATENTS
Patent Search 1) When a patent is said to be granted under the Act:
Patent Drafting
Patent Applications The case of Dr Snehlata C. Gupte v. Union of India & Ors (W.P. (C) No 3516 and 3517 of
Patent Filing 2007) Delhi High Court) was significant in determining when a patent can said to be granted
Patent Procedure under the Patent Act. The Court, while holding that the date of grant of a patent is the date
Patent Flowchart on which the Controller passes an order to that effect on the file, noted that the language, a
Patent Opposition patent shall be granted as expeditiously as possible (u/s 43) does point out that a patent has
Patent Annuity Payments to be granted once it is found that either the application is not refused in a pre-grant
Working of Patented opposition or otherwise is not found in contravention of any provision of the Act.
Inventions Therefore, the decision taken by the Controller on the file is the determining event for
Revocation of Patent ascertaining the date of grant of patent and the acts of sealing of the patent and entering the
Compulsory Licensing same in the Register are ministerial acts evidencing the grant of patent. The case highlights
Patent Filing Fees & Forms that Intention to Grant by the Controller on file is the date of grant.
Patent Infringement
Patent Act India
The Chemtura Corporation vs Union Of India (CS(OS) No. 930 of 2009 highlights the fact
Patent FAQ India
the administrative requirement of the Act must be strictly met and the facts must not be
PCT Application
suppressed from the Patent Office. It was held that the plaintiff had suppressed information
PCT Search
regarding prosecution of the patent applications at the USPTO and the EPO. The plaintiff
PCT International Filing
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 PCT International Filing
PCT Filing Procedure India
Indian Patent Office - ISA
PCT FAQ India
Section 8 & Rule 12
Patent Litigation
Patent Infringement &
Enforcement
Remedies Against
Patent Infringement
Patent Enforcement
Flowchart
Patent Case Laws
Foreign Filing License
TRADEMARKS
DESIGNS
COPYRIGHT
DOMAIN NAMES
GEOGRAPHICAL INDICATIONS
ANTI-COUNTERFEITING
IP ENFORCEMENT AND
LITIGATION
INFRINGEMENT & PASSING OFF
OF TRADEMARK
FRANCHISING LAW
MADRID PROTOCOL
argued that the patent was granted in India after due examination by the IPO and should be
valid. The defendants argued that due to non-sub-mission of facts of the claims being
narrowed down in the USPTO and EPO, the IPO could not look into the matter and granted the
patent with the broadest claims. The High Court held that the status of prosecution of a
patent application in jurisdictions abroad must be provided in detail, including information
regarding searches conducted and objections raised. The case underlined the fact that Section
8, though held to be a procedural formality, could solely be a ground for revocation under
Section 64 of the IPA. It points out that requirement of S. 8 are a continuous obligation and
should be done on a periodic basis.
The most common section used for invalidating a pharmaceutical related patent in pre-grant;
post grant or counter claim for infringement is the invalidation u/s 3 (d). The section
provides that salts, esters, ethers etc, are considered to be the same substance and hence
are non patentable unless they differ significantly in properties with regard to efficacy.
However the term efficacy has not been defined in the Act and its interpretation depends on
the discretion of the Controller.
In Tata Chemicals Limited vs Hindustan Unilever Limited (ORDER No.166 of 2012) IPAB
noted that once the Controller had called upon the applicant to furnish foreign particulars
under Section 8 (2), it becomes the duty of the applicant to furnish those details that are
required under Section 8(2)
The Supreme Courts decision in case of Novartis AG Vs Union of India would be touted as
the landmark judgment in all the years to come for the Pharma Industry as well as the Indian
Patenting System. The Supreme Court of India rejected Novartiss plea on its blood cancer
drug Glivec and denied patent to it.

SAARC IP LAWS
The court evaluated the patentability of the beta-crystalline form of imatinib mesylate as
per the requirements of Section 3(d). The Court dismissed Novartiss arguments that Section
INTERNATIONAL IP LAWS
3(d) does not apply in the instant case. The Court noted that the Zimmerman patent of 1993,
had identified the tumour treating potential of the imatinib free base and its derivatives, such
USEFUL LINKS as imatinib mesylate and that the prior art documents including the article published in
Cancer Research clearly identified the in-vivo experiments carried out with imatinib
mesylate.
The Supreme Court did not specifically clarified enhanced efficacy and restricted the
criteria of efficacy to therapeutic efficacy with respect to pharmaceutical drugs. The Court
had further ruled that an increase in bioavailability can qualify for protection under 3(d), if
evidence is provided to establish that such an increase leads to greater therapeutic efficacy.

The Supreme Court rejected the claims of Swiss pharma giant stating that the drug had failed
to qualify for a patent according to Indian law. The Court also held that patents could be
granted only in the case of genuine inventions.

Novartis had been fighting since 2006 to get the patent for Glivec, which as claimed by
oncologists is major advance in treating chronic myeloid leukaemia. It had been continuously
pushing for the patent arguing that if the rights of investors are not upheld then it will hit

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 research and development of new drugs.

Compulsory License in India:

Indias First Compulsory License On March 9, 2012, the Indian Patent Office granted its
first Compulsory License to Natco Pharma Ltd. for producing generic version of Bayer
Corporations's patented medicine Nexavar (Sorafenib Tosylate), which is used in the
treatment of Liver and Kidney cancer. While the multinational giant was selling the drug at
INR 2.80 lakh for a month's course, Natco promised to make available the same at a price of
about 3 % (INR 8800) of what was charged by Bayer. Natco was directed to pay 6 percent of
the net sales of the drug as royalty to Bayer. Among other important terms and condition of
the non assignable, non exclusive license were directions to Natco to manufacture the
patented drug only at their own manufacturing facility, selling the drug only within the Indian
Territory and supplying the patented drug to at least 600 needy and deserving patients per
year free of cost.

Aggrieved by the Controllers decision, Bayer immediately moved to the Intellectual Property
Appellate Board (IPAB) for stay on the order alleging that the grant of compulsory license
was illegal and unsustainable. The Board rejected Bayers appeal holding that if stay was
granted, it would definitely jeopardize the interest of the public who need the drug at the
later stage of the disease. It further held that the right of access to affordable medicine was
as much a matter of right to dignity of the patients and to grant stay at this juncture would
really affect them.

Bayer then filed an appeal challenging the compulsory licence granted to Natco by the
Controller-General. The Board stated that the invention must be available to the public at a
reasonably affordable price and if not, compulsory licence can be issued and observed that
the Sub-sections (a),(b) and (c) of S.84(1) are separated by the disjunctive or and
therefore, even if one condition is satisfied, the Controller will be well within his rights to
order compulsory licence.
The Board further noted that The R&D costs and the prices of other drugs do not assist in
deciding what the public can afford reasonably. It stated that the reasonably affordable price
necessarily has to be fixed from the view point of the public and the word afford itself
indicates whether the public can afford to buy the drug.

It also stated that even if it takes the appellants own number (i.e. the number of affected
patients) it finds that the supply made by it cannot be said to be adequate and the price
definitely is the factor that will determine whether the public will reach out for a particular
invention.
The Board held that the Controller was right in holding that the sales of the drug by the
appellant at the price of about 280,000/- was alone relevant for the determination of public
requirement and he was also right in considering the purchasing capacity of the public and
the evidence available to conclude that the invention was not reasonably affordable to the
public.

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 On the percentage of royalty that was to be paid by the Respondent to the Appellant (6%
that was fixed by the Controller), IPAB increased it by 1 percent but did not change any other
terms and conditions of the licence.
The IPAB dismissed the appeal and confirmed the grant of Compulsory license stating that it
has dealt with each of the issue in detail in view of the significance of the order of
compulsory licence made in India for the first time.

To know more about this case please read here: Patent Office grants its first Compulsory
License

For more information on Patent Case Laws in India please write to us at: info@ssrana.com

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