Novartis vS. Indian patent act,
it is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patent Gleevec. (Which is Imatinib, sold under the brand names Gleevec , is a chemotherapy medication used to treat cancer.) The Supreme Court upheld the Indian patent office's rejection of the patent application.
it is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patent Gleevec. (Which is Imatinib, sold under the brand names Gleevec , is a chemotherapy medication used to treat cancer.) The Supreme Court upheld the Indian patent office's rejection of the patent application.
summary of case:
The total duration of this case was 16 years if we consider from 1997 when Novartis filed patent application for glavac.
In 2005 india had a new patent law and the patent controller has denied the patent to novartis in 2006 what is filed an application in Madras High Court.
And in 2007 raj High Court hindi action by Novartis and in 2009 novartis send for Supreme Court and 2013 on 1st April the supreme court rejected the plea.
The total duration of this case was 16 years if we consider from 1997 when Novartis filed patent application for glavac.
In 2005 india had a new patent law and the patent controller has denied the patent to novartis in 2006 what is filed an application in Madras High Court.
And in 2007 raj High Court hindi action by Novartis and in 2009 novartis send for Supreme Court and 2013 on 1st April the supreme court rejected the plea.
History of indian patent law:
after gaining independence in 1947, there was a growing consensus that to boost manufacturing restrictive product patents must be temporarily removed.
In 1970, amendments to the Indian Patents Act abolished product patents but retained process patents with a reduced span of protection.
In 1970, amendments to the Indian Patents Act abolished product patents but retained process patents with a reduced span of protection.
The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement.
As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition.
India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.
As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition.
India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.
Arguments before the Supreme Court
Novartis
The legal team of Novartis was led by ex-Solicitor General of India Gopal Subramaniam and senior advocate T. R. Andhyarujina. Novartis had attempted to patent imatinib mesylate in beta crystalline form (rather than imatinib or imatinib mesylate), thus they sought to prevent extant literature on imatinib or imatininb mesylate from being considered as prior art. The thrust of the arguments by Novartis' legal team was two-fold: firstly, that the Zimmerman patents and the journal articles published by Zimmerman et al. do not constitute prior art for the beta crystalline form as it is only one polymorph of imatinib mesylate, thereby providing the required novelty and inventive step; and secondly, that imatinib mesylate in beta crystalline form has enhanced efficacy over imatinib or imatinib mesylate to pass the test of section 3(d).
Supreme Court decision
Supreme Court decided the matter de novo looking into matters of both fact and law.
The court first analysed the question of prior art by looking into Zimmerman patent and the related academic publications. It was clear from the Zimmerman patent that imatinib mesylate itself was not new and did not qualify the test of invention as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970. The court then examined the beta crystalline form of imatinib mesylate and wrote that it, "for the sake of argument, may be accepted to be new, in the sense that it is not known from the Zimmermann patent. (Whether or not it involves an “inventive step” is another matter, and there is no need to go into that aspect of the matter now). Now, the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it directly runs into section 3(d) of the Act with the explanation appended to the provision"
In applying 3(d) of the Act, the Court decided to interpret "efficacy" as "therapeutic efficacy" because the subject matter of the patent is a compound of medicinal value. Court acknowledged that physical efficacy of imatinib mesylate in beta crystalline form is enhanced in comparison to other forms and that the beta crystalline form of imatinib mesylate has 30 per cent increased bioavailability as compared to imatinib in free base form.However, as no material had been offered to indicate that the beta crystalline form of imatinib mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with imatinib free base in vivo animal model, the court opined that the beta crystalline form of imatinib mesylate, does not qualify the test of Section 3(d).
Thus in effect, Indian Supreme Court upheld the view that under Indian Patent Act for grant of pharmaceutical patents apart from proving the traditional tests of novelty, inventive step and application, there is a new test of enhanced therapeutic efficacy for claims that cover incremental changes to existing drugs.
The Court took pains to point out that the subject patent application was filed during a time of transition in Indian patent law, especially with regard to striking Section 5, which had barred product patents and adding section 3(d), for which there was no case law yet.The Court also took care to state the decision was intended to be narrow: "We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment."
Reception of Court ruling
The decision received extensive coverage from Indian and international media
It reignited debates on balancing public good with monopolistic pricing and innovation with affordability.
Several commenters, including Novartis, noted that a decision either way would not have affected the ability of generics companies in India to continue selling generic Gleevec. The new patent law India adopted in 2005 contains a grandfather clause that allows generic copies of drugs launched before 2005, which includes Gleevec, to continue to be sold, albeit with payment of a reasonable royalty to Novartis.
Other commenters noted that the case was unique with respect to its timing and the importance of the drug, and that large generalizations should not be taken from it. "As a case study,
Glivec is peculiar and unlikely to be representative going forward. Had it been invented a few years later (or TRIPS implemented a few years earlier), Glivec likely would be patented in India, even under 3(d) standards. Newly discovered compounds are likely to receive basic patents and to be less vulnerable to 3(d) rejections." Prashant Reddy, author of the Spicy IP blog and postgraduate student at Stanford University Law School, was quoted in Nature Drug Discovery as saying: “It was a very limited ruling in most aspects and very fact-specific. Although the Court has interpreted efficacy to mean only therapeutic efficacy, it has left the exact scope of therapeutic efficacy to be defined in future cases....Most importantly, the Court made the nuanced distinction between the rent-seeking practice of evergreening and the beneficial practice of incremental innovation, and has clarified that Indian patent law forbids only the former.
Opposition
Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd is quoted as saying "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."He also said that companies like Novartis would invest less money in research in India as a result of the ruling.
Novartis also emphasized that it continues to be committed to access to its drugs; according to Novartis, by 2013, "95% of patients in India—roughly 16,000 people—receive Glivec free of charge... and it has provided more than $1.7 billion worth of Glivec to Indian patients in its support program since it was started...."The New York Times quoted Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America, the industry trade group: “It really is in our view another example of what I would characterize as a deteriorating innovation environment in India. The Indian government and the Indian courts have come down on the side that doesn’t recognize the value of innovation and the value of strong intellectual property, which we believe is essential
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