Case Brief : Novartis AG Vs. Union Of India & Others
Facts
Novartis AG Vs. UOI: A well-known pharmaceutical company, Novartis International (The Appellant), submitted a patent registration application for the medication “Glivec.” The cancer-treating medication “Imatinib mesylate” in its beta crystal form was used in the creation of this medication. Because of restrictions on the grant of patents for products under Section 5 of the Patents Act, 1970, the application was first rejected in India.
The request to patent Glivec was reviewed following the 2005 amendment, which allowed patents for both techniques and goods. When the appellant first filed the application, it was denied by both the Madras Patent Office and the IPAB on the grounds that the medicament in question is a known substance and does not provide any “enhanced efficacy” over the previously patented “Zimmermann” medication in the United States. Accordingly, it cannot be said to incorporate an inventive step as defined by Act Section 3(d).
The IPAB justified its decision by arguing that preventing a patented product from “evergreening” would eventually obstruct the supply of reasonably priced medications. As a result, the appellants used Article 136 to file an SLP with the Supreme Court of India.
Issues
- Whether the appellant’s invention satisfies the “inventive step” requirement under section 2(1)(j)?
- Whether the appellant’s patent claim is prohibited from registration by virtue of section 3(d) of the Act?
Arguments of Parties
Appellant
Gopal Subramaniam, a former solicitor general of India, and T. R. Andhyarujina, a senior advocate, headed Novartis’ legal team.Novartis aimed to avoid existing literature on imatinib or imatinib mesylate from being regarded as prior art by attempting to patent imatinib mesylate in beta crystalline form (as opposed to imatinib or imatinib mesylate).
The two main points made by Novartis’ legal team were that:
- The beta crystalline form of imatinib mesylate is only one polymorph of imatinib mesylate, so it does not constitute prior art according to the Zimmerman patents and journal articles written by Zimmerman et al., which provides the necessary novelty and inventive step; and
- imatinib mesylate in beta crystalline form has improved efficacy compared to imatinib or imatinib mesylate to pass the section 3(d) test.It was claimed that the beta crystalline form possesses (i) more advantageous flow properties, (ii) greater thermodynamic stability, (iii) lower hygroscopicity, and (iv) increased bioavailability in order to demonstrate its enhanced efficacy over other forms.
Respondent
Along with two intervenors/amicus, the court was represented by seven named respondents. Paras Kuhad, the Additional Solicitor-General of India, led the responders.The court heard a number of arguments, but the main ones centred around demonstrating that imatinib mesylate in beta crystalline form was neither novel nor non-obvious because of information about the drug published in 1996 in Cancer Research and Nature, disclosures made to the FDA and in Zimmerman patents, and the fact that the term “efficacy” as used in section 3(d) should be understood to mean therapeutic efficacy rather than just physical efficacy.
To emphasise the public policy aspect of arguments on the accessibility and affordability of life-saving medications, the respondents cited a number of sources, including the Doha Declaration on the TRIPS agreement and public health, passages from parliamentary debates, and petitions from NGOs and the World Health Organisation.
Judgement: Novartis AG Vs. UOI
The Supreme Court of India’s two-judge panel denied Novartis’ appeal in April 2013 and maintained that Imatinib Mesylate’s beta crystalline form is a novel formulation of the well-known drug, Imatinib Mesylate, whose effectiveness was well-established. The Supreme Court has made it abundantly evident that, in the context of medicine, “Efficacy” in section 3(d) only refers to “Therapeutic Efficacy” and that, in this context, a drug’s other attributes are immaterial; the only characteristics that are directly related to efficacy in this context are its therapeutic efficacy.
The Supreme Court decided that, under section 3(d) of the Patent Act of 1970, a 30% improvement in bioavailability is equivalent to an increase in medicinal efficacy if supporting data is shown. According to section 3(d) of the Patent Act of 1970, the Supreme Court compared the efficacy of “Beta Crystalline form of Imatinib Mesylate” with “Imatinib Mesylate” based on its flow properties, better thermodynamic stability, and lower hygroscopicity. The Court concluded that none of these properties contribute to an increase in therapeutic efficacy, and Novartis has not produced any evidence demonstrating that the efficacy of “Beta Crystalline form of Imatinib Mesylate” is greater than that of “Imatinib Mesylate.”
Rationale: Novartis AG Vs. UOI
It was stated, rather correctly, that patents cannot be made any greener. In addition, the court protects the rights of common people and forbids pharmaceutical companies from charging high costs for drugs that are unaffordable for the majority of people. Patent Act Section 3(d) states that companies cannot commercialize identical medications by only changing the material’s molecular structure. Conversely, imatinib mesylate is devoid of a “innovative step.”
Consequently, patents cannot be perpetually greened. Patented pharmaceuticals cannot be evergreened since no one is allowed to make them after they receive a patent license. The exclusive license to use such a medication is owned solely by the patent owner. This provision safeguards the uniqueness of patents. The patentee holds the exclusive right to exploit and utilise the invention. Nobody other is able to make use of or misuse this privilege. Evergreening is forbidden by the terms of the compulsory licensing requirement.
Supreme Court Judgement PDF of Novartis AG vs UOI : CLICK HERE TO DOWNLOAD PDF
Case Related To : Patent Application
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