NOVARTIS AG v. UNION OF INDIA

 

NOVARTIS AG v. UNION OF INDIA

Novartis AG v. Union of India, decided by a two-judge panel of the Hon'ble Supreme Court of India, is one of India's landmark decisions. Novartis appealed IPAB's denial of its patent request for "Imatinibmesylate" in beta crystalline form, but the Supreme Court of India dismissed the appeal on the grounds that the contested medication did not exhibit enhanced or superior therapeutic efficacy when compared to the known substance, "Imatinibmesylate," suggesting that the contested medication did not necessitate an inventive step.

FACTS OF THE CASE

The compound imatinib, which might be used to make anti-tumor medications, was one of several chemical derivatives that Jürg Zimmermann, a medicinal scientist, got a US patent for on May 28, 1996 (the "Zimmermann patent"). Further analysis found that Imatini is more stable in its beta crystalline form. On May 17, 2005, it was granted a patent in the United States for its beta-crystalline form. "On July 17, 1998, Novartis submitted a patent application to the Chennai Patent Office for the beta crystalline form of imatinibmesylate. Because of better processing and preservation, Novartis stated that its product outperformed imatinibmesylate in it’s free-base form. When Novartis submitted their application, India's patent law was in a transitional phase. As a result, it was delayed. According to the company, the drug is used to treat gastrointestinal stromal tumours and chronic myeloid leukaemia (CML) (GIST). Section 5 of the Patent Act, 1970 restricted the award to techniques or processes rather than commodities when Novartis applied for a patent there. With the deletion of Section 5 of the Patent (Amendment) Act of 2005, goods as well as methods or techniques are now eligible for patent protection.

The Assistant Controller of Patents and Designs heard the matter on the "patentability of the beta crystalline form of Imatinib, and the application was denied." The claim was that it did not meet the requirement outlined in Section 3(d) of the Indian Patents Act, 1970 since there had been prior publication and there was no invention. When the Assistant Controller of Patents and Designs made their judgement, Novartis appealed it to the Madras High Court. They requested an order stating that section 3(d) was unconstitutional and in violation of the TRIPS agreement.

ISSUES

1. What is a known substance under the Act?
2. What is the meaning of efficacy under the Act?
3. Is a rise in bioavailability considered therapeutic efficacy?
4. Whether Novartis’ claimed invention “Beta crystalline form of imatinibmesylate” is more effective than the substance from which it was produced, i.e. “Imatinibmesylate”?

 

JUDGEMENT

A two-judge panel of the Indian Supreme Court rejected Novartis' petition in April 2013, concluding that ImatinibMesylate's beta crystalline form is a novel version of the well-known drug with well-proven efficacy. The Supreme Court was very clear in its ruling that the term "Efficacy" in section 3(d) only refers to "Therapeutic Efficacy" in the case of medicine and that all other aspects of the drug are irrelevant; "the properties that directly pertain to efficacy in the case of medicine are its therapeutic efficacy." According to the Supreme Court, "if the proof is supplied, a 30% increase in bioavailability qualifies as an enhancement in medicinal efficacy under section-3(d) of the Act."

 The Supreme Court found that none of these characteristics contribute to an increase in therapeutic efficacy as defined by section 3(d) of the Act, and Novartis has not provided any documentation demonstrating that Beta Crystalline's efficacy is greater. The Supreme Court compared the efficacy of ImatinibMesylate's Beta Crystalline form to that of ImatinibMesylate based on flow properties, better thermodynamic stability, and lower hygroscopicity.

 

CONCLUSION

For pharmaceutical companies seeking further patents in the future, the lack of clarity created by the court's failure to specify what constitutes sufficient evidence of greater efficacy generates a great lot of uncertainty. Whether an improvement in bioavailability results in an increase in therapeutic efficacy in each particular circumstance must be reported and supported by scientific evidence, the court ruled. Despite the court's finding that Novartis had not provided enough scientific evidence, it did not specify what kind or scope of computation would be necessary to prove greater effectiveness. Even if a certain quantity of evidence is necessary to demonstrate increased efficacy, it is absurd to want drug developers to accomplish so so early in the drug development process. Shamnad Basheer, a law professor at West Bengal University of Legal Sciences, stated in an amicus brief to the court in Novartis AG that it would be unrealistic for pharmaceutical manufacturers to seek patents only after they had already engaged in years of rigorous trials that could provide conclusive evidence that the most recent updated drugs perform more effectively than their earlier versions. Many years are often spent in the patent application process by pharmaceutical corporations. Since obtaining a patent ensures that such information won't be utilised by other parties, it motivates drug companies to conduct clinical research in order to gather data on efficacy. Therefore, requiring proof of efficacy at the stage of patenting may prevent the development of many new, potent medicines.