Patent Case Brief – Novartis v Union of India

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Citation – SC Civil Appeal No. 2706-2761 of 2013

Facts: In this case, sequence of events with prior art are as follows:
§ The Zimmerman patent in ’93, which disclosed the imatinib free base – this patent was not granted in India because India did not provide for pharmaceutical patents prior to 1995;
§ A publication in 1996, which referenced imatinib mesylate;
§ The 1998 patent application before the Indian Patent Office, which claimed the betacrystalline form of imatinib mesylate.
Novartis filed for patent of its “Beta Crystalline” form of “Imatinib Mesylate” in 1998 as per the TRIPS agreement of WTO. The application was processed in 2005 and was rejected in 2006 on the grounds that it failed to satisfy the requirement of novelty and non-obviousness as per the amended Indian Patent Act. Novartis appealed against the decision in Madras High Court that was then transferred to the IP Appellate Board. The IP Appellate board rejected the application on the grounds that the invention was not a new substance but an amended form of a known substance and that Novartis was unable to show the increase in efficacy as laid down in section 3(d) of the Indian Patent Act.
Novartis appealed before the Madras High Court that Section 3(d) violated Article 14 of the Constitution as the requirement of ‘enhanced efficacy’ under section 3(d) was vague and gave unrestricted power to the patent examiner. The High Court rejected the application and held that the object of section 3(d) was to prevent intellectual monopoly privileges and evergreening of patents.
Appealed to the Supreme Court

Issues:
1)
What is the ‘Known Substance’ for the purpose of section 3(d)?
2) What is the meaning of ‘efficacy’ in section 3(d)?
3) Does an increase in bioavailability qualify as increase in therapeutic efficacy under Section 3(d)?
4) Was the claimed invention by Novartis more efficacious than the substance that it was derived from?

Analysis:
1)
After the 2005 amendment, Section 3(d) required the claimed invention to be more efficacious than the ‘known substance’ from which the claimed invention was derived. In this case, Novartis was keen to have ‘Imatinib Free Base’ to be identified as he ‘known substance’ instead of ‘Imatinib Mesylate’ since it would be easier to prove greater efficacy in comparison to Imatinib Free Base. Supreme Court shot down this argument on the grounds that “Imatinib Mesylate” was anticipated by prior art (publication in 1996) and existed before the claimed invention hence it was a known substance.
Therefore, Imatinib Mesylate was presumed to be the known substance in this case.
2) While Novartis was arguing for a broader interpretation of ‘efficacy’ in Section 3(d) which would include other beneficial properties such as increased stability, etc., Supreme Court made it crystal clear that ‘efficacy’ in Section 3(d) only means therapeutic efficacy. The court held that “not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, is its therapeutic efficacy.
3) Bioavailability is the increased ability of the drug to dissolve into the bloodstream of the patient. The Supreme Court on this issue ruled that such an increase of 30% in bioavailability can qualify for protection under 3(d) if evidence is provided to establish that such an increase leads to greater therapeutic efficacy.
4) The Court compared the efficacy of the claimed invention with the known substance (Imatinib Mesylate) with reference to its flow properties, better thermodynamic stability and lower hygroscopicity and concluded that none of the three properties identified will qualify under section 3(d) as it doesn’t contribute to an increased therapeutic efficacy. Conclusion: The Supreme Court rejected the appeal filed by Novartis and concluded that since there was no substantive & conclusive material and evidence to prove that beta crystalline form of Imatinib Mesylate will produce an enhanced or superior therapeutic efficacy, therefore failed to meet the requirements under section 3(d).

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