Dr. Feroz Ali, Dr. Sudarsan Rajagopal, Dr. Venkata S. Raman & Roshan John
White Paper Published by AccessIBSA and the Shuttleworth Foundation
April 2018 | (CC-BY)
Executive Summary: This report identifies pharmaceutical drug patents granted in likely contravention of anti-evergreening provisions under section 3 of the Indian Patents Act, from a cohort of 2293 patents granted between 2009 and 2016. An estimate of the rate at which the Indian Patent Office (IPO) erroneously grants such patents, as well as the rationale for grants were arrived at by analysing the prosecution history of some grants and the claim language of all granted patents.
Extent of Secondary Patenting at the IPO
The majority (72%) of granted patents for pharmaceuticals are secondary patents, granted for marginal improvements over previously known drugs for which primary patents exist.
Do Applicants Bypass Stringent Requirements?
Only a small fraction (15%) of granted secondary patents were subjected to elaborate scrutiny, accompanied by a detailed written order of the Controller. In most cases, the relevant exception to patentability has not been appropriately cited in the final written order.
In 50 cases involving detailed scrutiny, applicants could have demonstrated improved therapeutic efficacy and synergism to overcome sections 3(d) and 3(e) respectively, which are the barriers set to patentability.
No applicant made relevant submissions of clinical data to demonstrate therapeutic efficacy, as stipulated by the Supreme Court’s decision in 2013 relating to Novartis’ secondary patent on Imatinib mesylate.
Applicants often bypassed stringent requirements under section 3(d) by disguising secondary patents as formulations and/or combinations. This helped to steer the argument away from a section 3(d) citation and towards section 3(e), since demonstrating synergy under section 3(e) is relatively an easier exercise compared to the requirements of efficacy data under section 3(d).
Error Rate at the IPO
Inconsistencies in practice exist at the IPO, even while dealing with different secondary patents for the same drug. Our earlier study demonstrated several instances where the IPO granted some secondary patents for a drug, while rejecting others. Differing standards may impact the access to medicines for a variety of diseases.
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