Majority of pharmaceutical drug patents granted by India might have skipped elaborate scrutiny, an analysis of patent grants by a team of researchers and patent lawyers reveals.
The report which studied the prosecution history of some grants and the claim language of all granted patents during 2009-2016 states that the grants were likely contravention of anti-evergreening provisions under section 3 of the Indian Patents Act.
Seventy two per cent of granted patents for pharmaceuticals are secondary patents, granted for marginal improvements over previously known drugs for which primary patents exist, they point out.
The report has been prepared by patent lawyers and researchers Feroz Ali, Sudarsan Rajagopal, Venkata S. Raman and Roshan John for accessibsa, a tri-continental project enabled by a fellowship from the Shuttleworth Foundation. The project focuses on innovation and access to medicines in India, Brazil and South Africa.
The report suggested that only fifteen per cent of granted secondary patents were subjected to elaborate scrutiny, accompanied by a detailed written order of the Indian Patent Controller. "In most cases, the relevant exception to patentability has not been appropriately cited in the final written order," it points out.
The report titled "How our safeguards against evergreening have failed, and why the system must be reformed," states that 1654 secondary patents got granted by overcoming anti-evergreening and other rejections that could be raised by the Indian Patent Office (IPO).
"This corresponds to an error rate as high as 72 per cent of secondary patents, of which 1206 were granted for formulations/compositions, 297 for combinations, 88 for physical variants, uses, salts, isomers, enantiomers and prodrugs, and 63 for a method of treatment."
The researchers recommend three key interventions to make patent grants more effective and appropriate. The first is to prepare an updated guideline for patent examiners. The current guidelines do not expound on how the anti-evergreening provisions should be applied while examining a patent application. There is little discussion on how the IPO has applied sections 3(e) and 3(i). Given that the IPO has now examined thousands of applications and their validity vis-a-vis sections 3(d), 3(e) and 3(i), a more detailed account on how the IPO has applied these provisions in practice should have been provided, the researchers suggested.
The second is to spell out the principles laid out by the Supreme Court in the Novartis Case (the "Novartis Standard") in the guiding document to ensure that patent examiners and controllers go by the spirit of the Supreme Court judgment on the issue of ever greening patents. "We recommend that the seven principles borne out of the Novartis case, must be included as a part of the guidelines in examining pharmaceutical applications. The IPO should strictly adhere to these principles while deciding an objection under section 3(d)," the report said.
The report also highlighted the need for an "anti- evergreening check list" for patent examiners. "The common format for sending the First Examination Report (FER) by the IPO to the patent applicant does not have any checklist on detecting secondary patents. We recommend that every application that is suspect of secondary patenting must undergo detailed scrutiny at different levels," they point out.
While Feroz Ali is the IPR Chair Professor at IIT Madras, Sudarsan Rajagopal is a London-based patent analyst. The accssibsa attempts to expand access to life-saving medicines and make arguments for intellectual property systems that support public health - with safeguards for both sovereign human rights and genuine pharmaceutical innovation.