MANAGEMENT ACCUSATIONS “The United States continues to have concerns that Section 3(d) of India’s Patents Act, as interpreted, may have the effect of limiting the patentability of potentially beneficial innovations”, including those enjoying patent protection in multiple other jurisdictions (p. 49)
REBUTTALS India’s Section 3(d) lawfully restricts patenting on new uses of medicines and new forms without evidence of significant therapeutic impact. It deters filing of weak, secondary patents that merely serve to lengthen monopoly protections and supra-competitive profits off sales to elites. If anything, India should enforce Section 3(d) even more vigorously as many secondary patents are being improvidently granted.
“[T]he United States urges India to improve and streamline its patent Opposition procedures are directly referenced as permissible in the WTO TRIPS Agreement and the knowledgeable inputs of opposition procedures (p. 49). generic companies and other opposition filers assist patent examiners in making informed, evidence-based decisions on the merits of patent applications. Oppositions have succeeded in weeding out dozens of unworthy pharma patent applications over the past 10 years. “[T]he United States continues to monitor India’s application of its compulsory licensing law”both with respect to pharmaceuticals and green technologies (pp. 50, 27).
India has granted exactly one compulsory license thus far, fully in compliance with national law, the TRIPS Agreement, and most especially the Doha Declaration on the TRIPS Agreement and Public Health. The US has quietly issued government use licenses on hundreds on patents in the US, but hypocritically states that it supports the Doha Declaration while challenging India’s judicious use of CLs.
“The United States also notes with concern the continuing challenges involved with the enforcement of patent rights in India, including challenges that some patent holders reportedly face in securing injunctions … .”(p. 50)
The WTO TRIPS Agreement allows countries’courts to offer remuneration (royalties) in lieu of injunctions in enforcement actions. Moreover, the US Supreme Court has sanctioned similar royalty damages in the famous eBay case.
When approving marketing approval applications from generic companies,“Indian state government authorities reportedly do not have a mechanism to confirm whether the item to be manufactured is under patent (p. 50).
Well, neither does Europe and both Europe’s and India’s denial of patent-registration linkage are fully lawful under TRIPS. Accordingly, generics facing weak or invalid patents can obtain marketing approval and the drug regulatory authority does not have to act as patent police.
“[T]he United States continues to urge India to provide an effective system for protecting against unfair commercial uses, as well as the unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.”(p. 50)
Big Pharma has consistently sought data/registration monopolies since it lost the battle for them in the negotiation of the TRIPS Agreement. The data exclusivity the US seeks, prevents the registration of generic equivalents by making the medicines regulatory authority blind to data previously submitted. Instead of being able to prove that a therapeutically equivalent generic should be expeditiously registered, the US data-monopoly proposal would require costly and unethical repetition of clinical trials to develop identical data to that already submitted.
The US is seeking enhanced enforcement measures including border India’s border control measures are fully TRIPS compliant, and India should not be forced to invest scarce government enforcement (p. 51). resources for public enforcement of what are private rights.
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