However, these steps are unlikely to pacify the US. It is unlikely that the US trade representative will exclude India from its priority watch list (PWL) of countries with weak/ineffective IPR regimes anytime soon. The Indian Pharmaceutical Alliance (IPA), which comprises top-notch domestic drug companies, has recently dispatched a letter to the USTR, making a strong case for removal of India from the PWL in its 2017 edition. The previous edition included India for allegedly failing to adequately protect IPR in its pharmaceutical sector and expressed concern about the lack of clarity on standards for sections 85 and 92 of the Patents Act pertaining to compulsory licence (CL).
While under Section 85 only a single issue of grant of compulsory licence by India and a solitary refusal had been reported prior to 2016, no case was reported in 2016, IPA noted. CL is a TRIPS-compliant mechanism under which the signatory nation can allow a local firm/s to manufacture a patented drug under certain defined circumstances, namely, “extreme urgency”, “national emergency” or “public non-commercial use”. “There are attempts by Big Pharma of the US to push India to undertake commitments that are beyond what the WTO’s TRIPS agreement prescribe,”IPA secretary general DG Shah said.
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