The main proposal includes a ‘legislative review’ of Section 3(d) and possibly defining the term ‘efficacy’. This proposal of the PMO is not as problematic as is being made out in the media since the 88th Report of the Department Related Parliamentary Standing Committee on Commerce in the year 2008 on the ‘Patents & Trademarks System in India’ contained the very same proposal. In para 5.35 the Committee clearly urges the Government to clarify the confusion on Section 3(d). I reproduce the pertinent portion of the Report below:
However, even Section 3(d) is not free from ambiguities. The Government should clarify the usage of terms ‘significantly’ and ‘efficacy’, which form part of Section 3(d), to clear the ambiguities involved in the interpretation of the said section. It needs to be ensured that the laws are not TRIPS-plus but just TRIPS compliant.
It is surprising that the PMO has sought to intervene at this stage when the question of Section 3(d) and its possible interpretation is pending before the Supreme Court in the Novartis-Glivec case.
The most controversial and mis-guided proposal in the PMO note is the question of ‘linkage’ between the patent office and the drug regulatory authorities. This again is a question pending before the Supreme Court in the Bayer-Cipla case. Bayer failed in its attempt before the Delhi High Court to establish this ‘linkage’ between the Patent Office and the DCGI. However of all the proposals, this is the easiest for the government to execute since all it requires is an amendment to the Drugs and Cosmetics Rules and not a positive legislation through Parliament. Such an amendment does not require to be voted on by Parliament since the rules are only required to be placed before the House for a few months after which they are deemed to be passed unless a MP objects to the same.
The PMO has also requested a consultation on the question of data exclusivity. It is surprising that the PMO has asked the Ministries to debate this proposal since the Department of Commerce has been emphatic in its rejection of such a demand in the FTAs that are being negotiated with the E.U.