J.F. Kennedy had once famously stated “Victory has a thousand fathers but defeat is an orphan”. With the Supreme Court’s recent judgment rejecting Novartis’s patent application for its cancer drug, there has been much chest-thumping and back-slapping amongst the activist community and the generic pharmaceutical industry. It was only a matter of time before the Communist Party of India (Marxist) CPI(M) joined the party to claim its stake to the victory.
The CPI(M)’s mouthpiece, People’s Democracy, published an article in its latest issue, claiming that the Supreme Court’s judgment in the Novartis case was a “vindication of the Left’s principled position” in 2005 when India’s patent law was being amended to make it TRIPs compliant. The Times of India has blindly lapped up the story in an article by Manoj Mitta over here.
Referring to the Supreme Court’s judgment on how these amendments were a result of deliberations between the ruling party and the government, the article in the People’s Democracy notes “The negotiations between the Left and the government were long and tortuous, with the government trying to obstruct at every step the introduction of progressive pro-health and pro-people amendments. In the face of such strong resistance, the Left was able to force the inclusion of several changes in the 2004 ordinance. At the end, twelve important amendments were made to the 2004 ordinance, including the insertion of section 3(d), mentioned earlier.”
It would appear from a reading of the above extract that the Left is claiming parentage of a provision of Section 3(d) of the Patent Act, 1970. I doubt this claim.
The exact history of the provision, notwithstanding what has been stated in the judgment of the Supreme Court, is still shrouded in mystery. The reason that I know is that a couple of years ago I had an opportunity to examine, under the RTI Act, the DIPP’s files on the Patent (Amendment) Act, 2005. You can access those posts over here and here.
Below is my story on the history of Section 3(d) as reconstructed through the official files of the DIPP.
First, a bit of context to the story: Section 3(d) was introduced as part of a larger set of amendments aimed at making India compliant with TRIPS. The first draft of these amendments was the Patent Ordinance, 2004 which was issued hurriedly by the UPA Government in December, 2004 to get India TRIPs compliant by the deadline of January 1, 2005. That Ordinance did not contain the present avatar of Section 3(d).
Eventually, the government introduced the Patent (Amendment) Bill, 2005 in Parliament on the 18th of March, 2005. This Bill was aimed at replacing the Ordinance which would have anyway lapsed within 6 months. However even this Bill, did not contain Section 3(d) in its present avatar. How then did Section 3(d) make its way into the Indian Patent Act?
The answer to that question lies in a file noting (available over here) by the then Director of the Department of Industrial Policy and Promotion (DIPP), which was responsible for piloting the Bill in Parliament. The file noting, dated March 17, 2005, that is just one day before the Bill was introduced in Parliament, was addressed to the Legislative Department of the Law Ministry with a request to vet a new set of amendments to the Bill which was going to be introduced in Parliament the next day. In his noting, the Director had informed the Law Ministry that last minute consultations with concerned groups/organizations (none of whom were named) had resulted in the new set of amendments. Attached to the Director’s file noting was a seven page note, containing a number of amendments to the Bill. One of these amendments was Section 3(d) in its present avatar, with a line in the note crediting its formulation to Justice V.R. Krishna Iyer, the famous retired judge of the Supreme Court. Eventually the amendment bill was introduced in Parliament and amended to accommodate the new Section 3(d) before voting.
Now it is not clear as to who exactly authored the note sent to the Law Ministry. It is however unlikely that this note was authored by the Left since most of their communications to the Ministry were on the official letterhead of the CPI(M).
The relevant record of the DIPP does contain a number of letters and petitions indicating that the Director at the DIPP was under immense pressure from the CPI(M), then a part of the UPA government and also the Indian Pharmaceutical Alliance (IPA), to restrict patentability of pharmaceutical substances to only new chemical entities, thereby completely forbidding the patenting of incremental innovation.
At the time, Pranab Mukherjee was the point-man for all negotiations with the Left and the record of the DIPP reveals that Sitaram Yechury and Harkishan Singh Surjeet had forwarded a list of amendments to Pranab-da who then forwarded them to Kamal Nath, the Minister for Commerce overseeing the DIPP. Both notes (which can be accessed over here and here) were unequivocal in their demand to limit patenting of pharmaceutical substances to only ‘New Chemical Entities’. The CPI(M) had never made a single suggestion which was similar to the present avatar of Section 3(d).
Similar suggestions were being made from another completely unlikely source: India’s Ambassador to Geneva, Mr. H.S. Puri. The main subject of Puri’s communications with the DIPP, was an editorial on January 18, 2005 in the New York Times (NYT), titled ‘India’s Choice’, criticising the Patent Ordinance, 2004. One of the issues raised by the NYT was ‘ever-greening’, which is the practice of patenting trivial innovations as opposed to incremental innovation which is beneficial to society. I had blogged about this earlier over here..
In pertinent part, the NYT editorial stated ‘Also, it is uncomfortably vague about whether companies could engage in ‘ever-greening’ - extending their patents by switching from a capsule to tablet, for example, or finding a new use for the product. This practice, a problem in America and elsewhere, extends monopolies and discourages innovation.’ Ambassador Puri warned the DIPP that ‘Criticism of the Ordinance by what is unarguably the most influential western newspaper – the New York Times – has to be taken seriously’.
On the basis of the suggestions in the editorial, Ambassador Puri took the liberty of recommending a set of amendments, one of which was a suggestion aimed at targeting ‘ever-greening’ but in effect worded to prohibit most incremental innovation in the pharmaceutical sector. The precise text of his recommendation was as follows ‘A clear stipulation prohibiting the patenting of different salts, hydrates, isomers, metabolites, and polymorphs, would prevent our patent system being tied up endlessly by litigation on grounds of patentability.’ The spirit of this recommendation was identical to those made by the CPI(M) and the IPA and that is to limit patentability to only ‘new-chemical entities’ thereby prohibiting the patenting of some pretty useful incremental innovation.
To his credit, the Director at the DIPP, put up a brave fight against the recommendations of the CPI(M) and the IPA, on the grounds that any move to restrict patentability would be in violation of India’s international obligations under Article 27 of TRIPs, which prohibited the discrimination of different technologies when it came to the question of patenting. The Section 3(d) as drafted by Justice Krishna Iyer (as claimed in the note to the Law Ministry), was different from the suggestions by the CPI(M), the IPA and Ambassador Puri, since it prima facie appeared to solve the ‘ever greening’ issue within the paradigm of Article 27 of TRIPs, while allowing for incremental innovation. For possibly this reason or maybe for other unknown reasons the Director at the DIPP finally relented and sent the amendments to the Law Ministry for a final vetting.
When the Bill was finally taken up for voting in Parliament, it appears from a reading of the debates in the Lok Sabha, that none of the M.Ps had any clue about the actual implications of Section 3(d) or at the very least, they did a good job of keeping it under the wraps. In their defence, the amendments to the Patent Act were the subject of a Joint Parliamentary Committee (JPC) and there had been no recommendation in the JPC report regarding Section 3(d) in its present avatar.
In Parliament, both the BJP and the CPI(M) had vociferously demanded that the Government limit patentability of pharmaceutical inventions to only new chemical entities, thereby prohibiting all forms of incremental innovation. In fact, Yashwant Sinha even introduced an amendment to that effect.
Faced with the heat of the Opposition, the then Commerce Minister Kamal Nath, informed the House that he would constitute an expert committee to examine whether such a demand by the Opposition would be in line with India’s obligations under Article 27 of TRIPs. That committee, which was headed by Dr. Mashelkar, after some ‘technical inaccuracies’, submitted a report in 2009, agreeing with the government stand, that prohibiting all incremental innovation would be in violation of Article 27 of TRIPs. In other words, the Left’s demand was rejected.
When the issue of Section 3(d) finally landed before the Supreme Court of India, the judges were faced with two dilemmas. The first pertained to the interpretation of efficacy. The Supreme Court ultimately ruled that as per the dictionary meaning of term and the context in which it was used in Section 3(d), it could only mean therapeutic efficacy. The second dilemma pertained to the actual meaning of therapeutic efficacy. While interpreting therapeutic efficacy, the Court was faced with what it termed as a “rigid position” taken by Mr. Anand Grover (counsel for a patient group) and a “less rigid position” taken by Shamnad who had intervened in his academic capacity. The “rigid position” would almost eliminate the possibility of patenting any incremental innovation. The Supreme Court’s solution was to simply not rule on this dilemma of having to draw the boundaries of therapeutic efficacy, instead leaving the issue to be resolved on a case-by-case basis in the future.
But, the Supreme Court was unequivocally clear in its conclusion that its judgment should not be interpreted to mean that Section 3(d) prohibited all incremental innovation. In paragraph 191, it clearly states the following “191. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”
In other words, even the Supreme Court rejected the kind of interpretation sought by the Left in Parliament. Incremental innovation continues to be protected under Indian law.
This wouldn’t be the first time that the Left has claimed credit for a successful policy despite having no role to play in its development. It won’t be the last.
0 comments:
Post a Comment