Encouraging drug innovation4 min read . Updated: 27 Aug 2009, 08:56 PM IST
Encouraging drug innovation
In a momentous decision for Indian patent law and pharmaceutical innovation policy, the government this month accepted the revised recommendations of the Mashelkar committee. This committee had been constituted in 2005 by the government to study whether a proposed amendment to India’s patents Act that would effectively deny patents to incremental pharmaceutical innovations would violate TRIPS, an international intellectual property agreement under the World Trade Organization. The committee answered in the affirmative.
Not only is this a logical and sound reading of TRIPS, it also ensures that India has taken a step in the right direction to encourage domestic pharmaceutical innovation.
When the report was first issued in 2005, it was mired in controversy, including an allegation that the committee had “plagiarized" bits of a report commissioned from me by a UK think tank. And though I was painted as the alleged victim of plagiarism, I consistently maintained that since the committee had annexed my report to the final report, there was no “plagiarism". Since then, the committee has retracted the report; it resubmitted it earlier this year, after correcting the allegedly plagiarized portions and reasoning out its key conclusions in a stronger manner.
A large part of the opposition to the Mashelkar report earlier had stemmed from the mistaken belief that the report condemned the existence of section 3(d) of the Indian patents Act, a controversial section introduced at the behest of public health activists and the Left Front in 2005. Thankfully, the committee has now made clear that the report has nothing to do with section 3(d).
Section 3(d) says that any new form of an existing pharmaceutical substance will qualify for patent protection, if it demonstrates increased efficacy. However, the proposed amendment referred to the Mashelkar committee goes far beyond this section and seeks to deny patents to even those new pharmaceutical forms that demonstrate a significantly enhanced benefit. Naturally, such a provision will violate TRIPS, which mandates that patents be granted without discrimination to all inventions in all fields of technology.
It’s worth reiterating that Mashelkar’s brief was never to examine the legal validity of section 3(d). Once again this aspect was lost or deliberately ignored by critics, many of whom were only interested in ad hominem attacks and in discrediting Mashelkar at any cost. They have not, as yet, been able to proffer any convincing critique of Mashelkar’s substantive conclusions on the TRIPS compatibility of the proposed amendment.
Notwithstanding Mashelkar’s recommendations, section 3(d) is, in fact, severely convoluted and requires some heavy-duty ironing by a court of law. Almost every word is riddled with an ambiguity or two, ambiguities that are already proving to be a litigators’ landmine. Little wonder then that the committee recommended that the government issue guidelines to clarify the scope of the section.
My own view is that rather than issuing guidelines at this stage, the government ought to wait for courts to interpret this section. Once we have a good body of case law, the government can proceed to issue guidelines that encapsulate the essence of such judicial pronouncements. In fact, a recent patent case being fought between Roche and Cipla over the patentability of Tarceva, a lung cancer drug, is scheduled to be listed before the Supreme Court in another two weeks. This, therefore, presents the perfect occasion for the apex court to step in and clarify the law relating to section 3(d).
And for those who think that section 3(d) is a mere paper tiger, consider the following statistics that emerged from a study I, along with one of my students, undertook:
Out of 68 cases so far where a pharmaceutical patent application was opposed by generic companies and/or public health groups, the patent office rejected the patent in 46 cases (i.e. approximately 68% of the time). And of these 46 rejections, a good 60% (28) were based on failure to comply with section 3(d).
This not only rules out any patent office bias in favour of patentees, but demonstrates that this section appears to be a potent weapon that is being actively deployed in the fight against frivolous pharmaceutical patents.
However, as stated earlier, the language of section 3(d) leaves much to be desired. And this ambiguity can be interpreted in a manner that either lets in frivolous patents or leads to the denial of patents to genuinely incremental inventions.
The Mashelkar committee report sets the right tone for this interpretative judicial exercise by noting that while “incremental innovations" involving new forms with significantly enhanced efficacy need to be encouraged, it is “important for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on ‘evergreening’ are scrupulously prevented", referring to the practice of extending patents by only tinkering with the substance. That’s a fairly logical proposition and one that does not require any complex vision or character assassination to comprehend.
Shamnad Basheer is the ministry of human resource development professor in intellectual property law at the National University of Juridical Sciences, Kolkata (NUJS). He thanks Shouvik Guha, a fifth-year student at NUJS for research assistance. Comments are welcome at firstname.lastname@example.org