Was it legitimate for the PMO to consider a representation from big bad MNC’s? Of course, it was! This is a democracy and all stakeholders are entitled to be heard. Would a smaller IP stakeholder representation have merited this kind of attention from the PMO?
Most likely not….and this is where we need to advocate for wider representation in the policy making process. Unfortunately, IP policy in India has been largely driven through a non transparent industry centric process. Think the woefully opaque Bayh Dole process, which was salvaged only towards at the end…
This must change. The government must appreciate that IP impacts not just industry but members of the public as well.
Given this context, my joy knew no bounds when i chanced upon a government policy note on compulsory licensing (CL)…which the government recently thew open for public review and comments yesterday. DIPP zindabad!
This augurs really well for the future of IP policy making in this country. Shouvik will bring you more detailed comments on this note.
In the meantime, lets reflect a bit on the actual content of the PMO note capturing the OPPI request. OPPI asks for the following:
1. That data exclusivity for pharmaceuticals be introduced, as per the recommendations of the Satwant Reddy report.
2. That guidelines be evolved to clarify the scope and ambit of section 3(d).
2. That injunction applications be decided by courts, without taking into account validity challenges by the defendant.
4. That the government consider amending the Drugs and Cosmetics Act to bring in patent linkage.
As for the first request on data exclusivity, my own view is that it may be too early for us to introduce pharma data exclusivity in India. If at all we need to protect this data, we ought to do it through a compulsory licensing regime, which I have elaborated on in this policy paper here.
More importantly, while the OPPI is right that the Satwant Reddy report was in favour of such exclusivity, they omitted to mention a critical fact: the report cautions that India may not be ready for data exclusivity and that this should be considered only in the future. Given that the report was penned in 2005-2006, we need to ask: Is India ready for data exclusivity yet?
I think its an important issue and needs to be discussed and debated..rather than being swept under the carpet.
Clarifying Section 3(d):
As for the second issue, I couldn’t agree more. We certainly need more clarity on section 3(d). And this call for clarity was personally echoed by Reddy and me in this piece here. Further, as Reddy notes in his blog piece, a Parliamentary Committee report has advocated such clarity. Who can take issue with a call for clarity? And indeed, as the old adage goes: clarity begins at home…
But should the government step in and formulate guidelines at this stage? Should we not wait till courts have had the occasion to mull over this issue and formulate interpretative canons for section 3(d). Being a die hard fan of the common law methodology, I’m in favour of waiting till our courts decide this issue…a highly adversarial battle fought between the best legal brains is likely to supply our courts with enough intellectual fodder to formulate a nuanced interpretation of the section. The court would also hopefully review the brilliant “numerical quantifier” suggestion offered by my co-blogger, Rajiv Choudhury. Given our proficiency with maths (we invented the zero, didnt we?), the last thing we need to run away from are numbers….
In particular, I anxiously await the Supreme Court’s take on the Novartis Gleevec case, which gives them a fantastic opportunity to plunge right into this complex section and iron out its many creases.
But perhaps my optimism and excessive reliance on the judiciary is misplaced.
Patent Injunctions Sans Validity Challenges:
Anyway, lets move on the most problematic of all OPPI suggestions. OPPI requests that injunction applications for patent infringement not consider “invalidity” challenges. In other words, given that a competitor can oppose a patent at the pre -grant and the post grant opposition stage, they should not be permitted to counterclaim invalidity when they are sued for patent infringement. This suggestion would have been extremely appealing, had we all had immense confidence in our patent office. Unfortunately, our patent office, much like many of us, are prone to errors…and significant ones at that. Sai Deepak’s succinct post analysing a recent section 3(d) case raises important issues about “discrimination” and fairness…is the Indian Patent Office applying the same standard to domestic entities as it is applying to MNC’s?
We ought to therefore retain the ability of a defendant to question the wisdom of the Indian Patent Office and challenge validity before courts. However, should the patent in question have survived an opposition challenge, the court must accord some deference to the patent office decision…assuming of course that the decision in favour of patentability is a sound and well reasoned one. This comports well with administrative law principles where specialist agency decisions are accorded some deference by courts of law. I elaborate on this “deference” aspect in a piece I penned for a Japanese conference. For those interested, here is the draft version. I’m still revising it and will post a final version soon.
As for the last suggestion, “patent linkage” was, is and will always remain a bad idea. But to cater to some of the concerns of innovators, the DCGI could perhaps adopt a “middle path” solution by making its process more transparent and listing out all drug applications that come in. This way, the innovator can sue in a court of law the moment it spots an application that intends to appropriate its patent.
IP Policy Co-ordination between Agencies:
Lastly, it is interesting to note that the PMO note is addressed to all the relevant IP/pharma departments/ministries (DIPP, Dept of Pharmaceuticals, Ministry of Law, Ministry of Health). However, it asks that the Department of Pharma co-ordinate the policy formulation process. Does this mean that the Dept of Pharma has been vested with the supervisory right over all affairs relating to patents and pharma? I reflect on the co-ordination problems between the various IP agencies in a blog post here.
In any case, the merits of the OPPI note notwithstanding, we ought to use this momentous occasion to advocate for greater representation of all stakeholders and greater transparency in the Indian policy making process. Jai Hind.