Data Exclusivity

PMO, MNC, CL and Indian IP Policy Making: Whither Representation and Transparency?


A note circulated by the Prime Ministers Office (PMO) asking various government ministries to consider a representation made by OPPI (the Indian pharmaceutical body representing the interests of innovator pharmaceutical companies, mainly MNC’s) has stirred a hornet’s nest.

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.

Data Exclusivity:

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.

Patent Linkage:

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.

Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

4 comments.

  1. Avatarpraveenrajrs

    The Preamble of Indian Constitution says that India is a “SOVEREIGN SOCIALIST SECULAR DEMOCRATIC REPUBLIC”.

    But, are we really making the policies and statutes for the people of India ?

    An ‘Economic Invasion’ happening ?

    Reply
  2. AvatarShamnad Basheer

    An insightful follower of this blog writes:

    “I would also be a little wary of all things in the Satwant Reddy Committee Report due to a couple of extraneous factors:

    1. That most members of the Committee were not aware of the final version even after it was submitted to the Government; and

    2. That Mrs. Reddy retired on the date of submission of the Report to the Government, or if we paraphrase that, Mrs. Reddy submitted the Report on the date of her retirement.

    While the first factor is by itself a serious departure from what may be acceptable behaviour in bureaucracy, the second factor is normally taken in the Government as hinting towards something not being entirely above board.
     
    What DIPP is doing is indeed laudable and should be de rigueur in all legislative process.

    Reply

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