Novartis at the Supreme Court: Intervening in a Polarised World

I also apologise to Mr Grover for the harsh language used. I was very angry at what I perceived as an attempt to malign me, and reacted in a way that I should not have. I do hope we can continue this debate in a healthy manner, putting aside our personal differences. Anyway, here goes.

After months of anxious wait, the famed Novartis Glivec case was resuscitated at the Supreme Court. Arguments began the day before and continued until today (with the necessary breaks of course; the halls of justice do not do night shifts). Since the composition of the bench (which now consists of Justice Dalveer Bhandari and Justice Deepak Verma) is slated to change and the judges are busy with other matters, the matter will be taken up only in September.

In fact, almost all of Novartis’ counsels in this case appear to have been Solicitor Generals at some point of time in their careers (Andyarujina, Nariman and now Subramanium). Shantibhushan who represented Novartis before the Madras High Court was several notches higher: he had been the law Minister).

Novartis argued for 3 days, but is yet to conclude its arguments. It will now have to wait till September. Once this is done, the respondents would be offered an opportunity to present their case. Appearing for Cipla is leading IP counsel, Pratibha Singh who will be led by senior counsel, Harish Salve. There are a number of other respondents, represented by the who’s who of the legal profession and IP bar.

The key issues for determination in this dispute are:

1. What does “efficacy” really mean? Does it mean therapeutic efficacy or would it include any kind of advantage possessed by a pharmaceutical derivative including heat stability etc?

2. What is the known substance against which the new form has to be compared under section 3(d)?

3. Can a pharmaceutical substance be “inventive” and still flunk the section 3(d) test?

4. Does the excessive price of a drug constitute a violation of public ordre and morality?

I filed an intervention petition before the court, stating that I was an academic with an active interest in the development of Indian patent law. I therefore requested the court’s permission to intervene and make submissions on the larger issues of patent law thrown up by the case. The court graciously permitted this intervention.

However, much to my surprise, Anand Grover (counsel for the Cancer Patients Aid Association) objected to my impleadment as an intervenor. I was not present, but had an account of these proceedings from my counsel.

Yesterday, Grover did something even more alarming by vociferously stating in court that I must make my oral submissions soon after Novartis’ counsels (Mr Andhyarjuna and Mr Subramanium), since I effectively represented Novartis and carried a brief for them.

I’m wondering as to where he got this notion from that an intervenor has to represent one of the parties? Is this part of Indian law and procedure? Are intervenors also subject to the George Bush test: either you’re with us or against us?

Or does an academic intervenor have the freedom to assist the court with the nuances of patent law, without necessarily supporting one party or the other?

I’m personally very keen on cultivating an “amicus curiae” like culture that we see in the US (where most high ticket litigations have plenty of briefs from professors offering academic inputs on points of law). My counsel, Gopal Sankaranarayanan (one of the finest lawyers of his generation) is also keen on spurring a culture of academic involvement with the courts—and actively encouraged me to participate in this litigation. He’s personally spending a good amount of his time working pro-bono on this case on my behalf.

“As a law teacher at a leading Indian law University, the applicant is committed to the growth and development of sound intellectual property policy for India. In particular, his research and writings have focussed on Indian patent law and listed below are some of his writings in this regard…..

It is submitted that, as evident from the above extract of the IPAB’s decision, the present matter involves the issue of patentability under Section 3(d) of the Patents Act, 1970. Since this section is yet to be interpreted in a comprehensive manner by any court of law, it has resulted in varying and diverging interpretations by different branches of the Indian Patent Office.

It is therefore critical that this Hon’ble Court lay down some broad guidelines for interpreting this section. Such interpretation will impact not only the future of the Indian pharmaceutical industry, but also the larger issue of access to affordable drugs by millions of ailing patients in India. In the respectful submission of the Applicant, these are issues of far reaching significance as also of public interest and affect, amongst others, the entire Indian population. The Applicant, therefore, seeks to intervene in the present proceedings and assist this Hon’ble Court on the aforesaid issues.”

I might say a few things that support the case of Grover, and a few things that may not be quite so. Illustratively, I noted in an earlier post on this very blog that, to the best of my understanding, the relevant comparison under section 3(d) ought to be between Imatinib Mesylate and the beta crystalline form. Assuming of course that a skilled person would be able to produce imatinib mesylate (in one form or the other) from the teachings of the ’92 base patent and other common general knowledge prevailing at that point in time. Such a comparison would make it more difficult for Novartis to prove significantly enhanced efficacy under section 3 (d). Till date, the only comparative data filed is between imatinib (free base) and the beta crystalline form of Imatinib Mesylate.

However, in another blog, I opined that the argument that patents can be denied on grounds of pricing is jurisprudentially flawed! As also the argument that something can be inventive and yet violate section 3(d).

ps: image from here.