Patent

Novartis at the Supreme Court: Intervening in a Polarised World


Please note: This an edited version of an earlier article written on this issue. The earlier blog article was very harsh in its tone, spurred in large part by my anger at what I saw to be a continuing attempt to silence me from engaging with issues of pharmaceutical patent law and policy, only because some of my writings were not to the liking of certain people.
I apologise to our readers for the outburst, but do hope that we can use this incident to engage in a wider debate on the need for better engagement of academics, law students and researchers with the judiciary. And the need to create space for new independent voices in an otherwise polarised debate on pharmaceutical patents and access to medicines.

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.

Novartis is represented by one of India’s leading law firms, Anand and Anand, which in turn is briefing senior counsels, Adhyarujina and Gopal Subramanium (who till recently had been the Solicitor General of India). It is interesting to note that Novartis was earlier represented by senior counsel Rohington Nariman, who took over recently as Solicitor General (SG) from Mr. Subramanium.

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.

For the record, a copy of my intervention petition was served to him, clearly stating as below:

“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).

On the interpretation of “efficacy”, my attempt will be to cull out broad standards for interpreting section 3(d).

In short, some of my submissions made to the court are likely to support one party, while others may support the other party. But that’s precisely because I don’t carry a brief for either Mr Grover or Novartis. My interest is not so much in the specific facts of this one case alone (Novartis), but in the long term sustainable development of Indian IP jurisprudence and policy. And I see the role of academic intervention as precisely this i.e. that of providing the court with independent inputs that may not necessarily be provided by either party to a case, since parties are likely to be focusing primarily on a short term win.

ps: image from here.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is 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 Professor Basheer joinedAnand 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. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

9 comments.

  1. AvatarAnonymous

    Wonderful! The humility to apologise in public is a quality that one does not find much these days. I personally did not think that it merited an apology: it was not all that harsh and Grover deserved what he got!

    Sets you apart from the rest, apart from your many other qualities: mastery over the subjects you take up, boldness in speaking your mind without fear or fervor, leadership on socially relevant causes (IDIA) etc. I could go on and on. You a true role model. We are with you, through and through. God bless.

    Reply
  2. AvatarAnonymous

    You could publish your IT returns in order to reaffirm that your intervention is purely on the policy issue and not influenced by any interested party. Least no one can thereafter question your motives. And why should Cancer society lawyer feel that you would support the case of Novartis.

    Reply
  3. AvatarKen

    Following Shamnad’s comment about whether it’s acceptable to take pricing into account while deciding whether or not to grant a patent, the comparison between what’s happening in India and what’s happening in Brazil is interesting. In Brazil, the health surveillance agency has a statutorily-sanctioned role in examining pharmaceutical patent applications, one that it has traditionally discharged by applying standard patentability criteria (novelty, inventive step) rigorously. Now the Brazilian government has instructed the health agency that, while it still may examine patent applications, it can not apply standard patentability criteria and, instead, must simply examine applications according to whether they pose “health risks.” Does “health risks” mean price? That’s not clear. See the interview with the former director of patent examination in the health surveillance agency in IP-Watch (http://www.ip-watch.org/weblog/2011/08/11/top-official-discusses-resignation-from-brazil%E2%80%99s-anvisa-over-patent-policy).

    Reply
  4. AvatarShamnad Basheer

    Sure Anon:

    all for it—particularly since this blog itself stands for transparency….and i’d personally like to see the funding details of some of these organisations that allegedly represent the interests of poor Indian patients.

    Reply
  5. AvatarShamnad Basheer

    Thanks for this Ken,

    The earlier Brazilian regime was certainly an interesting one…and was perhaps a brazen admission of the fact that the patent office could not be trusted with a rigorous review of pharma applications. Not sure if that model can be imported into India—since I’m not sure which other government agency we’d pass this buck onto. The more recent change is even more interesting–and like you say, one has to wait and see as to what kind of things qualify as “health risks”.

    Reply
  6. AvatarShamnad Basheer

    also while the earlier Anvisa arrangement (where it would check pharma applications for compliance with tradnl patentability criteria) was TRIPS compliant (since it is upto countries to decide their agency set up to review patent applications), the present arrangement may raise issues–if for eg, a patent is denied on the ground that the price of the product (if at all we have a product at the time of the patent) is too high.

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  7. AvatarKen

    Shamnad, re: TRIPS compliance (@2:17), that’s absolutely correct and a rather ironic aspect of the whole affair. For years PhARMA had been criticizing Brazil for having a “fourth criteria” when in fact Brazil was applying the same patentability criteria, just trying to do so more rigorously. But now there is, perhaps, a fourth criteria of “health risk.”

    Reply
  8. Avatarrajeev

    Mr. Samand Bashar
    Your apologetic tenor in you blog is ominous of an opportunity going to be missed.
    The issues you have raised especially relating to interpretation of efficacy in S3(d) must be settled through judicial intervention to settle disengagements.
    Your credentials and your intellect are unmatched. But you seem to be discounting them and looking not to annoy anyone to be able to contribute in the case. Sir such please all attitude will not take you anywhere.
    Has Mr. Grover felt that he has done something wrong by calling you an impersonator from Novartis and there is a need for apology. It will never come. Because whatever has happened in court was intentional and is a very common strategy adopted by many lawyers to belittle the present/perceived opposition . While your interest is to help the court resolves the issues but the interest of Mr. Grover & company is to get the verdict in their favor. Academic interest is inconsequential. It is as simple as this.
    The judges are the people who have to the final call. And they will never be found wanting to seek help if it helps them with their job. But for them the ‘amicus curie’ is not someone with credentials only. They will want the ‘amicus curie’ to survive the onslaught of parties involved and help derive judicious conclusions on the contested issues.
    You may have the best lawyer who is going to bat for you. Build your aggression so that you can transfer some of it into him so that he can bat long and also hit a few sixes instead of trying to play defensive with the intent of not annoying the baller.
    R.K.Jain
    Patent Agent

    Reply

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