Patent

Secret Sovaldi Hearings: Whither Transparency?


secret court

In yet another blow for transparency, the Indian patent office is apparently doing all it can to discourage members of the public from accessing the patent opposition hearings in the Sovaldi (Sofosbuvir) case. This despite the fact that this case is of monumental public importance (not just in India but internationally).

And more importantly, despite the clear existence of Rule 139 of the patent rules (pointed out to be by the wonderful Feroz Ali) which states that:

Hearing before the Controller to be in public certain cases

“Where the hearing before the Controller of any dispute between two or more parties relating to an application for a patent or to any matter in connection with a patent takes place after the date of the publication of the complete specification, the hearing of the dispute shall be in public unless the Controller, after consultation with the parties to the dispute who appear in person or are represented at the hearing, otherwise directs.”

Apparently a request for permission to attend the hearing was made by a reputed journalist in the IP and public health space–and permission has not been granted (or refused), despite two days going by.  A clear stalling strategy if ever there was one! One hopes that quick amends are made without the need to approach courts of law on this.

Background to Sofosbuvir (Sovaldi) Patent Dispute

Gileads’ patent application in India (covering the notoriously expensive drug Sofosbuvir for Hep C) was opposed by both the Indian generic industry and patient/access groups as below:

Industry Challenges

Natco Pharma, IPA (Indian Pharmaceutical Alliance), BDR Pharma, Optimus, India Cares

NGO Challenge

IMAK (a reputed international NGO that has had stellar success invalidating non meritorious pharma patents), Delhi Network of +ve People (a reputed NGO working on patient rights and access), Sankalp Rehabilitation Trust (again a reputed NGO that fought the first pharma product patent in the post TRIPS era in India, namely the one covering Pegasus).

On January 14, 2015, the patent office rejected the patent application. Subsequently, Gilead appealed, showing that parts of the Controllers’ order rejecting the patent claim were verbatim copies of representations from an opposition filed by Natco Pharma.

And yet the office claimed it was not relying on any of the oppositions (and therefore offered no hearing to Gilead). This paved the way for a nice court challenge and the court immediately ordered the patent office to freshly determine the issue after hearing all the parties. The present set of hearings were a continuation of this process.

Interestingly enough, Natco Pharma, once seen as a champion of public health and affordable medication (what, with its compulsory licensing record in the famous Nexavar case and all that) is now busy cosying up to the very same MNC, whose patent it once opposed. As news reports indicate, Natco (and the IPA) signed up to to a voluntary licensing agreement with Gilead and immediately decided to drop their patent challenge.

One is not certain at this stage what the terms of the license agreement between Gilead and Natco/IPA are. And whether they mandate the dropping of the patent challenge and/or any future challenge to the patent. Given the public health and competition law implications , this agreement must be immediately subject to antitrust scrutiny by the Competition commission of India. As should the other licensing agreements with around 11 or so Indian partners.

For more on the present set of hearings which commenced around 3 days ago, see this news item from the MSF website:

“In proceedings that could have major implications for millions of people waiting for affordable access to a lifesaving hepatitis C drug, the Indian Patent Office this week began hearings to determine whether US pharmaceutical company Gilead Sciences deserves a patent for sofosbuvir, a hepatitis C drug for which the company currently charges $1,000 per pill in the US.

Today’s hearings are in relation to a “patent opposition” filed by lawyers from the Initiative for Medicines, Access & Knowledge (I-MAK) in November 2013, together with the Delhi Network of Positive People (DNP+). In it, lawyers argued that sofosbuvir was “old science” and did not meet the standard needed for patenting in India. The international medical humanitarian organization Doctors Without Borders/Medecins Sans Frontieres (MSF), which relies on generic medicines for its medical activities around the world, supports this effort to ensure that open generic production of sofosbuvir is possible. Patents for sofosbuvir have been rejected in Egypt, China, and Ukraine, and further patent oppositions have been filed in Argentina, Brazil, Russia, Thailand, and the EU.”

ps: image from here

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.

6 comments.

  1. AvatarWorriedIndian

    I wonder what this is all about? When there are several challenges filed against a pending patent application, many of them by Public Interest Groups (which one assumes represent the general public and not any vested groups), where is the question of closed proceedings and secrecy? Why are your posts increasingly becoming heavily anti patent? I can understand public interest but this is stretching it too far.

    This was the first time one ever saw activist groups, heavily laced with placards and slogans, camping inside the Patent Office. What next? Are you clamouring for a full drama within the cramped hearing room of the Patent Office where the serious technical arguments of an important contentious proceeding are throttled by slogans whilst the proceedings are on? I mean what is this about? Let the due process of law be followed and if there are any grievances on merit owing to a perverse order of the Controller, let the higher authorities decide. Let’s not be too judgmental on everything.

    I hope you aren’t suggesting that in the interest of ‘transparency’, the Patent Office should start holding hearings in open grounds so that members of the “public” can become spectators. Totally absurd and skewed post I must say, Shamnad.

    Reply
    1. Shamnad BasheerShamnad Basheer Post author

      Unfortunately, whether you like it or not, that is the law of the land. These are public proceedings to which the public are entitled. And if our courts can suffer this public “engagement” and be transparent about it (permitting all and sundry to attend), why shield our patent office from this?

      You mention “due process”. Due process is not an artificial construct. It is to be found in the law/legal norms. And here, the statute/rules make clear that these are public proceedings. So if people want to come inside and witness proceedings (without disrupting them), they are entitled to. Transparent proceedings lie at the core of the age old maxim: justice must be seen to be done. What does the patent office suffer by throwing this open? Lets keep the debate civil please. Its easy to hurl ad-hominem invectives; and I can reciprocate in kind. But that will leave us both the poorer for it..and do absolutely nothing to further the substantive points in the debate.

      I don’t believe in this pro-patent vs anti-patent false dichotomy. What is pro-patent? Someone who clamours for 100 year patent protection? Or an infinite period of protection. Even the most ardent patent fans would never advocate that. Lets speak the language of pro innovation vs anti-innovation. If the patent furthers innovation, lets support it. Not otherwise. And that precisely is what this opposition is about. If you’re interested in arguing on the merits, do so. But if you’re only interested in hurling “absurd” and skewed” invectives, you are not welcome on this platform. Thanks!

      Reply
  2. AvatarAnon

    Just by the way, Rule 139 cited by you itself states that the Controller has the power to refuse a public hearing. The last line reads “…unless the Controller, after consultation with the parties to the dispute who appear in person or are represented at the hearing, otherwise directs.”

    Reply
    1. Shamnad BasheerShamnad Basheer Post author

      Absolutely! But this power of the controller to refuse the public hearing can be exercised only “after consultation with the parties to the dispute who appear in person or are represented at the hearing”. Clearly, no such consultation took place in this case! Civil society organisations that challenged this patent would be more than happy to have more public participation at these hearings!

      Reply

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