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, 2014, 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