A Writ Petition has been filed before the Delhi High Court, challenging the grant of patent for Gilead’s megahit anti Hepatitis-C virus (HCV) drug, sofobuvir which is known commercially everywhere as “Sovaldi”. The company charges a super hike price of $1,000 per pill in the USA. Though the price of the treatment in India is not expected to be very high due to local competition, with the generic version priced at a around $13.71 per pill in India, where domestic drugmakers may have planned to export the key raw material or others planning to launch the drug in the country are bound to be hit, argued by whom have decided to take the patent office to court.
The petition has been jointly filed by the non-for-profit group based in United States, Initiative for Medicines, Access & Knowledge (I-MAK) and the human rights group, Delhi Network of Positive People (DNP+). The challenge contends that the Indian Patent Office’s judgment is contrary to public interest, and that it fails to appraise the full scientific and legal evidence presented. The challenge further submits that the decision ignores key judicial precedents.
On May 9, 2016, the Indian Patent Office (IPO) granted a patent to Gilead Pharmasset, LLC (Gilead) holding that the invention was novel, inventive and did not fall within the preclusion of Section 3(d) of the Indian Patents Act. The heavy 58 page order rejected six pre-grant oppositions that had been filed and ordered the granting of the application.
The key arguments presented by the pre-grant opponents were: (i) lack of novelty, (ii) lack of inventive step and (iii) non-patentability in view of section 3(d). Considering the arguments of all the parties, the Controller in a very detailed technical analysis, held that the invention involved both novelty as well as inventive step and overcame the patentability barrier set by section 3(d). Specifically, The Controller observed that with respect to novelty, the prior art neither exemplified nor provided an enabling disclosure with respect to the claimed compound. Therefore, an arbitrary selection without the use of hindsight was impossible. As a result, he held that the claimed compounds were not anticipated by the cited prior art. Regarding inventive step, the Controller agreed with Gilead that the cited prior art documents failed to provide a clear teaching for a person skilled in the art to arrive at a substitution pattern as recited in the claims. With regard to non-patentability under section 3(d), the Controller held that it was difficult to accept that claimed compounds were derivatives of known compounds when such compounds having anti-HCV activity were simply not exemplified in any of the cited prior art documents. This was an ambo given to the “Sovaldi” by the patent office smashing a bundle of pre-grant oppositions. The battle still has scenes to show.