Global pharmaceutical major Novartis AG and Mitsubishi Pharma Corporation have lost a patent fight with Ahmedabad-based Torrent Pharmaceuticals in the US over Novartis' block buster multiple sclerosis drug Gilenya.
The US Patent and Trademark Office (USPTO)'s trial and appeal board quashed Novartis's patent claims stating they were obvious (and hence not inventions that merit patent protection). With $2.5 billion annual sales in 2014, Gilenya is the highest revenue generating drug for Novartis worldwide. Generic drug majors Apotex, Inc. and Mylan Pharmaceuticals Inc. had also joined the case on Torrent's side through a separate petition seeking review of patent claims made by Novartis.
The decision, which came on September 24, states that the first 32 claims made by the patent owners (Novartis and Mitsubishi) on a specific patent (No 8,324,283 B2) of Gilenya are too obvious to be granted. It also denied patent protection on the amended claims (33-64) made by the patent owners. While the first of the series of patents on Gilenya will begin to expire in the US in 2019, the specific patent under the current litigation would have extended the market exclusivity of Gilenya till 2026. The company has options to appeal against this verdict.
The board had taken up Torrent Pharma's petition to review the '283 patent on December 1. 2014. Two months later it looked into the combined petitions made by Apotex and Mylan too on the same case. The final decision was taken after an oral hearing involving both petitioners and patent owners on July 31, 2015, the 59-page decision notes.
The USPTO website states that the "Inter Partes Review" route taken by Torrent to challenge the specific Gilenya patent "may be instituted upon a showing that there is a reasonable likelihood that the petitioner would prevail with respect to at least one claim challenged". If the proceeding is instituted and not dismissed, a final determination by the Board will be issued within 1 year (extendable for good cause by 6 months). The procedure for conducting inter-partes review took effect on September 16, 2012, and applies to any patent issued before, on, or after September 16, 2012, it explains.
There are not too many instances of successful "inter parte review" challenges by generic drug makers in the US.
In a response to online journal fierce pharma, Novartis expressed its disappointment with the Board's decision and stated that the company is "evaluating the opinion and options, including a potential appeal of that decision."