Already facing a slowdown for its superstar hep C meds, Gilead Sciences may be a bit more tense this week. A key patent for Sovaldi is under fire in Europe, and officials have already pared back the blockbuster med’s patent claims.
Challenged by charity Medecins du Monde and some pharma companies, Gilead found its patent claims weakened after a two-day meeting at the European Patent Office, according to a MdM release. In fact, the decision “technically … means that sofosbuvir in itself is not protected by a patent any more," the charity says.
But that’s a claim refuted by Gilead, which argued that the drug remains covered by a “valid European patent” in a statement seen by STAT. Sovaldi could face generics four years earlier as a result of the ruling, the publication reported, but again Gilead denied that assertion.
In a statement, EPO said its experts "came to the conclusion that after deletion of claims to single compounds," the patent could be maintained "in an amended form." A spokesperson told FiercePharma that EPO can't say much "about the scope of protection of the patent in its amended form as this would be up to a patent court to establish, not a patent office."
Gilead told FiercePharma that "while the opposition division rejected certain of our patent claims for technicalities, the remaining claims cover sofosbuvir and were determined to be valid. The patent will be amended accordingly. We believe this decision recognizes the extraordinary innovation involved in the development of sofosbuvir.”
The ruling is subject to an appeals round.
Following the EPO meeting, MdM took its challenge a step further, calling for compulsory licenses to the drug. If EU governments took that step, generics would be available rapidly. The charity said countries should “immediately” issue CLs--an unlikely event, particularly in Europe. India, which has been active on that front, has only issued one compulsory license since it started entertaining the idea several years ago.
Governments have maintained that "compulsory [licensing] was a 'weak legal tool' to justify the fact that they were not willing to use it," Olivier Maguet, MdM drug pricing campaign manager, said in a statement, "despite the fact that it has been endorsed by national laws and WTO rules."
"Well, what we know today is that it is the patent that was weak," Maguet said.
For drugmakers, the patent decision comes at a time of increased pricing pressure, even in the U.S., as companies work to get the most out of their new launches. For its part, Gilead aggressively priced its hep C meds Sovaldi and Harvoni to achieve historically impressive launches, along the way catching fire from patient organizations and payers, who put up roadblocks to access.
But the company has struggled to maintain the growth pace in recent quarters as competing products from AbbVie, Bristol-Myers Squibb and Merck hit the market and payers pushed for discounts. One influential analyst last month called the entire sector a “flash in the pan,” predicting that Gilead’s sales will “erode massively.”
To combat the slump, analysts and investors have been pressing for M&A at Gilead, with the company so far showing restraint on any big buys. Responding to those questions last quarter, CEO John Milligan said the company "has been very open" about its desire to do deals, "especially deals of a certain size."
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Editor's note: This story was updated with a comment from Gilead.