Biogen sticks it to Kyle Bass with Tecfidera IPR win

Pharma patent challenger Kyle Bass has lost his second round at the U.S. Patent and Trademark Office in as many weeks, and this time, the win is Biogen’s.

Tuesday, the PTO’s Patent Trial and Appeal Board kept (PDF) the Big Biotech’s ‘514 dosing patent on multiple sclerosis star Tecfidera—set to expire in 2028—intact, dealing Bass and his Coalition for Affordable drugs a blow in the process. Bass now has the option to appeal the verdict, but that process could take 12 to 18 months, Mizuho Securities analyst Salim Syed wrote in a note to clients.

The decision represents the second straight setback for Bass, who has been using the PTAB’s inter partes review process to challenge drug patents of the companies he shorts—and profiting when his efforts spook investors and send shares south. Earlier this month, the board shot down his attempt to dismantle Acorda Therapeutics’ IP shield on MS med Ampyra, upholding all four of the patents in question.

Bass has been waging war with Biogen in particular for a while now. He first took the drugmaker to task over Tecfidera back in 2015, only to see his request for an IPR denied that September. But Bass asked the board to reconsider, and it finally agreed to institute the review last March.

While the win is good news for the Massachusetts drugmaker, it doesn’t exactly put the company in the clear. Biogen is still waiting to hear whether it’ll owe Denmark’s Forward Pharma royalties of 10% on U.S. Tecfidera sales, and the same three-judge panel that decided the Bass case will make the call, Syed noted. 

And while Tecfidera generics may be at bay for a while, other oral MS knockoffs may not be. Analysts expect that Biogen and rival Sanofi, which makes Aubagio, will have to contend with copies of Novartis’ Gilenya come 2019.