Bass' Tecfidera patent challenge gets hearing, puts IP at risk

Kyle Bass

"If at first you don't succeed, try, try again" may be the mantra for pharma patent challenger Kyle Bass. And it looks as if that strategy is working.

The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) said on Tuesday that it would conduct an inter partes review on Biogen's ($BIIB) multiple sclerosis pill Tecfidera, in response to a request from Bass' Coalition for Affordable Drugs.

That's something the PTAB refused to do back in September. But Bass asked the board to reconsider, and it did an about-face. And that may make pharma companies nervous.

Since early last year, Bass has been targeting pharma company patents and shorting their stocks--and profiting when his moves trigger share drops, though he also claims his moves help society by lowering drug prices. Until recently, Bass and his coalition had met with mixed results, but just over a week ago, another flip-flop from the PTAB--this time on Acorda Therapeutics' ($ACOR) multiple sclerosis med Ampyra--came out in his favor.

The decision doesn't necessarily spell doom for Biogen. It'll take the PTAB about a year to conduct the review and make a decision, and it's not guaranteed to upturn the Massachusetts biotech's IP shield.  But the med's patents are already under attack on other fronts; Forward Pharma ($FWP) is waging a patent fight with the drugmaker, and the EU revoked one of the patents on the pill just this month.

All things considered, Leerink Partners analyst Geoffrey Porges doesn't expect the company's Tecfidera exclusivity to last all that long. He predicts it'll extend through just 2019 in the U.S. and 2024 in Europe, he wrote to clients Tuesday.

And competition is the last thing Tecfidera needs. Last year, the company revealed that the once red-hot med's growth trajectory was slowing, and it later announced plans to chop 800 jobs in order to save money for a larger marketing push.

- read the PTAB decision (PDF)

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