NIH won't override patents on Astellas' pricey Xtandi to bring down prices

By Carly Helfand Jun 21, 2016 10:57am

Here’s a move that’s sure to help drugmakers breathe easy while sparking the ire of nonprofits and lawmakers alike: The National Institutes of Health (NIH) says it won’t be using its rights to override the patent on Astellas and Medivation's pricey prostate cancer pill Xtandi.

In response to a January request and follow-up correspondence since, NIH director Francis Collins Tuesday penned a letter to nonprofit Knowledge Ecology International (KEI) stating that the institutes would not be initiating a march-in investigation or utilizing the government’s license to skirt Xtandi’s patents to help bring down costs on the med.

As Collins explained in the letter, the decision to exercise those rights depends on a government-funded invention’s availability to the public. And “Xtandi is broadly available as a prescription drug,” he noted, pointing out that KEI's January letter provides no information suggesting that Xtandi "is currently or will be in short supply."

KEI and others, though--including the Union for Affordable Cancer Treatment and a handful of lawmakers that penned a March letter to Collins and HHS Secretary Sylvia Burwell--see things differently. High out-of-pocket costs for patients and restrictive formularies are limiting access to patients, the nonprofit argued in Monday blog post, and a lower price on the med would fix those issues.

Collins’ response was “an appalling dereliction of his duty to protect the public from unreasonable use of inventions funded by U.S. taxpayers,” KEI director James Love said in a statement--and it’s one the nonprofit plans to appeal.

“KEI plans to challenge the NIH’s flawed legal rationale in regards to its use of march-in rights and its lack of analysis on its refusal to use its royalty-free license,” it said in the blog post.

And if that doesn’t work? “KEI also plans to refile this case after a new President takes office next year if HHS declines our appeal,” it said.

Meanwhile, the decision is good news for Xtandi makers Astellas and Medivation, who share profits on the blockbuster med. It’s also a positive sign for wannabe buyers of Medivation, of which there are several: French drug giant Sanofi is currently embroiled in a hostile takeover pursuit of the California company, while rumor has it that plenty of Sanofi's rivals--including Pfizer, Novartis, Amgen, AstraZeneca and Gilead--are interested, too.

- read the letter (PDF)
- see KEI's blog post

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