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Warren Bid to Grab Xtandi Cancer Drug Patents Gets Firm Rebuke (1)

March 18, 2022, 6:19 PMUpdated: March 18, 2022, 9:19 PM

An effort by Sen. Elizabeth Warren (D-Mass.), other lawmakers, and advocacy groups to force the government to green-light production of a cancer drug by third-party manufacturers is meeting stiff opposition from nearly 100 interest groups and individuals.

President Joe Biden’s Health and Human Services Department should flat-out reject a plea for the government to grant so-called “march-in rights” for patents on the prostate cancer drug Xtandi, the Bayh-Dole Coalition and other individuals and interest groups said in a letter to HHS Secretary Xavier Becerra. Similar requests for march-in rights were rejected several times during the Obama administration, according to the letter.

A trustee of the Dana-Farber Cancer Institute and others petitioners have asked the HHS to license Xtandi patents for outside companies to produce copycats of the drug in attempt to lower prices, an effort that gained the support of Warren, along with Sen. Angus King (I-Maine) and Rep. Lloyd Doggett (D-Texas).

The Bayh-Dole Act’s march-in rights allow the government to license a private company’s patents to outside entities if the government helped funding the invention’s research and development.

But the law is “not a magic panacea to suddenly lower drug prices,” said Joe Allen, the Bayh-Dole Coalition’s executive director and a former Senate Judiciary Committee staff member during passage of the law, in an interview. The Bayh-Dole coalition is a organization composed of drug industry groups, university entities, and other organizations.

Medivation, acquired by Pfizer, was joined in developing the drug by Astellas. Astellas is considered the drug’s owner.

Citing findings from Knowledge Ecology International, Warren’s February letter to the HHS said that Xtandi’s average U.S. wholesale price was $130 while a 40mg capsule in Japan was priced a little over $20.

Among those signing onto the Bayh-Dole Coalition letter are the Wisconsin Alumni Research Foundation, U.S. Chamber for Commerce, and other organizations, along with a Johnson & Johnson manager and pharmacist and a former Novartis director.

(Updates with details of drug development in sixth paragraph.)

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

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