Posts Tagged: "march-in rights"

The March-In Drug Price Control Narrative Crumbles While Its Damage to American Innovation Grows

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act. For more than 43 years, the law was implemented as written. Every Administration—including the Biden Administration—rejected repeated attempts to misuse the law so the government could license copiers when critics felt that a product based on a federally-funded invention was too expensive. This was mainly sought under the guise of lowering drug prices. Even though the Administration issued a stinging denial of the most recent attempt last March, in December it reversed course.

Coalition of Academics Sends Letter Opposing Biden Administration’s March-In Rights Proposal

Today, a letter signed by a coalition of top academics opposing the Biden Administration’s efforts to exercise march-in rights under the Bayh-Dole Act of 1980 was sent to the White House. Signed by academics in fields including law, economic policy and sciences, the letter warns the Biden Administration that its efforts to drive down drug pricing by seizing patent rights will “undermine fundamental principles that have made the American IP system the golden standard for supporting domestic innovation.” A growing topic during recent Congressional debates, march-in rights under Bayh-Dole took on a new focus in early December when the National Institutes of Standards and Technology (NIST) and the U.S. Department of Commerce released a draft framework of factors that federal agencies should consider for the exercise of authority codified at 35 U.S.C. § 203 that would compel patent owners holding rights to federally-funded inventions to license those rights to “responsible applicants.”

Chamber’s GIPC Wants Details on Bayh-Dole Working Group

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent Freedom of Information Act (FOIA) requests on January 9 to the Department of Commerce and the National Institutes for Standards and Technology (NIST) regarding the Biden Administration’s recent Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. The proposed framework was published in the Federal Register in December by NIST and the Department of Commerce and included suggestions on whether and when to exercise “march-in rights” under the Bayh-Dole Act that would arguably significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding.

Tillis Demands Answers from Biden on March-In Proposal

Senator Thom Tillis sent a letter today to President Joe Biden asking him to answer three broad questions related to his proposal earlier this month that would allow government agencies considerable discretion in deciding whether and when to “march in” on patents. As we previously reported, the National Institute of Standards & Technology (NIST) and the Department of Commerce published a Federal Register Notice on December 8 seeking comments on a proposed framework for exercising march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding, particularly with respect to drug pricing.

New March-In Guidelines Threaten U.S. Innovation

One might think that we had enough crises already without creating a new one, but apparently that’s not the case. To much fanfare, the Biden Administration unveiled its long awaited “guidelines” for agency use of the march in rights provision of the Bayh-Dole Act. Ironically, it started this exercise just as it had joined every other administration in dismissing attempts to misuse the statute as a pretext for the government to micro-manage the price of a successfully commercialized government funded invention.