Posts Tagged: "NIST"

Massive Replication of Comments Submitted to NIST March-In Rights RFI Should Cause Concern

I have been critical of certain National Institute of Standards and Technology (NIST) proposals to alter the regulations related to the Bayh-Dole Act, in 2021 (Notice of Proposed Rulemaking, NPR), and specifically, the NIST “Framework” published for comments in December, 2023.  My Comments submitted in February addressed numerous legal infirmities, ranging from construction analysis to demonstrated ambiguity problems of the Request for Information/Comments (RFI) itself. 

March-In Drive Loses a Wheel: Generics Industry Says No to Biden Framework

In what has to be the unkindest cut of all, those expected to benefit from the proposed misuse of march-in rights so the government can impose drug price controls say they don’t support it either. The proponents promoting this hot house theory have seen it denounced by those who created the Bayh-Dole Act as being unauthorized under their law and seen evidence they can’t refute that it would have little impact on drug prices but would devastate small business entrepreneurs in all fields of federally supported research and development. And now they’ve lost the generic drug industry.

HHS Denies Appeal of Xtandi March-In Petition as Comments Close on Proposed Framework

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

Public Comments Reveal Widespread Unity in Opposition to NIST’s March-In Rights Framework

February 6 is the final day of the 60-day public comment period set by the National Institute of Standards and Technology’s (NIST) request for information on its draft interagency framework for exercising march-in rights under the Bayh-Dole Act of 1980. While lauded by drug pricing advocates, almost every other sector of the American economy has come out in opposition to the draft framework. Senator Thom Tillis (R-NC), the U.S. Chamber of Commerce and the Bayh-Dole Coalition have all publicly opposed NIST’s efforts to exercise legal authority for relicensing patent rights based on product pricing considerations.

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.