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Public Policy Newsletter Article

Biocom and Other State Associations Express Opposition to Misuse of March-In Rights

  • 2020-08-27T15:00:00.000+0000
  • Washington DC
  • Author: Laure Fabrega

On August 21, Biocom and 35 co-signers sent a letter to Health and Human Services (HHS) Secretary Alex Azar to express our opposition to proposals that would allow the federal government to exercise “march-in rights” on innovative therapeutics, vaccines, or diagnostics developed partially with federal funding. Both legislators and state attorney generals have suggested that the march-in rights provisions of the Bayh-Dole Act could be used to control the prices of medicines. Our letter cautioned that the misuse of march-in rights would discourage further investment into COVID-19 vaccines and therapeutics, and severely undermine the future of all innovative medicine development in the U.S.

The Bayh-Dole Act of 1980 established a new legal framework in which recipients of federal funding (such as universities and small businesses) could elect to take title to their inventions and license the invention to a company to develop it into a new product, rather than leaving ownership of inventions within the federal government. The Bayh-Dole Act is widely hailed as a policy that fostered the creation of the biotechnology industry and spawned a whole generation of scientist-entrepreneurs.

The “march-in” provisions of the Bayh-Dole Act are intended to be used in very limited circumstances by federal funding agencies to ensure that discoveries are turned into products, such as if the grantee or licensee to a patent “has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention.” March-in provisions are certainly not intended to be exercised by agencies to act as a price control mechanism for biopharmaceuticals or any other technologies derived from federally-funded research. This is not only a misread of the intention of the Bayh-Dole Act but introduces a stark disincentive to biomedical innovation at a time when the industry needs predictable and reliable IP protections to fight a global pandemic.

The 35 co-signers are Arizona Bioindustry Association (AZBio), BioCT, BioFlorida, BioForward Wisconsin, BioKansas, Bio Nebraska Life Sciences Association, BioNJ, BioOhio, BioUtah, California Life Sciences Association (CLSA), Colorado BioScience Association (CBSA), Georgia Bio, HealthCare Institute of New Jersey (HINJ), Idaho Technology Council (ITC), Illinois Biotechnology Innovation Organization (iBIO), Indiana Health Industry Forum (IHIF), Life Sciences Pennsylvania (LSPA), Life Science Tennessee, Life Science Washington, Massachusetts Biotechnology Council (MassBio), Medical Alley Association, Michigan Biosciences Industry Association (MichBio), Missouri Biotechnology Association (MOBIO), Montana BioScience Association, New Mexico Biotechnology & Biomedical Association (NMBio), NewYorkBIO, North Dakota Bioscience Association, North Carolina Biosciences Organization (NCBIO), Oregon Bioscience Association (OregonBio), Puerto Rico Bio Alliance, RI Bio, SCBIO, South Dakota Biotech Association, Texas Healthcare and Bioscience Institute (THBI), Virginia Biotechnology Association (VaBio)