Biden Administration’s Proposed March-in Framework (RECORDING)
The Biden Administration recently unveiled new guidance for exercising march-in rights under the Bayh-Dole Act. Under Bayh-Dole, universities and other contracting organizations are given rights to intellectual property generated from federally funded research and enabled to license these inventions to private sector partners who can then commercialize them. It includes a “march-in” provision that permits the government, in specific and limited circumstances, to require the patent holder to grant additional licenses to the patented technology.
The proposed framework for the first time includes “reasonableness of the price and other terms at which the product is made available” as a factor agencies can consider. Many in the IP community quickly condemned this proposal as a poison pill for commercializing inventions created through government funded research, hitting universities and startups hardest while also creating problems for companies that traditionally have partnered with those entities to transform early-stage research into commercialized products. Despite the Administration’s linkage of the proposed framework to drug pricing, the proposed guidelines would apply equally to all federal agencies, not just the National Institutes of Health, and thus could affect numerous technology sectors.
During this webinar, panelists will discuss the guidelines and potential consequences of the proposal.
Joseph Allen is Executive Director of the Bayh-Dole Coalition. As a professional staffer on the Senate Judiciary Committee to Sen. Birch Bayh (D-IN), he played a key role in successfully passing the Bayh-Dole Act of 1980 and its subsequent amendments. He later served as the director of the Office of Technology Commercialization at the Department of Commerce, which oversaw the implementation of Bayh-Dole and chaired the Interagency Committee on Technology Transfer.
Head of IP Policy & Advocacy
Emily Johnson is the Head of IP Policy & Advocacy for Amgen, one of the world’s leading biotechnology companies. Emily is responsible for influencing the development of sound public policy with respect to IP protections that are important to Amgen’s long-term success. Emily collaborates cross-functionally with Amgen’s IP, litigation, regulatory, antitrust, commercial, and government affairs teams to develop IP policy positions. She also engages with external trade organizations and government agencies and identifies and develops amicus brief opportunities in cases that raise significant IP issues for Amgen. Prior to Emily’s policy role, she litigated U.S. and foreign patent disputes, proceedings before the USPTO’s Patent Trial and Appeal Board, and appeals to the Federal Circuit. Emily had the privilege of clerking for the Honorable Arthur Gajarsa (now retired) at the US Court of Appeals for the Federal Circuit. Emily chairs the Pharmaceutical & Biotechnology Issues Committee of Intellectual Property Owners Association and serves on the Board of the Federal Circuit Bar Association.
Banner & Witcoff, Ltd.
Mercedes K. Meyer, Ph.D., represents leading life science and technology companies maintaining an extensive biotechnology and pharmaceutical patent management, prosecution, opinion and due diligence practice. With a doctorate in virology and degree in chemistry, Mercedes has a deep understanding of complex biotechnology and scientific research, which is key for advising life science clients on commercializing and protecting product innovations as well as performing diligence for investing in new technologies, particularly in corporate joint development projects. Mercedes advises on developing patent strategies, managing the intellectual property rights, and making associated investments and acquisitions. Mercedes also handles patent reexaminations and inter partes matters.
Vice President and Global Head of IP Affairs
Corey Salsberg is Vice President and Global Head of IP Affairs for Novartis, one of the world’s leading biopharmaceutical innovators. He is a globally recognized attorney, strategist and thought leader in the fields of intellectual property (IP) and innovation law and policy. An experienced practitioner and advocate, Corey is a frequent speaker and contributor around the world. His recent engagements include testifying before the United States Senate Judiciary Subcommittee on IP regarding AI and intellectual property (June 2023); public remarks at the USPTO Listening Sessions on AI and Inventorship (April 2023) and USPTO-FDA Collaboration Initiatives (January 2023); testifying before the United States Senate Judiciary Subcommittee on IP on the state of patent eligibility law in the US; public appearances before WIPO, the WHO, and other government and multilateral bodies; and a variety of keynotes and public podcasts. Corey is also proud to be an Officer and Member of the Board of Directors of the Federal Circuit Bar Association, a Member of the Board of Directors of IPO, a Member the Board of Directors of California Lawyers for the Arts, and a founder and member of the Steering Committee of the WIPO-World Economic Forum Inventors Assistance Program. He is featured in the 2021 and 2022 IAM 300, a list of the world's leading IP strategists, and has been named as an IP Corporate Star in Managing IP for each of the last three years.