March-in Power and Patent Rights: Bayh-Dole Act, NIST Framework, Implications for Patent Rights and Innovation
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE webinar will guide patent counsel on the use of march-in rights as the mechanism to lower drug prices. The panel will review the history of the Bayh-Dole Act, lessons learned from past march-in petitions, and the proposed NIST framework. The panel will discuss the implications and concerns for patent rights and innovation in the biopharma space.
Outline
- Review of the Bayh-Dole Act and march-in rights
- Proposed new framework to expand march-in rights into drug pricing
- Implications and concerns for patent rights and innovation
Benefits
The panel will review these and other key issues:
- How can the government use the Bayh-Dole Act to control drug pricing?
- What impact will the call for consideration of unreasonable pricing have on the question of using march-in rights?
- What will the use of march-in rights mean for patent rights? Patent holders?
Faculty
Joanna T. Brougher, Esq., MPH
Owner & Principal
BioPharma Law Group
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of... | Read More
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Mercedes K. Meyer, Ph.D.
Attorney
Banner Witcoff
Ms. Meyer, Ph.D., represents leading life science and technology companies maintaining an extensive biotechnology and... | Read More
Ms. 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, she 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. Ms. Meyer advises on developing patent strategies, managing the intellectual property rights, and making associated investments and acquisitions. She also handles patent reexaminations and inter partes matters.
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Donald R. Ware
Partner
Foley Hoag
Mr. Ware is a past Chair of the firm’s Intellectual Property Department and represents leading biopharma... | Read More
Mr. Ware is a past Chair of the firm’s Intellectual Property Department and represents leading biopharma manufacturers, research institutions, and universities in patent and inventorship disputes, technology transfer issues, and intellectual property strategy. He advises clients on FDA matters, including the FDA's regulatory pathway for approval of biosimilars, and issues arising under the Bayh-Dole Act. Mr. Ware has represented the patent holders in several Bayh-Dole March-In proceedings, including the first such proceeding, In re CellPro, Inc. In addition to his trial practice, he has extensive experience in appellate litigation, including appearances before the United States Supreme Court, the U.S. Court of Appeals for the Federal Circuit, and many other state and federal courts. Mr. Ware is also experienced in alternative dispute resolution, including mediation and arbitration, both as party counsel and as an arbitrator in the International Chamber of Commerce and the International Centre for Dispute Resolution.
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