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March-in Power and Patent Rights: Bayh-Dole Act, NIST Framework, Implications for Patent Rights and Innovation

A live 90-minute premium CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Tuesday, April 30, 2024 (in 8 days)

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

or call 1-800-926-7926

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.

Description

Despite not using march-in rights over the past 40 years to limit drug pricing, the Biden administration and governmental agencies are now turning to march-in as a potential means to lower drug pricing. Under the Bayh-Dole Act, the federal government has the right to “march in” on patented inventions created using federal funds to require the patent holder to license the patent to other applicants.

In December 2023, the White House announced a proposal to expand the use of march-in rights to include drug pricing as one of the grounds for march-in. To this end, the National Institute of Standards and Technology (NIST) published a draft Framework for Considering the Exercise of March-In Rights. In a policy shift, the framework calls on federal agencies to consider “unreasonable pricing” when determining whether to exercise march-in rights. In February, the FTC threw its support behind the proposed framework.

Universities and biopharma companies have raised concerns that use of march-in rights to control drug pricing will discourage innovation and the development of new therapies.

Listen as our authoritative panel of patent attorneys examines the use of march-in rights as a 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 holders and future innovation in the biopharma space.

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Outline

  1. Review of the Bayh-Dole Act and march-in rights
  2. Proposed new framework to expand march-in rights into drug pricing
  3. 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

Brougher, Joanna
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

Meyer, Mercedes
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

Ware, Don
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

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