Tech Transfer Central

The New Framework for March-In Rights: Potential Impact on University Partnerships and IP Licensing

Format: Webinar, On-Demand Video/Transcript, or DVD
Thursday, February 29, 2024 ~ 1:00-2:00 pm (Eastern Time)

Additional Lines: Orders for all live programs will include up to five additional lines at no additional charge for staff within your organization who can attend remotely, and all live programs will include our digital package. Click here for more details.

Price: $197

The U.S. government’s proposed framework for exercising march-in rights under Bayh-Dole –  including pricing considerations — has been met with a flurry of reactions. On one hand, supporters are praising the framework as a means to long-promised drug cost controls. On the other are cautionary skeptics and vocal critics – including tech transfer professionals, AUTM, BIO, The Bayh-Dole Coalition and many others — who envision these rights as going far beyond drug pricing and sending a dagger straight to the heart of government-funded innovation, university tech transfer, and U.S. competitiveness in critical technology fields.

Even though the NIH declined the March 2023 petition to exercise march-in rights on Xtandi, prominent members of Congress have been vocal with their disappointment on the issue, further fueling support for the measure. With the majority of university-based research and innovation being supported in some measure through government funding, it begs the question: How could this framework affect the future of our ability to develop and commercialize government-funded IP?

Will start-ups be able to attract VC funding without assurance that their patents won’t be co-opted by the government? Will licensees perceive new levels of risk that make deals harder to come by and reduce the royalty rates and other fees they’re willing to pay? Do license and funding agreements now need to address the potential for march-in rights based on drug pricing considerations, and how? Also at stake are precious partnerships between research institutions and corporations that could be jeopardized out of fears that any project supported by government funding risks the loss of rights to critical IP.

The future is uncertain around march-in rights and their potential impact, and that’s why we’ve teamed up with two experts from Foley Hoag to lead this critical and timely one-hour webinar:

The New Framework for March-In Rights

Join Foley Hoag attorney experts Donald Ware and Andrew London for this insightful program that will address:

  • The history of the Bayh-Dole Act and its record of success in stimulating university innovations and economic growth
  • An overview of the government’s march-in rights on patents under Bayh-Dole, and how march-in rights were designed to further Bayh-Dole’s purpose of promoting private investment in innovative technologies developed by non-profits
  • A review of past march-in petitions, including NIH’s consistent refusal to march-in based on licensee drug pricing practices
  • The Biden Administration’s Draft Framework for Considering the Exercise of March-In Rights and other ongoing attempts to use the government’s march-in rights as leverage to regulate drug pricing
  • What can we expect going forward? The future of the Bayh-Dole Act and its impact on technology transfer, including:
    • Licensee risk
    • Investment in university-owned IP
    • Industry and other partnerships
    • License agreement terms
    • Drug development
    • U.S. competitiveness

Plus: Get all of your questions answered during the interactive Q&A

Register today and you’ll gain valuable insights into how your university can navigate the future of the march-in rights framework

After the live session, keep the on-demand video for future training and education.

Meet your team of experts

Donald R. WareDonald R. Ware
Partner
Foley Hoag

Don 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. He has represented the patent holders in several Bayh-Dole march-in proceedings, including the first such proceeding, In re CellPro, Inc.

Andrew M. LondonAndrew M. London
Partner
Foley Hoag

Mr. London concentrates his practice on disputes arising from federal and state healthcare regulation and state Attorney General investigations. He has significant experience litigating regulatory and other public law matters in both federal and state court. Andrew’s practice also includes advising clients on regulatory enforcement proceedings and strategic counseling on regulatory and administrative processes. Andrew advises healthcare providers, payers, drug and device manufacturers and related entities in matters related to the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Bayh-Dole Act and state healthcare programs.

Additional Lines

Orders for all live programs will include up to five additional lines at no additional charge for staff within your organization who can attend remotely, and all live programs will include our digital package – the on-demand video and transcript. These will be delivered soon after the live program with no extra fee. 

Overseas participants

We know your schedule may not mesh easily with the time of this live webinar in the United States. All of our live programs include a digital package that consists of the on-demand, streaming video of the presentation, plus a transcript and the original program materials. This is available to all registrants at no extra charge so you can share it whenever you wish throughout your organization.

Register Today!

Cost for this live program is $197 and includes up to five additional lines at no additional charge for staff within your organization who can attend remotely. We are also including our digital package – the on-demand video and transcript – at no extra charge so you can share it whenever you wish throughout your organization.

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We stand 100% behind the quality and value of our products. If you are dissatisfied, simply let us know and we will send you an immediate refund for your entire order -- no questions asked.

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Please review your State Bar’s policy on distance learning credits prior to submitting the non-refundable application fee.

We submit CLE applications (excluding NY, NJ, IL, LA & PA) for an additional $50 (California is $90, Florida is $225, Texas is $150). Approval times vary per state and cover all attorneys in attendance. Application is not a guarantee of approval and attendance forms must be submitted following the program.

CLP Credits are also available.

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