Patents, Price Controls and the IRA: Understanding the Impact of the Inflation Reduction Act on IP Due Diligence Analyses in the Life Sciences Industries

November 28, 2023 11:45am

Caitlin E. Olwell
Counsel
Akin Gump Strauss Hauer & Feld LLP

Ha Kung Wong
Partner
Venable Fitzpatrick LLP

Jeffrey L. Kopacz
SVP | Head of IP & Contracts
SalioGen Therapeutics

The profound implications of the pricing controls in the Inflation Reduction Act (IRA) on pharmaceutical and biotech innovation are of such concern that a lawsuit has been filed, challenging the law’s constitutionality. As such, it is imperative that life sciences IP transactional attorneys understand the affect the IRA is having on profitability, innovation, and deal-making strategies now. Topics of discussion will include:

  • Understanding how price negotiation may circumvent pharmaceutical patent values
    • How is the value of IP impacted when drugs are not approved for Medicare/Medicaid formularies?
    • How does renegotiation affect the value of the drug’s patent?
  • Evaluating the influence of the IRA on mergers, acquisitions, and licensing agreements
    • Discussing proactive measures to adapt to the IRA and optimize business strategies
    • Practical strategies for safeguarding IP value when your drug is selected or likely to be selected for negotiation
  • Interpreting the CMS guidance on the implementation of the IRA
  • Update on the lawsuits challenging the IRA
  • Exploring the balance between government control and industry innovation
    • Analyzing the potential consequences of price controls on patents and profits
    • Assessing the implications for research and development budgets and innovation
    • Anticipating long-term effects on portfolio strategies and early-stage companies