Life Sciences IP Due Diligence

2024 has been a year of monumental developments in case law, policy, and regulations in the Life Sciences that have affected IP due diligence review. Hear from in-the-know practitioners on how the due diligence process has shifted, and how to ensure successful and thorough review processes, guiding you through the eye of the storm.

This session will provide insights on the shifting life sciences policy landscape as an introduction to themes discussed in more detail later in the program.

• Understanding the impact of the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo on regulatory agency determinations from the Food and Drug Administration (FDA), the US Patent and Trademark Office (USPTO), and Federal Trade Commission (FTC)
• Analyzing the significance of the FTC’s position on Orange Book delistings and how this may affect diligence reviews
• Assessing the impact of the government’s potential use of march-in rights on life sciences intellectual property and how this would affect IP value
• Examining the impact of the PTO’s proposed rule on Terminal Disclaimers and the request for comments on the experimental use exception
• Revisiting the Inflation Reduction Act and the challenges it presents to patent value
• Analyzing recent reforms to patent eligibility following the introduction of the Patent Eligibility Restoration Act
• Anticipating the position of the next administration on life sciences IP rights, policies, and regulations

Cellect and Xencor, are among the most ground shifting life sciences patent cases in the last year—if not decade. They go to the very heart of patent claims through their holdings on obviousness-type double patenting and means-plus-function claims, adding another layer of consideration to life sciences IP due diligence review. These developments create new demand for a patent portfolio that’s not too big and not too little, but juuuust right.

• Analyzing the Federal Circuit’s decisions in Cellect and Xencor, and understanding their impact on obviousness considerations in IP due diligence reviews
  • Obviousness type double patenting
  • Means-plus-function claims
• Anticipating whether the Supreme Court will grand certiorari to Cellect and how the Court may decide
• Mitigating double patenting concerns to ensure a robust IP portfolio
• Flagging potential means-plus-function claims to avoid pitfalls in IP valuation review
  • How Goldilocks means-plus-function claims could lead to different results in cases like Amgen, and Baxalta.
• Understanding the use of means-plus-function limitations to claim antibodies

In May of 2024 the USPTO released its proposed rule on Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting, with commenting closed in July.

Under the proposed rule, in an attempt to reduce patent thickets, all tied-together patents will be limited by each of the other’s terminal disclaimer claims. The rule’s intent is promoting competition and incentivizing innovation. The FTC has offered a comment in support of the proposed rule, but IPO and AIPLA have expressed concern.

Work with fellow practitioners to develop due diligence strategies and best practices to address terminal disclaimer and double patenting concerns in the midst of a review. Share your approach to mitigation and issue spotting and learn new methods from your peers in the IP due diligence space.

In July of 2023 the Supreme Court issued its decision in Amgen v. Sanofi, unanimously holding that several of Amgen’s patent claims were invalid for lack of enablement. A year and a half later, the lower courts and Federal Circuit have begun to rely on this decision in their own case analyses.

• Understanding how the lower courts and Federal Circuit are interpreting Amgen and how this will affect your IP due diligence review
• Determining whether the claims in your patents are narrow enough to survive while remaining broad enough to protect your IP
• Comparing US enablement and European plausibility assessments to inform patent strategy
• Developing claims both offensively and defensively

Hear from UPC practitioners about how the Court’s decisions over the last year and a half have informed due diligence strategies, IP reviews, and mitigation methods not only in the EU, but in the US, and globally. Key points of discussion will include:

• Zooming-in on the distinction between the US and EU treatment of Amgen v. Sanofi
• How the UPC is determining essentiality and their decisions regarding standard essential patents
• Regulatory differences between American and European treatment of pediatric exclusivity, orphan drugs, biologics, and patent term extensions
• Examining the impact of these developments on global patent reviews

• Examining how new case law, as well as new legal and regulatory developments, are influencing Freedom to Operate (FTO) reviews in the life sciences
• Exploring different approaches to FTO analysis based on these developments
• Finding solutions to potential areas of infringement
• Assessing the scope of FTO potential FTO impediments to products and technologies with or without patent protection

Hear from leading life sciences Business Development professionals on pressing IP concerns and critical patent portfolio considerations for successful life sciences deals.

Inform due diligence reviews by identifying focus-points and prioritizing value-indicators while remaining on the lookout for potential red flags. Gain key understanding on best methods to value intellectual property rights.