Key expert takeaways on the IRA, European court expansion, and patent delisting for life sciences leaders.
Recent expert discourse at the Pharma & Biotech Patent Litigation North America Conference has illustrated the complex, evolving environment for life sciences innovators.
Four emerging themes are challenging conventional patent lifecycle management and monetization strategies. Industry discussions have centered on the impacts of the Inflation Reduction Act (IRA), patent delistings in the FTC’s Orange Book, the implications of skinny and “chubby” labels, and recent decisions coming out of European courts. This review summarizes these developments as highlighted by leading intellectual property attorneys and pharmaceutical executives.
IRA impact on litigation
Drug pricing provisions in the IRA are reshaping intellectual property strategy and litigation timing across the life sciences sector. Several drug manufacturers have challenged the IRA drug price negotiation program in various courts; to date, none have been successful.
- As drugs are selected for maximum fair price (MFP) negotiations, pressure on patent challenges may increase and generic challengers may find earlier at-risk entry more attractive as infringement damages could be lower.
- The IRA allows CMS to aggregate all dosage forms and strengths of an active ingredient for the purpose of negotiations, allowing both immediate -release and extended-release versions of the same product to be treated as one product during price negotiations. This provision may impact brand strategy, as extending the life cycle by introducing an extended -release version of an existing immediate -release product, or vice versa, may be less appealing to manufacturers.
For more information on the Inflation Reduction Act, see CRA’s three part series published in Managed Healthcare Executive.
Recent decisions in European Courts and the Unified Patent Court (UPC) demonstrate a “long-armed” approach to jurisdiction
The European Court of Justice’s far-reaching ruling in BSH Hausgeräte v. Electrolux continues to exert significant influence, resulting in “long-armed” decisions that effectively extend the authority of the court at issue beyond its home geography.
- In September 2025, the Munich Regional Court provided an example of the “long-armed” jurisdiction in use when it granted an injunction against an Eylea biosimilar for 22 countries.
- Ongoing patent infringement suits in Munich’s Regional Court between BMW and US based Onestat are cases to watch. Onestat is seeking injunctive relief and damages, in what could be the first time a German regional court will issue a ruling on a US patent.
To date, there have been no hearings on damages issues at the UPC. For more information on prospects and challenges for expert evidence at the UPC, see CRA’s article published in Law360.
Patent delisting
Recent FTC scrutiny on Orange Book listings, particularly around the delisting of medical device-related patents, could disrupt first-filer ANDA exclusivity and the broader Hatch-Waxman framework. The FTC has issued three waves of warning letters to manufacturers, focusing on device patents and requesting removal from the Orange Book.
- In Teva v. Amneal, the Federal Circuit affirmed the District Court’s order to delist the device patents, ruling that for drug-device combinations “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient.”[1]
For more information on patent delisting issues, see “Anticompetitive Conduct and Patents Listed in the Orange Book,” published in CPI by CRA’s Erin McDermott and Daniel Shack.
Skinny vs. chubby labels
Under 505(j)(2)(A)(viii), a generic manufacturer may “carve out” certain approved uses of a product from its application, commonly referred to as a “skinny label.” In contrast, a “chubby label” includes additional language on the label (compared to the existing branded label) in an attempt to avoid accusations of infringement on the branded product.
- An example of a litigated chubby label involves MSN Pharmaceutical’s label for its generic form of Entresto (sacubitril/valsartan). This generic added the phrase “indicated for chronic heart failure and reduced ejection fraction” on its label, which had appeared on an earlier version of the branded label. Recently, the court ruled in favor of the generic, allowing the expanded language.
- There are multiple instances of chubby labels and manufacturers should consider form over substance when broadening language on a label in an effort to increase sales as it may not have the desired result and may allow for easier generic entry via skinny labels.
Charles River Associates’ life sciences litigation team provides specialized economic support for these evolving challenges.
Our senior-led teams bring over 30 years of life sciences experience to support legal strategies in this changing landscape.
For expert witness testimony, economic analysis, or strategic litigation support related to these industry developments, contact our pharmaceutical litigation experts.
US Court of Appeals for the Federal Circuit Decision, Teva v. Amneal, No. 23-cv-20964-SRC-MAH (December 20, 2024) at 2-3, 18.[1]
