United States: Patent

The Federal Circuit recently reviewed a patent infringement case involving communication systems that use non-uniform satellite constellations to transmit digital information. While the lower court had granted summary judgment on patent eligibility and found infringement, the appellate court reached a split decision on the validity of the patents. The case highlights the ongoing challenges in determining patent eligibility under the Alice framework, particularly for claims involving mathematical concepts ve

The Court of Appeal of the Unified Patent Court has confirmed that actions can be brought concerning pending European patent applications approaching grant, and that such actions render subsequently filed opt-outs ineffective. However, a critical question remains unresolved: while the UPC is competent to hear these pre-grant actions, their admissibility based on timing has yet to be determined, leaving patent applicants in uncertain territory regarding opt-out strategy.

The UK High Court has rejected a challenge to Novartis's supplementary protection certificate for sacubitril and valsartan, addressing a fundamental question about how the "product" protected by an SPC should be defined. The decision clarifies whether a specific co-crystal formulation or the broader combination of active ingredients constitutes the relevant product under the SPC Regulation.

The U.S. Patent and Trademark Office has granted institution in four inter partes review proceedings challenging Janssen Biotech's golimumab method-of-treatment patents, finding that petitioners demonstrated a reasonable likelihood of prevailing on at least one challenged claim. These IPR proceedings run parallel to ongoing BPCIA litigation between Janssen and biosimilar developers Accord BioPharma and Bio-Thera Solutions.

The European Union has published the final text of its comprehensive pharmaceutical legislation reform, introducing significant changes to regulatory data protection, orphan drug exclusivity, and antimicrobial resistance measures.

The UPC Court of Appeal has endorsed a more holistic approach to assessing inventive step in patent disputes, marking a significant development in European patent law. This analysis examines how the UPC's methodology compares with the EPO's problem-solution approach and the practices of national courts like those in the UK and Germany.

Life sciences companies increasingly rely on artificial intelligence and machine learning tools to drive drug discovery, but this technological shift introduces complex intellectual property challenges. How can companies protect AI-assisted discoveries when patent law requires human inventors, and what governance measures are necessary to safeguard both patent rights and trade secrets in an era where machines contribute substantially to the creative process?

Most founders think patent risk comes from the outside. A competitor copies your technology. Someone files an IPR. Someone designs around your claims.

Recent developments in patent law are creating significant uncertainty for life sciences companies. The USPTO's evolving stance on obviousness-type double patenting, increasingly stringent enablement requirements following Amgen v. Sanofi, and the Supreme Court's clarification of skinny-label protections in Hikma v. Amarin are fundamentally reshaping how pharmaceutical and biotechnology companies must approach patent strategy and generic competition.