The pharmaceutical industry has been watching Hikma Pharmaceutical USA Inc. v. Amarin Pharma, Inc. (No. 24-889) closely for its potentially sweeping implications for generic drug competition, as discussed in our prior posts – Supreme Court to Address ‘Skinny Label’ Patent Disputes and Supreme Court Hears Skinny Label Arguments in Hikma v. Amarin, Signaling Impact
The Supreme Court heard oral argument on April 29, 2026, in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), the closely watched skinny-label case for which the Court granted certiorari earlier this year. As discussed in our prior post, Supreme Court to Address ‘Skinny Label’ Patent Dispute,the case has significant implications
Recent decisions across the Federal Circuit and district courts reflect a tightening approach to approximation in patent claims. In Enviro Tech Chemical Services, Inc. v. Safe Foods Corp., the Federal Circuit invalidated claims where “about” lacked objective boundaries. Enviro Tech Chem. Servs., Inc. v. Safe Foods Corp., No. 2024-2160, 2026 WL 1204374 (Fed.
In the competitive pharmaceutical and biotechnology industries, where robust patent portfolios are essential for protecting innovative biologics and enabling successful biosimilar development and market entry, securing favorable outcomes at the USPTO is paramount. Patent allowance rates in pharmaceutical and biotechnology art units reveal that large pharmaceutical companies significantly outperform smaller competitors at the USPTO.
Given
In a recent order, USPTO Director John A. Squires convened the Patent Trial and Appeal Board’s Appeals Review Panel (ARP) and granted sua sponte rehearing in an ex parte appeal involving obviousness-type double patenting (OTDP). The ARP will review the PTAB’s prior reversal of OTDP rejections as to claims 1-18 of Application No. 17/135,529. See
On February 6, 2026, the USPTO updated its guidance on anonymous requests for ex parte reexamination. When a patent has previously been the subject of an IPR or PGR that produced a final written decision on at least one claim, an anonymous requester must now include an affirmative statement that the real party in interest
In the evolving biosimilar landscape, patent challenges remain a critical strategy to clear the path for market entry. Recent reforms at the Patent Trial and Appeal Board (PTAB) under Director John Squires have significantly altered the inter partes reviews (IPRs) landscape, leading to a steep decline in institution rates. While this shift may initially appear
Biosimilars continue to make a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a
Introduction
On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement.
This case centers on a contentious question: If a generic drug is labeled only for non-infringing uses (a so-called
On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed at dramatically reducing the cost and timeline of biosimilar development (U.S. Food and Drug Administration,FDA Moves to Accelerate