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
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
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
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
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
On February 27, 2026, Genentech filed a complaint at the U.S. International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS (“BMAB 1500”), violates 19 U.S.C. § 1337 (“Section 337”). Biocon’s Biologics License Application (“BLA”) for
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,
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)
Biosimilars continue to make a significant impact on global
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
