Introduction
Psychedelic drug development is moving from a largely experimental field toward a suddenly much more compelling pharmaceutical industry, with a rapidly expanding clinical pipeline that now includes multiple late-stage candidates across depressive, anxiety, trauma-related, and substance use disorders. While
The battle over foundational CRISPR-Cas9 patent rights has reached another milestone. In March 2026, the Patent Trial and Appeal Board (PTAB) reaffirmed its priority determination in favor of the Broad Institute in Interference No. 106,115, concluding once again that the
On June 16, 2026, U.S. District Judge Gregory B. Williams of the United States District Court for the District of Delaware issued a memorandum order resolving three partial motions to dismiss counterclaims and strike affirmative defenses in GlaxoSmithKline Biologicals SA’s
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
Targeted protein degradation (TPD) has moved from promising concept to near-commercial reality in under a decade. By hijacking the cell’s ubiquitin-proteasome system, TPD therapies eliminate disease-driving proteins entirely rather than merely inhibiting them. This approach is particularly powerful against “undruggable”
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
