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,
On February 2, 2026, U.S. District Court for the Eastern District of Pennsylvania Judge Joshua D. Wolson, sitting by designation in the U.S. District Court for the District of Delaware in the Arbutus Biopharma Corporation and Genevant Sciences GmbH (collectively
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
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
Background
Artificial Intelligence (“AI”) has been utilized by innovative companies across the array of industry spaces, but its impact on biotech (and human health in general) could become the most significant among all sectors.
AI is being leveraged across the
On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate.[1] The bill is designed to limit the number of
The first half of 2025 has brought many changes at the United States Patent and Trademark Office (“USPTO”), including policy changes at the Patent Trial and Appeal Board (“PTAB”). At the end of March 2025, the issuance of the Interim
Introduction
Acting Director of the USPTO, Coke Morgan Stewart, issued a memorandum last week that will change the way petitioners levy challenges to patents via inter partes review (IPR).[1] The change will apply to any petition for IPR
