Blogs

Following up on our 2024 Trial Statistics Trends at the PTAB, this blog post expands on the statistics and trends at the PTAB for the Fiscal Year 2025 (“FY25”), which runs from October 1, 2024 through September 30, 2025. Petitions Filed In FY25, 1,433 petitions were filed, which was 145 petitions more than the petitions... Continue Reading

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 Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation memorandum (the... Continue Reading

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 filed on or after September 1, 2025. Overview of the 2025 Memorandum The 2025 Memorandum curbs the... Continue Reading

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... Continue Reading

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... Continue Reading

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 BMAB 1500 references Genentech’s PERJETA (pertuzumab), a HER2-directed monoclonal antibody therapy used in treatment of... Continue Reading

It is fairly standard language in privacy policies: “This privacy policy may be amended or updated from time to time, so please check back regularly for updates.”  It sends the message that the company can change its data practices and policies without ever notifying the end-user. It tells the end-user that the burden is on them... Continue Reading

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence.[1] The executive order provides a sprawling list of directives aimed at establishing standards for AI safety and security and protecting privacy. While the executive order acknowledges the executive branch’s lack of authority for any lawmaking or rulemaking, AI... Continue Reading

Following its many warnings of impending enforcement action against entities providing Artificial Intelligence (“AI”) products, the FTC has officially launched an investigation into OpenAI[1]. The FTC initiates its investigation on the heels of the Center for AI and Digital Policy’s July 10, 2023 supplement to its March 30, 2023 complaint, which requests that the FTC... Continue Reading

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” targets that lack deep binding pockets. PROTACs (proteolysis-targeting chimeras) and molecular glues remain the most... Continue Reading

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 “Arbutus”) v. Moderna, Inc. and ModernaTx, Inc. (collectively “Moderna”), No. 1:22-cv-00252 (D. Del.) case, made... Continue Reading

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 drug development spectrum to accelerate inherently burdensome tasks including the identification of targets and leads,... Continue Reading