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 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... Continue Reading

Biosimilars continue to make a significant impact on global healthcare.  These products are highly similar to an already-approved reference product, offering a more affordable treatment option without compromising on safety or efficacy.  Regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) play a critical role in shaping their... Continue Reading

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 ‘skinny... 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

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

Introduction: Harnessing Cellular Machinery for Precision Medicine Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the field of targeted protein degradation, leaving intellectual property (IP) protections and strategies in hot pursuit. Unlike traditional inhibitors, which only... Continue Reading