Blogs

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

The USPTO’s recent guidance on discretionary denials has shifted patent practitioners back to the Fintiv and Sotera Wireless framework. The Prior Framework: Fintiv & Sotera Wireless In Apple Inc. v. Fintiv, Inc., No. IPR2020-00019 (PTAB Mar. 20, 2020), the Patent Trial and Appeal Board (the “Board”) implemented a holistic view of six factors (the Fintiv... Continue Reading

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 cost and timeline of biosimilar development (U.S. Food and Drug Administration,FDA Moves to Accelerate Biosimilar... Continue Reading

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 drug patents that may be asserted by patent holders (often branded drug companies) in patent infringement... Continue Reading

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025).[1] This appeal concerned the question of when and how a single-patient study can provide sufficient data to... 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

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

As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and Comirnaty® COVID-19 vaccines. Key suits were filed by third party mRNA and lipid pioneers that, while not having any mRNA-based products on the market themselves,... Continue Reading