Duane Morris – Duane Morris Life Sciences Law

On May 4, 2026, the U.S. Food and Drug Administration’s Center for Veterinary Medicine opened a new round of grant funding for its Animal and Veterinary Innovation Centers program via a notice of funding opportunity, with applications due June 12, 2026. The program promotes the broader animal and veterinary innovation agenda, through which FDA has outlined its strategy for tackling unmet needs impacting animal and human health. CVM anticipates awarding up to five grants this cycle, each renewable for up to four years depending on progress and the availability of funds.

Read the full Alert on the Duane Morris LLP website.

May 26, 2026May 26, 2026 by Duane Morris

DOJ Proposes Antitrust Settlement with Data Consultant, Requiring Sweeping Changes to Meat Industry Data-Sharing Practices

By Driscoll R. Ugarte, Sean P. McConnell and Taylor Hertzler

On May 7, 2026, the U.S. Department of Justice’s Antitrust Division filed a proposed settlement in the U.S. District Court for the District of Minnesota to resolve claims against Agri Stats Inc. for unlawful information sharing among the nation’s largest meat processors. The settlement aims to dismantle what the government alleges was a decadeslong practice of exchanging competitively sensitive pricing, output and cost data among rival broiler chicken, pork and turkey processors. Stakeholders across the agricultural supply chain—from poultry integrators and hog producers to livestock feed companies and meat buyers—should take note of this enforcement action, which may signal heightened DOJ scrutiny of data-sharing arrangements in the animal agriculture sector.

Read the full Alert on the Duane Morris LLP website.

May 21, 2026May 26, 2026 by Duane Morris

Montana’s Draft Rules for Experimental Treatment Centers Under SB 535 – Key Highlights for Stakeholders

By Vicki G. Norton, Ph.D. and Brandon A. Chan, Ph.D.

Montana Senate Bill 535 established a framework for licensed experimental treatment centers to offer patients access to experimental treatments that have completed Phase I clinical trials but have not yet received full approval from the United States Food and Drug Administration. On April 10, 2026, the Montana Department of Public Health and Human Services published a notice of proposed rulemaking proposing the adoption of 25 new rules to implement SB 535’s licensing and operational requirements for experimental treatment centers.

Read the full Alert on the Duane Morris LLP website.

May 20, 2026May 20, 2026 by Duane Morris

Ambiguity of Measurement Conditions for Relevant Chemical Property Leads to Federal Circuit Affirming Noninfringement of Epoprostenol Patents

By Thomas J. Kowalski, Ryan C. Smith, Ph.D. and Brandon A. Chan, Ph.D.

Numerical patent claim limitations can be helpful to both define the metes and bounds of the claimed subject matter to deter potential infringers as well as distinguish from the prior art in advocating for patentability of the underlying subject matter during prosecution. Often, relevant chemical properties such as pH are numerically recited in patent claims. However, one aspect that may be overlooked during claim drafting is consideration of any relevant conditions at which the recited numerical claim limitations are applicable. For example, properties of compositions of matter such as pH can vary depending on the environmental conditions at which the value is measured, including temperature and pressure. Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2024-1641, 2026 WL 1314700 (Fed. Cir. May 13, 2026) provides an example of the pitfalls of reciting a claimed range of chemical properties without any further insight as to the conditions in which the properties are measured and the resulting treatment by the court in ascribing a meaning to such claims.

Read the full Alert on the Duane Morris LLP website.

May 19, 2026May 19, 2026 by Duane Morris

Highlights from the Food & Drug Law Institute’s Annual Conference 2026

By Frederick R. Ball and Victoria (Tori) Hawekotte

Attorneys from Duane Morris’ Life Sciences and Medical Technologies Industry Group attended the Food & Drug Law Institute’s Annual Conference, which featured participation from senior leadership at the Food and Drug Administration. Former FDA Commissioner Martin Makary highlighted the agency’s aim to decrease time to decision on applications and increase efficiency of reviews. He also discussed the trend of research and manufacturing moving internationally and potential reforms to make domestic manufacturing and research more feasible.

Read the full Alert on the Duane Morris LLP website.

April 23, 2026April 23, 2026 by Duane Morris

DEA Issues Order Expediting Cannabis Rescheduling to Schedule III

By Paul P. Josephson, Michael D. Schwamm and Tracy Gallegos

On April 22, 2026, a final order issued by the Acting Attorney General and the Drug Enforcement Administration took effect, fundamentally altering the federal regulatory landscape for marijuana. The order moves FDA-approved drug products containing marijuana and marijuana subject to qualifying state-issued medical marijuana licenses from Schedule I to Schedule III of the Controlled Substances Act (CSA).

Though a welcome and long hoped-for action, it is critical to note this is not a broad legalization of all adult use (recreational) cannabis sales. Nor does it legalize the controversial category of hemp-derived THC products.

Read more about the order on the Duane Morris Cannabis Industry Blog.

April 22, 2026April 22, 2026 by Duane Morris

The Healthcare Class Action Review – 2026: A Deep Dive Into Healthcare Litigation Trends

By Gerald L. Maatman, Jr. and Jennifer A. Riley

The Healthcare Class Action Review – 2026 is a comprehensive new eBook that examines the most significant developments in healthcare-related class actions over the past year. Healthcare organizations today operate at the intersection of regulation, innovation, and patient expectations. Class action litigation involving healthcare companies, including hospitals, healthcare providers, pharmaceutical companies, biotechnology firms, medical device and health technology companies, and diagnostic and testing companies has evolved from a peripheral phenomenon into a central feature of complex class action litigation. The Healthcare Class Action Review – 2026 offers a clear, structured analysis of these trends, helping legal professionals, compliance teams, and industry leaders stay informed and prepared.

Download your copy of The Healthcare Class Action Review – 2026.

April 21, 2026April 21, 2026 by Duane Morris

DOJ: First DEI-Related FCA Case Is Settled

By Daniel Walworth

On April 10, 2026, the U.S. Department of Justice announced its first False Claims Act settlement arising from allegations that an organization’s diversity, equity and inclusion programs constituted illegal discrimination. The $17 million settlement, announced by DOJ’s Civil Division, resolved allegations of unlawful DEI practices in connection with federal funding. All recipients of federal funds should take note of this shift from policy pronouncements to tangible, concrete enforcement action.

Read the full Alert on the Duane Morris LLP website.

March 4, 2026March 4, 2026 by Duane Morris

Not So Fast, My Friend: Explicit Apprehension of Prior Art Reference Disclosure Is Insufficient to Support a Finding of Inequitable Conduct on Summary Judgment

By Thomas J. Kowalski, Vicki G. Norton, Ph.D., Jarrad M. Gunther and Brandon A. Chan, Ph.D.

In defending against allegations of patent infringement, there are numerous avenues to invalidating an asserted patent or rendering it unenforceable. Invalidity contentions can include asserting that the claims are anticipated or rendered obvious over the prior art such that the patent should never have issued, or that the claims are indefinite, insufficiently described or not enabled by the specification. Inequitable conduct—asserting that the applicant breached its duty of candor and good faith before the United States Patent and Trademark Office with a specific intent to deceive through the omission of material information—may be used to render the asserted patent or family of patents unenforceable. Unlike invalidity contentions, which are analyzed and proven on a claim-by-claim basis, a finding of inequitable conduct can render the underlying patent or family of related patents unenforceable.

Read the full Alert Duane Morris LLP website.

January 7, 2026January 13, 2026 by Duane Morris

FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies

By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte

The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.

Read the full Alert on the Duane Morris LLP website.