Duane Morris Life Sciences Law

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.

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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.

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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.

On January 16, 2026, the Supreme Court of the United States granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889) to address when induced-infringement liability can attach to a generic drug launched under a “skinny label.” The grant centers on review of the Federal Circuit’s decision allowing Amarin’s inducement claims to proceed notwithstanding Hikma’s carveout, and it tees up the relationship between the Food and Drug Administration’s (FDA) carveout pathway and 35 U.S.C. § 271(b).

Read the full Alert on the Duane Morris LLP website.