Category: General

By Driscoll R. Ugarte, Brandon A. Chan, Ph.D., Victoria (Tori) Hawekotte and Taylor Hertzler

The New World screwworm is a parasitic fly whose larvae burrow into the flesh of warm-blooded animals, feeding on healthy tissue and causing myiasis that is often fatal if left untreated. It can infest livestock, pets, wildlife and, in rare cases, people. Although long eradicated from the United States, it has moved northward through Central America and Mexico in recent years, prompting a sweeping multiagency federal response. This Alert outlines the key regulatory developments and identifies practical steps that livestock producers, animal drug sponsors, veterinarians and supply chain participants should consider now to manage compliance obligations and mitigate risk.

Read the full Alert on the Duane Morris LLP website.

By Driscoll R. Ugarte and Taylor Hertzler

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.

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.

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.

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.