General – Duane Morris Life Sciences Law

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 21, 2026January 21, 2026 by Jason Luo, Ph.D.

U.S. Supreme Court Grants Certiorari in Hikma v. Amarin, Placing “Skinny Label” Inducement in Focus

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.

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.

December 12, 2025January 13, 2026 by Duane Morris

USPTO Signals Strong Support for Patent Eligibility in Cutting-Edge Technologies

The USPTO’s new director has singled out AI, distributed ledger technologies and diagnostics as prime areas of innovation that merit patent protection. Companies, investors and other stakeholders are closely watching how the USPTO’s active guidance may better align patent practice with the ingenuity and societal benefits these technologies represent.

Read the full story on the Duane Morris LLP website.

December 1, 2025December 1, 2025 by Duane Morris

Financing and Exit Strategies in Life Sciences: Aligning Capital with Compliance and IP Value

By Driscoll R. Urgate, P.A.

Financing and exit transactions in the life sciences industry differ fundamentally from those in traditional technology or manufacturing sectors. Scientific risk, regulatory oversight, and intellectual property rights intersect at every stage of a company’s growth, from seed capital through commercialization and acquisition. Investors and acquirers do not simply value a company’s technology, they assess its regulatory posture, data integrity, and the duration and durability of its exclusivity.

This article explores how capital-raising and exit strategies in life sciences require a multidisciplinary approach that integrates corporate structure, intellectual property strategy, and FDA compliance. It provides information for executives and general counsel navigating venture financings, public offerings, and M&A exits, and offers practical steps for aligning legal and operational strategy to preserve and enhance enterprise value.

Read the full article on the Duane Morris website.

November 18, 2025November 18, 2025 by Duane Morris

Vicki Norton to Speak at Personalized Cancer Vaccine Summit

Duane Morris Partner Vicki G. Norton, Ph.D., will be speaking at the Personalized Cancer Vaccine Summit in Boston on Thursday, November 20. She will be on the panel “Health Economics, IP & Early Access: Navigating Legal Grey Zones in the Race to Personalized Cancer Vaccines.” The panel will discuss:

How emerging legal frameworks, such as Montana’s Right To Try, could impact patient access to unapproved personalized vaccines and what that means for regulatory strategy.
Balancing IP protection vs. platform flexibility in an era where proprietary algorithms, tumor-specific libraries, and bioinformatic tools are central to value creation.
The role of patent exclusivity, trade secrets, and data protection in enabling commercial viability for PCVs – especially when facing fragmented regulatory landscapes.