life sciences – Duane Morris Life Sciences Law

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.

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.

May 22, 2025 by Duane Morris

Montana Set to Become a “Wild West” Hub for Experimental Medical Treatments and Therapies

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

The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration. Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request “expanded access” or compassionate use to gain access to investigational drugs pending FDA’s permission. Right-to-try laws seek to bypass the FDA’s more rigorous requirements for expanded access and permit terminally ill patients to access investigational drugs, biologics and devices that have completed Phase I but have yet to receive FDA approval. Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018. Recently, Montana has sought to further expand access to experimental treatments.

Read the full story on the Duane Morris LLP website.

December 12, 2023December 12, 2023 by Sean P. McConnell

Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction

On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.

Under the terms of the proposed licensing agreement between Genzyme Corporation, a wholly-owned subsidiary of Sanofi, and Maze, Sanofi would acquire an exclusive license to Maze’s glycogen synthase 1 products and related technology, including its candidate MZE001, a drug in development to treat the potentially fatal genetic order Pompe disease. According to a statement by Jason Coloma, Ph.D., Maze’s CEO, the FTC’s challenge “is the first time ever the FTC has moved to block a license of a Phase 1 investigational medicine.” The challenge seems consistent, however, with revised draft merger guidelines proposed by the FTC and Department of Justice that indicate that transactions “should not entrench or extend a dominant position” by, for example, “[e]liminating a nascent competitive threat.”

Continue reading “Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction”

June 26, 2023 by Duane Morris

Outlook for Life Sciences M&A: Industry Drivers Still Strong

In a recent GEN Edge article, Duane Morris partner Rebecca Guzman discussed the state of M&A activity in the life sciences.

“Following the most robust year for life sciences M&A on record, the sector saw a sharp decline in 2022 to levels below what we last experienced pre-pandemic. Many analysts pointed to supply chain issues, clinical development delays and other lingering effects of the COVID-19 pandemic as the cause. The 2021 catalysts of innovation following the pandemic breakout had finally worn off. On the surface, it appeared that key industry players had taken a step back, or even hit pause, but continued background activity tells a different story. While deal flow declined, the underlying drivers of M&A activity throughout 2022 (and continuing through today) remain strong.”

Read the full article at genengnews.com.

April 7, 2020 by Duane Morris

COVID-19 Therapies: Protecting Against Government Intrusion

As the COVID-19 pandemic continues to disrupt our lives, wreak havoc on our economy and force millions to social distance, shelter at home or even quarantine, scientists across the globe have turned their focus and expertise to developing new treatments and vaccines aimed at containing the effects of this virus.

The need for this life-saving work has never been more apparent or more urgent. We owe them a sincere debt of gratitude as our lives may literally depend on their success. And as the hard work of these scientists starts to bear fruit, the demand for these treatments will be so urgent and of such magnitude that no single company will likely be able to scale up, manufacture and distribute the treatment to all those in need.

The U.S. government has several options at its disposal to intervene―if necessary―to ensure a low priced treatment is rapidly made available to those in need.

To read the full text of this Duane Morris Alert, please visit the firm website.

February 6, 2020 by Duane Morris

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.