Duane Morris

Duane Morris's articles

  1. Life Sciences

Product Liability and IP Strategies for Wearables – Duane Morris Life Sciences Law

Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern. REGISTER About the Program As wearables continue to reshape industries—from healthcare to consumer tech—their legal implications are evolving just as rapidly. […]
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  1. Life Sciences

Cybersecurity and Data Privacy Concerns for Wearables – Duane Morris Life Sciences Law

Duane Morris will host the second session of its Wearables Webinar Series, Cybersecurity and Data Privacy Concerns for Wearables, on Tuesday, October 21, 2025, from 12:00 p.m. to 12:30 p.m. Eastern. REGISTER About the Program The growing popularity of wearable devices that track consumers’ everyday health has been good for business. It […]
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  1. Life Sciences

Commerce Department Singles Out Harvard for Bayh-Dole March-In Rights Enforcement – Duane Morris Life Sciences Law

There has been much concern and discussion about Commerce Secretary Howard Lutnick’s recent letter to Harvard University indicating the U.S. government’s exercise of its “march-in rights” for government-funded research resulting in IP owned by Harvard under the Bayh-Dole Act. Under the Bayh-Dole Act, recipients of U.S. government research contracts can own […]
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  1. Life Sciences

Take Care When Paying Volume-Based Compensation to Sales Agents to Avoid Anti-Kickback Statute Violations – Duane Morris Life Sciences Law

By  Frederick R. Ball, Coleen W. Hill and Victoria (Tori) Hawekotte Pharmaceutical companies sometimes compensate sales agents per volume sold. The Fifth and Seventh Circuits have indicated that a company may structure such arrangements without running afoul of the Anti-Kickback Statute (AKS). However, such arrangements carry risk of violating the AKS and should […]
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  1. Life Sciences

Montana Set to Become a “Wild West” Hub for Experimental Medical Treatments and Therapies – Duane Morris Life Sciences Law

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 […]
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  1. Life Sciences

Federal Court Grants EPA Request to Stay Litigation Challenging 2024 Ethylene Oxide Regulation Pending Agency’s Reconsideration

By Sharon L. Caffrey, Jeffrey S. Pollack and Coleen W. Hill In June 2024, industry and environmentalist parties filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a national emission standards for hazardous air pollutants regulation applicable to commercial sterilization facilities, which was […]
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  1. Life Sciences

First Circuit Embraces More Restrictive View of False Claims Act Kickback Enforcement Provision – Duane Morris Life Sciences Law

By: Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Joseph R. Welsh The United States Court of Appeals for the First Circuit’s opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the effect of a kickback on healthcare decisions under the False Claims […]
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  1. Life Sciences

Federal Court Enjoins Enforcement of NIH’S Rate Change Notice Regarding Indirect Costs – Duane Morris Life Sciences Law

By Dan Walworth, Rolando Sanchez, Frederick Ball, Geoffrey Goodale and Sara Smith Since taking office, the Trump Administration has taken steps to reshape the United States’ federal funding infrastructure. One such action relates to the National Institutes of Health’s (“NIH”) rate change, imposing a 15% cap for indirect costs, for new grants and for existing […]
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  1. Life Sciences

What Companies Need to Know About Regulatory and IP Risks – Duane Morris Life Sciences Law

As the medtech AI market surges toward $615 billion by 2034, companies must navigate complex licensing, regulatory, and intellectual property challenges. Understanding these key issues is essential to unlocking the full potential of AI-driven healthcare innovation. The global market value for medical technology utilizing artificial intelligence (AI) is projected to reach […]
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