Duane Morris

Duane Morris's articles

  1. Life Sciences

House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline […]
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  1. Life Sciences

Artificial Intelligence in Medtech – Duane Morris Life Sciences Law

Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML). ML, at its core, learns from training datasets to identify patterns, which can then be applied to new […]
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  1. Life Sciences

Obviousness-Type Double Patenting Immunity for First-Filed, First-Issued and Later-Expiring Patent in a Family – Duane Morris Life Sciences Law

Recently, the relationship and intersection between obviousness-type double patenting (ODP) and any awarded Patent Term Adjustment (PTA) and/or Patent Term Extension (PTE) has received significant attention. The United States Court of Appeals for the Federal Circuit held in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), that PTA and PTE, being codified […]
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  1. Life Sciences

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance – Duane Morris Life Sciences Law

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone […]
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  1. Life Sciences

Federal Trade Commission Poised to File Suit Against Pharmacy Benefit Managers Based on Unlawful Medication Pricing – Duane Morris Life Sciences Law

On July 10, 2024, multiple media sources reported that the Federal Trade Commission intends to file suit against the nation’s three largest pharmacy benefit managers over​ allegations of improper pricing in connection with their negotiations with drug manufacturers that dramatically increased prices for consumers and lined the PBMs’ pockets with lucrative […]
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  1. Life Sciences

Doing No Harm but Exporting Without Appropriate License Can Violate Regulations – Duane Morris Life Sciences Law

By Brandon A. Chan, Ph.D., and Brian Goldstein On June 24, 2024, the Department of Commerce’s Bureau of Industry and Service (BIS) imposed an administrative penalty on Indiana University (IU) as part of a settlement agreement following IU’s discovery and self-disclosure to BIS that its Bloomington Drosophila Stock Center engaged in the export of materials […]
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  1. Life Sciences

The Changing Beauty Regulatory Landscape – Duane Morris Life Sciences Law

Duane Morris attorney Kelly Bonner was quoted in an article in WWD on June 25, 2024. “A big deadline in the beauty and personal care regulatory landscape is fast approaching, with much more to come — although some experts believe this still isn’t enough. Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed […]
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  1. Life Sciences

FDA’s New Rule Regulates Lab-Developed Tests Under FD&C Act – Duane Morris Life Sciences Law

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act). LDTs have increased in volume, complexity and […]
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  1. Life Sciences

How They’ll Have an effect on Patent Prosecution Methods – Duane Morris Life Sciences Legislation

The USPTO is soliciting feedback relating to its proposed charge will increase for fiscal yr 2025. Written feedback have to be acquired on or earlier than June 3, 2024, to make sure consideration. Thus, it’s essential that each in-house attorneys and outdoors counsel assessment and contemplate how these adjustments, a few […]
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  1. Life Sciences

FDA Confirms No Asbestos in Beauty Talc Merchandise for a Third 12 months in 2023 – Duane Morris Life Sciences Legislation

On April 5, 2024, the U.S. Meals and Drug Administration (FDA) confirmed that its third-party testing of beauty talc merchandise for 2023 recognized no traces of asbestos in any of the 50 beauty samples examined. FDA’s 2023 outcomes, which had been reported in a Cosmetics Constituent Replace, are per its testing for 2022 and 2021, which […]
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  1. Life Sciences

Bayh-Dole Act March-In Rights A part of White Home Plan to Decrease Drug Costs – Duane Morris Life Sciences Legislation

Following enactment of the Inflation Discount Act, which gives for Medicare drug worth negotiations, the White Home has introduced new actions to decrease drug prices, together with the discharge of a proposed framework for businesses to train march-in rights beneath the Bayh-Dole Act to advertise public accessibility to tax-payer-funded medication. If adopted, the […]
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  1. Life Sciences

A CLE Webinar from Ryan C. Smith, Ph.D. – Duane Morris Life Sciences Legislation

“Has your establishment obtained authorities funding? Is authorities funding behind your patents? Are you licensing patents that have been developed with authorities help? In that case, you actually ought to hearken to this informative webinar. Your rights and financial pursuits could possibly be dramatically impacted by March-In Rights.” Uncover the nuances […]
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