1. Life Sciences

Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

Written by Posted on Less than 0 min read




In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient.

Read the full Alert on the Duane Morris LLP website.



Member since

More from Duane Morris

  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 […]
Written by
  1. Life Sciences

FDA’s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler – Duane Morris Life Sciences Law

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug’s efficacy. In view of the warning letter—only the second of […]
Written by
  1. Life Sciences

FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA

Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product […]
Written by
  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 […]
Written by
  1. Life Sciences

Neighborhood Pharmacists Demand CMS Take Enforcement Motion Towards PBMs – Duane Morris Life Sciences Legislation

As information surfaced on February 27 that Congress is punting long-debated pharmacy profit supervisor reforms, the neighborhood pharmacy foyer demanded CMS instantly take enforcement motion in opposition to improper PBM practices that the foyer says may trigger almost a 3rd of impartial pharmacies to shutter this yr. […] Jonathan Swichar, associate […]
Written by
  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 […]
Written by
  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 […]
Written by
  1. Life Sciences

FTC Voices Help for March-In Rights on Patents to Assist Management Drug Costs – Duane Morris Life Sciences Legislation

The Federal Commerce Fee (FTC) has introduced its help of the federal authorities’s use of “march-in rights” as a mechanism to regulate the worth of prescription drugs. The Nationwide Institute of Requirements and Know-how (NIST) late final yr issued its “Draft Interagency Steerage Framework for Contemplating the Train of March-In Rights” that might […]
Written by
  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 […]
Written by
  1. Life Sciences

FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take […]
Written by
  1. Life Sciences

Boston Partner Daniel Pierce Interviews Treventis CEO Chris Barden – Duane Morris Life Sciences Law

Daniel R. Pierce, Corporate and IP partner in the Boston office, recently spoke with Chris Barden, CEO of firm client Treventis, about his background, his company’s research into misfolded proteins to develop cures for central nervous system diseases like Alzheimer’s, as well as Chris’ thoughts and experience at the BIO Conference. Can you tell us […]
Written by
  1. Life Sciences

What Spas Need to Know – Duane Morris Life Sciences Law

The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion […]
Written by
  1. Life Sciences

Federal Regulatory Laws Due Overhaul after MoCRA – Duane Morris Life Sciences Law

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisanand industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers […]
Written by
  1. Life Sciences

FDA’s Final Guidance on Decentralized Clinical Trials Published – Duane Morris Life Sciences Law

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using […]
Written by
  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 […]
Written by
  1. Life Sciences

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug […]
Written by
  1. Life Sciences

FDA Issues Draft Guidance Q&A on Developing Potential Cellular and Gene Therapy Products – Duane Morris Life Sciences Law

In November 2024, the U.S. Food and Drug Administration (FDA) issued draft Guidance responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft Guidance on CGT products. Read the full Alert on the Duane Morris LLP Website. Duane Morris Member since […]
Written by
  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 […]
Written by
  1. Life Sciences

FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants – Duane Morris Life Sciences Law

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In […]
Written by
  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 […]
Written by
Next
No Comments
Leave a comment Cancel
Comments to: Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

Login

Welcome to Life Science News!
"Explore the Latest Discoveries and Breakthroughs in Life Science with Life Science News!"
Read Smart, Save Time
Pick all the topics you are interested in to fill your homepage with stories you'll love.
Join our community
Registration is closed.