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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

Foley & Lardner LLP on

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

Latham & Watkins LLP

How Pharma Should Prep for the Six-bill Avalanche From Congress

Latham & Watkins LLP on

The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Sheppard Mullin Richter & Hampton LLP on

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Goodwin

Federal Circuit Affirms Injunction Against Celltrion in Aflibercept BPCIA Litigation

Goodwin on

On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

Fish & Richardson on

In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Morgan Lewis - As Prescribed

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

Morgan Lewis - As Prescribed on

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Smart & Biggar

2024 highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on

In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more

Morgan Lewis

Blockbuster Biologics Review | Issue 25

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Goodwin

Alexion and Samsung Settle Eculizumab BPCIA Case

Goodwin on

​​​​​​​On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Smart & Biggar

2024 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on

In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Foley & Lardner LLP

The Rise of GenAI in Personalized Medicine and Beyond

Foley & Lardner LLP on

GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more

Jones Day

EU Parliament Adopts SPC Reform Proposals: Clarifying the Protection Scope for Biologics

Jones Day on

On February 28, 2024, following the European Commission's four 2023 proposals, the European Parliament adopted a legislative resolution on the amended proposal to create a Unitary Supplementary Protection Certificate ("USPC")...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

Wilson Sonsini Goodrich & Rosati on

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more

Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

Venable LLP on

As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

Jones Day on

On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

Goodwin

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

Goodwin on

​​​​​​​On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

WilmerHale on

Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Goodwin

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

Goodwin on

On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

Polsinelli on

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

Goodwin

Updates on Aflibercept BPCIA Litigation - March 2024

Goodwin on

As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in...more

Venable LLP

The PTAB Finds Claims of Two EYLEA® Patents Unpatentable and Regeneron Files its Sixth Complaint Against a Proposed EYLEA®...

Venable LLP on

The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more

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