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Pharmaceutical Patents

Cooley LLP

Cooley’s 2024 Life Sciences M&A Year in Review: M&A Slims Down in 2024, but Will Appetites Grow in 2025?

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With every new year comes reflection and resolutions. But as we go to press well into January, it is worth a reminder that studies show nearly 90% of New Year’s resolutions will have already failed by the end of the month....more

Troutman Pepper Locke

West Virginia AG Reaches $17M Settlement With Pfizer and Ranbaxy Over Antitrust and Consumer Protection Violation Claims

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West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more

McDermott Will & Emery

[Webinar] IP Focus | US Patent Law Under the New Trump Administration - February 5th, 10:00 am JST

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McDermott is committed to providing insightful commentary on intellectual property (IP) developments from around the world to our Japanese clients. During these sessions, a variety of speakers from McDermott’s offices in the...more

Venable LLP

Celltrion Files IPR on Regeneron’s EYLEA® Patent

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On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more

Cooley LLP

Precedential Federal Circuit Decision Overturns Lack of Written Description Based on Later-Discovered Technology

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On January 10, 2025, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., reversing a lower court decision that claims of a Novartis patent...more

AEON Law

Patent Poetry: Federal Circuit Reverses Novartis Patent Decision

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The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s patent for the heart drug Entresto were invalid due to lack of written description....more

Knobbe Martens

A Patent Must Describe What Is Claimed, Not What Infringes

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Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...more

Akin Gump Strauss Hauer & Feld LLP

District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more

Alston & Bird

Intellectual Property Litigation Newsletter | January 2025

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Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that that changing a definition has consequences, an apex...more

Lathrop GPM

Federal Circuit Upholds Validity of Entresto Patent In Precedential Decision Concerning Written Description and Enablement

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In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...more

Womble Bond Dickinson

2024 Hatch-Waxman Year in Review

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In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

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In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more

McDermott Will & Emery

Skilled Artisan’s View Is Decisive in Assessing Asserted Claim Drafting Error

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The Court of Appeal (CoA) of the Unified Patent Court (UPC) clarified the legal standard for correcting obvious type inaccuracies in patent claims, explaining that the view of a skilled person at the filing date is decisive...more

Goodwin

Year in Review: Top Legal Developments of 2024

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​​​​​​​As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more

Alston & Bird

Patent Case Summaries | Week Ending January 10, 2025

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Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

A&O Shearman

Brussels enterprise court clarifies requirements for SPC manufacturing waiver

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In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2025 #2

In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025) In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - January 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) - January 2025

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

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