News & Analysis as of

Patent Infringement Intellectual Property Protection Life Sciences

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: In re: Xencor, Inc.

In re: Xencor, Inc., Appeal No. 2024-1870 (Fed. Cir. Mar. 13, 2025) Our case of the week is an appeal from a decision of the Appeals Review Panel of the Patent Trial and Appeal Board, concerning Xencor’s patent application...more

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

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Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) - March 2025

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Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Stipulated Dismissal of Gene Therapy Elevidys® Manufacturing Litigation

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On February 19, 2025, Wilson Wolf Manufacturing and Sarepta’s stipulated dismissal with prejudice of Case No. 1:19-cv-02316 (D. Del.) related to the manufacturing of Elevidys® (delandistrogene moxeparvovec-rokl) was granted....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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion. In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the...more

McDermott Will & Emery

Eye-Catching: Biosimilars Injunction Prevails

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more

Robins Kaplan LLP

Silvergate Pharms., Inc. v. Bionpharma Inc.

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Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.)  Drug Product and Patent(s)-in-Suit: Epaned®...more

Jones Day

No Need to Show Reasonable Expectation of Success Regarding Inherent Property

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The Federal Circuit affirmed six PTAB decisions that held unpatentable as obvious 79 claims of three Cytiva Bioprocess (“Cytiva”) challenged patents and reversed the PTAB decision upholding four claims....more

A&O Shearman

UPC Court of Appeal confirms strict approach to correcting patent errors by interpretation

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Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

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This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms., Inc.

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Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more

Robins Kaplan LLP

Galderma Labs., L.P. v. Lupin Inc.

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Oracea® (doxycycline USP) - Case Name: Galderma Labs., L.P. v. Lupin Inc., No. 2024-1664, 2024 WL 4998071 (Fed. Cir. Dec. 6, 2024) (Circuit Judges Moore, Linn, and Prost presiding; Opinion by Moore, C.J.) (Appeal from D....more

Troutman Pepper Locke

Budding Lessons From Landmark Plant Seed Patent Battle

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The landmark legal battle over who owns the intellectual property rights in genetically modified plants is heating up. Originally published in Law360 - October 23, 2024....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

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab 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

Smart & Biggar

2024 highlights in Canadian life sciences IP and regulatory law

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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

DLA Piper

Case-Narrowing Decisions are a One-Way Street: Reviewing Exeltis USA v. Lupin Ltd.

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Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more

A&O Shearman

Balancing innovation and public health: third-party interests in the UPC's landmark ruling of Edwards Lifesciences vs. Meril

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In a landmark decision (UPC_CFI_15/2023) delivered on November 15, 2024, the Unified Patent Court's Local Division in Munich (UPC, LDM) ruled in favor of Edwards Lifesciences Corporation in a patent infringement case against...more

DLA Piper

Silvergate Pharmaceuticals v. Bionpharma: The Relevance of Offers of Confidential Access Under the Hatch-Waxman Statute and Awards...

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In Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., the US District Court for the District of Delaware decided an open question regarding pre-filing investigation and attorney fees under Title 35 of the US Code, Section...more

DLA Piper

Delaware Court of Chancery Patent Ownership Dispute Addresses Jurisdiction for Pharmaceutical Companies

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A litigation regarding patent ownership rights is heating up in the Delaware Court of Chancery, a court of equity that is an atypical forum for pharmaceutical company and intellectual property disputes. CyDex Pharmaceuticals,...more

Robins Kaplan LLP

New ANDA Cases - Federal District Court Cases That Are Filed Pursuant to the Hatch-Waxman Act

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

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