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Patent Invalidity Claim Construction Pharmaceutical Industry

A&O Shearman

UPC Court of Appeal clarifies approach to claim construction

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Insulet v EOFlow UPC_CoA_768/2024 (Ord_69078/2024) The Unified Patent Court (UPC) Court of Appeal has issued a significant decision that provides important guidance on the interpretation of patent claims in UPC...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

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

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

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On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more

Robins Kaplan LLP

In re Entresto

Robins Kaplan LLP on

Entresto® (valsartan/sacubitril) - Case Name: In re Entresto, 125 F.4th 1090 (Fed. Cir. Jan. 10, 2025) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, C.J.) (Appeal from D. Del., Andrews, J.)  Drug...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...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

Robins Kaplan LLP

Exelixis, Inc. v. MSN Labs. Private Ltd.

Robins Kaplan LLP on

Cabometyx® (cabozantinib (L)-malate) - Case Name: Exelixis, Inc. v. MSN Labs. Private Ltd., No. 22-228-RGA, 2024 WL 4491176 (D. Del. Oct. 15, 2024) (Andrews, J.)  Drug Product and Patent(s)-in-Suit: Cabometyx®...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

McDermott Will & Emery

Complex or Not Written Description Is Evaluated Against Claims

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The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more

Knobbe Martens

A Patent Must Describe What Is Claimed, Not What Infringes

Knobbe Martens on

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

Lathrop GPM

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

Lathrop GPM on

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

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

Smart & Biggar

Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

Smart & Biggar

Federal Court upholds validity of one pneumococcal vaccine patent, but holds two other patents invalid

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Update: Wyeth’s appeal was discontinued. On April 30, 2021, the Federal Court issued its decision relating to the validity of three patents relating to Pfizer’s PREVNAR 13, a 13-valent pneumococcal polysaccharide protein...more

Goodwin

Mylan and Partner Biocon Win on Insulin Ruling

Goodwin on

We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December...more

Smart & Biggar

Seedlings’ LifeCard patent found invalid and not infringed by Pfizer’s EpiPen

Smart & Biggar on

Update: On July 28, 2021, the Federal Court of Appeal dismissed Seedling’s appeal from Justice Grammond’s decision: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154 (see article here). On January 2,...more

McDermott Will & Emery

Definiteness, Drug Labels and Diclofenac, Oh My

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

Troutman Pepper Locke

CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction

Troutman Pepper Locke on

In an inter partes review proceeding, a challenger cannot raise patent-eligibility as a ground of invalidity. Rather, the invalidity grounds are limited to lack of novelty and obviousness. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016)

The Federal Circuit recently affirmed a district court's claim construction and determination that claim terms were not indefinite in Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc....more

Akin Gump Strauss Hauer & Feld LLP

IP Newsflash - June 2015

FEDERAL CIRCUIT CASES - CAFC: If (No Factual Findings), Then (No Deference) - Two days ago, on remand from the U.S. Supreme Court, the Federal Circuit in Shire v. Watson again affirmed its reversal of the...more

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