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Patent Invalidity Pharmaceutical Patents Claim Construction

Robins Kaplan LLP

In re Entresto

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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

Sage Products, LLC v. Stewart (Fed. Cir. 2025)

When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton...more

Jones Day

Expert Testimony Supporting POPR Can Be An Effective Strategy

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It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...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

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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

WilmerHale

Federal Circuit Patent Watch: Federal Circuit Orders Remanded Case Reassigned to New Judge, Finding That Trial Judge’s Statements...

WilmerHale on

Precedential and Key Federal Circuit Opinions - HD SILICON SOLUTIONS LLC v. MICROCHIP TECHNOLOGY INC. [OPINION] (2023-1397, 2/6/2025) (Lourie, Stoll, Cunningham) - Lourie, J. The Board affirmed the Final Written...more

Robins Kaplan LLP

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

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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

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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

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

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

Bradley Arant Boult Cummings LLP

Preliminary Injunction Halts Sales of Tumor-Informed Cancer Screening Test

Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #2

Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2022 #4

Mosaic Brands, Inc. v. Ridge Wallet LLC, Appeal Nos. 2022-1001, -1002 (Fed. Cir. Dec. 20, 2022) - In our Case of the Week, the Federal Circuit discussed the corroboration requirement concerning the amount of evidence...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Haug Partners LLP

AztraZeneca AB v. Mylan Pharms. Inc.: Claim Construction of a Percentage Term Guided by the Written Description and Prosecution...

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On December 8, 2021, the Federal Circuit in AztraZeneca AB v. Mylan Pharms. Inc. held that the claim construction of a percentage term should “‘most naturally align[] with the patent’s description of the invention,’ as...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

Haug Partners LLP

How Different Claim Construction Standards Can Ultimately Determine the Validity of a Patent

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Recently, the Federal Circuit issued a decision in Immunex Corp. v. Sanofi-Aventis U.S. LLC addressing the different claim construction standards used by the Patent Trial and Appeal Board (“PTAB”) (broadest reasonable...more

McDonnell Boehnen Hulbert & Berghoff LLP

IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

The Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute.  35 U.S.C. § 112(b).  The...more

McDonnell Boehnen Hulbert & Berghoff LLP

Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020)

Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome...more

Goodwin

Mylan and Partner Biocon Win on Insulin Ruling

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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

McDermott Will & Emery

Broad Genus of HCV Compounds Wasn’t Enabled or Described

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In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more

McDermott Will & Emery

Definiteness, Drug Labels and Diclofenac, Oh My

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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

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