News & Analysis as of

Pharmaceutical Patents Appeals

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2024 #3

Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more

White & Case LLP

Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family

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On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more

A&O Shearman

Federal Circuit Upholds Preliminary Injunction Barring Sale Of Cancer Test

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On July 12, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) affirmed a decision by the U.S. District Court for the Middle District of North Carolina granting a preliminary injunction that barred...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

McDermott Will & Emery

Is Pleading “Generic” Enough to Plead Inducement?

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The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded...more

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Knobbe Martens

Federal Circuit Review | June 2024

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Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more

Smart & Biggar

Supreme Court of Canada dismisses Apotex’s application for leave to appeal macitentan inducing infringement decision

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As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal of a decision relating to macitentan (Janssen’s OPSUMIT), which found that Apotex would induce infringement of Janssen’s patent....more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

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The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more

Goodwin

The Appeals Review Panel’s In Re Xencor Decision: The USPTO Provides Its Position on Written Description and Means-Plus-Function...

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On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - May 2024 #3

Copan Italia SPA v. Puritan Med. Prods. Co. LLC, Appeal No. 2022-1943 (Fed. Cir. May 14, 2024) The Federal Circuit’s only precedential opinion concerning a patent case this week had nothing to do with patent law....more

Haug Partners LLP

DexCom, Inc., v. Abbott Diabetes Care, Inc.: Federal Circuit Finds Forum Selection Clause Does Not Bar IPR Proceedings Based on...

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In DexCom, Inc., v. Abbott Diabetes Care, Inc., 89 F.4th 1370 (Fed. Cir. 2024), the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction, finding that a patentee could...more

Goodwin

Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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​​​​​​​As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...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

McDermott Will & Emery

Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

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Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for...more

Smart & Biggar

Federal Court of Appeal affirms paliperidone palmitate claims are not unpatentable methods of medical treatment

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In a 2022 decision involving Janssen and Pharmascience, the Federal Court found that the claims of Canadian Patent No. 2,655,335 (335 patent, relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA)) were not invalid...more

Smart & Biggar

FCA upholds inducement of infringement findings relating to paliperidone palmitate.

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As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

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In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Smart & Biggar

LUMIGAN RC formulation patent found valid and infringed

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In a patent infringement action brought by Allergan and AbbVie under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), in relation to 0.01% w/v bimatoprost solution for ophthalmic...more

Smart & Biggar

Canadian IP Litigation 2023: Year in Review

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The year 2023 witnessed several developments in Canadian IP litigation. From summary judgment finding its limits to the denial of a permanent injunction for the first time in almost three decades, several cases decided in...more

Smart & Biggar

Federal Court finds PMPRB reasonably concluded Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN

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On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more

McDermott Will & Emery

PTO Continues to Wave Wands in Assessing Enablement

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In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

WilmerHale

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

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Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

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