News & Analysis as of

Appeals Pharmaceutical Industry

Wilson Sonsini Goodrich & Rosati

The PTAB Review - August 2024

This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...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

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

Ward and Smith, P.A.

Should I Care About the Purdue Pharma Decision?

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On June 27, 2024, the United States Supreme Court decided the Purdue Pharma appeal. In a five-to-four decision, the Supreme Court held that a bankruptcy court may not extend to non-debtors the benefits of a Chapter 11...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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...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

Faegre Drinker Biddle & Reath LLP

Washington Appellate Court Holds Statute of Repose Constitutional and Applicable in All Cases Applying Its Product Liability Act

Statutes of repose serve as substantive outer limits on product liability claims after a certain time period following the product’s sale or use, potentially providing a complete defense in some jurisdictions and a rebuttable...more

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

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On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

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On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...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...

Goodwin on

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

ArentFox Schiff

Breaking: Third Circuit Declares Mallinckrodt’s Future Royalty Payment Obligations Dischargeable – Caution, Warning, and Options

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On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111, reminding everyone that “creditors take on risks” when it ruled that the debtor...more

McDermott Will & Emery

This Week in 340B: April 30 – May 6, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Smart & Biggar

Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

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On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

McDermott Will & Emery

This Week in 340B: April 16 – April 22, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Goodwin

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

Goodwin on

​​​​​​​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

Knobbe Martens

Routine Optimization of Result-Effective Variable Can Bridge Gaps in Prior Art

Knobbe Martens on

PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark.  Appeal from the Patent Trial and Appeal Board....more

McDermott Will & Emery

This Week in 340B: April 2 – April 8, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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

Dechert LLP

Dechert Re:Torts - Issue 14

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A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

Smart & Biggar

BYOOVIZ is confusing with BEOVU: Federal Court finds violation of Novartis’ trademark rights

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In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its...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

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