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Dismissals Patent Infringement Pharmaceutical Industry

WilmerHale

Federal Circuit Patent Watch: Allegations of induced infringement can be based on skinny label in combination with public...

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Precedential and Key Federal Circuit Opinions - BETEIRO, LLC v. DRAFTKINGS INC. [OPINION] (2022-2275, 06/21/2024) (Dyk, Prost, Stark) - Stark, J. The Court affirmed the district court’s dismissal of multiple, related...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2024

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Appeal No. 2023-1169 (Fed. Cir. June 25, 2024) In the Court’s only precedential patent opinion last week, the Federal Circuit reversed the district court’s dismissal of...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

Venable LLP

EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction

Venable LLP on

On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

Smart & Biggar

Federal Court of Appeal and Federal Court release three decisions relating to macitentan (Janssen’s OPSUMIT)

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Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220 - Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770...more

WilmerHale

Federal Circuit Patent Watch: Federal Circuit rejects invitation to create a bright-line rule regarding whether numerical ranges...

WilmerHale on

Precedential and Key Federal Circuit Opinions - MALVERN PANALYTICAL INC. v. TA INSTRUMENTS-WATERS LLC [OPINION] (2022-1439, 11/1/2023) (Prost, Hughes, and Cunningham) - Prost, J. The Court vacated the district court’s...more

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

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The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

Smart & Biggar

Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...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

Plaintiff cannot amend Statement of Claim more than 45 days after receipt of NOAs to plead infringement of further patents.

Smart & Biggar on

On May 5, 2021, the Federal Court dismissed a motion by Biomarin Pharmaceutical Inc (Biomarin) to amend its Statement of Claim to allege infringement of two patents that had not been asserted within the 45-day deadline...more

Smart & Biggar

Federal Court of Appeal Upholds Decision Allowing Taro to Plead Validity Attacks beyond Notice of Allegation

Smart & Biggar on

On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more

Smart & Biggar

Supreme Court denies leave of interlocutory decision in pregabalin section 8 case

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On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) a decision upholding an interlocutory decision on a question relevant to the assessment of section 8...more

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

Dechert LLP on

Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

Goodwin

Pfizer Moves to Dismiss Amgen’s Suit Over Proposed Neulasta Biosimilar

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As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more

Goodwin

Coherus and Amgen Stipulate to Dismissal of Adalimumab Infringement Case

Goodwin on

As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and...more

Goodwin

Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

Goodwin on

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the...more

Goodwin

Janssen Voluntarily Dismisses Infliximab Patent Suit Against Samsung Bioepis

Goodwin on

On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda), a biosimilar of Remicade®...more

Proskauer - New England IP Blog

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Goodwin

Amgen’s Neulasta Declaratory Judgment Action Dismissed in District of New Jersey

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On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As...more

McDermott Will & Emery

A Brand Must Allege Facts to Survive a Motion to Dismiss Induced Infringement Claims - Otsuka Pharmaceutical Co., Ltd. v. Zydus...

Addressing the pleading standard for induced infringement, the U.S. District Court for the District of New Jersey dismissed Otsuka Pharmaceutical’s claims finding that a formulaic recitation of the legal standard without...more

Patterson Belknap Webb & Tyler LLP

Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with...

On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three generic drug manufacturers based on settlements they had reached regarding a...more

Morris James LLP

ANDA Case Is Dismissed For Lack Of Personal Jurisdiction

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The disputed technology is a generic rivastigmine patch. Defendant is a New Jersey corporation with a principal place of business in Vermont. Only specific jurisdiction is at issue since it is not “at home” in Delaware. ...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

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