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Pharmaceutical Patents Noninfringement

Axinn, Veltrop & Harkrider LLP

Going Global on Polymorphs

We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more

WilmerHale

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

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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

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Goodwin

Update on mRNA Vaccine Patent Litigation

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​​​​​​​We previously reported on patent infringement litigations between Alnylam and Moderna. Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna....more

Goodwin

Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging...

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Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences...more

Robins Kaplan LLP

Astellas US LLC v. Hospira, Inc.

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Case Name: Astellas US LLC v. Hospira, Inc., No. 18-cv-1675-CFC, 2022 WL 1591277 (D. Del. May 19, 2022) (Connolly, J.)   Drug Product and Patent(s)-in-Suit: Lexiscan® (regadenoson); U.S. Patents Nos. 106,183 (“the ’183...more

Robins Kaplan LLP

Horizon Medicines LLC v. Alkem Labs. Ltd. (UPDATED)

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Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 2021-1480, 2021 WL 5315424 (Fed. Cir. Nov. 16, 2021) (Circuit Judges Dyk, O’Malley, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D. Del., Andrews, J.)...more

Robins Kaplan LLP

Almirall, LLC v. Torrent Pharms., Ltd.

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Case Name: Almirall, LLC v. Torrent Pharms., Ltd., Civ. No. 20-1373-LPS (D. Del. July 13, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Aczone® Gel, 7.5% (Dapsone); U.S. Patent No. 9,517,219 (“the ’219 patent”)...more

WilmerHale

CAFC Patent Cases - May 2021 #2

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Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Smart & Biggar

Federal Court finds silodosin formulation patent valid but not infringed

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On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan...more

Fox Rothschild LLP

Chief Judge Stark Grants Defendant’s Motion For Summary Judgment Of No Infringement Under Doctrine Of Equivalents

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By Memorandum Opinion entered by The Honorable Leonard P. Stark in Osseo Imaging, LLC v. Planmeca USA Inc., Civil Action No. 17-1386-LPS (D.Del. October 28, 2020), the Court, inter alia, denied Defendant’s motion for summary...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Holds That Claims of a Patent Asserted During a Patent Term Extension Are Not Infringed by the Carboxylic Acid...

Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more

Akin Gump Strauss Hauer & Feld LLP

Bases and Esters and Salts . . . Redux! Federal Circuit Affirms Non-Infringement Ruling Because PTE Statute Benefitting Ester Drug...

The Federal Circuit affirmed the grant of a defendant’s Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that under the plain text of patent term extension (PTE) statute an accused drug...more

Goodwin

BREAKING NEWS: Celltrion Prevails Over Janssen in Infliximab Biosimilar Appeal

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Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar. The court heard oral argument in the appeal yesterday....more

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Goodwin

FDA Approves Sandoz’s Biosimilar Pegfilgrastim

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As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its...more

Knobbe Martens

Patent Claim Reciting a List “Consisting Essentially of” Is Indefinite Where the Basic and Novel Property of the Invention Is...

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HZNP Medicines LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc. Before Prost, Newman, and Reyna.  Appeal from the District Court for the District of New Jersey. Summary: Claims using “consisting...more

K&L Gates LLP

Amgen v. Sandoz - New Developments in Biosimilars Litigation

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INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more

Goodwin

Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

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On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...more

Wilson Sonsini Goodrich & Rosati

District Court Case Highlights Nuances Associated with Determining If a Generic or Biosimilar Applicant Is Entitled to Protection...

A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more

Goodwin

Janssen Appeals District Court’s Summary Judgment of Non-Infringement in INFLECTRA Litigation

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As we have previously covered, last month the court in Janssen v. Celltrion (D. Mass., J. Wolf) issued a memorandum opinion granting Celltrion’s motion for summary judgment of non-infringement of the sole remaining...more

Smart & Biggar

Shire’s VYVANSE patent valid, prohibition order issued

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On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more

Goodwin

Sandoz Files Responsive Brief in Amgen v. Sandoz Appeal

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As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars....more

Goodwin

Trial Begins in Insulin Glargine Follow-On Biologics Litigation

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On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement...more

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