Astellas Pharma Inc. v. Creekwood Pharmaceuticals LLC

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Astellas Pharma Inc. v. Creekwood Pharmaceuticals LLC: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of Astellas Pharma Inc. v. Creekwood Pharmaceuticals LLC (Case Number: 1:25-cv-00045) is a patent infringement lawsuit filed in the U.S. District Court for the District of Delaware on January 10, 2025. The plaintiffs, Astellas Pharma Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global Development, Inc., are alleging patent infringement by Creekwood Pharmaceuticals LLC related to the submission of an Abbreviated New Drug Application (ANDA) for generic versions of Myrbetriq® extended-release tablets[3].

Nature of the Action

This litigation revolves around Creekwood’s ANDA submission under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), which seeks FDA approval to market generic pharmaceutical products. The plaintiffs claim that Creekwood’s ANDA products infringe on several patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), specifically U.S. Patent Nos. 10,842,780, 11,707,451, 12,059,409, and 12,097,189[1].

Patents-in-Suit

The patents in question are associated with the formulation and use of mirabegron, a drug used for the treatment of overactive bladder (OAB). The ‘780 patent, for example, covers sustained-release pharmaceutical compositions comprising mirabegron, including specific formulations and methods of treatment[5].

Paragraph IV Certification

Creekwood filed a Paragraph IV certification as part of its ANDA submission, asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of Creekwood’s ANDA products. This certification is a critical component of the Hatch-Waxman Amendments, allowing generic manufacturers to challenge the validity of brand-name drug patents[1][2].

Jurisdiction and Venue

The court has jurisdiction over the subject matter under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. Personal jurisdiction over Creekwood is established due to its incorporation in Delaware and the foreseeable harm and injury to the plaintiffs resulting from Creekwood’s actions. Venue is proper in the District of Delaware pursuant to 28 U.S.C. §§ 1391 and 1400(b)[1].

Claims of Infringement

The plaintiffs allege that Creekwood’s submission of the ANDA and the intended commercial manufacture, use, offer for sale, and sale of the generic products will induce infringement of at least one or more claims of the patents-in-suit. Specifically, the plaintiffs argue that Creekwood’s actions will infringe the ‘780 Patent, among others, with the requisite intent under 35 U.S.C. § 271(b)[1].

Potential Harm to Plaintiffs

Astellas argues that unless Creekwood is enjoined by the court, Astellas will suffer substantial and irreparable harm due to the infringement. Astellas claims it does not have an adequate remedy at law, emphasizing the need for injunctive relief to protect its patent rights[1].

Regulatory Framework

The case is governed by the Hatch-Waxman Amendments to the FDCA, which provide a framework for the approval of generic drugs. These amendments allow generic manufacturers to file ANDAs while challenging the validity or non-infringement of the brand-name drug patents. This regulatory framework is crucial in balancing the interests of brand-name and generic drug manufacturers[2].

Similar Litigation Precedents

Astellas has been involved in similar patent infringement cases related to Myrbetriq®, such as the case against Sandoz Inc., where Astellas sued for patent infringement based on ANDA submissions. These cases highlight the ongoing legal battles in the pharmaceutical industry over patent rights and generic drug approvals[5].

Key Takeaways

  • Patent Infringement Claims: Astellas alleges that Creekwood’s ANDA submission infringes on several patents related to Myrbetriq®.
  • Paragraph IV Certification: Creekwood’s certification challenges the validity and enforceability of the patents-in-suit.
  • Jurisdiction and Venue: The court has jurisdiction and proper venue in the District of Delaware.
  • Potential Harm: Astellas seeks injunctive relief to prevent substantial and irreparable harm.
  • Regulatory Context: The case is governed by the Hatch-Waxman Amendments, balancing brand-name and generic drug interests.

FAQs

Q: What is the basis of the lawsuit filed by Astellas against Creekwood?

A: The lawsuit is based on patent infringement claims related to Creekwood’s submission of an ANDA for generic versions of Myrbetriq® extended-release tablets.

Q: Which patents are involved in the litigation?

A: The patents involved are U.S. Patent Nos. 10,842,780, 11,707,451, 12,059,409, and 12,097,189.

Q: What is a Paragraph IV certification, and why is it relevant?

A: A Paragraph IV certification is a statement by a generic drug manufacturer that the brand-name drug patents are invalid, unenforceable, or will not be infringed. This certification is crucial in the Hatch-Waxman framework.

Q: Why is the District of Delaware the proper venue for this case?

A: The District of Delaware is the proper venue due to Creekwood’s incorporation in Delaware and the foreseeable harm and injury to the plaintiffs resulting from Creekwood’s actions.

Q: What relief is Astellas seeking in this litigation?

A: Astellas is seeking injunctive relief to prevent substantial and irreparable harm resulting from the alleged patent infringement.

Cited Sources

  1. United States District Court, District of Delaware. Astellas Pharma Inc. et al v. Creekwood Pharmaceuticals LLC, Case 1:25-cv-00045-UNA, Document 1, Filed 01/10/25.
  2. United States District Court, District of Delaware. Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc. v. Hospira, Inc., Case 1:18-cv-01675-CFC-CJB, Document 947, Filed 05/19/22.
  3. Justia Dockets & Filings. Astellas Pharma Inc. et al v. Creekwood Pharmaceuticals LLC, Case Number: 1:25-cv-00045.
  4. Casetext. Gerold v. Astellas Pharma U.S., Inc.
  5. United States Court of Appeals for the Federal Circuit. Astellas Pharma, Inc. v. Sandoz Inc., Case No. 23-2032, Opinion Filed 09/18/24.

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