Introduction
The litigation between Actelion Pharmaceuticals Ltd and Apotex Inc. is a significant case in the pharmaceutical industry, involving patent infringement and anticompetitive practices. Here, we will delve into the key aspects of the case, including the parties involved, the nature of the dispute, jurisdictional issues, and the relief sought by Actelion.
The Parties Involved
- Actelion Pharmaceuticals Ltd: A Swiss corporation with its primary place of business in Allschwil, Switzerland. Actelion Pharmaceuticals US, Inc. is its subsidiary, incorporated in the State of Delaware with its principal place of business in Titusville, New Jersey[1].
- Apotex Inc. and Apotex Corp.: Apotex Inc. is a Canadian entity, and Apotex Corp. is a Delaware corporation. Both are wholly-owned by Apotex Holdings Inc. and operate in concert as part of the same business group[1].
Nature of the Dispute
The dispute centers around the infringement of United States Patent No. 7,094,781 (the ’781 patent) by Apotex. Actelion alleges that Apotex’s submission of an Abbreviated New Drug Application (ANDA) to the FDA, which included a Paragraph IV Certification regarding the ’781 patent, constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A)[1].
Jurisdiction and Venue
The case is filed in the United States District Court for the District of Delaware. The court has jurisdiction over the subject matter under 28 U.S.C. §§ 1331, 1338(a), and 35 U.S.C. § 271. Personal jurisdiction over Apotex Corp. is established due to its significant contacts with the State of Delaware, including its business operations and revenue generation within the state[1].
Awareness of Patent Validity
Actelion argues that Apotex was aware of the validity and enforceability of the ’781 patent through a Consent Judgment in a previous case involving Laurus Labs Limited and PharmaQ, Inc., where the defendants admitted the patent’s validity[1].
Infringement Claims
Actelion claims that Apotex’s actions, including the submission of the ANDA and potential commercial manufacture, use, offer for sale, or sale of the generic product, would infringe the ’781 patent under various sections of 35 U.S.C. § 271. Actelion also asserts that Apotex is jointly and severally liable for these infringements[1].
Relief Sought
Actelion seeks several forms of relief:
- A judgment declaring that Apotex has infringed the ’781 patent.
- A permanent injunction to prevent Apotex from commercially manufacturing, using, offering to sell, or selling the generic product in the United States.
- An order that the effective date of any FDA approval for the ANDA be no earlier than the expiration date of the ’781 patent.
- Monetary relief for any infringement that occurs before the patent’s expiration[1].
Irreparable Harm and Exceptional Case
Actelion argues that it will suffer irreparable harm if Apotex’s infringing activities are not enjoined, as it does not have an adequate remedy at law. The case is deemed exceptional due to Apotex’s alleged failure to comply with the duty of care in converting its certification and propagating invalidity defenses without a good-faith basis[1].
Anticompetitive Allegations in Related Cases
In a related case, Actelion faced antitrust counterclaims from generic companies, including allegations of anticompetitive conduct to maintain monopoly power. The court found disputes of material fact regarding whether Actelion’s REMS (Risk Evaluation and Mitigation Strategy) program and other actions prevented generic companies from obtaining samples, thus denying summary judgment[2].
Key Takeaways
- The litigation revolves around patent infringement and anticompetitive practices in the pharmaceutical industry.
- Actelion alleges that Apotex’s ANDA submission and potential commercial activities infringe the ’781 patent.
- Jurisdiction is established in the District of Delaware due to Apotex’s significant contacts with the state.
- Actelion seeks a judgment, permanent injunction, and monetary relief.
- The case highlights the complexities of patent litigation and antitrust issues in the pharmaceutical sector.
FAQs
What is the primary issue in the Actelion Pharmaceuticals Ltd v. Apotex Inc. case?
The primary issue is the alleged infringement of United States Patent No. 7,094,781 by Apotex through its submission of an ANDA to the FDA.
Why is the case filed in the District of Delaware?
The case is filed in the District of Delaware due to the court’s jurisdiction over federal patent cases and Apotex Corp.’s significant business contacts within the state.
What relief is Actelion seeking from the court?
Actelion seeks a judgment declaring infringement, a permanent injunction against Apotex’s commercial activities, an order delaying FDA approval until the patent expires, and monetary relief for any infringement.
What are the anticompetitive allegations against Actelion in related cases?
In related cases, Actelion is accused of using its REMS program and other tactics to prevent generic companies from obtaining samples, thereby maintaining its monopoly power.
Why is the case considered exceptional?
The case is considered exceptional due to Apotex’s alleged failure to comply with the duty of care in converting its certification and propagating invalidity defenses without a good-faith basis.
Cited Sources:
- Actelion Pharmaceuticals Ltd v. Apotex Inc., Complaint, Case 1:23-cv-00734-UNA, Document 1, Filed 07/06/23.
- Actelion Pharmaceuticals Ltd v. Government Employees, et al., Case 1:18-cv-03560-GLR, Document 351, Filed 09/06/24.
