Introduction
The litigation between Actelion Pharmaceuticals US, Inc., Actelion Pharmaceuticals Ltd, and Nippon Shinyaku Co., Ltd. (collectively, "Actelion") against Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals, Inc. (collectively, "Alembic") is a significant case in the realm of pharmaceutical patent law. Here, we will delve into the key aspects of this litigation, including the nature of the action, jurisdiction and venue, the patents-in-suit, and the implications of the case.
Nature of the Action
This civil action is filed under the Patent Laws of the United States, specifically 35 U.S.C. §§ 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02. The complaint alleges patent infringement by Alembic related to their submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA)[2].
Jurisdiction and Venue
The court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331, 1338, 2201, and 2202. Personal jurisdiction over Alembic is established due to their substantial and continuous contacts with Delaware, including the commission of tortious acts of patent infringement within the state. Alembic's business activities, such as formulating, manufacturing, marketing, and selling generic prescription pharmaceuticals in Delaware, further solidify the court's jurisdiction[2].
The Parties Involved
- Actelion Pharmaceuticals US, Inc.: A corporation organized under the laws of the State of Delaware, with its principal place of business in New Jersey.
- Actelion Pharmaceuticals Ltd: A Swiss corporation with its primary place of business in Allschwil, Switzerland.
- Nippon Shinyaku Co., Ltd.: A Japanese corporation with its primary place of business in Kyoto, Japan.
- Alembic Pharmaceuticals Limited: An Indian entity with its principal place of business in Vadodara, Gujarat, India.
- Alembic Pharmaceuticals, Inc.: An entity that operates in concert with Alembic Ltd. and is considered an agent or integrated part of the same business group[2].
Patents-in-Suit
The litigation centers around the infringement of United States Patent Nos. 8,791,122 (“the ’122 patent”) and 9,284,280 (“the ’280 patent”). These patents are crucial to the development, regulatory approval, marketing, sale, and distribution of specific pharmaceutical products[2].
Alembic's ANDA Submission
Alembic Ltd. submitted ANDA No. 217717 under Section 505(j) of the Federal Food, Drug, and Cosmetic Act, seeking FDA approval for a generic version of a drug protected by the patents-in-suit. This submission is the core of the infringement allegations, as Actelion claims that Alembic's actions would infringe their patent rights[2].
Infringement Allegations
Actelion alleges that Alembic's ANDA submission constitutes infringement, active inducement of infringement, and/or contribution to the infringement by others, either literally or under the doctrine of equivalents, under 35 U.S.C. § 271(a), (b), or (c). The complaint seeks relief to prevent further infringement, including preliminary and permanent injunctions, and an order setting the effective date of any FDA approval to be no earlier than the expiration date of the patents-in-suit[2].
Relief Sought
Actelion seeks several forms of relief, including:
- A declaratory judgment that Alembic's ANDA product infringes the patents-in-suit.
- A preliminary and permanent injunction to prevent Alembic from engaging in the commercial manufacture, use, offer to sell, sale, marketing, distribution, or importation of the infringing product.
- An order that the FDA set the effective date of approval for Alembic's ANDA to be no earlier than the date of expiration of the patents-in-suit[2].
Implications and Analysis
This case highlights the complexities and challenges in pharmaceutical patent litigation, particularly in the context of generic drug approvals. The outcome of this litigation can have significant implications for both the innovator companies like Actelion and the generic manufacturers like Alembic.
Innovator vs. Generic Manufacturer Dynamics
The Hatch-Waxman Act, under which ANDA submissions are made, aims to balance the interests of innovator companies and generic manufacturers. This case illustrates the tensions that arise when generic companies seek to enter the market before the expiration of the innovator's patents.
Jurisdictional Considerations
The establishment of personal jurisdiction over foreign entities like Alembic Ltd. is crucial in such cases. It underscores the importance of demonstrating substantial and continuous contacts with the jurisdiction where the lawsuit is filed.
Patent Protection and Infringement
The case emphasizes the importance of patent protection for pharmaceutical companies. Actelion's efforts to enforce their patent rights against Alembic's ANDA submission are typical of the strategies innovator companies employ to safeguard their intellectual property.
Key Takeaways
- The litigation involves allegations of patent infringement related to Alembic's ANDA submission.
- Actelion seeks various forms of relief, including declaratory judgments and injunctions.
- The case highlights the complexities of pharmaceutical patent litigation and the balance between innovator and generic companies.
- Jurisdictional considerations are critical in establishing personal jurisdiction over foreign entities.
FAQs
What is the nature of the action in Actelion v. Alembic?
The action is a civil lawsuit for patent infringement under the Patent Laws of the United States and the Declaratory Judgment Act.
Which patents are involved in the litigation?
The patents-in-suit are United States Patent Nos. 8,791,122 and 9,284,280.
Why is the court's jurisdiction important in this case?
The court's jurisdiction is crucial because it establishes the legal authority to hear the case, particularly against a foreign entity like Alembic Ltd.
What relief is Actelion seeking in the lawsuit?
Actelion seeks a declaratory judgment of infringement, preliminary and permanent injunctions, and an order setting the effective date of FDA approval for Alembic's ANDA.
How does this case impact the pharmaceutical industry?
The case impacts the balance between innovator companies and generic manufacturers, highlighting the importance of patent protection and the complexities of ANDA submissions.
Citations
- Case 1:22-cv-01450-UNA Document 1 Filed 11/03/22 Page 1 of 12 - Actelion Pharmaceuticals US, Inc. v. Alembic Pharmaceuticals Limited, Complaint.
- Case 1:22-cv-01450-UNA Document 1 Filed 11/03/22 Page 1 of 12 - Actelion Pharmaceuticals US, Inc. v. Alembic Pharmaceuticals Limited, Complaint.
- Case 3:24-cv-09110-RK Document 1 Filed 09/11/24 Page 1 of 53 - Jazz Pharmaceuticals Ireland Limited v. InvaGen Pharmaceuticals, Inc., Complaint.
