Background
The litigation between Helsinn Healthcare S.A. and Fresenius Kabi USA, LLC revolves around patent infringement claims related to Helsinn's Aloxi® brand products, specifically palonosetron hydrochloride, used for preventing chemotherapy-induced nausea and vomiting.
The Parties Involved
- Helsinn Healthcare S.A.: The plaintiff, a Swiss-based pharmaceutical company, holds several patents related to palonosetron hydrochloride.
- Fresenius Kabi USA, LLC: The defendant, an American subsidiary of a German pharmaceutical manufacturer, sought to market its own generic version of palonosetron hydrochloride.
The Dispute
Patent Infringement Claims
Helsinn alleged that Fresenius Kabi's filing of an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of palonosetron hydrochloride would infringe several of Helsinn's patents, including the '724, '725, '424, '219, and '094 patents[1].
Jurisdictional Challenges
Similar to other cases involving Helsinn, jurisdictional issues were a significant part of the dispute. Fresenius Kabi argued that there was no general or specific jurisdiction over it in the district where the lawsuit was filed. Helsinn countered that Fresenius Kabi's registration to do business in the state and its appointment of an agent for service of process constituted consent to general jurisdiction[1].
Legal Standards and Arguments
Motion to Dismiss: Rule 12(b)(2) and Rule 12(b)(6)
Fresenius Kabi moved to dismiss the complaint for lack of personal jurisdiction under Federal Rule of Civil Procedure 12(b)(2) and for failure to state a claim under Rule 12(b)(6). Helsinn argued that Fresenius Kabi's activities, including the filing of the ANDA and the intent to market the generic product, were sufficient to establish jurisdiction[1].
General Jurisdiction
The court had to determine whether Fresenius Kabi was subject to general jurisdiction in the state where the lawsuit was filed. Helsinn argued that Fresenius Kabi's registration to do business and appointment of an agent for service of process were indicative of its consent to general jurisdiction. However, Fresenius Kabi contended that these actions were mandatory for any corporation doing business in the state and did not constitute consent to jurisdiction[1].
Specific Jurisdiction
The court also considered whether specific jurisdiction existed, focusing on whether the lawsuit arose out of or was related to Fresenius Kabi's activities within the state. Helsinn argued that the ANDA filing and the intent to market the generic product were directly related to the state, while Fresenius Kabi claimed that these activities were not purposefully directed at the state's residents[1].
Court Decisions and Rulings
Denial of Motion to Dismiss
In a similar case, the court denied a motion to dismiss based on jurisdictional grounds, accepting all factual allegations as true and construing the complaint in the light most favorable to the plaintiff. The court determined that the allegations were well-pleaded and sufficiently demonstrated a plausible entitlement to relief[1].
Patent Infringement Analysis
The court would have to analyze whether Fresenius Kabi's ANDA filing constituted an act of infringement under 35 U.S.C. § 271(e)(2), which allows for the filing of an ANDA to be considered an act of infringement for the purpose of obtaining a declaratory judgment. This analysis would involve interpreting the scope of Helsinn's patents and determining whether Fresenius Kabi's proposed generic product fell within that scope[2].
Settlements and Consent Judgments
In many ANDA litigation cases, parties often settle before a final judgment. For example, in other cases involving Helsinn, settlements have resulted in the dismissal of all claims and counterclaims, with the generic manufacturer agreeing not to market their product until the expiration of the relevant patents or under the terms of a settlement agreement[5].
Broader Implications
Hatch-Waxman Act
This litigation is part of the broader landscape of ANDA litigation under the Hatch-Waxman Act, which balances the interests of brand-name drug manufacturers and generic drug manufacturers. The Act allows generic manufacturers to file ANDAs while the brand-name drug's patents are still in effect, provided they certify that the patents are invalid or will not be infringed by their generic product[3].
Patent Validity and Infringement
Cases like this highlight the ongoing debates about patent validity and infringement in the pharmaceutical industry. The Supreme Court's decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., for instance, clarified that a commercial sale to a third party who is required to keep the invention confidential can constitute invalidating prior art for subsequently-issued patents[4].
Key Takeaways
- Jurisdictional Challenges: The case underscores the importance of jurisdictional arguments in ANDA litigation, particularly the distinction between general and specific jurisdiction.
- Patent Infringement: The filing of an ANDA can be considered an act of infringement, allowing brand-name manufacturers to seek declaratory judgments.
- Settlements: Many ANDA litigations result in settlements that delay the entry of generic products into the market.
- Broader Implications: The case is part of the larger framework of the Hatch-Waxman Act and ongoing legal debates about patent validity and infringement in the pharmaceutical industry.
Frequently Asked Questions
What is the Hatch-Waxman Act, and how does it relate to ANDA litigation?
The Hatch-Waxman Act is a federal law that allows generic drug manufacturers to file Abbreviated New Drug Applications (ANDAs) with the FDA while the brand-name drug's patents are still in effect. This act balances the interests of brand-name and generic drug manufacturers by providing a pathway for generic drugs to enter the market while respecting patent rights.
How does the filing of an ANDA constitute an act of infringement?
Under 35 U.S.C. § 271(e)(2), the filing of an ANDA can be considered an act of infringement for the purpose of obtaining a declaratory judgment. This provision allows brand-name manufacturers to sue generic manufacturers for patent infringement based on the ANDA filing.
What are the key jurisdictional issues in ANDA litigation?
Jurisdictional issues in ANDA litigation often revolve around whether the court has general or specific jurisdiction over the defendant. General jurisdiction requires the defendant to be "at home" in the state where the lawsuit is filed, while specific jurisdiction requires that the lawsuit arise out of or be related to the defendant's activities within the state.
How common are settlements in ANDA litigation?
Settlements are quite common in ANDA litigation. These settlements often result in the dismissal of all claims and counterclaims, with the generic manufacturer agreeing not to market their product until the expiration of the relevant patents or under the terms of a settlement agreement.
What is the significance of the Supreme Court's decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.?
The Supreme Court's decision clarified that a commercial sale to a third party who is required to keep the invention confidential can constitute invalidating prior art for subsequently-issued patents. This ruling has significant implications for patent validity in the pharmaceutical industry.
Cited Sources:
- Helsinn Healthcare S.A. v. Hospira, Inc., UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY, CIVIL ACTION NO. 15-2077 (MLC) (D.N.J. Apr. 5, 2016).
- Hospira, Inc. v. Fresenius Kabi USA, LLC, UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION, No. 16 C 651 (N.D. Ill. Nov. 27, 2017).
- Hatch-Waxman and BPCIA Developments in June 2018, JD Supra, July 9, 2018.
- Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. 434 (January 22, 2019).
- ANDA Litigation Settlements, Robins Kaplan LLP Law Firm, Summer 2019.
