- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
April 15, 2024Robins Kaplan Named to 2024 BTI Client Service A-Team
-
April 9, 2024Robins Kaplan LLP Files Complaint Against Social Media Giants Meta, Snap, TikTok on Behalf of Spirit Lake Nation, Menominee Indian Tribe of Wisconsin
-
April 8, 2024Tara Sutton, Emily Tremblay Shortlisted for Euromoney’s Women in Business Law Awards
-
April 24, 2024IP Leadership Executive Summit
-
April 24, 2024IP Odyssey: Navigating the Latest Developments in Intellectual Property Law
-
April 30, 2024Navigating Generational Dynamics
-
March 2024e-Commerce: Pitfalls and Protections
-
March 22, 2024‘In re Cellect’:
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Acorda Therapeutics Inc. v. Mylan Pharms. Inc.
The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware.
April 07, 2016
Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring Opinion by O’Malley, J.) (Appeal from D. Del., Stark, C.J.)
Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); Onglyza® (saxagliptin); Kombiglyze™ (saxagliptin and metformin HCl)
Nature of the Case and Issue(s) Presented: This appeal involved two separate district court actions against Mylan in the District of Delaware. Chief Judge Stark (in the Acorda case) and Judge Sleet (in the AstraZeneca case) denied Mylan’s motions to dismiss, concluding that Delaware had sufficient contacts related to the subject of these cases that it could exercise specific personal jurisdiction over Mylan. The two judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to such jurisdiction in registering to do business: they took different views of the status of Supreme Court decisions supporting such jurisdiction, e.g., Pa. Fire Ins. Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93, (1917), in light of later decisions such as Daimler AG v. Bauman, 134 S. Ct. 746, (2014). But the latter disagreement did not alter the finding of personal jurisdiction in these cases. In each case the district court certified its decision for interlocutory review, and the Federal Circuit granted permission to appeal, ultimately siding with Chief Judge Stark that there was specific personal jurisdiction over Mylan in Delaware.
Why Plaintiffs Prevailed: Mylan is incorporated and has its principal place of business in West Virginia, but is registered to do business in Delaware with an appointed in-state agent to accept service of process. More importantly, Mylan filed an ANDA with the FDA to market its generic drugs throughout the United States, including Delaware. The Federal Circuit characterized the ANDA as “tightly tied, in purpose and effect, to the deliberate making of sales in Delaware” such that filing the ANDA served as a “formal act” indicating intent to engage in marketing of the proposed generic drugs. Accordingly, the Federal Circuit held that filing an ANDA meant that Mylan had sufficient minimum contacts with Delaware such that Mylan was subject to specific personal jurisdiction in the District of Delaware.
The Federal Circuit looked to the purpose of the 35 U.S.C. § 271(e)(2) to support its holding. In drafting § 271(e)(2), Congress provided a means by which a generic drug manufacturer could assert that it intended to “commit real world acts that would make it liable for infringement.” This provision distinguished ANDA filers from other would-be infringers. Further, due the expense and effort required to prepare an ANDA, the filing of an ANDA realistically establishes a plan to market the generic drug. Additionally, because states are not forbidden from exercising their judicial power to prevent planned future conduct (for example, by issuing injunctions), exerting jurisdiction over an ANDA filer did not offend the traditional notions of fair play and substantial justice. Thus, the Federal Circuit affirmed the Acorda court’s rulings, and held that the District of Delaware properly had jurisdiction over Mylan.
Judge O’Malley agreed with the result, but contended that general jurisdiction provided a more straightforward analysis. Judge O’Malley reasoned that Mylan was subject to general jurisdiction in Delaware because it registered to do business in the state and appointed an in-state agent to accept service of process. In other words, Mylan had voluntarily elected to conduct business in the Delaware. According to Judge O’Malley, this was sufficient to establish general jurisdiction. Judge O’Malley also noted that he would find that Mylan was also specific jurisdiction based on the effects test of Calder v. Jones, rather than based on future intent. In so doing, Judge O’Malley concluded that the effect of the ANDA was to harm the intellectual property rights of Delaware corporations.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.