On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
Joseph Rutkowski is an Associate and is based in the firm’s Boston office. His practice focuses on a variety of civil litigation matters, including patent litigation, trade secret disputes, and complex commercial litigation. Joseph’s primary focus is intellectual property litigation, including matters involving pharmaceuticals and the Hatch-Waxman Act, and he is experienced in all stages of litigation.
On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits filed in the state. (See Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015); AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). For coverage of the oral argument in these appeals, see our prior blog post.) The Federal Circuit found that specific personal jurisdiction exists over Mylan in Delaware because Mylan’s ANDA filings reliably indicate its intent to engage in actions that will harm plaintiffs’ patent rights in the jurisdiction. The court did not reach the issue on appeal of whether Mylan’s compliance with Delaware’s registration statute established consent to general personal jurisdiction in the state, an issue on which the lower court opinions split. However, Judge Kathleen M. O’Malley, concurring in the majority’s judgement, would also have found Mylan consented to general personal jurisdiction in light of Delaware’s interpretation of its registration statute.
Filing an ANDA Satisfies the Minimum Contacts Requirement of Specific Personal Jurisdiction
The court held that “the particular actions Mylan has already taken–its ANDA filings–for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware” satisfy the minimum contacts with Delaware required to establish specific personal jurisdiction. The court began by observing that, if Mylan had already begun the generic drug marketing activities for which it seeks permission by filing an ANDA, “there is no doubt that it could be sued for infringement in Delaware,” and elsewhere that it seeks to market the generic ANDA products. Mylan’s ANDA filings, in turn, are “formal acts that reliably indicate plans to engage in” that same infringing activity. Thus, the ANDA filings, like the contemplated marketing acts they seek approval for, establish personal jurisdiction over Mylan in Delaware.
Our Biosimilar webinar series continued this month with Tom Wintner’s BPCIA Patent Litigation presentation. Tom discussed the general framework of litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), including the “patent dance” information exchange under 42 U.S.C. §262(l), and three case studies that inform our current understanding of emerging judicial interpretation of BPCIA requirements.
For those who missed the webinar, some of the key takeaways include the following:
- Biosimilar litigation is ultimately about patent litigation, but much of the underlying patent issues have been obscured because current litigation focuses on when and how the BPCIA applies and the BPCIA’s requirements when it does apply.
Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation. Some of the key takeaways include:
- overviews of FDA guidance on demonstrating biologic product biosimilarity and “interchangeability” (the latter of which means that the biosimilar may be substituted for the FDA-approved reference product without intervention by the prescribing health care provider);
- FDA’s “stepwise” approach to determining biosimilarity, under which more robust initial comparative evidence may reduce FDA clinical study requirements later on;
- current state of FDA draft product labeling guidance that would require, for example, reference products and biosimilars to share a common core name with unique suffixes; and
- exclusivity periods for original reference and biosimilar products.
For a more detailed write-up of the presentation, see our post on Mintz Levin’s Health Law & Policy Matters blog, here.
Tom Wintner, a member in Mintz Levin’s Intellectual Property group, will present the next webinar in the Biosimilar series – BPCIA Patent Litigation – on Thursday, February 25, 2016. This session will offer practical advice regarding litigating patents under the BPCIA and provide an update on current litigation under the law.
Sign up here to attend Tom’s litigation webinar or the other Biosimilar webinars coming up in March and April.
On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal jurisdiction over generic pharmaceutical manufacturers in Hatch-Waxman litigation.
Decisions Below Denying Motions to Dismiss for Lack of Personal Jurisdiction
Generic ANDA filer Mylan appealed from denial of its motion to dismiss in AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). Judge Gregory M. Sleet found specific personal jurisdiction over the foreign corporate defendant in Delaware based on Mylan’s sending a Paragraph IV notice letter to AstraZeneca in Delaware. Judge Sleet also found, citing the Supreme Court’s recent holding in Daimler AG v. Bauman, 134 S. Ct. 746 (U.S. 2014), that Mylan’s registration to do business in Delaware did not constitute consent to personal jurisdiction, and thus general personal jurisdiction, in Delaware.
On Monday Mylan also argued its appeal of the denial of a similar motion to dismiss in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015). In that case, Chief Judge Leonard P. Stark found specific personal jurisdiction exists over Mylan in Delaware based on Mylan’s sending a Paragraph IV notice letter to the Delaware-incorporated Acorda, even though the notice letter was not mailed to Delaware. Judge Stark, unlike Judge Sleet, also found general personal jurisdiction over Mylan because Mylan consented to personal jurisdiction in the state by voluntarily registering to do business there.
On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss a Hatch-Waxman patent infringement action for an alleged lack of personal jurisdiction following the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014). Eli Lilly & Co. v. Mylan Pharmaceuticals, Inc. (S.D. Ind. Mar. 12, 2015). The Eli Lilly court denied generic defendant Mylan’s motion to dismiss, finding specific jurisdiction appropriate in Indiana based on the unique nature of Hatch-Waxman ANDA litigation and the defendant’s forum contacts. Continue Reading Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds