March 18 — The Delaware federal district court has the authority to hear Acorda's suit to block Mylan from selling generic versions of the MS drug Ampyra, a federal appeals court held March 18.
Mylan had argued that the U.S. District Court for the District of Delaware didn't have the jurisdiction for the litigation because Mylan was based in West Virginia and it filed the applications with the Food and Drug Administration in Maryland.
In a separate suit in the same trial court, Mylan had made the same argument concerning AstraZeneca's lawsuit to block a generic of its type II diabetes drugs Onglyza and Kombiglyze.
But the district court in two separate decisions held it had the jurisdiction, although the judges reached different conclusions as to why. A three-judge panel of the U.S. Court of Appeals for the Federal Circuit affirmed in an opinion authored by Judge Richard G. Taranto, saying that the district court had specific personal jurisdiction over Mylan.
Specific personal jurisdiction refers to jurisdiction based on a person's minimum contacts with the forum state when the claim arises out of or is related to those contacts.
The litigation involves the filing of abbreviated new drug applications or ANDAs to sell generic drugs, and the resulting patent infringement litigation under the Hatch-Waxman Act.
“It's a good decision for brand manufacturing companies because it allows personal jurisdiction over a generic manufacturer in a Hatch-Waxman case anywhere in the country,” said Robert E. Colletti, of Frommer Lawrence & Haug LLP, New York. “Under the decision, specific jurisdiction is established because an ANDA filed with the Food and Drug Administration shows a plan that leads to the deliberate making of sales and potentially real word of infringement that harm brand name manufacturers.”
In a separate opinion by the Federal Circuit, Judge Kathleen M. O'Malley said that she agreed with the majority's opinion but also believed that the district court could exercise general personal jurisdiction over Mylan, which exists when a court in a given state has jurisdiction over a defendant in that state irrespective of the nature of the claim.
The Biotechnology Innovation Organization, the Pharmaceutical Research and Manufacturers of America and Teva Pharmaceuticals filed amicus briefs supporting the branded companies.
The Generic Pharmaceutical Association filed a brief in support of Mylan.
According to the appeals court's decision, under the authority of a new drug application or NDA, 21 U.S.C. § 355(a), (c), Acorda markets Ampyra to help individuals with multiple sclerosis. In seeking approval for Ampyra, Acorda identified five patents for listing in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication—what is known as the agency's “Orange Book.” Acorda owns four of the patents and is the exclusive licensee of the fifth, which is owned by Alkermes.
In January 2014, Mylan filed its ANDA with the FDA under 21 U.S.C. § 355(j), seeking approval to market generic versions of Ampyra, certifying that Acorda’s Orange Book patents for Ampyra are invalid or wouldn't be infringed.
Mylan also filed ANDAs seeking approval to market generic versions of Onglyza and Kombiglyze and made the same certification.
Acorda, Alkermes and AstraZeneca each filed separate suits against Mylan in the District of Delaware for patent infringement under 35 U.S.C. § 271(e)(2)(A).
Mylan argued that it is incorporated and based in West Virginia, submitted its ANDAs to the FDA in Maryland and did much if not all of its preparation of its ANDA filings in West Virginia. A Delaware district court had no jurisdiction over it, Mylan contended.
Chief Judge Leonard P. Stark in the Acorda case and Judge Gregory M. Sleet in the AstraZeneca case denied the motions to dismiss. They disagreed about whether the Delaware district court could exercise general personal jurisdiction on the ground that Mylan had consented to such jurisdiction in registering to do business, with Stark contending that a district court could do this.
On appeal, the Federal Circuit decided the case solely on the grounds of specific personal jurisdiction.
“In our view, the minimum-contacts standard is satisfied by 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,” Taranto wrote. “[Mylan's] ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs. Delaware is undisputedly a State where Mylan will engage in that marketing if the ANDAs are approved.”
The court also noted that the magnitude and costs of the work required before the ANDA is filed soundly link the ANDA filing to the filer’s entry into the market to compete with the brand-name manufacturer if approval is obtained and that it had emphasized the link in its decisions in Apotex, Inc. v. Daiichi Sankyo, Inc.,781 F.3d 1386, 2015 BL 93613 (Fed. Cir.,2015) and Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 2008 BL 66398 (Fed. Cir. 2008).
Taranto wrote that Mylan didn't meaningfully develop an argument that a rigid past/future dividing line governs the minimum-contacts standard. “Specifically, Mylan does not show that a State is forbidden to exercise its judicial power to prevent a defendant’s planned future conduct in the State, but must wait until the conduct occurs. Such a rule would run counter to the legal tradition of injunctive actions to prevent a defendant’s planned, non-speculative harmful conduct before it occurs,” Taranto wrote.
In her concurrence, O'Malley said that she agreed with Stark that the district court could have had general personal jurisdiction over Mylan in the case, citing for support the Supreme Court's decision in 243 U.S. (1917).
Theodore B. Olson, of Gibson, Dunn & Crutcher LLP, Washington, argued for Acorda and Alkermes.
Acorda is also represented by Kaye Scholer LLP. Alkermes is represented by Morris, Nichols, Arsht & Tunnell LLP.
Kannon K. Shanmugam, of Williams & Connolly LLP, Washington, argued for AstraZeneca.
Paul D. Clement, of Bancroft PLLC, Washington, argued for the Mylan defendants-appellants. Mylan also was represented by Wilson, Sonsini, Goodrich & Rosati.
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