CAFC finds personal jurisdiction of defendant Mylan in Acorda/Ampyra case
MS case involving Ampyra.
The bottom line:
The decisions of the district court that Mylan is
subject to specific personal jurisdiction in the district
court for Delaware are affirmed.
Mylan moved to dismiss on the ground that Delaware could not
(and so the federal court may not) exercise personal
jurisdiction—either general or specific personal jurisdiction—
over Mylan in these cases. Chief Judge Stark and
Judge Sleet denied the motions. Although they reached
different conclusions about whether Delaware could
exercise general personal jurisdiction over Mylan based
on consent given in registering to do business in the State,
they both concluded that Delaware could exercise specific
personal jurisdiction, based on Mylan’s suit-related contacts
with Delaware. On interlocutory appeal, we affirm,
holding that Mylan is subject to specific personal jurisdiction
in these cases. We do not address the issue of general
This is a Hatch-Waxman case:
Under the authority of the FDA’s approval of its New
Drug Application (NDA), 21 U.S.C. § 355(a), (c), Acorda
markets Ampyra® to help individuals with multiple
sclerosis walk. In seeking approval for Ampyra®, Acorda
identified five patents for listing in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations
publication—the “Orange Book.” See 21 U.S.C.
§ 355(b)(1); 21 C.F.R. §§ 314.3, 314.53. Acorda owns four
of the patents and is the exclusive licensee of the fifth,
owned by Alkermes. In January 2014, Mylan filed an
Abbreviated New Drug Application (ANDA) with the FDA
under 21 U.S.C. § 355(j), seeking approval to market
generic versions of Ampyra®. Under paragraph IV of
§ 355(j)(2)(A)(vii), Mylan certified that Acorda’s Orange
Book patents for Ampyra® are invalid or would not be
infringed by Mylan’s marketing of its proposed drug.
Acorda and Alkermes then sued Mylan in the District of
Delaware for patent infringement, invoking the declaration
of 35 U.S.C. § 271(e)(2)(A) that the submission of a
paragraph IV certification constitutes an act of infringement.
general link: http://www.cafc.uscourts.gov/opinions-orders