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The Federal Circuit gave a nod to the famous personal jurisdiction case International Shoe by making the determination that the West Virginia pharma company Mylan purposefully availed itself of Delaware law through its actions in seeking FDA approval to market generics.
The circuit's decision comes on the heels of two major plaintiffs' suits against Mylan: Acorda and AstroZeneca.
Acorda, the plaintiff in one of the federal cases, owns several patents and licenses related to its Ampyra drug, which is used to help multiple sclerosis sufferers walk. Mylan filed an Abbreviated New Drug Application hoping to obtain the green light from the FDA to market and create generic versions of the Ampyra. Mylan asserted in its petition that its generic version would not be an infringement of Acorda's IP rights. Acorda sued.
Similarly, AstroZeneca has the rights to Onglyza and Kombiglyze. Mylan also submitted to ANDAs seeking FDA approval to market generic versions of these drugs. They sued Mylan too.
Motions to Dismiss
Mylan moved to dismiss both lawsuits (they were separate) on due process grounds. It was asserted that Delaware was not the proper forum because Mylan could not be rightfully haled into court. The judges in both cases denied both motions to dismiss by Mylan and found that there were significant minimum contacts related to suit within the state of Delaware, but disagreed on the issue of whether or not such contacts were so numerous and systematic that general jurisdiction should apply.
General jurisdiction would have to wait, as the answer was not addressed at the Federal Circuit level. The Federal Circuit affirmed the decisions of both court opinions in the Acorda and AstraZeneca cases. The issue, the circuit found, was whether or not the facts comported with the usual personal jurisdiction analysis that would allow a defendant to be haled into court of the plaintiff's choosing so long as doing so was consistent with "traditional notions of fair play and substantial justice" (famous words). If the defendant "purposefully direct[s]" such related activities at the forum, then personal jurisdiction is proper.
In both cases, it was clear that Mylan had already begun marketing its general versions of the drugs in Delaware -- and so, it was doubtless that personal jurisdiction ought to have attached. The ANDA filings themselves gave a "sufficiently close connection" to the forum state and the plaintiffs' injuries and IP rights.
Since Mylan had even gone so far as to taken the "costly, significant step of applying to the FDA for approval to engage in future activities" in Delaware, the court found that there was little doubt that such activities went beyond the minimum required contacts to hale Mylan into Delaware District Court.