Acorda and AstraZeneca claim victory over Mylan
The US Court of Appeals for the Federal Circuit has rejected Mylan’s attempt to dismiss two patent lawsuits on the grounds of lack of personal jurisdiction.
In its judgment, the federal circuit upheld two lower court rulings that prevented Mylan dismissing two lawsuits brought against it: one by Acorda Therapeutics and Alkermes, and the other by AstraZeneca.
The disputes centre on Acorda’s multiple sclerosis drug Ampyra (dalfampridine) and AstraZeneca’s drugs Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin HCI extended-release), which help treat people with type 2 diabetes.
Acorda owns four patents directed to Ampyra and is the exclusive licensee of the fifth, owned by Alkermes.
In January 2014, Mylan filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market generic version of Ampyra.
Acorda and Alkermes then sued Mylan at the US District Court for the District of Delaware alleging patent infringement
AstraZeneca, which owns three patents directed to its two drugs, sued Mylan at the same Delaware court after Mylan had filed two ANDAs seeking approval to market generic versions of the drugs.
In both cases Mylan filed a motion to dismiss based on lack of personal jurisdiction. If a court does not have personal jurisdiction over a party, its rulings cannot be enforced.
In its arguments Mylan said it is incorporated in West Virginia and has its principal place of business there. It submitted its ANDAs in Maryland, and did much of its preparation for the ANDA filings in West Virginia.
Mylan sent notices of its ANDA filings to Acorda in New York and to Alkermes in Ireland. It sent its notices to AstraZeneca’s headquarters in Sweden and subsidiary in Delaware.
But the Delaware court ruled in both cases that when a generic company files an ANDA at the FDA it opens the door to personal jurisdiction in any state where the generic company will market the drug.
The court added that Delaware had sufficient “contacts related to the subject of these cases” in order to exercise specific personal jurisdiction over Mylan.
In its judgment, handed down on March 16, the federal circuit upheld the rulings.
“Mylan has registered to do business and appointed an agent to accept service in Delaware. And, of particular importance, Mylan intends to direct sales of its drugs into Delaware,” it said.
It added that Acorda and AstraZeneca also have connections with Delaware: Acorda is incorporated in Delaware and AstraZeneca’s US subsidiary has its principal place of business there.
