The Court of Appeals for the Federal Circuit Finds Specific Jurisdiction in ANDA Patent Cases

Posted on Mar 21, 2016 in Blog

On March 18, 2016, the Court of Appeals for the Federal Circuit ruled for the first time that an ANDA filer can basically be sued anywhere unless it is unfair, widening broadly jurisdiction in ANDA cases. Mylan Inc. was sued twice in Delaware based on two ANDA filings and argued the Delaware court did not have specific or general jurisdiction over it. The Appeals Court affirmed the two district court opinions finding Mylan subject to specific jurisdiction there.  One concurring opinion would have found general jurisdiction because Mylan was registered to do business in Delaware.

The Federal Circuit found specific jurisdiction because Mylan’s ANDA filings indicated plans to market the proposed generic drugs indisputably in Delaware and that marketing was “suit related.” The Federal Circuit noted that Mylan frequently faced Delaware ANDA suits so it was not unfair to expect it to defend in Delaware on these two cases. Mylan had argued there was neither general nor specific jurisdiction in Delaware because of its incorporation and headquarters in West Virginia.

The Delaware courts both found there to be specific jurisdiction but they did not agree on whether there was general jurisdiction.

Based on this precedential opinion, ANDA filers will likely find themselves subject to suit in many more jurisdictions than under prior precedent.

For more information, see Acorda Therapeutics Inc. et al. v. Mylan Pharmaceuticals Inc. et al., CV 15-1456, and AstraZeneca AB v. Mylan Pharmaceuticals Inc., CV 15-1460, in the U.S. Court of Appeals for the Federal Circuit.

– by Robert S. Silver