Cumberland Pharms., Inc. v. Mylan Institutional LLC, No. 12 C 3846, Slip Op. (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.).

Judge Pallmeyer, after a bench trial, found that defendants (collectively “Mylan”) had not met their burden of proving plaintiff Cumberland’s ‘445 patent – to an intravenous treatment for suspected acetaminophen overdoses – was invalid by clear and convincing evidence. Because Mylan had admitted infringement, Mylan was, therefore, liable for infringement.

Of particular note, the Court found:

  • The FDA’s correspondence with Cumberland did disclose one element of the patented treatment.
  • Similarly, the FDA’s correspondence – even if multiple documents were combined as a single prior art reference – did not teach each element of the accused claims and, therefore, did not anticipate the ‘445 patent.
  • It would not have been obvious to one of ordinary skill in the art to remove the chelating agent as claimed by the ‘445 patent.