Endo Pharmaceuticals Inc., Mallinckrodt LLC, vs. Actavis LLC

Endo Pharmaceuticals Inc., Mallinckrodt LLC, vs. Actavis LLC, FKA Actavis Inc., Actavis South Atlantic LLC, Teva Pharmaceuticals USA, Inc., US Court of Appeals for the Federal Circuit.

Case Summary: Gaurav Mohindra

Appeal from the United States District Court for the District of Delaware

Plaintiff “Endo” sued defendants “Actavis” in district court alleging that two Abbreviated New Drug Applications filed by Actavis infringed claims from a patent licensed to Endo by Mallinckrodt.  The District Court held that Actavis failed to prove that any of the asserted claims were invalid as obvious or anticipated and entered judgement of infringement.  Actavis appealed the district court’s decision to the Federal Circuit Court of Appeals.

On appeal, Actavis puts forward that the District Court erred by misconstruing the claims, and in determining that the claims in questions were not obvious in light of prior art.  In rendering its analysis, the Federal Circuit provided the standard of review and legal standard for claim construction.  “Claim construction must begin with the words of the claims themselves…. Words of a claim are generally given their ordinary and customary meaning…that they would have to a person of ordinary skill in the art in question at the time of the invention.”  The Court continued by emphasizing the importance of the specification for claim construction, and prosecution history.  The Court further indicated that extrinsic evidence may also be applied, however such evidence generally holds less significance than the intrinsic record.

After laying out the framework, the Court found that the District Court properly construed the claims in question by properly relying on the intrinsic and extrinsic evidence.  In its analysis, the Federal Circuit reviewed the claims themselves, the specification, and extrinsic evidence (expert testimony) and found that the evidence supports the Districts Court’s construction of the clams.

The Federal Circuit further found that the District Court did not clearly err in finding that person having ordinary skill in the art at the time of the invention would not have a reasonable expectation of success in combining the prior art.  An interesting consideration of this case is that the District Court relied, in part, on confidential communications between the patentee and the FDA, says Gaurav Mohindra

The District Court found that those communications did not provide a reasonable expectation of success because they were not teachings and provided no substantive information about how the patentee were to produce the claimed compound.  The Federal Circuit found that the FDA communications recited a goal without teaching how the goal is attained.