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ARTICLE · 06 MAY 2014

When Is A Claimed Drug Formulation Enabled And Adequately Described?

Addressing the requirements for enablement and written description, the U.S. Court of Appeals reversed a district court’s ruling of patent invalidity.

United StatesIntellectual Property

Alcon Research Ltd. v. Barr Labs., Inc.

Addressing the requirements for enablement and written description, the U.S. Court of Appeals for the Federal Circuit reversed a district court's ruling of patent invalidity, finding that the patent's discussion of exemplary compositions and procedures in the challenged written description could be used to achieve the claimed invention.  Alcon Research Ltd. v. Barr Labs., Inc., Case Nos. 12-1340, -1341 (Fed. Cir., Mar. 18, 2014) (Lourie, J.).

Alcon developed a glaucoma and hypertension drug, Travatan Z®.  Barr Laboratories submitted an Abbreviated New Drug Application (ANDA) to receive approval for an ophthalmic travoprost solution as a generic for Travatan Z®.  Thereafter, Alcon sued Barr, asserting that the ANDA constituted an act of infringement of its patents.  The district court found that Barr's ANDA product did not infringe Alcon's asserted claims and that the asserted claims were invalid for lack of enablement and

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