When Is a Claimed Drug Formulation Enabled and Adequately Described?

by McDermott Will & Emery
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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 lack of an adequate written description.  Alcon appealed.

The Federal Circuit stated that the infringement inquiry provoked by an ANDA filing under the Hatch-Waxman system … is focused on a comparison of the asserted patents against the product that is likely to be sold following ANDA approval.  Under this approach, the Federal Circuit affirmed the district court’s ruling that Barr’s ANDA product did not infringe, noting that the generic product proposed in Barr’s ANDA is significantly different from the compositions tested in the study proffered by Alcon as evidence of infringement.

This case also occasioned a Federal Circuit analysis of the statutory obligations of enablement and written description.  The Court noted that, for enablement, the patentee must both describe the claimed invention adequately and enable its production and use.  To show that a patent claim is not enabled and therefore invalid, a challenger must provide evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without undue experimentation.  Distinct from enablement, the written description requirement relates to whether the disclosure allows one skilled in the art to visualize or recognize the identity of the subject matter purportedly described and understand that the inventor was in possession of it at the time of filing.  For a validity challenger to succeed in its challenge, enablement and lack of adequate written description must be established by clear and convincing evidence.

As for enablement, the Federal Circuit reversed the district court, finding that the patent’s discussion of exemplary compositions and procedures could be used by a person of skill in the art to achieve the claimed invention.  While some experimentation may have been required, the Federal Circuit found that changing parameters of the procedures would not render Alcon’s claimed invention inoperable nor would such experimentation be undue.

The Federal Circuit also reversed the district court regarding written description, explaining that the specification disclosed many formulations and processes.  Further, the Court noted that Barr failed to submit clear and convincing evidence that a person skilled in the art “would not have understood from the [patent disclosures] that the patentee’s invented, or possessed, the methods of the asserted claims,” without which there was no basis on which to find a lack of adequate written description.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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