District Court's Lack of Enablement and Written Description Rulings Contrary to Law: Federal Circuit | Practical Law

District Court's Lack of Enablement and Written Description Rulings Contrary to Law: Federal Circuit | Practical Law

In Alcon Research Ltd. v. Barr Laboratories, Inc., the US Court of Appeals for the Federal Circuit reversed the district court's holding that two patent claims asserted by Alcon against Barr as part of an ANDA litigation concerning Barr's generic version of Travatan Z were invalid for lack of enablement and inadequate written description.

District Court's Lack of Enablement and Written Description Rulings Contrary to Law: Federal Circuit

by Practical Law Intellectual Property & Technology
Law stated as of 18 Mar 2014 • USA (National/Federal)
In Alcon Research Ltd. v. Barr Laboratories, Inc., the US Court of Appeals for the Federal Circuit reversed the district court's holding that two patent claims asserted by Alcon against Barr as part of an ANDA litigation concerning Barr's generic version of Travatan Z were invalid for lack of enablement and inadequate written description.
In Alcon Research Ltd. v. Barr Laboratories, Inc, the US Court of Appeals for the Federal Circuit affirmed the district court's finding of non-infringement but reversed its finding of invalidity for lack of enablement and inadequate written description under the pre-America Invents Act (AIA) version of 35 U.S.C. § 112 (No. 2012-1340, -1341, (Fed. Cir. Mar. 18, 2014)).
This case arose when Barr Laboratories, Inc. (Barr) filed an Abbreviated New Drug Application (ANDA) seeking approval to manufacture and sell a generic version of Alcon Research Ltd.'s (Alcon) glaucoma drug, Travatan Z. In response, Alcon sued Barr in the US District Court for the District of Delaware for infringement of US Patent Nos. 5,631,287 ('287 patent) and 6,011,062 ('062 patent), among other patents. The '287 and '062 patents are directed to methods of enhancing the chemical stability of opthalmic compositions including a prostaglandin compound as an active ingredient by adding a stabilizing polyethoxylated castor oil (PECO) to the composition.
After a bench trial, the district court found in relevant part that:
  • Barr's ANDA product did not infringe the '287 or '062 patent.
  • Barr proved by clear and convincing evidence that the '287 and '062 patents were invalid under 35 U.S.C. § 112 because at the time of the invention a person of ordinary skill in the art (POSA):
    • could not carry out the full scope of the asserted claims without undue experimentation (lack of enablement); and
    • would not have recognized that the inventors were in possession of the claimed invention (inadequate written description).
On appeal, the Federal Circuit:
  • Affirmed the district court's non-infringement finding.
  • Reversed its lack of enablement and inadequate written description findings based on the district court's misinterpretation of controlling law.
Regarding enablement, the Federal Circuit first reiterated the standard it set out in In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988), that to prove lack of enablement a party must show by clear and convincing evidence that a POSA would not be able to practice the claimed invention without "undue experimentation." Under Wands, the patent challenger must first make a showing that a POSA would need some degree of experimentation to practice the invention. Once the challenger makes this showing, the court can then consider the Wands factors to determine whether the experimentation was "undue" instead of routine. The Federal Circuit then held that:
  • The district court erred by applying the Wands factors as a generalized enablement test without first requiring Barr to make a threshold showing that any experimentation is necessary to practice the claimed methods.
  • Barr failed to show that any claimed method was inoperable or that a POSA would not be able to practice it without undue experimentation, even if a POSA may need to consider many variables to optimize the method.
Regarding written description, the Federal Circuit held that the patents satisfy the written description requirement because they demonstrate that, when they filed the patent applications, the inventors possessed the idea that a PECO could enhance the chemical stability of a prostaglandin composition, even if the patents do not include data regarding every conceivable PECO and prostaglandin formulation. In reaching its holding, the Federal Circuit:
  • Rejected Barr's argument that the patents' disclosures do not support their broad claims because they only include data regarding the enhanced physical stability of a single prostaglandin compound.
  • Noted that the district court improperly confused the enablement and written description requirements.
While the Federal Circuit's decision does not change standards for establishing lack of enablement or inadequate written description, it does serve as a reminder of the distinct requirements of these two defenses and the high bar that challengers face in overcoming the presumption of patent validity to prove them.