United States: Enablement Analysis Requires Showing That Undue Experimentation Would Be Necessary In Order To Practice The Claimed Invention

In Alcon Research Ltd. v. Barr Laboratories, Inc., Nos. 12-1340, -1341 (Fed. Cir. Mar. 18, 2014), the Federal Circuit affirmed the district court's finding of noninfringement by the defendant, Barr Laboratories, Inc. ("Barr"), affirmed the district court's denial of Barr's postjudgment motion to amend for JMOL of noninfringement, and reversed the district court's finding of invalidity for lack of enablement and lack of an adequate written description.   

Alcon Research Ltd. ("Alcon") owns U.S. Patent Nos. 5,631,287 ("the '287 patent") and 6,011,062 ("the '062 patent"), which are directed to methods for enhancing the stability of prostaglandin compositions, including its glaucoma and ocular hypertension drug Travatan Z®, which contains travoprost, the synthetic prostaglandin fluprostenol isopropyl ester.  Claim 1 of the '287 patent reads:  "A method of enhancing the chemical stability of an aqueous composition comprising a therapeutically-effective amount of a prostaglandin, wherein the method comprises adding a chemically-stabilizing amount of a polyethoxylated castor oil [("PECO")] to the composition."  Slip op. at 3 (alteration in original) (citation omitted).  Claim 12, which depends from claim 1, requires that the composition be "a topically administrable ophthalmic composition."  Id. (citation omitted).  Claim 19 of the '062 patent (CIP of the '287 patent) is identical to claim 12 of the '287 patent except that it limits the requisite PECO to one "selected from the group of PEG-5 to PEG-200 hydrogenated castor oils."   Id. (citation omitted).

Barr submitted an ANDA to the FDA, seeking approval of a generic version of Travatan Z®.  Alcon initiated suit, asserting that Barr's ANDA submission infringed claim 12 of the '287 patent and claim 19 of the '062 patent, as well as claims from four other patents, including U.S. Patent Nos. 5,510,383 ("the '383 patent") and 5,889,052 ("the '052 patent").  However, Alcon did not assert the '383 and '052 patents at trial, and neither party adduced any evidence that specifically related to these two patents.  The district court determined that Barr did not infringe the asserted claims, and that the asserted claims were invalid for lack of enablement and written description.  Barr then filed a postjudgment motion pursuant to Fed. R. Civ. P. 59(e) to amend the district court's judgment and to enter JMOL of noninfringement of the '383 and '052 patents.  The motion was denied.  Both parties appealed.   

On appeal, the Federal Circuit first addressed the question of infringement and held that Alcon failed to present evidence of infringement.  Alcon sought to prove that the addition of PECO in Barr's ANDA product would chemically stabilize the prostaglandin travoprost and thus infringe the two asserted claims, and relied on data of a stability study that it conducted during its development work to infer that the addition of PECO would chemically stabilize travoprost in Barr's ANDA composition.  The district court concluded that Barr's ANDA composition was very different from the compositions used in Alcon's study in respect to, e.g., the pH value, concentration of travoprost, concentration of PECO, the presence of antimicrobial preservative, and the buffer solution.  The Federal Circuit affirmed the district court's determination that the Alcon data "had no bearing on whether Barr's proposed generic product infringed Alcon's patents," stating that "[t]he formulations tested in Alcon's stability study were meaningfully different from the product described in Barr's ANDA and thus provided no basis from which to draw any reliable inferences regarding whether the PECO in Barr's composition would chemically stabilize the prostaglandin."  Slip op. at 10.  The Federal Circuit therefore affirmed the district court's holding of noninfringement.

"After the challenger has put forward evidence that some experimentation is needed to practice the patented claim, the factors set forth in Wands then provide the factual considerations that a court may consider when determining whether the amount of that experimentation is either 'undue' or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out."  Slip op. at 12 (citing In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)).

The Federal Circuit next addressed the question of enablement, agreeing with Alcon that the district court erred in its enablement analysis.  The Court held that Barr had the burden of proof to show that Alcon's patents lacked enabling disclosures, but failed to carry that burden.  Noting that the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), require a challenger to show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without undue experimentation, the Court found that Barr "proffered no evidence that any experimentation, let alone undue experimentation, . . . would be necessary in order to practice the claimed invention.  Without that evidence, there is no foundation for the district court's nonenablement ruling."  Slip op. at 13. 

Turning to the written description requirement, the Federal Circuit explained that there is no requirement that the disclosure contain either examples or an actual reduction to practice; rather, the critical inquiry is whether the patentee has provided a description that in a definite way identifies the claimed invention in sufficient detail that a person of ordinary skill would understand that the inventor was in possession of it at the time of filing.  The Court noted that the '287 patent details the claimed invention and discloses a step-by-step description of how a person of ordinary skill in the art may use the invention, provides exemplary formulations and discloses data from accelerated stability testing showing the effect of PECO and prostaglandin concentration on stability, and describes various classes of prostaglandins and various types of PECOs and other formulation parameters.  The '062 patent, a CIP of the '287 patent, includes additional disclosures regarding preferred PECOs and prostaglandins, and three additional examples. The Court noted that Barr adduced no evidence, let alone clear and convincing evidence, of a lack of written description to an ordinarily skilled artisan.  Thus, the Court held that the disclosures of the '287 and '062 patents demonstrated that the inventors conceived of and described their invention at the time the applications were filed, and "[t]hat is all that the written description requirement demands."  Id. at 17. 

Finally, the Court addressed Barr's Rule 59(e) postjudgment motion to amend judgment and to enter JMOL of noninfringement of the '383 and '052 patents.  The Court adopted the law of the Third Circuit because the issues were of a procedural nature.  Alcon informed Barr of its decision to drop the '383 and '052 patents, and Barr subsequently omitted them from the pretrial order.  Thus, the Court noted that the '383 and '052 patents were not litigated, or fairly placed in issue, during the trial.  The Court found that "a patentee's announcement that it was no longer pursuing particular claims, coupled with its ceasing to litigate them, was sufficient to remove those claims from the case even without such formalities."  Id. at 20.  In addition, the Court noted that Barr did not file a counterclaim for DJ of noninfringement of the patents, and as a result, "it is up to the patentee to decide what claims are to be litigated and decided at trial."  Id. at 21.  Accordingly, the Court affirmed the district court's decision to deny Barr's Rule 59(e) motion.

Judges: Newman, Lourie (author), Bryson

[Appealed from D. Del., Judge Davis]

This article previously appeared in Last Month at the Federal Circuit, April 2014.

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