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

Case Name: Alcon Research Ltd. v. Barr Labs., Inc., Nos. 2012-1340, 2012-1341, 2014 U.S. App. LEXIS 5023 (Fed. Cir. Mar. 18, 2014) (Circuit Judges Newman, Lourie, and Bryson presiding; Opinion by Lourie, J.) (appeal from D. Del., Davis, J.)

Drug Product and Patent(s)-in-Suit:  Travatan Z® (travaprost); U.S. Patents Nos. 5,631,287 (“the ’287 patent”), 6,011,062 (“the ’062 patent”), 5,510,383 (“the ’383 patent”), and 5,889,052 (“the ’052 patent”)

Nature of the Case and Issue(s) Presented: Barr submitted its ANDA seeking approval to manufacture, use, and sell an ophthalmic travoprost solution as a generic version of Travatan Z. Barr’s ANDA filing was second to that of Par Pharmaceuticals, Inc. Although the ’287 and ’062 patents were not listed in the Orange Book, Alcon initiated suit asserting that Barr’s ANDA submission constituted an act of infringement of claim 12 of the ’287 patent, claim 19 of the ’062 patent, and claims from four other patents, including its Orange Book-listed ’383 and ’052 patents. However, Alcon did not assert its ’383 and ’052 patents at trial and neither party adduced any evidence that specifically related to those patents. Barr stipulated that its generic product infringed the remaining two patents that Alcon had asserted and that those patents were not invalid

Alcon appeals from the final judgments of the district court finding that Barr did not infringe claim 12 of Alcon’s ’287 patent and claim 19 of Alcon’s ’062 patent, and holding those claims invalid for lack of  enablement and lack of an adequate written description under 35 U.S.C. § 112 ¶ 1. Barr cross-appeals from the district court’s denial of Barr’s post-judgment motion pursuant to Fed. R. Civ. P. 59(e) to amend the district court’s judgment and enter judgment as a matter of law (“JMOL”) of non-infringement as to Alcon’s ’383 and ’052 patents. The Federal Circuit held that the district court was not clearly erroneous in finding that Barr’s product would not infringe the asserted claims of the ’287 and ’062 patents, and that the court did not abuse its discretion in denying Barr’s motion to amend for JMOL of non-infringement of the ’383 and ’052 patents. The Federal Circuit further held that the district court’s invalidity determinations as to the asserted claims of the ’287 and ’062 patents were not in accordance with law. Accordingly, the Federal Circuit affirmed in part and reversed in part.

Why Barr Prevailed:  Alcon attempted to prove that the addition of PECO in Barr’s proposed generic product would chemically stabilize the prostaglandin travoprost and thus infringe the asserted claims of the ’287 and ’062 patents.  Alcon relied solely on a theory that the data reported in Table 7 of a stability study that Alcon conducted during its development work could be extrapolated to infer that the addition of PECO would chemically stabilize travoprost in Barr’s ANDA composition. Critically, however, the district court found, and the parties did not dispute on appeal, that the composition of the generic product proposed in Barr’s ANDA is significantly different from the compositions tested in Alcon’s study. The test formulations used by Alcon were maintained at pH 6.0-6.1 and contained 0.005% weight by volume of travoprost, varying concentrations of PECO, the antimicrobial preservative benzalkonium chloride, and a buffer solution comprising tromethamine, boric acid, and mannitol. In contrast, Barr’s ANDA product is maintained at a different pH, is composed of 0.004% weight by volume of travoprost and a buffered preservative system comprising propylene glycol, sorbitol, and zinc chloride, but does not contain benzalkonium chloride or a tromethamine/ boric acid/mannitol buffer solution. The Federal Circuit found that the 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, which was the claimed invention.

Next, the Federal Circuit analyzed Barr’s Section 112 arguments. With regard to the district court’s non-enablement holding, the Federal Circuit found that the claims as a whole merely required that the addition of PECO to the composition provide some increase in chemical stability; the claims did not require a particular level of stability or a particular magnitude of increase. Moreover, the patents disclose exemplary compositions within the scope of the claims, detail how those example compositions are prepared from commercially-available ingredients, and provide step-by-step procedures for adding PECO to a prostaglandin composition in a way that embodies the claimed invention. The district court’s non-enablement ruling was premised on testimony that many “variables” may affect the chemical stability of prostaglandins in ophthalmic formulations. “Adjusting variables may be relevant to optimizing the stability of a given prostaglandin composition, but Barr proffered no evidence that any experimentation, let alone undue experimentation, with those variables would be necessary in order to practice the claimed invention.” Without that evidence, the Federal Circuit held that there was no foundation for the district court’s non-enablement ruling. With regard to the court’s lack-of-written-description holding, the Federal Circuit found that the ’287 patent provided exemplary formulations that embody the claimed invention, reciting concentrations of every ingredient, disclosing data generated by the inventor from accelerated stability testing showing the effect of PECO and prostaglandin concentration on stability and comparing the effect of PECO to that of a more commonly used surfactant, polysorbate 80. Because the ’062 patent is a continuation-in-part of the ’287 patent, it contained largely the same written description, including additional disclosures regarding the preferred types of hydrogenated PECOs that may be used with the claimed invention, two additional specifically preferred prostaglandins, and three additional exemplary formulations. The Federal Circuit thus reversed the district court’s Section 112 rulings.

Lastly, the Federal Circuit addressed whether Alcon’s infringement claims regarding its ’383 and ’052 patents were actually at issue during the trial below and whether the district court erred in denying Barr’s Rule 59(e) post-judgment motion to amend. Because Alcon informed Barr of its decision to drop its claims based on those patents and Barr subsequently omitted them from the pretrial order, the district court was right to acknowledge that the claims regarding the ’383 and ’052 patents were no longer in the case as of the time of trial. As such, the district court did not abuse its discretion in denying Barr’s motion to amend for JMOL of infringement.

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