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

• Citation: 745 F.3d 1180
• Decision Date: 18 March 2014
• Docket Number: Nos. 2012–1340,2012–1341.,s. 2012–1340
• Parties: ALCON RESEARCH LTD., Plaintiff–Appellant, v. BARR LABORATORIES, INC., Defendant–Cross–Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

745 F.3d 1180

ALCON RESEARCH LTD., Plaintiff–Appellant,

v.BARR LABORATORIES, INC., Defendant–Cross–Appellant.

Nos. 2012–1340, 2012–1341.

United States Court of Appeals, Federal Circuit.

March 18, 2014.

Adam L. Perlman, Williams & Connolly LLP, of Washington, DC, argued for plaintiff-appellant. With him on the brief were Glenn J. Pfadenhauer, Kevin Hardy, and David M. Krinsky. Of counsel was Kannon K. Shanmugam.

William P. Ferranti, Winston & Strawn LLP, of Chicago, IL, argued for defendant-cross appellant. With him on the brief was George C. Lombardi. Of counsel on the brief was Bradley C. Graveline, Sheppard Mullin Richter & Hampton, LLP, of Chicago, IL.

Before NEWMAN, LOURIE, and BRYSON, Circuit Judges.

LOURIE, Circuit Judge.

Alcon Research Ltd. (“Alcon”) appeals from the final judgments of the United States District Court for the District of Delaware finding that Barr Laboratories, Inc. (“Barr”) does not infringe claim 12 of Alcon's U.S. Patent 5,631,287 (the “'287 patent”) and claim 19 of Alcon's U.S. Patent 6,011,062 (the “'062 patent”) and holding those claims invalid for lack of enablement and lack of an adequate written description under 35 U.S.C. § 112, ¶ 1.¹Alcon Research Ltd. v. Barr Labs. Inc., 837 F.Supp.2d 364 (D.Del.2011). Barr cross-appeals from the district court's denial of Barr's post-judgment motion pursuant to Federal Rule of Civil Procedure 59(e) to amend the district court's judgment and enter judgment as a matter of law (“JMOL”) of noninfringement as to Alcon's U.S. Patents 5,510,383 (the “' 383 patent”) and 5,889,052 (the “' 052 patent”). Alcon Research Ltd. v. Barr Labs. Inc., No. 09–0318, 2012 WL 928189 (D.Del. Mar. 16, 2012).

We conclude 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 noninfringement of the '383 and '052 patents. However, we conclude 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, we affirm in part and reverse in part.

Background

Alcon owns the '287 and '062 patents, which are directed to methods for enhancing the stability of prostaglandin compositions, including Alcon's glaucoma and ocular hypertension drug Travatan Z®, which contains travoprost, the synthetic prostaglandin fluprostenol isopropyl ester. Claim 12 of the '287 patent depends from claim 1 of that patent and reads as follows:

1. 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.

12. The method of claim 1 wherein the composition is a topically administrable ophthalmic composition.

'287 patent col. 8 ll. 57–61, col. 10 ll. 53–54. The '062 patent is a continuation in part of the '287 patent. '062 patent col. 1 ll. 1–10. Claim 19 of the '062 patent, which depends from claim 12 of that 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 PEG200 hydrogenated castor oils.” Id. col. 11 l. 65–col. 12 l. 3, col. 14 ll. 15–16.

Barr submitted Abbreviated New Drug Application (“ANDA”) 91–411 to the U.S. Food and Drug Administration (the “FDA”), 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. Alcon, 837 F.Supp.2d at 368. Although the '287 and '062 patents are not listed as referenced to Travatan Z® in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the “Orange Book”) maintained by the FDA, 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, viz., U.S. Patents 6,503,497 and 6,849,253, and that those patents were not invalid. Id.²

Following a Markman hearing, the district court construed the claimed phrase “enhancing the chemical stability” to mean “to increase or increasing the ability of the prostaglandin to resist chemical change (as distinguished from merely increasing the physical stability of the prostaglandin or composition),” i.e., “reducing or decreasing [travoprost] degradation.” Id. at 369;see also Alcon Research Ltd. v. Barr Labs. Inc., No. 09–0318, 2011 WL 3901878, at *15–16 (D.Del. Sept. 6, 2011). The court distinguished physical stability as referring to physical phenomena such as absorption, adsorption, and precipitation. Id.

The court also construed the claim term “prostaglandin” to correspond to the disclosure in the written description of the patents regarding the prostaglandins that may be used with the invention. Alcon, 2011 WL 3901878, at *13–14. The court thus determined the term “prostaglandin” to mean “the natural compounds PGE 1, PGE 2, PGE 3, PGF 1a, PGF 2a, PGF 3a, PGD 2, and PGI 2 (prostacyclin), as well as analogues and derivatives of such natural compounds (including the pharmaceutically acceptable esters and salts of such natural compounds and their analogues and derivatives), which have similar biological activities of either greater or lesser potencies.” Id. at *15.Travoprost is a type PGF 2a prostaglandin analog.

After a bench trial, the court found that Barr's ANDA product did not infringe either claim 12 of the '287 patent or claim 19 of the '062 patent because Alcon failed to prove by a preponderance of the evidence that Barr manufactured its generic Travatan Z® product by a method that comprised adding a chemically-stabilizing amount of PECO to its composition. Alcon, 837 F.Supp.2d at 369. The court noted that Alcon did not test Barr's product and determined that Alcon's only evidence was an accelerated stability study conducted by Alcon during its development work that compared several travoprost compositions with different amounts of PECO. Id. at 373–80.

The court found that Table 7 of Alcon's development study recorded data showing that some amount of travoprost was lost over an eight week test period, but the parties disputed the reason for that loss, viz., physical instability versus chemical instability. Id. at 374–80. The court nevertheless found that the results “could be attributed to a number of factors other than PECO enhancing the chemical stability of the Travoprost, e.g., experimental error or uncertainty, adsorption, precipitation, or other physical loss” and that, in any event, “the tested formulations differ[ed] significantly from Barr's ANDA product.” Id. at 376. Accordingly, in finding noninfringement, the court ultimately concluded that because “variables such as pH, buffer, buffer concentration, preservatives, chelating agents, and other excipients can affect the chemical stability of prostaglandins in opthalmic formulations,” as Alcon conceded, “the compositional differences between [Alcon's] Solubility Study formulations and Barr's ANDA product preclude[d] ... relying on the Solubility Study data to draw any reliable inferences with respect to the stability of Barr's ANDA product.” Id. at 376–77.

The court also held claim 12 of the '287 patent and claim 19 of the ' 062 patent invalid under 35 U.S.C. § 112, ¶ 1, for lack of enablement and lack of an adequate written description. Id. at 370, 380–84. The court concluded that Barr proved by clear and convincing evidence that one skilled in the art could neither carry out the full scope of the asserted claims without undue experimentation nor would have recognized that the inventors were in possession of the claimed invention at the time the patent applications were filed because: (i) the claims were too broad; (ii) the patent disclosure was too limited; and (iii) the art of chemically stabilizing prostaglandins was too unpredictable. Id. However, the court rejected Barr's asserted defenses that Alcon's claims were invalid for anticipation, obviousness, and indefiniteness. Id. at 370–71, 384–92.

Barr then moved for JMOL of noninfringement of Alcon's '383 and '052 patents, which the court denied, “declin[ing] to make any findings or draw any conclusions about the infringement or validity of [those] patents” because “neither party presented any evidence” on them and thus they “were not actually litigated and adjudicated” or fairly placed at issue during trial. Id. at 371, 392. Barr subsequently filed a post-judgment motion pursuant to Federal Rule of Civil Procedure 59(e) to amend the district court's judgment and to enter JMOL of noninfringement of those two patents on the ground that the court's resolution of the matter in the first instance constituted a clear error of law that required correction in order “to prevent manifest injustice.” Alcon, 2012 WL 928189, at *8.

The court again denied Barr's motion. Id. at *7–12. The court reasoned that, because Barr had never filed a counterclaim, Barr had no basis to assert that it was entitled to a declaratory judgment of noninfringement given that Alcon lacked fair notice of the risk of such an adverse determination. Id. at *7, *11. The court held that “the parties' joint pretrial submissions reflected the parties' understanding that the unasserted claims were no longer a part of the case.” Id. at *10. Accordingly, the court concluded that the pleadings should “be conformed to the judgment, not vice versa.” Id. at *9 (quoting ...