Alcon Research Ltd. v. Barr Labs. Inc., CIVIL ACTION NO. 09-CV-0318-LDD

Decision Date13 December 2011
Docket NumberCIVIL ACTION NO. 09-CV-0318-LDD
PartiesALCON RESEARCH LTD., Plaintiff, v. BARR LABORATORIES INC. et al., Defendants.
CourtUnited States District Courts. 3th Circuit. United States District Court (Delaware)
OPINION

Legrome D. Davis, J.

I. Introduction

Plaintiff Alcon Research, Ltd. ("Alcon") brought this patent infringement action in response to Defendants' Par Pharmaceutical, Inc. ("Par") and Barr Laboratories Inc. ("Barr") filing of Abbreviated New Drug Applications (ANDAs)1 for FDA approval to market generic versions of Alcon's Travatan® and Travatan Z® products. Travatan® and Travatan Z® are topical prescription eye drops used to treat glaucoma and ocular hypertension, a condition associated with glaucoma. Although both Travatan® and Travatan Z® contain the same active ingredient, i.e., the prostaglandin Travoprost in a concentration of 0.004% w/v, Travatan® contains benzalkonium chloride ("BAC" or "BAK"), a conventional antimicrobial agent, while Travatan Z® does not.

Leading up to trial, Alcon asserted four (4) patents against the Defendants. Two (2) of the patents-in-suit - U.S. Patent Nos. 5,631,287 ("the '287 patent") and 6,011,062 ("the '062 patent"), collectively the "Schneider patents" or the "castor oil patents" - relate to methods of enhancing the chemical stability of prostaglandin-containing compositions by adding polyethoxylated castor oil ("PECO") to the compositions. The other two (2) patents - U.S. Patent Nos. 6,503,497 ("the '497 patent") and 6,849,253 ("the '253 patent"), collectively the "Chowhan patents" or the "borate-polyol patents" - describe aqueous ophthalmic compositions containing a water soluble borate-polyol complex to enhance the antimicrobial activity of the compositions. Following a Markman hearing, we issued an Order on September 6, 2011, construing several disputed claim terms of the four (4) aforementioned patents-in-suit. (Doc. Nos. 213, 214).

We conducted a bench trial on the issues of infringement and validity from November 2, 2011, through November 8, 2011. As indicated above, trial began with four (4) patents and two (2) Defendants. However, following the first day of testimony, which focused on the Chowhan patents, Alcon and Par, the first ANDA filer, agreed to settle their dispute, leaving Barr as the only remaining Defendant. (Doc. No. 242). Barr then stipulated that it infringed the two (2) Chowhan patents and that those patents are not invalid (Doc. No. 243), leaving only the two (2) castor oil patents in contention. We then heard testimony from Alcon and Barr on the castor oil patents, and both Alcon and Barr fully briefed the salient issues post-trial. Having considered the documentary evidence and testimony, we make the following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).

II. Findings of Fact
A. The Castor Oil Patents (U.S. Patent Nos. 5,631,287 and 6,011,062)

1. Alcon contends that the manufacture of Barr's ANDA product, i.e., Barr's generic version of Travatan Z®, infringes Claim 12 of the '287 patent and Claim 19 of the '062 patent. (Tr. 471:3-21).

2. Claim 12 of the '287 patent depends from Claim 1 of the '287 patent ('287 patent, 10:53-54).

3. As such, Claim 12 of the '287 patent covers 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 to the composition, and wherein the composition is a topically administrable ophthalmic composition. ('287 patent, 8:57-61; 10:53-54).

4. Claim 19 of the '062 patent depends from Claim 12 of the '062 patent ('062 patent, 14:15-16).

5. As such, Claim 19 of the '062 patent covers 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 selected from the group of PEG-5 to PEG-200 hydrogenated castor oils to the composition, and wherein the composition is a topically administrable ophthalmic composition. ('062 patent, 11:65-12:3; 14:15-

16).
6. As should be readily apparent, the two (2) claims-in-suit are identical except that Claim 12 of the '287 patent is open to any PECO, while Claim 19 of the '062 patent limits the PECO to one selected from the group of PEG-5 to PEG-200 hydrogenated castor oils.
B. A Person of Ordinary Skill in the Art ("PHOSITA")
1. We agree with Dr. Kent, Barr's expert, that the hypothetical PHOSITA with respect to the technical field of the castor oil patents would have a Ph.D. in chemistry or a related field with limited experience (0 to 3 years), or a B.S. or M.S. with more practical experience (5 or more years) in the fields of pharmacy, analytical chemistry, organic chemistry, or chemical engineering. (Tr. 684:8-21).
2. Specifically, we believe that a PHOSITA would have a background in chemistry because the claimed invention is drawn to chemically-stabilizing a prostaglandin-containing composition using PECO. Therefore, the PHOSITA here should have significant chemistry-related knowledge and/or experience to understand and practice the claimed methods. (Tr. 685:3-20).
3. However, all of our factual findings and legal conclusions would remain the same if we were to adopt the PHOSITA definition espoused by Alcon in its pretrial proposed findings of fact and conclusions of law, i.e., that a PHOSITA in the art of pharmaceutical formulations and compositionswould have at least a master's degree in pharmacy, pharmaceutics, or a related field, and have at least two (2) years experience working on the development of pharmaceutical formulations and/or compositions involving varying dosage forms. (Doc. No. 220, at 14). In other words, the relatively minor differences in the PHOSITA definitions propounded by Plaintiff Alcon and Defendant Barr have no material effect on our analysis and ultimate conclusions in this matter.
C. Infringement
1. The only disputed issue regarding infringement of Claim 12 of the '287 patent and Claim 19 of the '062 patent, i.e., the asserted castor oil patent claims, is whether or not the amount of PECO in the composition of Barr's ANDA product is a "chemically-stabilizing amount" such that Barr's method of manufacturing its ANDA product enhances the chemical stability of the composition. (Tr. 843:8-12).
2. As set forth in our claim construction Order, the phrase "enhance / enhancing the chemical stability" in the castor oil patent claims means "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.)" (Doc. No. 214). Travoprost is the prostaglandin in Barr's ANDA product. (Tr. 412:21-25).
3. One enhances the chemical stability of an ophthalmic composition such as Barr's ANDA product by reducing or decreasing the degradation of the

active ingredient, here, the prostaglandin Travoprost. (Tr. 412:1-25). As distinguished from chemical stability, physical stability refers to physical phenomena such as absorption, adsorption, and precipitation. (Tr. 320:20-322:23). If the PECO in Barr's ANDA product merely enhances the physical stability of Travoprost, as opposed to enhancing its chemical stability, at least in part, then Barr does not infringe Claim 12 of the '287 patent and Claim 19 of the '062 patent, i.e., the asserted castor oil patent claims.

4. Alcon failed to prove by a preponderance of the evidence that Barr manufactures its ANDA product, i.e., its generic version of Travatan Z®, by a method that comprises adding a chemically-stabilizing amount of PECO to its composition to enhance the chemical stability of the composition.

5. Given Barr's stipulation of infringement, Alcon proved by a preponderance of the evidence that Barr's ANDA product falls within the scope of Claims 7, 21, 41, and 43 of the '497 patent and Claim 18 of the '253 patent, i.e., the borate-polyol patents. (Doc. No. 243).

D. Enablement and Written Description Under 35 U.S.C. § 112, First Paragraph
1. The asserted castor oil patent claims are extremely broad. (Tr. 800-11).
2. The castor oil patent disclosures provide relatively limited information and guidance to a person skilled in the art regarding how to practice the claimed invention (Tr. 795-800).
3. The art of chemically stabilizing prostaglandins is quite unpredictable. (Tr. 417:3-20; 420:13-25; 417:21-23; 418:22-419:4; 419:13-25; 692:11-693:9; 698-704; 708; 809-11; '287 patent, 6:23-26).
4. Given the breadth of the asserted claims, the relatively limited disclosure, and the unpredictability of the art, Barr proved by clear and convincing evidence that one skilled in the art could not carry out the full scope of the asserted castor oil patent claims without undue experimentation, and a person skilled in the art would not recognize that the inventors of the castor oil patents were in possession of the claimed invention at the time the castor oil patent applications were filed.
E. Indefiniteness Under 35 U.S.C. § 112, Second Paragraph
1. Barr failed to prove by clear and convincing evidence that the claim term "enhancing the chemical stability" is insolubly ambiguous, despite the lack of an explicit comparator in the patent disclosure or claims ("enhanced with respect to what?"). Specifically, one skilled in the art would understand the "enhancing the chemical stability" limitation in the asserted castor oil patent claims to mean that using PECO in the formulation must provide increased chemical stability as compared to not using PECO. Stated differently, using the claimed invention (adding a chemically stabilizing amount of PECO) must increase the chemical stability of the prostaglandin as compared to not using the invention.
2. The claim term "therapeutically effective amount" is not insolublyambiguous. As we suggested in our claim construction
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