Senju Pharmaceutical Co. v. Lupin Ltd.

162 F. Supp. 3d 405, 2015 WL 7302138
CourtDistrict Court, D. New Jersey
DecidedNovember 18, 2015
DocketCivil Action Nos. 14-667 (JBS/KMW), 14-4149 (JBS/KMW), 14-5144 (JBS/KMW), 15-335 (JBS/KMW), 14-6893 (JBS/KMW), 15-3240 (JBS/KMW)
StatusPublished
Cited by2 cases

This text of 162 F. Supp. 3d 405 (Senju Pharmaceutical Co. v. Lupin Ltd.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Senju Pharmaceutical Co. v. Lupin Ltd., 162 F. Supp. 3d 405, 2015 WL 7302138 (D.N.J. 2015).

Opinion

MARKMAN OPINION

SIMANDLE, Chief Judge:

I. INTRODUCTION

Plaintiffs Senju Pharmaceútical Co., Ltd., Bausch & Lomb Inc., and Bausch & Lomb Pharma Holdings Corp. (collectively, “Plaintiffs”) brought these various patent infringement actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 281, against Defendants Lupin, Ltd., Lupin Pharmaceuticals, Inc., Innopharma Licensing, Inc., Innopharma Licensing, LLC, In-nopharma, Inc., and Innopharma, LLC (collectively, “Defendants”) concerning Defendants’ submissions of abbreviated new drug applications (“ANDAs”) seeking FDA approval to market a generic version of Plaintiffs’ drug Prolensa®, which is used to treat patients who have undergone cataract surgery. Plaintiffs allege that Defendants’ ANDA submissions infringe the various patents covering Plaintiffs’ Prolensa® product: U.S. Patent Nos. 8,129,431 (“the ’431 patent”), 8,669,290 (“the ’290 patent”), 8,754,131 (“the ’131 patent”), 8,871,813 (“the ’813 patent”), and 8,927,606 (“the ’606 patent”) (collectively, the “patents-in-suit”).

Before the Court is the parties’ request for claim construction of three disputed terms in these patent infringement actions:1

1. “in an amount sufficient to stabilize said first component,” as it [410]*410appears in asserted claim 1 of the ’290 patent, claim 1 of the ’131 patent, claim 1 of the ’813 patent, and claim 1 of the 606 patent; and “stable,” as it appears in asserted claims 1, 7, 8, 10, 13, 14, 19, 20, 22, 25 of the ’290 patent, claims 1, 6, 7, 9,12,13,18-22, 24 of the ’131 patent, claims 1, 7, 9, 13, 19-21 of the ’813 patent, claims 1, 9, 11, 12, 18, 19, 25, 26 of the ’606 patent.
2. “consisting essentially of’ and “consists essentially of,”2 as they appear in asserted claims 1 and 18 of the ’431 patent, claims 1, 7, and 13 of the ’813 patent, claims 7, 13, 19, and 25 of the ’290 patent, claims 6, 12, 18, and 24 of the ’131 patent, and claims 9, 18, and 25 of the ’606 patent;
3. “satisfies the preservative efficacy standard of US Pharmacopoeia as follows: viable cell counts of bacteria (S. aureus, P. aeruginosa) 24 hours and 7 days after inoculation decrease to not more than 1/10 and not more than 1/1000, respectively, and thereafter, the cell count levels off or decreases; and viable cell count of fungi (C. albicans, A. ni-ger) 14 days after inoculation decreases to not more than 1/10, and thereafter, the cell count keeps the same level as that of 14 days after inoculation,” as it appears in asserted claims 25-29 of the ’131 patent.

For the reasons that follow, the Court construes the disputed phrases as follows: 3

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II. BACKGROUND

A. Factual and Procedural Background 4

Plaintiff holds the patents for novel formulations of bromfenac, an active ingredient in Plaintiffs drug Prolensa®, which has been approved by the Food and Drug Administration (hereinafter, the “FDA”) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. The patents at issue in this case, namely, the ’431 patent, the ’290 patent, the ’131 patent, the ’813 patent, and the ’606 patent, together disclose and claim an ophthalmic bromfenac formulation which contains (1) bromfenac and (2) tylox-apol, a non-ionic surfactant, and methods [412]*412of using these formulations to treat ocular pain and inflammation.

The ’431, ’290, ’131, ’813, and ’606 patents all share essentially the same specification, and all claim an “Aqueous Liquid Preparation Containing 2-Amino-3-(4-Bro-mobenzoyl)Phenylacetic Acid.” (See, e.g., ’431 patent, PI. Opening Claim Constr. Br. Ex. 1.)5 2-Amino-3-(4-bromo-benzoyl)phenylacetic acid is the chemical name of bromfenac, which is a non-steroidal anti-inflammatory drug (“NSAID”) that is used to treat inflammatory diseases of the anterior or posterior segment of the eye. (See, e.g., ’431 patent at 1:24-45.) The patents-in-suit claim the addition of tyloxa-pol to an aqueous liquid preparation of bromfenac. The addition of tyloxapol stabilizes the solution within a pH range that is non-irritating to the eyes, and inhibits the deterioration of the preservative effect of a widely-used preservative, benzalkonium choride, allowing for a longer shelf life.6 (Id. at 2:35-47.)

The claims in the ’431, ’290, ’131, and ’813 patents are directed to the new formulation of bromfenac. Independent claim 1 of the ’431 patent, for example, states:

1. An aqueous liquid preparation consisting essentially of the following two components, wherein the first component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt thereof or a hydrate thereof, wherein the hydrate is at least one selected from a hydrate, 1 hydrate, and % hydrate and the second component is tyloxapol, wherein said liquid preparation is formulated for ophthalmic administration, and wherein when a quaternary ammonium compound is included in said liquid preparation, the quaternary ammonium compound is benzalkonium chloride.

(’431 patent at 11:66-12:9.) The independent claims of the ’290, 131, and ’813 patents contain similar language. Claim 1 of the ’290 patent, for example, replaces the phrase “consisting essentially of’ with “comprising,” specifies that the first component is the “sole pharmaceutical active ingredient contained in the preparation,” and adds limitations that tyloxapol be present “in an amount sufficient to stabilize said first component,” and that the aqueous liquid preparation be “stable.” (’290 patent, PI. Opening Claim Constr. Br. Ex. 2, at 12:2-12.) The 131 patent is a division of the ’290 patent, and claim 1 adds the additional limitation that the first component, the “sole pharmaceutical active ingredient contained in the preparation,” “is present in the preparation at a concentration from about 0.05 w/v % to about 0.2 w/v (131 patent, PI. Opening Claim Constr. Br. Ex. 3.) The ’813 patent is a division of the ’290 patent and claim 1 specifies an aqueous liquid preparation that consists essentially of five components — the first two already specified, plus boric acid, sodium tetraborate, and water. (’813 patent, PL Opening Claim Constr. Br. Ex. 4.)

The ’606 patent is directed to a method for treating an inflammatory disease of the eye, by administering a composition comprising bromfenac and tyloxapol to the eye “at a dose and a frequency effective to treat said inflammatory disease.” (’606 pat[413]*413ent, PL Opening Claim Constr. Br. Ex. 5, at 11:30-31.)

Beginning in late 2013, Defendants began to send Notice Letters to Plaintiffs, pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), informing Plaintiffs that Defendants have submitted ANDAs with the FDA with Paragraph IV certifications on the patents-at-issue to seek approval to manufacture and sell generic bromfenac ophthalmic solution prior to the expiration of the ’431,-’290, ’131, ’813, and ’606 patents.

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162 F. Supp. 3d 405, 2015 WL 7302138, Counsel Stack Legal Research, https://law.counselstack.com/opinion/senju-pharmaceutical-co-v-lupin-ltd-njd-2015.