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Alcon Research, Ltd. v. Watson Laboratories, Inc.

United States District Court, D. Delaware

February 15, 2017

ALCON RESEARCH, LTD., Plaintiff,
v.
WATSON LABORATORIES, INC., Defendant.

          REPORT AND RECOMMENDATION

          SHERRY R. FALLON UNITED STATES MAGISTRATE JUDGE.

         I. INTRODUCTION

         In this Hatch- Waxman action filed by plaintiff Alcon Research, Ltd. ("Alcon") against defendant Watson Laboratories, Inc. ("Watson"), Alcon alleges infringement of United States Patent Nos. 7, 947, 295 ("the '295 patent") and 8, 921, 337 ("the '337 patent") (the "asserted patents" or the "patents-in-suit"). Presently before the court is the matter of claim construction. This order sets forth the court's recommendations of constructions for the disputed claim terms discussed in the briefing and at the Markman hearing held on January 13, 2017.

         II. BACKGROUND

         A. The Parties

         Alcon is a Delaware corporation with its headquarters in Fort Worth, Texas. (D.I. 1 at ¶ 3) Alcon manufactures and sells the drug product known as Ilevro®, an FDA-approved ophthalmic suspension for topical administration to the eye. (Id. at ¶¶ 24, 27) Alcon is also the owner by assignment of the patents-in-suit. (Id. at ¶¶ 25-26)

         Watson is a Nevada corporation having a place of business in Corona, California, and a place of business in Parsippany, New Jersey. (Id. at ¶ 4) Watson is in the business of manufacturing and selling generic versions of branded pharmaceutical products for the United States market. (Id.)

         B. The Asserted Patents

         1. The '295 Patent

         The '295 patent is entitled "Ophthalmic compositions containing a synergistic combination of two polymers, " and was issued on May 24, 2011. ('295 patent) The '295 patent claims pharmaceutical compositions that are commercialized by Alcon under the trade name Ilevro® for the treatment of pain and inflammation associated with cataract surgery. (D.I. 1 at ¶ 24)

         The '295 patent claims compositions that combine two polymers to produce a synergistic increase in viscosity. ('295 patent, abstract) The patent's specification explains that the claimed compositions are pharmacologically superior to the nepafenac compositions previously known because the polymeric ingredients enhance the viscosity of solution compositions, and keep the insoluble ingredients suspended or easily redispersible in suspension compositions. ('295 patent, col. 1:18-25) The compositions of the invention may be applied less frequently due to the enhanced viscosity resulting from the combination of two polymers. ('295 patent, col. 4:34-42)

         2. The '337 Patent

         The '337 patent is entitled "Carboxyvinyl polymer-containing nanoparticle suspensions, " and was issued December 30, 2014. ('337 patent) The '337 patent claims pharmaceutical compositions that are commercialized by Alcon under the trade name Ilevro® for the treatment of pain and inflammation associated with cataract surgery. (D.I. 1 at ¶ 24)

         The '337 patent claims ophthalmic compositions that are particularly suitable for delivering sparingly soluble pharmaceutical compounds, including nepafenac, into the eye. ('337 patent, abstract; col. 1:14-17; col. 2:29-33) The composition of nanoparticles are suspended in a vehicle comprising a carboxyvinyl polymer, a galactomannan, and borate to stabilize the viscosity, thereby increasing the bioavailability of the drug. (Id. at col. 2:25-29; 2:47-51; abstract) The inventive compositions are pharmacologically superior to the compositions previously known in the art because they form a gel when applied to the eye due to chemical interactions between the galactomannan and the borate when they come into contact with the slightly higher pH of the eye. (Id. at col. 2:45-47; 3:35-42; 6:40-42) This allows the drug to penetrate the eye tissue without being diluted or flushed from the eye by the tear film. (Id. at col. 1:20-30) Moreover, the inventive composition claims a reduction in the particle size of nepafenac in certain compositions to enhance the bioavailability of nepafenac in the topical ophthalmic suspension. (Id. at col. 2:47-54; col. 4:47-49) The compositions of the invention need only be applied once or twice daily due to the increased viscosity and bioavailabilty of nepafenac. (Id. at col. 2:34-37)

         C. Procedural Posture

         This case arises out of Watson's submission of Abbreviated New Drug Application ("ANDA") No. 208816 to the United States Food and Drug Administration ("FDA"), which seeks approval to market a generic version of Alcon's Ilevro® nepafenac ophthalmic suspension. (D.I. 1 at ¶¶ 1-2) Alcon is the assignee of the patents-in-suit, which are listed in the Orange Book in connection with Ilevro®. (Id. at ¶¶ 25-27)

         Alcon filed suit against Watson on March 4, 2016, alleging that Watson's submission of ANDA No. 208816 infringes the '295 and '337 patents. (D.I. 1 at ¶ 8) Further, Alcon alleges that upon FDA approval of Watson's ANDA, Watson will infringe the patents-in-suit by making, using, offering to sell, and selling its generic nepafenac ophthalmic suspension. (Id. at ¶ 9)

         On June 30, 2016, this action was referred by Judge Robinson for discovery and all motions to dismiss, amend, transfer, and any discovery motions permitted. The case was reassigned to Chief Judge Stark on December 21, 2016. Chief Judge Stark referred the case to the undersigned magistrate judge for all purposes through case-dispositive motions, including claim construction. (D.I. 50) The parties completed briefing on claim construction on December 30, 2016. (D.I. 39; D.I. 44; D.I. 46; D.I. 49) A Markman hearing was held on January 13, 2017.

         III. LEGAL STANDARD

         "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWHCorp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). Construing the claims of a patent presents a question of law. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 388-90 (1996). However, subsidiary fact finding is sometimes necessary. TevaPharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015).

         In construing the claims, the court should look first and foremost to the words of the claims themselves, which "are generally given their ordinary and customary meaning, " which is "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3d at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted); see also Eon Corp. IP Holdings v. Silver Spring Networks, Inc.,815 F.3d 1314, 1320 (Fed. Cir. 2016). Claim terms are typically used consistently throughout the patent, and "usage of a term in one claim can often illuminate the meaning of the same term in other claims." Phillips, 415 F.3d at 1314 (observing that "[o]ther ...


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