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

United States District Court, D. Delaware

November 30, 2017





         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"), 8, 921, 337 ("the '337 patent"), and 9, 662, 398 ("the '398 patent") (collectively, the "asserted patents" or the "patents-in-suit"). Presently before the court is the matter of claim construction regarding the '398 patent.[1] This sets forth the court's recommendations of constructions for the disputed claim terms discussed in the briefing and at the Markman hearing held on November 1, 2017.


         A. The Parties

         Alcon is a Delaware corporation with its headquarters in Fort Worth, Texas. (D.I. 107 at ¶ 4) Alcon manufactures and sells the drug product known as Ilevro®, an FDA-approved ophthalmic suspension for topical administration to the eye containing the active pharmaceutical ingredient ("API") nepafenac. (Id. at ¶ 18) Alcon is also the owner by assignment of the patents-in-suit. (Id. at ¶¶ 19-21)

         Watson is a Nevada corporation having a place of business in Corona, California, and a place of business in Parsippany, New Jersey. (Id. at ¶ 5) Watson is in the business of manufacturing and selling generic versions of branded pharmaceutical products for the United States market. (Id.)

         B. 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. 107 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 ¶¶ 19-21)

         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) 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 of the '295 and '337 patents 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. (D.I. 55) On February 15, 2017, the court issued a Report and Recommendation on the construction of the disputed terms in the '295 and '337 patents, which was adopted on November 9, 2017. (D.I. 58; D.I. 147)

         On May 30, 2017, the '398 patent issued to Alcon. (D.I. 106) On June 14, 2017, the parties filed a stipulation and proposed order to amend the case schedule and to file an amended complaint. (D.I. 106) On June 26, 2017, Alcon filed its amended complaint, adding the '398 patent to the present action. (D.I. 107) 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)

         C. The'398 Patent

         The '398 patent, entitled "Carboxylvinyl Polymer-Containing Nanoparticle Suspensions, " is listed in connection with Ilevro® in the Orange Book. (D.I. 106) The '398 patent is a continuation of the '337 patent. (Id.) Watson submitted an amendment to AND A No. 208816 to the FDA, seeking approval to engage in the commercial manufacture, use, and/or sale of Watson's AND A product in the United States before the expiration of the '398 patent. (Id.)

         The '398 patent claims ophthalmic compositions that are particularly suitable for delivering sparingly soluble pharmaceutical compounds, including nepafenac, into the eye. ('398 patent, col. 1:29-34) 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. (Mat col. 1:18-21) 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. 2:54-61) This allows the drug to penetrate the eye tissue without being diluted or flushed from the eye by the tear film. (Id. at col. 1:32-34)


         "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. AWH Corp., 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. Teva Pharms. 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 claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment. . . [b]ecause claim terms are normally used consistently throughout the patent. . . .").

         It is likewise true that "[differences among claims can also be a useful guide .... For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003) (citing Ecolab Inc. v. Paraclipse, Inc., 285 F.3d 1362, 1375 (Fed. Cir. 2002).

         Other intrinsic evidence, including the patent specification, "is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). "[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481 F.3d 1371 (Fed. Cir. 2007). The specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004).

         In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. The prosecution history, which is also "intrinsic evidence, " "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

         A court also may rely on "extrinsic evidence, " which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. ("[C]onclusory, unsupported assertions by experts as to the definition of a claim term are not useful to a court."). Overall, while extrinsic ...

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