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Allergan Sales, LLC v. Sandoz, Inc.

United States Court of Appeals, Federal Circuit

August 29, 2019

ALLERGAN SALES, LLC, ALLERGAN, INC., Plaintiffs-Appellees
v.
SANDOZ, INC., ALCON LABORATORIES, INC., Defendants-Appellants

          Appeal from the United States District Court for the District of New Jersey in No. 2:17-cv-10129-WHW-CLW, Senior Judge William H. Walls.

          Jonathan Elliot Singer, Fish & Richardson, PC, San Diego, CA, argued for plaintiffs-appellees. Also represented by Deanna Jean Reichel, Minneapolis, MN; Susan E. Morrison, Wilmington, DE.

          John C. O'Quinn, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellants. Also represented by Sean M. McEldowney, Calvin Alexander Shank; Bryan Scott Hales, Chicago, IL; Benjamin A. Herbert, Los Angeles, CA.

          Before Prost, Chief Judge, Newman, and Wallach, Circuit Judges.

          OPINION

          Wallach Circuit Judge.

         Appellees Allergan Sales, LLC and Allergan, Inc. (together, "Allergan") sued Appellants Sandoz, Inc. and Alcon Laboratories, Inc. (together, "Sandoz") in the U.S. District Court for the District of New Jersey ("District Court"), asserting that Sandoz's Abbreviated New Drug Application ("ANDA") No. 91-087 for a generic version of Allergan's ophthalmic drug Combigan® infringes U.S. Patent Nos. 9, 770, 453 ("the '453 patent"), 9, 907, 801 ("the '801 patent"), and 9, 907, 802 ("the '802 patent") (collectively, "the Patents-in-Suit") owned by Allergan. The District Court found limiting a number of "wherein" clauses in the Pa-tents-in-Suit, Allergan Sales LLC v. Sandoz, Inc., No. 2:17-cv-10129, 2018 WL 3675235, at *7 (D.N.J. July 13, 2018) (Opinion) (J.A. 5-25), and granted Allergan's motion for a preliminary injunction, Allergan Sales, LLC v. Sandoz, Inc., No. 2:17-cv-10129 (D.N.J. July 13, 2018) (Order) (J.A. 1-4).[1]

         Sandoz appeals. We possess jurisdiction pursuant to 28 U.S.C. § 1292 (2012). We affirm.

         Background

         Entitled "Combination of Brimonidine and Timolol for Topical Ophthalmic Use," the Patents-in-Suit share a common specification that relates "to the topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension." '453 patent col. 1 ll. 33-35.[2] The specification explains that the combination is "preferably formulated as 0.01 to 0.5 percent by weight brimonidine and 0.1 to 1.0 percent by weight timolol solution in water at a pH of 4.5 to 8.0, e.g. about 6.9." Id. col. 2 ll. 40-43. The specification states, however, that "[o]ther ingredients . . . may be desirable," including "preservatives, co-solvents[, ] and viscosity building agents." Id. col. 2 ll. 46-49.

         "Example I" of the Patents-in-Suit is an exemplary "combination formulation" prepared to include 0.20% (w/v) brimonidine tartrate, 0.68% (w/v) timolol maleate, [3] 0.005% (w/v) benzalkonium chloride, an "isotonic phosphate buffer system at pH 6.9," and other ingredients. Id. col. 3 l. 59- col. 4 l. 6; see id. col. 4 ll. 7-24 (providing a Table of ingredients for the Example I formulation). The specification also describes a clinical study, referred to as "Example II," that "compare[d] the safety and efficacy of twice-daily dosed[4] brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution combination," i.e., the Example I formulation, "with that of twice-daily dosed timolol ophthalmic solution 0.5% . . . and three-times-daily dosed[5] ALPHAGAN® (brimonidine tartrate ophthalmic solution) 0.2% . . . in patients with glaucoma or ocular hypertension." Id. col. 4 ll. 29-37. The study concluded that the Example I formulation "administered BID . . . was superior to [t]imolol (timolol 0.5%) BID and [b]rimonidine (brimonidine tartrate 0.2%) TID in lowering the elevated [intraocular pressure ('IOP')] of patients with glaucoma or ocular hypertension." Id. col. 9 ll. 2-6. The study also concluded that the Example I formulation "administered BID demonstrated a favorable safety profile that was comparable to [t]imolol BID and better than [b]rimonidine TID with regard to the incidence of adverse events and discontinuations due to adverse events." Id. col. 9 ll. 6-10. The Example II results are reflected in the disputed "wherein" clauses, which may be divided into two types: efficacy and safety, i.e., adverse events.

         Independent claim 1 of the '453 patent is representative and recites:

A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate, wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day and wherein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.

Id. col. 9 l. 16-col. 10 l. 7 (emphases added).

         Discussion

         I. Claim Construction

         A. Standard of Review and Legal Standard

         "The proper construction of a patent's claims is an issue of Federal Circuit law[.]" Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1228 (Fed. Cir. 2011) (citation omitted). "[C]laim construction must begin with the words of the claims themselves." Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1301 (Fed. Cir. 2006) (citation omitted). "[W]ords of a claim are generally given their ordinary and customary meaning," i.e., "the meaning that the term would have to a person of ordinary skill in the art [('PHOSITA')] in question at the time of the invention[.]" Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc) (internal quotation marks and citation omitted). "The words used in the claims are interpreted in light of the intrinsic evidence of record, including the written description, the drawings, and the prosecution his-tory[.]" Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324 (Fed. Cir. 2002) (citation omitted). The PHOSITA "is deemed to read [a] claim term not only in the context of the particular claim in which [it] appears, but in the context of the entire patent, including the specification." Phillips, 415 F.3d at 1313.[6] Prosecution history may also be looked to in order to supply additional evidence of a claim term's intended meaning. See Home Diagnostics, Inc. v. Lifescan, Inc., 381 F.3d 1352, 1356 (Fed. Cir. 2004).[7] While courts may also consider extrinsic evidence in claim construction, "such evidence is generally of less significance than the intrinsic record." Wi-LAN, Inc. v. Apple Inc., 811 F.3d 455, 462 (Fed. Cir. 2016) (citation omitted).[8] Where, as here, the intrinsic evidence alone determines the proper claim construction, we review the district court's ultimate legal conclusion de novo. CardSoft, LLC v. VeriFone, Inc., 807 F.3d 1346, 1350 (Fed. Cir. 2015) (citing Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841-42 (2015)).

         B. The District Court Properly Construed the "Wherein" Clauses as Limiting

         The District Court found the disputed "wherein" clauses to constitute claim limitations. Allergan Sales, 2018 WL 3675235, at *7. Specifically, the District Court "f[ound] that the 'wherein' clauses are limiting because they are material to patentability and express the inventive aspect of the claimed invention," viz., "Combigan®'s ability to reduce daily administrations from TID to BID without a loss of efficacy, and with reduced adverse events." Id. at *5-6. On appeal, Sandoz disputes the District Court's construction, arguing, inter alia, that: (1) the "wherein" clauses "merely state the intended results of administering Combigan[®] twice daily," Appellant's Br. 36; see id. at 36-49; and (2) the recited results are not "material to patentability," id. at 50; see id. at 50-62. We disagree with Sandoz.

         Consistent with claim construction principles, we look first to the language of the claims, followed by the language of the specification and prosecution history. See Phillips, 415 F.3d at 1315. Independent claim 1 of the '453 patent recites both a representative efficacy "wherein" clause, '453 patent col. 9 l. 20-col. 10 l. 1 ("[W]herein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day."), [9] and a representative safety "wherein" clause, id. col. 10 ll. 1-7 ("[W]herein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.").[10] Sandoz contends that these clauses "merely state . . . intended results," Appellant's Br. 36, because they reflect the results of administering the Example I formulation, viz., Combigan®, as witnessed during the Example II clinical study, see, e.g., id. at 36 ("The asserted method claims have one and only one step: administration of the claimed composition. Everything else is literally the results observed during clinical trials of Combigan[®]."); see also Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby [or wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (explaining that claim language that "is only a statement of purpose and intended result" and that "does not result in a manipulative difference in the steps of [a] claim" is generally not limiting). We disagree. While we recognize some overlap between the language of the "wherein" clauses and those results, we must read the claims in view of the "entire specification." Sinorgchem Co., Shandong v. Int'l Trade Comm'n, 511 F.3d 1132, 1145 (Fed. Cir. 2007) (emphasis added); see Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016) ("[T]he specification is always highly relevant to the claim construction analysis and is, in fact, the single best guide to the meaning of a disputed term." (internal quotation marks and citation omitted)).

         The specification of the Patents-in-Suit demonstrates that the claimed invention is ultimately a formulation (and methods of using that formulation) that allows for increased efficacy and safety, i.e., a decreased risk of adverse events. See '453 patent col. 1 ll. 48-53 ("[T]here is a need to increase the efficacy of many topical ophthalmic agents, without increasing the systemic concentration of such topical agents, since it is well known that many of such topically-applied ophthalmic agents cause systemic side effects, e.g. drowsiness, heart effects, etc."), col. 4 ll. 29-37 (explaining that the Example II clinical study was a comparative study of the "safety and efficacy" of the Example I formulation), col. 6 l. 2-col. 8 l. 14 (detailing "Conclusions" with regard to the "Efficacy" and "Safety" of the Example I formulation), col. 9 ll. 2-10 (explaining that the Example I formulation was found to be "superior . . . in lowering the elevated IOP of patients with glaucoma or ocular hypertension" and "demonstrated a favorable safety profile . . . with regard to the incidence of adverse events and discontinuations due to adverse events"). These benefits are described throughout the specification with reference to prior art topical ophthalmic treatments, viz., Timolol BID and "0.2% w/v brimonidine tartrate" TID, as recited in the claims; indeed, the Example II clinical study directly compares use of the Example I formulation with those prior art treatments and concludes that the claimed method is "superior" in both efficacy and safety. Thus, the specification demonstrates that Allergan believed the increased efficacy and safety of the claimed methods to be material to patentability.

         Consistent with this understanding, Allergan relied on the efficacy and safety of the claimed methods during prosecution of the Patents-in-Suit in responding to the examiner's rejections. See Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1579 (Fed. Cir. 1995) ("[A]rguments made during prosecution regarding the meaning of a claim term are relevant to the interpretation of that term in every claim of the patent absent a clear indication to the contrary."). For example, in distinguishing the claimed methods over the prior art, Allergan explained that the prior art

does nothing to teach or suggest that the claimed fixed combination of brimonidine tartrate and timolol maleate administered twice daily would be as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day, nor that administration of the claimed ...

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