`
`
`APPENDICES
`APPENDICES
`
`
`
`1a
`
`APPENDIX A
`NOTE: This disposition is nonprecedential.
`
`UNITED STATES COURT
`OF APPEALS
`FOR THE FEDERAL CIRCUIT
`______________________
`
`ALLERGAN SALES, LLC,
`Plaintiff-Cross-Appellants
`
`v.
`
`SANDOZ, INC., ALCON LABORATORIES, INC.,
`ALCON RESEARCH, LTD.,
`Defendants-Appellants,
`
`____________________
`
`2017-1499, 2017-1500, 2017-1558,
` 2017-1559
`______________________
`Appeals from the United States District Court for the
`Eastern District of Texas in Nos. 2:12-cv-00207-JRG,
`2:15-cv-00347-JRG, Judge J. Rodney Gilstrap.
`______________________
`Decided: December 22, 2017
`______________________
`JONATHAN ELLIOT SINGER, Fish & Richard-
`son, PC, San Diego, CA, argued for plaintiff-cross-ap-
`pellant. Also represented by SUSAN E. MORRISON,
`ROBERT M. OAKES, Wilmington, DE; DEANNA
`JEAN REICHEL, Minneapolis,
`
`
`
`
`
`2a
`
`
`
` JOHN C. O’QUINN, Kirkland & Ellis LLP, Wash-
`ington, DC, argued for defendants-appellants. Also
`represented by SEAN M. MCELDOWNEY, CALVIN
`ALEXANDER SHANK; BRYAN SCOTT HALES, Chi-
`cago, IL.
`______________________
`
`Before MOORE, MAYER, and HUGHES, Circuit
`Judges.
`
`HUGHES, Circuit Judge.
`Allergan Sales, LLC sued generic drug manufac-
`turers under the Hatch-Waxman Act, alleging in-
`fringement of U.S. Patent Nos. 7,030,149, 7,320,976,
`and 8,748,425. The U.S. District Court for the Eastern
`District of Texas found the asserted claims not invalid
`but only claims of the ’425 patent infringed. We find
`no reversible error in the district court’s finding of no
`invalidity. Nevertheless, because we find that the ac-
`cused proposed generic drug contemplates adminis-
`tering dosages of a specific composition that is not
`claimed in any of the patents, we affirm in- part and
`reverse-in-part.
`I
`
`Allergan holds the approved new drug application
`for Combigan®, which is used to lower intraocular
`pressure in glaucoma and ocular hypertension pa-
`tients. Combigan® is a “fixed combination” ophthal-
`mic solution consisting of 0.2% brimonidine tartrate
`and 0.68% timolol maleate for twice-daily dosage.
`
`
`
`
`
`
`
`
`
`3a
`
`Allergan claims that the ’149, ’976, and ’425 pa-
`tents cover Combigan®. These patents share a com-
`mon specification, which describes: (1) a “Brimonidine
`Tartrate 0.20% (w/v)” and “Timolol Maleate 0.68%
`(w/v) (Equivalent to 0.50% (w/v) timolol)” pharmaceu-
`tical composition; and (2) a clinical study using that
`composition for twice daily administration. See, e.g.,
`J.A. 347–50. In particular, Allergan claims that claim
`4 of the ’149 patent, claim 1 of the ’976 patent, and
`claims 1–8 of the ’425 patent protect Combigan® and
`its administration.
`Claim 4 of the ’149 patent recites a method of re-
`ducing the number of daily administrations of 0.2%
`brimonidine and 0.5% timolol in a single composition
`from three times a day to two times a day “without
`loss of efficacy.” J.A. 350.
`Claim 1 of the ’976 patent recites a method of ad-
`ministering “a therapeutically effective amount” of
`composition comprising 0.2% brimonidine and 0.5%
`timolol twice daily. J.A. 356.
`Claim 1 of the ’425 patent recites administering
`twice daily a single combination comprising 0.2%
`brimonidine tartrate and 0.5% timolol free base to “re-
`duce[] the incidence of one or more adverse events”
`listed in the claim. J.A. 366. Claims 2–8 of the patent
`depend from claim 1, each specifically reciting only
`one of the adverse events enumerated in claim 1. Id.
`Sandoz, Inc., Alcon Laboratories, Inc., and Alcon
`Research, Ltd. (collectively, Sandoz) filed and main-
`tained an abbreviated new drug application (ANDA)
`with the U.S. Food and Drug Administration, seeking
`its approval to market generic versions of Combigan®.
`Allergan sued Sandoz for direct, induced, and contrib-
`utory infringement, asserting numerous patents in
`
`
`
`
`
`
`
`
`
`4a
`
`three different actions, only the last two of which pro-
`ceeded to a consolidated bench trial on the ’149, ’976,
`and ’425 patents.
`The district court found the asserted claims of the
`patents not invalid as obvious. The court also found
`that claim 4 of the ’149 patent satisfies the written de-
`scription requirement. The court finally determined
`that Sandoz’s ANDA does not infringe claim 4 of the
`’149 patent or claim 1 of the ’976 patent, but does in-
`fringe claims 1–8 of the ’425 patent.
`Sandoz appeals the district court’s no-invalidity
`and infringement determinations. Allergan cross-ap-
`peals the finding of non-infringement. We have juris-
`diction under 28 U.S.C. § 1295(a)(1).
`II
`
`We review the district court’s legal determinations
`de novo and factual findings for clear error. Braintree
`Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1358
`(Fed. Cir. 2014). Obviousness is a question of law that
`we review de novo, and we review any underlying fac-
`tual questions for clear error. Honeywell v. United
`States, 609 F.3d 1292, 1297 (Fed. Cir. 2010). “Whether
`a claim satisfies the written description requirement
`is a question of fact that, on appeal from a bench trial,
`we review for clear error.” Alcon Res. Ltd. v. Barr
`Labs., Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014). In-
`fringement is a question of fact that we review for
`clear error. Id. at 1186.
`
`A
`Sandoz first argues that all asserted claims are in-
`valid as obvious. A claim is invalid if, at the time the
`invention was disclosed, a person having ordinary
`
`
`
`
`
`
`
`
`
`5a
`
`skill in the art would have found the patented inven-
`tion obvious in light of the prior art. See 35 U.S.C. §
`103; KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 415–
`16 (2007). But patents are presumed to be valid and
`overcoming that presumption requires clear and con-
`vincing evidence. 35 U.S.C. § 282; Microsoft Corp. v.
`i4i Ltd. P’ship, 564 U.S. 91, 95 (2011).
`The district court found the asserted claims not in-
`valid as obvious, reasoning that Sandoz presented
`substantially the same arguments and evidence in an
`earlier dispute with Allergan in which we held that
`claim 4 of the ’149 patent recited an efficacy limitation
`that is neither suggested nor inherent in any prior art
`in the record. J.A. 74–76; see also Allergan, Inc. v.
`Sandoz Inc., 726 F.3d 1286, 1293–94 (Fed. Cir. 2013).
`Relying on that precedential decision, the court found
`that all asserted claims recited analogous efficacy lim-
`itations, neither suggested nor inherent in prior art
`produced by Sandoz. J.A. 163.
`Sandoz contends that the court erred because the
`asserted claims merely recite the inherent results of
`administering an obvious combination. We disagree.
`As we concluded in the earlier dispute regarding claim
`4 of the ’149 patent, the concomitant administration
`of brimonidine and timolol ophthalmic composition
`twice daily is obvious in view of the prior art. See J.A.
`122–25; Allergan, 726 F.3d at 1294. Each asserted
`claim, however, expressly recites an additional effi-
`cacy limitation that further restricts the method of ad-
`ministering the composition twice daily: (1) “without
`loss of efficacy” in claim 4 of the ’149 patent, see J.A.
`350; (2) “a therapeutically effective amount” in claim
`1 of the ’976 patent, see J.A. 356; and (3) “reduc[ing]
`the incidence of one or more adverse events” in claim
`
`
`
`
`
`
`
`
`
`6a
`
`1 of the ’425 patent1, see J.A. 366. See also Allergan,
`726 F.3d at 1293. Those efficacy limitations are not
`disclosed by any prior art reference in the record. To
`the contrary, the prior art shows that the combination
`dosed twice daily produces a loss of efficacy in the af-
`ternoon. J.A. 107–116; see also Allergan, 726 F.3d at
`1294. The efficacy limitations are also not inherent in
`the administration of the ophthalmic composition, a
`finding adequately supported by the record. See, e.g.,
`J.A. 2572–75, 3007–09, 3117–19, 3243–45. Accord-
`ingly, the asserted claims merely recite those admin-
`istrations of the composition that satisfy the efficacy
`limitations—but not those that end up in, for example,
`a loss of efficacy, examples of which abound in the
`prior art offered by Sandoz.
`In light of the foregoing, the district court did not
`err by finding that Sandoz failed to present clear and
`convincing evidence to overcome the presumption that
`the asserted claims are valid.
`B
`Sandoz next argues that claim 4 of the ’149 patent
`is invalid for lack of written description in the specifi-
`cation based on its expert testimony that the claim en-
`compasses hundreds of brimonidine and timolol com-
`binations.
`The written description requirement provides that
`a patentee’s application for a patent must “clearly al-
`low persons of ordinary skill in the art to recognize
`that [he] invented what is claimed.” Ariad Pharm.,
`Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
`2010) (en banc) (quoting Vas–Cath Inc. v. Mahurkar,
`
`1 Claims 2–8 include similar limitations, but each claim
`specifically recites only one of the adverse events enumerated in
`claim 1. See J.A. 366.
`
`
`
`
`
`
`
`
`
`7a
`
`935 F.2d 1555, 1563 (Fed. Cir. 1991)). “[T]he test for
`sufficiency is whether the disclosure of the application
`relied upon reasonably conveys to those skilled in the
`art that the inventor had possession of the claimed
`subject matter as of the filing date.” Id. Relevant here,
`a sufficient description of a genus requires the “disclo-
`sure of either a representative number of species fall-
`ing within the scope of the genus or structural fea-
`tures common to the members of the genus so that one
`of skill in the art can visualize or recognize the mem-
`bers of the genus.” Id. at 1350. Even a single repre-
`sentative embodiment can support written descrip-
`tion of a claimed genus. See, e.g., Invitrogen Corp. v.
`Clontech Labs., Inc., 429 F.3d 1052, 1073 (Fed. Cir.
`2005); Bilstad v. Wakalopulos, 386 F.3d 1116, 1124–
`25 (Fed. Cir. 2004).
`Claim 4 of the ’149 patent recites 0.2% brimonidine
`and 0.5% timolol. J.A. 350. Given the construction of
`the terms brimonidine and timolol to include their
`free base and salt forms, see J.A. 1594, 1597, the dis-
`trict court correctly credited Allergan’s expert testi-
`mony at trial that a person of ordinary skill in the art
`would have understood the claim to encompass only
`six possible combinations of brimonidine and timolol
`and their respective free base and salt forms, see J.A.
`150—not, as Sandoz claims, hundreds of combina-
`tions. More critically, the specification discloses one of
`those six possible combinations, 0.2% brimonidine tar-
`trate and 0.68% timolol maleate composition. See J.A.
`347. Tellingly, Sandoz’s expert failed to identify any
`additional composition beyond that particular combi-
`nation. J.A. 150–51. It was also undisputed at trial
`that the only salt of brimonidine available as of the
`filing of the ’149 patent was brimonidine tartrate and
`that only one salt of timolol actually available—tim-
`olol maleate. J.A. 151–52. The specification therefore
`
`
`
`
`
`
`
`
`
`8a
`
`discloses a representative—indeed, the sole—embodi-
`ment of the claimed genus and a person of ordinary
`skilled in the art, reading the specification, would
`have immediately discerned the claimed limitation.
`Accordingly, the district court did not err by finding
`that the claim satisfies the written description re-
`quirement.
`
`C
`Sandoz finally argues that the district court erred
`in finding infringement of claims 1–8 of the ’425 pa-
`tent. Allergan asserted only literal infringement of
`those claims. “To establish literal infringement, every
`limitation set forth in a claim must be found in an ac-
`cused product, exactly.” Advanced Steel Recovery,
`LLC v. XBody Equip., Inc., 808 F.3d 1313, 1319 (Fed.
`Cir. 2015) (quoting Southwall Techs., Inc. v. Cardinal
`IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995)).
`The district court found that the proposed generic
`contains 0.5% timolol free base and therefore in-
`fringed the claims of the ’425 patent. J.A. 116–18, 158.
`That finding is erroneous for two related reasons.
`Claims 1–8 are narrowly and specifically drawn, recit-
`ing administration of 0.2% brimonidine tartrate and
`0.5% timolol free base. J.A. 366. Both Combigan® and
`the proposed generic, however, contain 0.68% timolol
`maleate, an ophthalmic compound distinct from 0.5%
`timolol free base. See, e.g., J.A. 2786–87 (Sandoz’s ex-
`pert explaining why the pro-posed generic does not
`contain 0.5% timolol free base). The district court re-
`lied on the equivalency of the two compounds in find-
`ing literal infringement—that is, 0.5% timolol free
`base recited in claims 1–8 as chemically equivalent to
`0.68% timolol maleate contained in the proposed ge-
`neric. See J.A. 117, 158. Because chemical equivalency
`
`
`
`
`
`
`
`
`
`9a
`
`is not sufficient for literal infringement of these
`claims, the court clearly erred.
` The Hatch-Waxman Act provides for a technical
`infringement upon submission of an ANDA, but only
`“for a drug claimed in a patent.” 35 U.S.C. §
`271(e)(2)(A). Here, Combigan® contains a 0.2%
`brimonidine tartrate and 0.68% timolol maleate solu-
`tion, as its FDA-approved label makes clear. J.A.
`2310; see also J.A. 116–17. But claims 1–8 of the ’425
`patent expressly recite 0.5% timolol free base, not
`0.68% timolol maleate. Therefore, as a matter of law,
`Combigan® is not the “drug claimed in” the ’425 pa-
`tent, and Sandoz’s ANDA does not infringe under §
`271(e)(2)(A). See also Warner-Lambert Co. v. Apotex
`Corp., 316 F.3d 1348, 1354 (Fed. Cir. 2003) (“[I]t is not
`an act of infringement to submit an ANDA for ap-
`proval to market a drug for a use when neither the
`drug nor that use is covered by an existing patent.”).
`In sum, the district court erred by finding that Al-
`lergan showed literal infringement of claims 1–8 of
`the ’425 patent.
`
`D
`Allergan argues on its cross-appeal that the dis-
`trict court erred in finding that Sandoz’s proposed ge-
`neric does not infringe claim 4 of the ’149 patent and
`claim 1 of the 976 patent. Allergan again asserted only
`literal infringement with respect to those claims. Both
`the claims specifically recite 0.2% brimonidine. But
`the proposed generic contains 0.2% brimonidine ti-
`trate, a distinct pharmaceutical compound that re-
`duces to 0.132% brimonidine—indeed, Allergan’s ex-
`pert confirmed so. J.A. 2710–11; see also J.A. 117. As
`
`
`
`
`
`
`
`
`
`10a
`
`such, the district court did not err by finding that Al-
`lergan failed to show literal infringement of claim 4 of
`the ’149 patent and claim 1 of the ’976 patent.
`III
`
`We have considered remaining arguments and find
`them unpersuasive. Accordingly, we affirm the dis-
`trict court’s finding of no invalidity of the asserted
`claims and non-infringement of the claims of the ’149
`and ’976 patents, but reverse the finding of infringe-
`ment of claim 1 of the ’425 patent.
`
`AFFIRMED-IN-PART AND REVERSED-IN-
`PART
`
`No costs.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`11a
`
`APPENDIX B
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`
`ALLERGAN SALES,
`LLC,
`Plaintiff,
`
`v.
`SANDOZ INC., ET
`AL.,
`Defendants.
`
`
`
`Case No. 2:12-cv-207-
`JRG
`(Lead Case)
`
`§
`§
`§
`§
`§
`§
`§
`§
`§
`
`
`
`
`MEMORANDUM OPINION AND ORDER
`Before the Court are Plaintiff Allergan Sales,
`LLC’s (“Allergan”) Opening Claim Construction Brief
`(Dkt. No. 232), Sandoz, Inc., Alcon Laboratories, Inc.,
`Alcon Research, Ltd., and Falcon Pharmaceuticals,
`Ltd.’s (collectively, “Sandoz”) Responsive Claim Con-
`struction Brief (Dkt. No. 235), and Allergan’s Reply
`Claim Construction Brief (Dkt. No. 238). The Court
`held a hearing on March 2, 2016, to determine the
`proper construction of the disputed terms in this case.
`Having considered the parties’ arguments and the
`claim construction briefing, the Court issues this
`
`
`
`
`
`
`
`
`
`12a
`
`Memorandum Opinion and Order construing the dis-
`puted terms.
`BACKGROUND
`I.
`This is a case brought by Plaintiff Allergan under
`the provisions of the Hatch-Waxman Act, alleging
`that Defendants’ application for approval to market a
`generic version of Allergan’s Combigan® product, and
`Defendants’ proposed product,
`infringes United
`States Patent Nos. 7,030,149 (“the ’149 patent”);
`7,320,976 (“the ’976 patent”); 7,642,258 (“the ’258 pa-
`tent”); and 8,748,425 (“the ’425 patent”). The ’149 pa-
`tent, titled “Combination of Brimonidine Timolol for
`Topical Ophthalmic Use,” issued on April 18, 2006.
`The ’976 patent is similarly titled, “Combination of
`Brimonidine and Timolol for Topical Ophthalmic
`Use,” and issued on January 22, 2008. The ’258 and
`’425 patents bear the same title and issued on Janu-
`ary 5, 2010, and June 10, 2014, respectively. In gen-
`eral, the patents-in-suit concern compositions com-
`prising both brimonidine and timolol and methods of
`treating a patient exhibiting elevated intraocular
`pressure (“IOP”) associated with diseases such as
`glaucoma or ocular hypertension with a composition
`comprising both brimonidine and timolol.
`The ’149, ’976, and ’258 patents were previously
`construed by Judge T. John Ward of this Court in a
`claim construction order involving the same parties to
`this litigation. Allergan, Inc. v. Sandoz, Inc., et al., No.
`2:09-cv-97, 2011 WL 1599049 (E.D. Tex. April 27,
`2011) (Dkt. No. 151, “Allergan I Markman”). That
`prior litigation involving the ’149, ’976, and ’258 pa-
`tents is referred to below as Allergan I. The Court is-
`sued its findings of fact and conclusions of law on Au-
`gust 22, 2011, finding that Defendants’ generic ver-
`sions of Combigan® infringed the asserted claims of
`
`
`
`
`
`
`
`
`
`13a
`
`those patents, and that those patents are not invalid.
`Allergan, Inc. v. Sandoz, Inc., et al., 818 F. Supp. 2d
`974 (E.D. Tex. 2011). Defendants appealed the Court’s
`decision that the patents in that case were not invalid,
`and Plaintiff appealed a portion of the Court’s claim
`construction. On May 1, 2013, the Court of Appeals for
`the Federal Circuit reversed a portion of this Court’s
`validity decision, finding that the asserted claims of
`U.S. Patent No. 7,323,463 were invalid as obvious.
`However, the Federal Circuit upheld the validity of
`claim 4 of U.S. Patent No. 7,030,149.1
`In separate litigation before this Court, Allergan
`also asserted two additional patents from the same
`family against Sandoz: U.S. Patent Nos. 8,133,890
`(“the ’890 patent”) and 8,354,409 (“the ’409 patent”).
`Allergan Sales, LLC v. Sandoz, Inc., et al., No. 2:12-
`cv-207 (E.D. Tex. April 13, 2012). That litigation is re-
`ferred to below as Allergan II. On September 5, 2013,
`this Court construed certain terms of the ’890 and ’409
`patents following briefing and a hearing. Allergan
`Sales, LLC v. Sandoz, Inc., et al., No. 2:12-cv-207 (E.D.
`Tex. Sept. 5, 2013) (Dkt. No. 171, “Allergan II Mark-
`man”). In so doing, the Court considered the claim
`construction in Allergan I, but reached a different con-
`struction as to the terms “brimonidine” and “timolol.”
`Allergan II was stayed pending the appeal in Allergan
`I.
`
`
`1 Because the ’149 Patent expires on the same day as two other
`patents at issue in that case (and this one)—the ’976 and ’258
`patents—and because as a result of the Federal Circuit’s affir-
`mance of claim 4 of the ’149 patent, Defendants would be unable
`to market their generic versions of Combigan® until April 19,
`2022, the Federal Circuit did not address the validity of the
`claims of the ’976 and ’258 patents.
`
`
`
`
`
`
`
`
`
`14a
`
`On January 23, 2015, Allergan received notice that
`Sandoz had filed an amendment to its ANDA No. 91-
`087. Allergan subsequently filed suit against Sandoz,
`alleging infringement of the ’149, ’976, ’258 and ’425
`patents. Allergan Sales, LLC v. Sandoz Inc., No. 2:15-
`cv-347 (E.D. Tex.). Following initiation of the instant
`litigation, the Court consolidated it with Allergan II.
`LEGAL PRINCIPLES
`II.
`It is understood that “[a] claim in a patent provides
`the metes and bounds of the right which the patent
`confers on the patentee to exclude others from mak-
`ing, using or selling the protected invention.” Burke,
`Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334,
`1340 (Fed. Cir. 1999). Claim construction is clearly an
`issue of law for the court to decide. Markman v.
`Westview Instruments, Inc., 52 F.3d 967, 970–71 (Fed.
`Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996).
`To ascertain the meaning of claims, courts look to
`three primary sources: the claims, the specification,
`and the prosecution history. Markman, 52 F.3d at
`979. The specification must contain a written descrip-
`tion of the invention that enables one of ordinary skill
`in the art to make and use the invention. Id. A pa-
`tent’s claims must be read in view of the specification,
`of which they are a part. Id. For claim construction
`purposes, the description may act as a sort of diction-
`ary, which explains the invention and may define
`terms used in the claims. Id. “One purpose for exam-
`ining the specification is to determine if the patentee
`has limited the scope of the claims.” Watts v. XL Sys.,
`Inc., 232 F.3d 877, 882 (Fed. Cir. 2000).
`Nonetheless, it is the function of the claims, not the
`specification, to set forth the limits of the patentee’s
`invention. Otherwise, there would be no need for
`
`
`
`
`
`
`
`
`
`15a
`
`claims. SRI Int’l v. Matsushita Elec. Corp., 775 F.2d
`1107, 1121 (Fed. Cir. 1985) (en banc). The patentee is
`free to be his own lexicographer, but any special defi-
`nition given to a word must be clearly set forth in the
`specification. Intellicall, Inc. v. Phonometrics, Inc.,
`952 F.2d 1384, 1388 (Fed. Cir. 1992). Although the
`specification may indicate that certain embodiments
`are preferred, particular embodiments appearing in
`the specification will not be read into the claims when
`the claim language is broader than the embodiments.
`Electro Med. Sys., S.A. v. Cooper Life Sciences, Inc., 34
`F.3d 1048, 1054 (Fed. Cir. 1994).
`This Court’s claim construction analysis is sub-
`stantially guided by the Federal Circuit’s decision in
`Phillips v. AWH Corporation, 415 F.3d 1303 (Fed. Cir.
`2005) (en banc). In Phillips, the court set forth several
`guideposts that courts should follow when construing
`claims. In particular, the court reiterated that “the
`claims of a patent define the invention to which the
`patentee is entitled the right to exclude.” 415 F.3d at
`1312 (quoting Innova/Pure Water, Inc. v. Safari Wa-
`ter Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir.
`2004)). To that end, the words used in a claim are gen-
`erally given their ordinary and customary meaning.
`Id. The ordinary and customary meaning of a claim
`term “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.” Id. at 1313. This principle
`of patent law flows naturally from the recognition that
`inventors are usually persons who are skilled in the
`field of the invention and that patents are addressed
`to, and intended to be read by, others skilled in the
`particular art. Id.
`
`
`
`
`
`
`
`
`
`16a
`
`Despite the importance of claim terms, Phillips
`made clear that “the person of ordinary skill in the art
`is deemed to read the claim term not only in the con-
`text of the particular claim in which the disputed term
`appears, but in the context of the entire patent, in-
`cluding the specification.” Id. Although the claims
`themselves may provide guidance as to the meaning
`of particular terms, those terms are part of “a fully in-
`tegrated written instrument.” Id. at 1315 (quoting
`Markman, 52 F.3d at 978). Thus, the Phillips court
`emphasized the specification as the primary basis for
`construing the claims. Id. at 1314–17. As the Supreme
`Court stated long ago, “in case of doubt or ambiguity
`it is proper in all cases to refer back to the descriptive
`portions of the specification to aid in solving the doubt
`or in ascertaining the true intent and meaning of the
`language employed in the claims.” Bates v. Coe, 98
`U.S. 31, 38 (1878). In addressing the role of the speci-
`fication, the Phillips court quoted with approval its
`earlier observations from Renishaw PLC v. Marposs
`Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir.
`1998):
`Ultimately, the interpretation to be given a
`term can only be determined and confirmed
`with a full understanding of what the inventors
`actually invented and intended to envelop with
`the claim. The construction that stays true to
`the claim language and most naturally aligns
`with the patent’s description of the invention
`will be, in the end, the correct construction.
`Phillips, 415 F.3d at 1316. Consequently, Phillips em-
`phasized the important role the specification plays in
`the claim construction process.
`
`
`
`
`
`
`
`
`
`17a
`
`The prosecution history also continues to play an
`important role in claim interpretation. Like the spec-
`ification, the prosecution history helps to demonstrate
`how the inventor and the Patent and Trademark Of-
`fice (“PTO”) understood the patent. Id. at 1317. Be-
`cause the file history, however, “represents an ongo-
`ing negotiation between the PTO and the applicant,”
`it may lack the clarity of the specification and thus be
`less useful in claim construction proceedings. Id. Nev-
`ertheless, the prosecution history is intrinsic evidence
`that is relevant to the determination of how the inven-
`tor understood the invention and whether the inven-
`tor limited the invention during prosecution by nar-
`rowing the scope of the claims. Id.; see Microsoft Corp.
`v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1350 (Fed. Cir.
`2004) (noting that “a patentee’s statements during
`prosecution, whether relied on by the examiner or not,
`are relevant to claim interpretation”).
`Phillips rejected any claim construction approach
`that sacrificed the intrinsic record in favor of extrinsic
`evidence, such as dictionary definitions or expert tes-
`timony. The en banc court condemned the suggestion
`made by Texas Digital Systems, Inc. v. Telegenix, Inc.,
`308 F.3d 1193 (Fed. Cir. 2002), that a court should dis-
`cern the ordinary meaning of the claim terms
`(through dictionaries or otherwise) before resorting to
`the specification for certain limited purposes. Phillips,
`415 F.3d at 1319–24. According to Phillips, reliance
`on dictionary definitions at the expense of the specifi-
`cation had the effect of “focus[ing] the inquiry on the
`abstract meaning of words rather than on the mean-
`ing of claim terms within the context of the patent.”
`Id. at 1321. Phillips emphasized that the patent sys-
`tem is based on the proposition that the claims cover
`only the invented subject matter. Id.
`
`
`
`
`
`
`
`
`
`18a
`
`Phillips does not preclude all uses of dictionaries
`in claim construction proceedings. Instead, the court
`assigned dictionaries a role subordinate to the intrin-
`sic record. In doing so, the court emphasized that
`claim construction issues are not resolved by any
`magic formula. The court did not impose any particu-
`lar sequence of steps for a court to follow when it con-
`siders disputed claim language. Id. at 1323–25. Ra-
`ther, Phillips held that a court must attach the appro-
`priate weight to the intrinsic sources offered in sup-
`port of a proposed claim construction, bearing in mind
`the general rule that the claims measure the scope of
`the patent grant.
`III. CONSTRUCTION OF AGREED TERMS
`The Court hereby adopts the following agreed to
`constructions:
`
`Term
`
`Patent Claims
`
`“% … by
`weight”; “%
`by weight”;
`“%
`…
`(w/v),” “%”
`
`single
`“a
`composi-
`tion”
`
`’149 patent claim
`4
`’976 patent claim
`1
`patent
`’258
`claims 1–3, 7–9
`’425 patent claim
`1
`’149 patent claim
`4
`
`
`
`
`
`
`
`Agreed Construc-
`tion
`“ratio of the weight
`of the ingredient in
`question divided by
`the total volume of
`the solution, with
`this
`ratio
`ex-
`pressed as a per-
`centage”
`
`plain and ordinary
`meaning
`
`
`
`“about”
`
`“brimoni-
`dine
`tar-
`trate”
`
`“timolol
`maleate”
`“timolol
`free base”
`“as
`com-
`pared to the
`administra-
`tion of”
`af-
`“the
`fected eye”
`
`19a
`
`’976 patent claim
`1
`’258 patent claim
`4
`’425 patent claim
`1
`’258 patent claim
`4
`’425 patent claim
`1
`’425 patent claim
`1
`
`“approximately”
`
`plain and ordinary
`meaning
`
`plain and ordinary
`meaning
`plain and ordinary
`meaning
`plain and ordinary
`meaning
`
`’976 patent claim
`1
`’425 patent claim
`1
`
`“an eye exhibiting
`elevated intraocu-
`lar pressure”
`
`
`(Dkt. No. 229 at 1, “Joint Claim Construction and Pre-
`hearing Statement,” Dec. 9, 2015.)
`IV. CONSTRUCTION OF DISPUTED TERMS
`a. “brimonidine”
`Plaintiff’s Proposed
`Construction
`“brimonidine tartrate”
`
`Defendants’ Proposed
`Construction
`“the chemical compound
`brimonidine, including its
`free base and tartrate salt
`forms”
`
`
`
`
`
`
`
`
`
`
`
`20a
`
`(Joint Claim Construction and Prehearing Statement,
`Ex. A.) The term appears in claim 4 of the ’149 patent,
`claim 1 of the ’976 patent, and claims 1, 4 and 7 of the
`’258 patent.2
`i. The Parties’ Positions
`Allergan submits that the term “brimonidine”
`should be construed to mean “brimonidine tartrate,”
`as it was for the same patents in Allergan I. See (Al-
`lergan I Markman). Allergan argues that issue preclu-
`sion bars Sandoz from now seeking a different con-
`struction of this term (and others) because Sandoz
`previously litigated the construction of “brimonidine”
`(and other terms) in these same patents and received
`final judgment. Allergan also argues that the patent
`specification expressly defines “brimonidine” as
`“brimonidine tartrate,” providing the full chemical
`name for brimonidine tartrate and a chemical draw-
`ing of the compound. ’149 Patent at 1:39–53. Allergan
`further argues that brimonidine tartrate is the form
`of brimonidine used in Examples 1 and 2 of the ’149
`patent.
`Sandoz responds that issue preclusion does not bar
`it from now seeking a different construction of
`brimonidine (and other terms) because the factors re-
`quired for issue preclusion are not met here. Sandoz
`further argues that the Court, in its discretion, should
`decline to find issue preclusion even if each of the re-
`quired factors is found. Sandoz also argues that the
`Court’s construction of “brimonidine” in Allergan II
`
`
`2 Because the patents share a common specification, reference is
`made herein to the ’149 patent specification.
`
`
`
`
`
`
`
`
`
`21a
`
`for the ’890 and ’409 patents as “the chemical com-
`pound brimonidine, including its free base and tar-
`trate salt forms” should be applied here.
`In support, Sandoz also points to claim 4 of the ’258
`patent, dependent from claim 1, which further defines
`the brimonidine in claim 4 as “brimonidine tartrate.”
`Sandoz argues that under the doctrine of claim differ-
`entiation, brimonidine in claim 1 of the ’258 patent
`(and the other independent claims) must include more
`than just brimonidine tartrate. Am. Med. Sys., Inc. v.
`Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir. 2010).
`Sandoz also points to patents cited in the “Back-
`ground” section of the patent specification, arguing
`that these prior art patents describe brimonidine as
`including salt or free base forms. Finally, Sandoz ar-
`gues that the prosecution history of the subsequently
`issued ’890 patent supports its position.
`ii. Analysis
`1. Issue Preclusion
`Under Fifth Circuit law,3 issue preclusion applies
`where (1) the identical issue was previously adjudi-
`cated; (2) the issue was actually litigated; and (3) the
`previous determination was necessary to the decision.
`Pace v. Bogalusa City Sch. Bd., 403 F.3d 272, 290 (5th
`Cir. 2005); see also In re Freeman, 30 F.3d 1459, 1465
`(Fed. Cir. 1994).4
`
`
`3 Because issue preclusion is a procedural matter, Fifth Circuit
`law applies here. See Bayer AG v. Biovail Corp., 279 F.3d 1340,
`1345 (Fed. Cir. 2002).
`4 Under Federal Circuit law, the same three factors apply. A
`fourth factor, that there was a full and fair opportunity to litigate
`the issue in the previous action, is also relevant under Federal
`Circuit law. Freeman, 30 F.3d at 1465. Under that law, the Court
`
`
`
`
`
`
`
`
`
`22a
`
`Sandoz specifically argues that issue preclusion is
`not appropriate in this instance because (1) the iden-
`tical issue was not previously adjudicated due to the
`fact that the prosecution history and the accused prod-
`uct have changed from Allergan I, making this a dif-
`ferent issue from that which was previously adjudi-
`cated; (2) the term “brimonidine” was not actually lit-
`igated due
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