Court Opinion

ID: 4649401
Source: CourtListenerOpinion
Date Created: 2021-01-06 16:00:45.230122+00
Date Added: 2024-06-11T08:01:25.010156
License: Public Domain

Case: 19-1607   Document: 67     Page: 1   Filed: 01/06/2021

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                 ______________________

   HORIZON PHARMA, INC., HORIZON PHARMA
                USA, INC.,
                 Plaintiffs

       HORIZON MEDICINES LLC, NUVO
   PHARMACEUTICAL (IRELAND) DESIGNATED
            ACTIVITY COMPANY,
             Plaintiffs-Appellants

                            v.

 DR. REDDY'S LABORATORIES INC., DR. REDDY'S
            LABORATORIES, LTD.,
              Defendants-Appellees

 --------------------------------------------

   HORIZON PHARMA, INC., HORIZON PHARMA
                USA, INC.,
                 Plaintiffs

       HORIZON MEDICINES LLC, NUVO
   PHARMACEUTICAL (IRELAND) DESIGNATED
            ACTIVITY COMPANY,
             Plaintiffs-Appellants

                            v.

   LUPIN LTD., LUPIN PHARMACEUTICALS INC.,
                   Defendants
Case: 19-1607     Document: 67       Page: 2    Filed: 01/06/2021

 2       HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.

                   ______________________

  2019-1607, 2019-1609, 2019-1611, 2019-1612, 2019-1614
                 ______________________

     Appeals from the United States District Court for the
 District of New Jersey in Nos. 2:15-cv-03324-SRC-CLW,
 2:15-cv-03326-SRC-CLW, 2:15-cv-03327-SRC-CLW, 2:16-
 cv-04918-SRC-CLW, 2:16-cv-04920-SRC-CLW, 2:16-cv-
 04921-SRC-CLW, 2:16-cv-09035-SRC-CLW, Judge Stanley
 R. Chesler.
                 ______________________

                  Decided: January 6, 2021
                   ______________________

     JAMES B. MONROE, Finnegan, Henderson, Farabow,
 Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap-
 pellant Horizon Medicines LLC. Also represented by
 CHARLES COLLINS-CHASE.

     MICHAEL HAWES, Baker Botts, LLP, Houston, TX, for
 plaintiff-appellant Nuvo Pharmaceutical (Ireland) Desig-
 nated Activity Company. Also represented by JEFFREY
 SEAN GRITTON, STEPHEN M. HASH, Austin, TX.

     ALAN HENRY POLLACK, Windels Marx Lane and Mitten-
 dorf LLP, Madison, NJ, for defendants-appellees. Also rep-
 resented by WILLIAM H. BURGESS, JOHN C. O'QUINN,
 Kirkland & Ellis LLP, Washington, DC.
                  ______________________

     Before MOORE, O’MALLEY, and HUGHES, Circuit Judges.
 HUGHES, Circuit Judge.
     Appellants Horizon Medicines LLC and Nuvo Phar-
 maceutical (Ireland) Designated Activity Company appeal
 the United States District Court for the District of New
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 HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.    3

 Jersey’s grant of summary judgment that the claims of U.S.
 Patent Nos. 9,220,698 and 9,393,208 are invalid for indefi-
 niteness. The parties’ primary dispute on appeal is the dis-
 trict court’s construction of the claim term “target.”
 Because we agree with the district court’s construction of
 the term “target” to mean “set as a goal,” we affirm.
                               I
     Millions of Americans take non-steroidal anti-inflam-
 matory drugs (NSAIDs) each day as a treatment for pain
 or inflammation, but many of these NSAIDs are associated
 with gastrointestinal complications, often caused by the
 presence of acid in the stomach and the upper small intes-
 tines. In recent years, attempts have been made to de-
 crease     these    gastrointestinal    complications     by
 administering agents, such as proton pump inhibitors
 (PPIs), that inhibit stomach acid secretion. U.S. Patent
 Nos. 9,220,698 (the ’698 patent) and 9,393,208 (the ’208 pa-
 tent) are directed to methods of delivering a pharmaceuti-
 cal composition comprising the NSAID naproxen and the
 PPI esomeprazole to a patient.
     The parties agree that claim 1 of the ’698 patent is rep-
 resentative of the asserted claims of both the ’698 patent
 and the ’208 patent. Claim 1 reads:
     1. A method for treating osteoarthritis, rheuma-
     toid arthritis, or ankylosing spondylitis comprising
     orally administering to a patient in need thereof an
     AM unit dose form and, 10 hours (±20%) later, a
     PM unit dose form, wherein:
     the AM and PM unit dose forms each comprises:
     naproxen, or a pharmaceutically acceptable salt
       thereof, in an amount to provide 500 mg of
       naproxen, and
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 4     HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.

     esomeprazole or a pharmaceutically acceptable salt
       thereof in an amount to provide 20 mg of
       esomeprazole;
     said esomeprazole, or pharmaceutically acceptable
        salt thereof, is released from said AM and PM
        unit dose forms at a pH of 0 or greater,
     the AM and PM unit dose forms target:
     i) a pharmacokinetic (pk) profile for naproxen
        where:
       a) for the AM dose of naproxen, the mean Cmax is
          86.2 µg/mL (±20%) and the median Tmax is 3.0
          hours (±20%); and
       b) for the PM dose of naproxen, the mean Cmax is
          76.8 µg/mL (±20%) and the median Tmax is 10
          hours (±20%); and
     ii) a pharmacokinetic (pk) profile for esomeprazole
         where:
       a) for the AM dose of esomeprazole, the mean
          area under the plasma concentration-time
          curve from when the AM dose is administered
          to 10 hours (±20%) after the AM dose is ad-
          ministered (AUC0–10,am) is 1216 hr*ng/mL
          (±20%),
       b) for the PM dose of esomeprazole, the mean
          area under the plasma concentration-time
          curve from when the PM dose is administered
          to 14 hours (±20%) after the PM dose is ad-
          ministered (AUC0–14,pm) is 919 hr*ng/mL
          (±20%), and
       c) the total mean area under the plasma concen-
          tration-time curve for esomeprazole from
          when the AM dose is administered to 24 hours
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 HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.     5

          (±20%) after the AM dose is administered
          (AUC0–24) is 2000 hr*ng/mL (±20%); and
     the AM and PM unit dose forms further target a
       mean % time at which intragastric pH remains
       at about 4.0 or greater for about a 24 hour period
       after reaching steady state that is at least about
       60%
 ’698 Patent 52:26–67 (emphasis added).
      Appellants Horizon and Nuvo sued Dr. Reddy’s Labor-
 atories Inc., Dr. Reddy’s Laboratories, Ltd., and several
 other defendants who are not part of this appeal, for patent
 infringement in multiple lawsuits in the United States Dis-
 trict Court for the District of New Jersey. The actions were
 consolidated for pretrial purposes, and the issues in this
 appeal were resolved in proceedings and orders common to
 all the district court cases.
     The district court held a Markman hearing and issued
 a Markman order for several terms in the patent claims,
 but only the construction of the term “target” is contested
 in this appeal. See Horizon Pharma, Inc. v. Dr. Reddy’s
 Labs., Inc., 2017 WL 5451748 (D.N.J. 2017) (Markman Or-
 der). At the Markman hearing, Appellants contended that
 “target” has its ordinary meaning, which is “produce.” Id.
 at *4. Appellees contended that “target” is indefinite, but
 in the alternative, that it has its ordinary meaning, which
 is “with the goal of obtaining.” Id. at *5.
     The district court declined to find “target” indefinite at
 claim construction, but agreed with Appellees’ proposed
 construction, slightly adjusted for grammatical fit. Id. at
 *5. The district court found that construing “target” to
 mean “set as a goal” fit with the court’s understanding of
 what “target” ordinarily means, with several dictionary
 definitions, and with claim 1 and the patent as a whole. Id.
     The district court found Appellants’ arguments for
 their proposed construction unpersuasive, noting that the
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 6       HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.

 only pieces of intrinsic evidence Appellants cited were a
 “specification passage in which the treatment method is de-
 scribed as producing certain PD and PK profiles, as well as
 one in which the treatment method is said ‘to target’ a spe-
 cific PD profile.” Id. at *4 (emphasis added). The court
 found that the specification’s use of both words (target and
 produce) does not mean that the words are interchangeable
 or that one necessarily means the other. Id. Addressing
 Appellants’ expert testimony in support of its proposed con-
 struction, the district court found it to be “the kind of con-
 clusory, unsupported assertion that, under Phillips, is not
 useful in claim construction.” Id. (citing Phillips v. AWH
 Corp., 415 F.3d 1314, 1318 (Fed. Cir. 2005) (en banc)).
      Appellees then moved for summary judgment of inva-
 lidity on the ground of indefiniteness. The district court
 first held that the target clauses are claim limitations,
 based primarily on Appellants’ reliance on the target
 clauses to distinguish the claimed invention from the prior
 art during patent prosecution. 1 Horizon Pharma, Inc. v.
 Dr. Reddy’s Labs., Inc., 2018 WL 6040265 at *4 (D.N.J.
 2018) (Summary Judgment Opinion). The court then held
 that the patent claims were indefinite because, while the
 goal itself was clearly defined, the “act of targeting that
 goal” was not. Id. The court found that “pills cannot be
 said to set goals,” and even if the claims were understood
 to say that it is a treating physician who sets the goals, the
 claims would require a treating physician to “avoid having
 a subjective intent to achieve the defined outcomes.” Id. at
 *4–5. The district emphasized that even if “[t]he claim lan-
 guage delineating the target [were] clear as day . . . ‘target’
 would still be indefinite.” Id. at *7.
     Finally, Appellants argued that the disagreement of
 the parties’ experts was a factual dispute that precluded a
 grant of summary judgment. Id. at *8. However, the

     1    This holding is not challenged on appeal.
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 HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.      7

 district court found that Appellants’ expert’s opinion was
 “not a factual assertion, but a legal conclusion” and that
 the court “need not credit conclusory statements by experts
 and need not find such statements sufficient to raise mate-
 rial factual disputes.” Id. Accordingly, finding no dispute
 as to any genuine issue of material fact, the district court
 granted summary judgment, holding the asserted claims of
 the ’698 patent and the ’208 patent invalid due to indefi-
 niteness. Id. at *8–9.
                               II
      The “ultimate construction” of a patent claim is an is-
 sue of law which we review de novo, and we review the “fac-
 tual findings that underlie a district court’s claim
 construction” for clear error. Teva Pharms. USA, Inc. v.
 Sandoz, Inc., 574 U.S. 318, 332–33 (2015). Indefiniteness
 is a question of law which we review de novo. Teva Pharms.
 USA, Inc. v Sandoz Inc., 789 F.3d 1335, 1341 (Fed Cir.
 2015). We review the grant of summary judgment under
 the law of the regional circuit. BSG Tech LLC v.
 Buyseasons, Inc., 899 F.3d 1281, 1285 (Fed. Cir. 2018). The
 Third Circuit reviews the grant or denial of summary judg-
 ment de novo. Cranbury Brick Yard, LLC v. United States,
 943 F.3d 701, 708 (3d Cir. 2019).

                               A
     “[T]he words of a claim are generally given their ordi-
 nary and customary meaning.” Phillips, 415 F.3d at 1312
 (internal quotation marks and citations omitted). “[T]he
 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.” Id.
 at 1313. “In some cases, the ordinary meaning of claim lan-
 guage as understood by a person of skill in the art may be
 readily apparent even to lay judges, and claim construction
 in such cases involves little more than the application of
 the widely accepted meaning of commonly understood
 words.” Id. at 1314.
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 8     HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.

     This is such a case. Here, the claim term “target” is a
 commonly understood word, and nothing Appellants point
 to in the specification or the prosecution history suggests
 that it should be given anything other than its ordinary
 meaning. We agree with the district court that the use of
 both the terms “target” and “produce” at different points in
 the specification does not mean that these words have the
 same meaning. If anything, this suggests that the patent
 applicants were aware of their separate meanings and
 chose to use “target” in the patent claims instead of “pro-
 duce.” We also find Appellants’ expert testimony unper-
 suasive. Appellants’ expert merely concluded that “[a]
 person of ordinary skill in the art would have understood
 that the claim term ‘target’ means ‘produce’” and cited the
 same language from the specification that we find unper-
 suasive here. J.A. 2222–23, ¶¶ 28–29.
     While it is true that “the specification may reveal a spe-
 cial definition given to a claim term by the patentee that
 differs from the meaning it would otherwise possess,” Phil-
 lips, 415 F.3d at 1316, the specification here does not. We
 therefore construe the claim term “target” to mean “set as
 a goal” as the district court did.
     Appellants make much of this court’s statements in
 other cases that “claims should be so construed, if possible,
 as to sustain their validity.” Phillips, 415 F.3d at 1327,
 (quoting Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir.
 1999)). But this principle applies only where “the court
 concludes, after applying all the available tools of claim
 construction, that the claim is . . . ambiguous.” Liebel-
 Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir.
 2004). Here, because the meaning of the claim term “tar-
 get” is not ambiguous, this principle does not apply.
                               B
     Patent claims are indefinite if they do not “inform those
 skilled in the art about the scope of the invention with rea-
 sonably certainty.” Nautilus, Inc. v. Biosig Instruments,
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 HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.    9

 Inc., 572 U.S. 898, 910 (2014). One circumstance in which
 claims are indefinite is where the claims, as properly con-
 strued, are nonsensical. See Trs. of Columbia Univ. v. Sy-
 mantec Corp., 811 F.3d 1359, 1366–67 (Fed. Cir. 2016)
 (holding claims describing the extraction of machine code
 instructions from something that did not have machine
 code instructions indefinite as “nonsensical in the way a
 claim to extracting orange juice from apples would be”). We
 agree with the district court that the “target” clauses of
 claim 1 render the claim indefinite because “[t]he fact that
 a goal is clearly defined does not mean that the act of tar-
 geting that goal is clearly defined, and this is the crux of
 the definiteness problem here.” Summary Judgment Opin-
 ion at *4. As the district court explained, both clauses are
 incomprehensible. Id. Reading the claim literally, a dose
 form, which is an inanimate object, cannot set a goal. That
 the proper construction of the claims is nonsensical does
 not warrant judicial redrafting of the claims. Becton Dick-
 inson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 799 n.6 (Fed.
 Cir. 1990); see also Chef Am., Inc. v. Lamb-Weston, Inc., 358
 F.3d 1371, 1374 (Fed. Cir. 2004) (“Even a nonsensical re-
 sult does not require the court to redraft the claims of the
 [patent].” (internal quotation marks omitted)). Accord-
 ingly, we affirm the district court’s holding that the claims
 of the ’698 patent and the ’208 patent are invalid for indef-
 initeness.
                               C
     Appellants’ final contention is that the district court
 improperly granted summary judgment because of a disa-
 greement between the parties’ experts. As this court has
 previously stated, “a conclusory statement on the ultimate
 issue does not create a genuine issue of fact.” Imperial To-
 bacco Ltd. v. Philip Morris, Inc., 899 F.2d 1575, 1581 (Fed.
 Cir. 1990) (emphasis in original).
    Here, Appellants’ expert merely made conclusory state-
 ments about what a skilled artisan would understand
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 10    HORIZON PHARMA, INC.   v. DR. REDDY'S LABORATORIES INC.

 about the meaning of the claim term “target” and quoted
 text from the patent’s specification that did not support
 this conclusion. This type of cursory conclusion does not
 create a genuine dispute of material fact, and we therefore
 affirm the district court’s grant of summary judgment.
                              III
     We have considered Appellants’ other arguments and
 find them unpersuasive. We agree with the district court’s
 construction of the claim term “target” to mean “set as a
 goal,” and we affirm the district court’s grant of summary
 judgment holding the claims of the ’698 patent and the ’208
 patent invalid for indefiniteness.
                       AFFIRMED