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`NOTE: This disposition is nonprecedential.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
`
`

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`Case: 19-1607 Document: 67 Page: 2 Filed: 01/06/2021
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`2
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`HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.
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`______________________
`
`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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`Case: 19-1607 Document: 67 Page: 3 Filed: 01/06/2021
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`HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.
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`3
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`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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`HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.
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`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.
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`(±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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`HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.
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`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.
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`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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`HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.
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`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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`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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`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
`
`
`
`
`