HORIZON PHARMA, INC. et al v. DR. REDDY'S LABORATORIES INC. et al
Filing
334
Federal Circuit OPINION filed for the court by Moore, Circuit Judge; O'Malley, Circuit Judge and Hughes, Circuit Judge on 1/6/2021. Non precedential Opinion. Federal Circuit Case No.'s 19-1607, 19-1609, 19-1611, 19-1612, and 19-1614. etc.(dam)
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NOTE: This disposition is nonprecedential.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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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, 2:16cv-04918-SRC-CLW, 2:16-cv-04920-SRC-CLW, 2:16-cv04921-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-appellant Horizon Medicines LLC. Also represented by
CHARLES COLLINS-CHASE.
MICHAEL HAWES, Baker Botts, LLP, Houston, TX, for
plaintiff-appellant Nuvo Pharmaceutical (Ireland) Designated Activity Company. Also represented by JEFFREY
SEAN GRITTON, STEPHEN M. HASH, Austin, TX.
ALAN HENRY POLLACK, Windels Marx Lane and Mittendorf LLP, Madison, NJ, for defendants-appellees. Also represented 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 Pharmaceutical (Ireland) Designated Activity Company appeal
the United States District Court for the District of New
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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 indefiniteness. The parties’ primary dispute on appeal is the district 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-inflammatory 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 intestines. In recent years, attempts have been made to decrease
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 patent) are directed to methods of delivering a pharmaceutical composition comprising the NSAID naproxen and the
PPI esomeprazole to a patient.
The parties agree that claim 1 of the ’698 patent is representative of the asserted claims of both the ’698 patent
and the ’208 patent. Claim 1 reads:
1. A method for treating osteoarthritis, rheumatoid 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.
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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 administered (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 administered (AUC0–14,pm) is 919 hr*ng/mL
(±20%), and
c) the total mean area under the plasma concentration-time curve for esomeprazole from
when the AM dose is administered to 24 hours
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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 Laboratories 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 District 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 Order). 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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only pieces of intrinsic evidence Appellants cited were a
“specification passage in which the treatment method is described as producing certain PD and PK profiles, as well as
one in which the treatment method is said ‘to target’ a specific 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 construction, the district court found it to be “the kind of conclusory, 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 invalidity 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 language 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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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 material 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 indefiniteness. Id. at *8–9.
II
The “ultimate construction” of a patent claim is an issue of law which we review de novo, and we review the “factual 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 judgment 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 ordinary 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 language 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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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 “produce.” We also find Appellants’ expert testimony unpersuasive. 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 unpersuasive here. J.A. 2222–23, ¶¶ 28–29.
While it is true that “the specification may reveal a special definition given to a claim term by the patentee that
differs from the meaning it would otherwise possess,” Phillips, 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.” LiebelFlarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir.
2004). Here, because the meaning of the claim term “target” 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 reasonably 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 construed, are nonsensical. See Trs. of Columbia Univ. v. Symantec 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 targeting that goal is clearly defined, and this is the crux of
the definiteness problem here.” Summary Judgment Opinion 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 Dickinson & 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 result does not require the court to redraft the claims of the
[patent].” (internal quotation marks omitted)). Accordingly, we affirm the district court’s holding that the claims
of the ’698 patent and the ’208 patent are invalid for indefiniteness.
C
Appellants’ final contention is that the district court
improperly granted summary judgment because of a disagreement 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 Tobacco Ltd. v. Philip Morris, Inc., 899 F.2d 1575, 1581 (Fed.
Cir. 1990) (emphasis in original).
Here, Appellants’ expert merely made conclusory statements 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
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