Hznp Finance Limited, Horizon Therapeutics USA, Inc. v. Actavis Laboratories Ut, Inc.

United States Court of Appeals
for the Federal Circuit
______________________

HZNP FINANCE LIMITED, HORIZON
THERAPEUTICS USA, INC.,
Plaintiffs-Appellants

v.

ACTAVIS LABORATORIES UT, INC.,
Defendant-Cross-Appellant
______________________

2017-2149, 2017-2152, 2017-2153, 2017-2202, 2017-2203,
2017-2206
______________________

Appeals from the United States District Court for the
District of New Jersey in Nos. 1:14-cv-07992-NLH-AMD,
1:15-cv-05025-NLH-AMD, 1:15-cv-06131-NLH-AMD, 1:15-
cv-06989-NLH-AMD, 1:15-cv-07742-NLH-AMD, 1:16-cv-
00645-NLH-AMD, Judge Noel Lawrence Hillman.
______________________

ON PETITION FOR REHEARING EN BANC
______________________

C
ARYN BORG-BREEN, Green, Griffith & Borg-Breen
LLP, Chicago, IL, filed a petition for rehearing en banc for
plaintiffs-appellants. Also represented by R
OBERT FRITZ
GREEN, JESSICA TYRUS.

JOHN CHRISTOPHER ROZENDAAL, Sterne Kessler Gold-
stein & Fox, PLLC, Washington, DC, filed a response to the
petition for defendant-cross-appellant. Also represented
Case: 17-2149 Document: 96 Page: 1 Filed: 02/25/2020

HZNP FINANCE LIMITED v. ACTAVIS LABORATORIES UT, INC. 2
by KRISTINA CAGGIANO KELLY, MICHAEL E. JOFFRE,
WILLIAM H. MILLIKEN.
______________________

Before P
ROST, Chief Judge, NEWMAN, LOURIE, DYK,
MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN,
H
UGHES, and STOLL, Circuit Judges.
LOURIE, Circuit Judge, with whom NEWMAN,
O’MALLEY, and STOLL, Circuit Judges, join, dissents from
the denial of the petition for rehearing en banc.
P
ER CURIAM.
O R D E R
A petition for rehearing en banc was filed by appellants
HZNP Finance Limited and Horizon Therapeutics USA,
Inc. A response to the petition was invited by the court and
filed by cross-appellant Actavis Laboratories UT, Inc. The
petition for rehearing was first referred to the panel that
heard the appeal, and thereafter, the petition for rehearing
en banc and the response were referred to the circuit judges
who are in regular active service. A poll was requested,
taken, and failed.
Upon consideration thereof,
I
T IS ORDERED THAT:
1) The petition for panel rehearing is denied.
2) The petition for rehearing en banc is denied.
3) The mandate of the court will issue on March 3,
2020.
FOR THE COURT

February 25, 2020 /s/ Peter R. Marksteiner
Date Peter R. Marksteiner
Clerk of Court
Case: 17-2149 Document: 96 Page: 2 Filed: 02/25/2020

United States Court of Appeals
for the Federal Circuit
______________________

HZNP FINANCE LIMITED, HORIZON
THERAPEUTICS USA, INC.,
Plaintiffs-Appellants

v.

ACTAVIS LABORATORIES UT, INC.,
Defendant-Cross-Appellant
______________________

2017-2149, 2017-2152, 2017-2153, 2017-2202, 2017-2203,
2017-2206
______________________

Appeals from the United States District Court for the
District of New Jersey in Nos. 1:14-cv-07992-NLH-AMD,
1:15-cv-05025-NLH-AMD, 1:15-cv-06131-NLH-AMD, 1:15-
cv-06989-NLH-AMD, 1:15-cv-07742-NLH-AMD, 1:16-cv-
00645-NLH-AMD, Judge Noel Lawrence Hillman.
______________________
LOURIE, Circuit Judge, with whom NEWMAN, O’MALLEY,
and S
TOLL, Circuit Judges, join, dissenting from the de-
nial of the petition for rehearing en banc.
I respectfully dissent from the court’s decision not to
rehear this case en banc. I believe the panel majority, af-
firming the district court, has erroneously misconstrued
the “consisting essentially of” language in evaluating the
definiteness requirement of 35 U.S.C. § 112.
The petition for rehearing asserts that the panel erred
in holding that the claims reciting “consisting essentially
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HZNP FINANCE LIMITED v. ACTAVIS LABORATORIES UT, INC. 2
of” are indefinite because the basic and novel properties
that the specification indicates the claimed composition
possess are indefinite. I agree with the petition.
It is not disputed that “consisting essentially of” gener-
ally means that the composition not contain, in addition to
its enumerated components, materials that materially af-
fect the basic and novel properties of the invention. PPG
Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed.
Cir. 1998). The majority here, affirming the district court,
concluded that the claim was indefinite because of incon-
sistencies in the meaning of “better drying time.”
However, better drying time is not in the claim, and it
is the claims that the statute requires be definite. Claim
49 of U.S. Patent 8,252,838 (“the ’838 patent”), at issue,
certainly is definite on its face. It reads:
49. A topical formulation consisting essentially of:
1–2% w/w diclofenac sodium;
40–50% w/w DMSO;
23–29% w/w ethanol;
10–12% w/w propylene glycol;
hydroxypropyl cellulose; and
water to make 100% w/w,
wherein the topical formulation has a vis-
cosity of 500–5000 centipoise.
’838 patent col. 30 ll. 60–67. It recites diclofenac, the main
active ingredient of the composition, three other specific ex-
cipients, all with precise and definite quantity ranges; one
more excipient with no range; and the remainder consist-
ing of water. Drying time is not recited.
The “consisting essentially of” language connotes that
those specified are the claim’s essential ingredients, but it
is not closed to others. The word “essential” is key. The
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HZNP FINANCE LIMITED v. ACTAVIS LABORATORIES UT, INC. 3
possibility of inclusion of others, implied by the language
at issue here, does not make what is recited and essential
indefinite.
The utility of the claimed invention, recited in the spec-
ification, is as an anti-inflammatory, or analgesic, because
those are the principal properties of diclofenac, the main
ingredient of the composition. The specification also indi-
cates that the advantages of the claimed composition are
better drying time, higher viscosity, increased transdermal
flux, greater pharmacokinetic absorption, and favorable
stability. ’838 patent col. 4 ll. 22–27. This disclosure in-
forms the public about the nature of the claimed invention
and may satisfy other requirements of § 112 as well as the
utility requirement of § 101. These advantages are cer-
tainly relevant to showing that an invention has utility and
may be important in overcoming a rejection for obvious-
ness. But it is the language of the claims that must not be
indefinite, not the understanding or clarity of an advantage
of the invention. The advantages of the invention, its util-
ity and its basic and novel properties, are not in the claims.
Aside from the specifics of “better drying time” in this
case, the issue is of broader importance. Advantages of an
invention recited in the specification or in the prosecution
history, but not in the claims, are not part of the claims.
Certainly the written description should be consulted to in-
terpret claims, as they are drafted to be read together. See
35 U.S.C. § 112 (2010) (“The specification shall contain a
written description of the invention . . . [and] shall conclude
with one or more claims particularly pointing out and dis-
tinctly claiming the subject matter which the applicant re-
gards as his invention.”). But the advantages of an
invention and disclosure of how to make and use an inven-
tion are not to be incorporated into claims for purposes of
evaluating their indefiniteness. It is the language of the
claims that determines their definiteness.
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HZNP FINANCE LIMITED v. ACTAVIS LABORATORIES UT, INC. 4
The language at issue here, “consisting essentially of,”
is clear, definite, language indicating that the constituents
of a claim cannot include materials that affect the basic and
novel properties of the claimed composition. Such materi-
als may exist in an almost infinite variety. Certainly, such
a claim should not be successfully asserted against a com-
position that contains materials that render the composi-
tion unfit for its stated purpose. But until a suit arises, one
does not know what such an inconsistent material might
be. That does not make the claim indefinite.
In an infringement suit, the meaning of the “consisting
essentially of” language should boil down to a fact question,
i.e., whether the presence of an unrecited material in an
accused product is in fact inconsistent with, or defeats the
purpose of, the claimed composition. See PPG, 156 F.3d at
1357 (holding that, for a claim reciting glass “consisting es-
sentially of” certain materials, the district court properly
“left it to the jury to determine whether the amounts of [an
unclaimed ingredient had] a material effect on the basic
and novel characteristics of the glass”). There may be no
question that a poison, such as arsenic, might be excluded
from a claim. But the fact that one generally has to deter-
mine this question at trial does not make the claim indefi-
nite. To hold to the contrary is to vitiate established usage
that indefiniteness of claims is to be determined based on
what the claim recites, not advantages cited in the specifi-
cation.
An example of how converting uncertainty concerning
measuring a property of an invention into indefiniteness of
claims may lead to unintended and incorrect results is as
follows:
Assume a claim recites a new and nonobvious com-
pound, the usual situation of invention of a new pharma-
ceutical, not a composition of several components as here.
It is not necessary under our law to recite in the claims the
utility of the claimed compound, say, as an anti-
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HZNP FINANCE LIMITED v. ACTAVIS LABORATORIES UT, INC. 5
inflammatory. That is stated in the specification. It is also,
under current law, unnecessary to recite in the claims how
that effect is measured. The utility or advantage of the
claimed compound are not generally challenged in exami-
nation unless they are not credible. MPEP § 2107 (9th ed.
Rev. 08.2017, Jan. 2018). Thus, aspects of the utility or its
measurement are not relevant to indefiniteness of the
claims. And since how one measures anti-inflammatory ac-
tivity does not create an indefiniteness issue, why should
measuring better drying time? In fact, one wonders
whether, if this patent did not recite the methods by which
better drying time was measured, any indefiniteness of the
“consisting essentially of” language would have arisen at
all. Unfortunately, under the rule this opinion purports to
adopt, any uncertainty concerning advantages, utility, or
methods of determining such could, wrongly in my view, be
translated into indefiniteness of claims.
To be sure, this example does not deal with the “con-
sisting essentially of” language, but the principle of import-
ing an uncertainty in measuring an advantage of an
invention could have unintended potential effects well be-
yond this particular case. It should not be sound precedent.
I therefore respectfully dissent from the court’s deci-
sion not to rehear this case en banc to clarify that the “con-
sisting essentially of” language does not render these and
similar claims that do not recite advantages of an invention
or methods of measuring them indefinite.
Case: 17-2149 Document: 96 Page: 7 Filed: 02/25/2020