Research Foundation of State University v. Mylan Pharmaceuticals Inc.

NOTE: This disposition is nonprecedential.

United States Court of Appeals
for the Federal Circuit
______________________

THE RESEARCH FOUNDATION OF STATE
UNIVERSITY OF NEW YORK,
Plaintiff,

AND

NEW YORK UNIVERSITY,
Plaintiff-Cross Appellant,

AND

GALDERMA LABORATORIES INC., AND
GALDERMA LABORATORIES, L.P.,
Plaintiffs-Cross Appellants,

v.

MYLAN PHARMACEUTICALS INC.,
Defendant-Appellant.

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

MYLAN PHARMACEUTICALS INC.,
Plaintiff-Appellant,

v.

GALDERMA LABORATORIES INC., AND
GALDERMA LABORATORIES, L.P.,
Defendants-Cross Appellants,
2 RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS

AND

SUPERNUS PHARMACEUTICALS, INC.,
Defendant-Appellee.
______________________

2012-1523, -1524, -1555, -1556, -1557
______________________

Appeals from the United States District Court for the
District of Delaware in Nos. 09-CV-0184 and 10-CV-0892,
Judge Leonard P. Stark.

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

THE RESEARCH FOUNDATION OF STATE
UNIVERSITY OF NEW YORK,
Plaintiff,

AND

SUPERNUS PHARMACEUTICALS, INC.,
Plaintiff-Appellee,

AND

NEW YORK UNIVERSITY,
Plaintiff-Cross Appellant,

AND

GALDERMA LABORATORIES INC., AND
GALDERMA LABORATORIES, L.P.,
Plaintiffs-Cross Appellants,

v.

IMPAX LABORATORIES, INC.,
Defendant-Appellant.
RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS 3

______________________

2012-1545, -1546, -1590, -1591, -1592
______________________

Appeals from the United States District Court for the
District of Delaware in Nos. 09-CV-0703 and 11-CV-0477,
Judge Leonard P. Stark.

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

GALDERMA LABORATORIES INC. AND
GALDERMA LABORATORIES, L.P.,
Plaintiffs-Cross Appellants,

AND

SUPERNUS PHARMACEUTICALS, INC.,
Plaintiff-Appellee,

v.

LUPIN LIMITED AND
LUPIN PHARMACEUTICALS, INC.,
Defendants-Appellants.
______________________

2012-1566, -1596
______________________

Appeals from the United States District Court for the
District of Delaware in No. 10-CV-1112, Judge Leonard P.
Stark.

------------------------------
4 RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS

THE RESEARCH FOUNDATION OF STATE
UNIVERSITY OF NEW YORK,
Plaintiff,

AND

NEW YORK UNIVERSITY,
Plaintiff-Appellant,

AND

GALDERMA LABORATORIES INC. AND
GALDERMA LABORATORIES, L.P.,
Plaintiffs-Appellants,

v.

LUPIN LIMITED AND
LUPIN PHARMACEUTICALS, INC.,
Defendants-Cross Appellants.
______________________

2012-1597, -1598, -1599
______________________

Appeals from the United States District Court for the
District of Delaware in No. 09-CV-0483, Judge Leonard P.
Stark.
______________________

Decided: August 7, 2013
______________________

ANDREW P. ZAPPIA, LeClairRyan, of Rochester, New
York, argued for New York University. With him on the
brief was WENDELL W. HARRIS.

GERALD J. FLATTMANN, JR., Paul Hastings LLP, of
New York, New York, argued for Galderma Laboratories
RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS 5

Inc., et al., and Supernus Pharmaceuticals, Inc. With him
on the brief were MELANIE R. RUPERT and EVAN D.
DIAMOND. Of counsel on the brief was STEPHEN B.
KINNAIRD, of Washington, DC. Of counsel was CHRISTINE
WILLGOOS, of New York, New York.

DAVID S. STEUER, Wilson Sonsini Goodrich & Rosati,
of Palo Alto, California, argued for Mylan Pharmaceuti-
cals Inc. With him on the brief were MATTHEW REED and
KIRIN GILL. Of counsel on the brief were TUNG-ON KONG,
of San Francisco, California, and LORELEI WESTIN, of San
Diego, California.

WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik
LLP, of Chicago, Illinois, for Lupin Limited, et al. With
him on the brief were PAUL J. MOLINO, JOSEPH T. JAROS,
and ROBERT M. TEIGEN.

ERIC H. WEISBLATT, Wiley Rein, LLP, of Washington,
DC, for Impax Laboratories, Inc. With him on the brief
was GREGORY R. LYONS.
______________________

Before NEWMAN, REYNA, and TARANTO, Circuit Judg-
es.
PER CURIAM.
In related district-court actions, plaintiff Galderma
Laboratories, L.P., along with other patent-asserting
parties, alleged that the Abbreviated New Drug Applica-
tions submitted by Mylan Pharmaceuticals Inc., Lupin
Limited, and Impax Laboratories, Inc., each constituted
an act of infringement under 35 U.S.C. § 271(e)(2). After
a four-day bench trial addressing five patents, the district
court granted the patent-asserting parties relief on one
patent: it rejected invalidity challenges to the asserted
claims of that patent and held that those claims would be
infringed by the proposed manufacture, use, and sale of
generic versions of Oracea®. Research Found. of State
6 RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS

Univ. of New York v. Mylan Pharms. Inc., 809 F. Supp. 2d
296 (D. Del. 2011). The district court denied relief on the
other patents, some of which it held invalid as to all of the
asserted claims. Id. at 307. Appeals and cross-appeals
are now before this court.
We affirm the district court in every respect, except
with regard to three dependent claims of the Amin Pa-
tents, namely, claims 2 and 14 of U.S. Patent No.
5,789,395 and claim 2 of U.S. Patent No. 5,919,775. And
we find only that issue to warrant discussion, given the
extensive analysis of the district court. We conclude that
the district court erroneously (though understandably)
applied its finding of anticipation of the independent
claims of the Amin Patents without addressing the addi-
tional claim elements of the three specified dependent
claims. We vacate the district court’s invalidity judgment
as to those dependent claims and remand for further
proceedings.
The Amin Patents claim methods for treating medical
conditions, such as inflammatory disorders, characterized
by increased endogenous nitric oxide production. Specifi-
cally, the Amin Patents claim the use of tetracyclines—a
class of antibiotics that includes doxycycline—to inhibit
nitric oxide production or nitric oxide synthase expression
or activity. Galderma licensed the Amin Patents and,
along with co-assignees New York University and the
Research Foundation of the State University of New York,
asserted twelve claims from the Amin Patents. Three of
the dependent claims—claims 2 and 14 of the ’395 patent
and claim 2 of the ’775 patent—require, in addition to the
nitric-oxide limitations of the independent claims, that
the administered “tetracycline compound has substantial-
ly no anti-microbial activity.”
During trial, Mylan identified eight prior-art refer-
ences that disclosed treating periodontitis or rheumatoid
arthritis, both chronic inflammatory disorders, with
between 40 and 200 mg of a tetracycline daily. The
district court found that the “higher dosage” prior-art
RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS 7

references, i.e., daily tetracycline dosages between 60 and
200 mg, inherently anticipated the Amin Patents because
“[t]he record shows that at these dosages . . . [nitric oxide]
production or [nitric oxide synthase] expression will be
inhibited.” See Research Found., 809 F. Supp. 2d at 329.
The district court made no findings on the prior-art refer-
ences that disclosed lower tetracycline dosages, between
40 and 60 mg. Id. And the district court made no find-
ings on whether any of the prior art contained the addi-
tional limitations found in the asserted dependent claims,
including whether any of the eight prior-art references
disclosed the limitation of claims 2 and 14 of the ’395
patent and claim 2 of the ’775 patent that the “tetracy-
cline compound has substantially no anti-microbial activi-
ty.” Id.
A determination that a patent claim is invalid as an-
ticipated under 35 U.S.C. § 102 “requires that a prior art
reference disclose every limitation of the claimed inven-
tion, either explicitly or inherently.” Liebel-Flarsheim Co.
v. Medrad, Inc., 481 F.3d 1371, 1381 (Fed. Cir. 2007).
What suffices to anticipate one claim may not suffice for
another claim containing different elements. In particu-
lar, when a dependent claim adds an element to an inde-
pendent claim, and the challenger sufficiently raises the
point, an anticipation analysis must examine the addi-
tional element—which, by definition, it will not have been
necessary to analyze in assessing anticipation of the
independent claim not containing the added element. See
Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d
1358, 1370-71 (Fed. Cir. 2003).
In invalidating all of the asserted claims of the Amin
Patents, the district court found that certain references
inherently disclosed use of a tetracycline to inhibit endog-
enous nitric-oxide production, but it never determined, as
required, whether those treatments also had “substantial-
ly no anti-microbial activity.” This limitation made
claims 2 and 14 of the ’395 Patent and claim 2 of the ’775
Patent materially different from the independent claims
8 RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS

for the purpose of determining validity, and the district
court erred by not addressing it.
We reject the suggestion of the patent-asserting par-
ties that this court not only vacate but reverse on these
claims, a suggestion based on the premise that the record
conclusively establishes “that the four Higher Dosage
References relied upon cannot meet the substantially no
antimicrobial effect limitation.” Br. for New York Univ.
at 44. Even if the larger dosage references did not antici-
pate the three dependent claims at issue for that reason—
a question on which we express no view—reversal would
not be appropriate because the district court made no
findings about what the lower dosage references disclosed
expressly or inherently. Without such findings, this court
cannot rule out anticipation of the three dependent claims
(let alone any other preserved grounds of invalidity of
those claims). See Research Corp. Techs., Inc. v. Microsoft
Corp., 536 F.3d 1247, 1254-55 (Fed. Cir. 2008). Thus, we
go no further than to vacate the invalidity judgment as to
these three claims.
We do so despite readily understanding how the dis-
trict court likely came to overlook the additional elements
of these dependent claims. In their post-trial papers, the
patent-asserting parties mentioned the additional ele-
ments of these claims in a proposed finding of fact, Gal-
derma’s Post-Trial Proposed Findings of Fact at 23, ¶ 162
Research Found. of State Univ. of New York, 809 F. Supp.
2d 296 (Civ. No. 09-184), but focused their arguments on
the independent claims, specifically, on whether the eight
identified prior-art references inherently disclosed use of
a tetracycline to inhibit endogenous nitric-oxide produc-
tion. See Galderma’s Post-Trial Brief at 22-24, Research
Found. of State Univ. of New York, 809 F. Supp. 2d 296
(Civ. No. 09-184). Despite the patent-asserting parties’
scant attention to the distinction between these depend-
ent claims and their independent claims, however, the
patent-challenging parties in this court did not argue
waiver or the like, but addressed the point entirely on its
RESEARCH FOUNDATION v. MYLAN PHARMACEUTICALS 9

merits. Indeed, they admitted that the patent-asserting
parties presented the distinct challenge to the dependent
claims. See Letter from Appellant Mylan Pharmaceuti-
cals Inc., Research Found. of State Univ. of New York v.
Mylan Pharmaceuticals Inc., No. 13-1047 (Fed. Cir. July
22, 2013).
For the foregoing reasons, we affirm the district court
judgment except as to claims 2 and 14 of the ’395 Patent
and claim 2 of the ’775 Patent. We vacate the district
court’s judgment of invalidity of those claims and remand
for further proceedings consistent with this opinion.
COSTS
No costs.
AFFIRMED-IN-PART, VACATED-IN-PART, AND
REMANDED