NOTE: This disposition is nonprecedential.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 Pharmaceuticals 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 Judges.

PER CURIAM. 

In related district-court actions, plaintiff Galderma

Laboratories, L.P., along with other patent-asserting

parties, alleged that the Abbreviated New Drug Applications 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 Patents, 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 additional 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. Specifically, 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 substantially no anti-microbial activity.” 

During trial, Mylan identified eight prior-art references 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 references that disclosed lower tetracycline dosages, between 

40 and 60 mg. Id. And the district court made no findings on whether any of the prior art contained the additional 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 “tetracycline compound has substantially no anti-microbial activity.” Id. 

A determination that a patent claim is invalid as anticipated under 35 U.S.C. § 102 “requires that a prior art 

reference disclose every limitation of the claimed invention, 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 particular, when a dependent claim adds an element to an independent claim, and the challenger sufficiently raises the 

point, an anticipation analysis must examine the additional 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 endogenous nitric-oxide production, but it never determined, as 

required, whether those treatments also had “substantially 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 parties 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 anticipate 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 district court likely came to overlook the additional elements 

of these dependent claims. In their post-trial papers, the 

patent-asserting parties mentioned the additional elements of these claims in a proposed finding of fact, Galderma’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 production. 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 dependent 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 Pharmaceuticals 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