N OTE : This disposition is nonprecedential. 

# United States **Court of Appeals**  **for the Federal Circuit**

______________________
THE RESEARCH FOUNDAT ION OF STATE UNIVERSITY OF NEW YO RK, Plaintiff,

AND

NEW YORK UNIVERSITY, Plaintiff

- Cross Appellant,

AND

GALDERMA LABORATORIE S INC., AND GALDERMA LABORATORIE S, L.P., Plaintiffs

- Cross Appellants,

v.

MYLAN PHARMACEUTICALS INC., Defendant

- Appellant.

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

MYLAN PHARMACEUTICAL S INC., Plaintiff

- Appellant,

v.

GALDERMA LABORATORIE S INC., AND GALDERMA LABORATORIE S, L.P., Defendants

- Cross Appellants,RESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 2

AND

SUPERNUS PHARMACEUTI CALS, 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 FOUNDAT ION OF STATE UNIVERSITY OF NEW YO RK, Plaintiff,

AND

SUPERNUS PHARMACEUTI CALS, INC., Plaintiff

- Appellee,

AND

NEW YORK UNIVERSITY,

P laintiff

- Cross Appellant,

AND

GALDERMA LABORATORIE S INC., AND GALDERMA LABORATORIE S, L.P., Plaintiffs

- Cross Appellants,

v.

IMPAX LABORATORIES, INC., Defendant

- Appellant.RESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 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

- 111 2, Judge Leonard P. Stark.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -RESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 4

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

______________________

A NDREW P. Z APPIA , LeClairRyan, of Rochester, New York, argued for New York University. With him on the brief was W ENDELL W. H ARRIS

.

G ERALD J. F LATTMANN , J R

. , Paul Hastings LLP, of New York, New York, argued for Galderma LaboratoriesRESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 5

Inc., et al. , and Supernus Pharmaceuticals, Inc. With him on the brief were M ELANIE R. R UPERT and E VAN D. D I AMOND

. Of counsel on the brief was S TEPHEN B. K INNAIRD , of Washington, DC. Of counsel was C HRISTINE W ILLGOOS , of New York, New York.

D AVID S. S TEUER , Wilson Sonsini Goodrich & Rosati, of Palo Alto, California, argued for M ylan Pharmaceut icals Inc. With him on the brief were M ATTHEW R EED and K IRIN G ILL

. Of counsel on the brief were T UNG -O N K ONG , of San Francisco, California

, and L ORELEI W ESTIN , of San Diego, California.

W ILLIAM A. R AKOCZY , Rakoczy Molino Mazzochi Siwik LLP, of Chicago, Illinois, for L upin Limited, et al. With him on the brief were P AUL J. M OLINO , J OSEPH T. J AROS , and R OBERT M. T EIGEN

.

E RIC H. W EISBLATT , Wiley Re in, LLP, of Washington, DC, for Impax Laboratories, Inc. With him on the brief

was G REGORY R. L YONS

.

______________________
Before N EWMAN , R EYNA , and T ARANTO , Circuit Judges.
P ER C URIAM

. In related district

- court actions, p laintiff Galderma Laboratories, L.P., along with other patent

- asserting parties, alleged that the Abbreviated New Drug Applic ations 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 o n 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 StateRESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 6
Univ. of New York v. Mylan Pharm s. 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 P atents, 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 add itional claim elements of the thr ee 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 Am in 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. G alderma 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 substantia lly no anti

- microbial activity .” During trial, Mylan identif ied eight pri or- art refe rences that disclosed treating periodontitis or rheumatoid arthritis, both chronic inflammatory disorders

, with between 40 and 200 mg of a tetracycline daily

. The district court fou nd that the “ higher dos ag e” prior

- artRESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 7

references

, i.e. , daily t etracycline 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 refe rences that disclosed lower tetracycline dosages

, between 40 and 60 mg. Id. And the district court made no fin dings on whether any of the prior art contained the add itional limitation s 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 “tetrac ycline compound has substantially no ant i- microbial activ ity. ” Id.

A determination that a patent claim is invalid as a nticipated under 35 U.S.C. § 102 “ requires that a prior art reference disclose every limitation of the claimed inve ntion, either explicitly or inherently. ” Li ebel

- 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 partic ular, when a dependent claim adds an element to an ind ependent claim

, and the challenger sufficiently raises the point, an anticipation analysis must examine the add itional element

— which, by definition, it will not have been necessary to analyze in assessing anticipation of the independent claim not containing the added el ement. See Dayco Prod s. , 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 endo genous nitric

- oxide production, but it never determined , as required, whether those treatments also had “substantia lly no anti

- microbial activity.” Th is limitation made claims 2 and 14 of the ’395 Patent and claim 2 of the ’775 Patent materially different from the independent claimsRESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 8
for the purpose of determining validity, and the district

cou rt erred by not addressing it. We reject the suggestion of the patent

- asserting pa rties that this court not only vacate but reverse on these cla i ms , 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. E ven if the larger dosage references did not antic ipate 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 dos ag e references disclosed expressl y or inherently. Without such findings, t his 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 di strict court likely came to overlook the additional elements of these dependent claims. I n t he ir post

- trial papers, the patent

- assert ing parties mentioned the additional el ements of these claims in a proposed finding of fact, Ga lderma’s Post

- Tri al Proposed Findings of Fact at 23, ¶ 162 Research Found. of State Univ. of New York

, 809 F. Supp. 2d 2 96 (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 tetracycli ne to inhibit endogenous nitric

- oxide produ ction. See Galderma’s Post -T rial 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 depen dent 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 itsRESEARCH FOUNDATION v. MYLAN PHARMACEUTICAL S 9
merits. Indeed, they admitted that the patent

- assert ing parties presented the distinct challenge to the dependent claims

. See Letter fr om Appellant Mylan Pharmaceut icals 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.

C OS TS
No costs.

AFFIRMED

- IN

- PART, VACATED

- IN

- PART, AND REMANDED