Galderma Labs., L.P. v. Tolmar, Inc., 2013-1034
| Decision Date | 11 December 2013 |
| Docket Number | 2013-1034 |
| Parties | GALDERMA LABORATORIES, L.P., GALDERMA S.A., AND GALDERMA RESEARCH AND DEVELOPMENT, S.N.C., Plaintiffs-Appellees, v. TOLMAR, INC., Defendant-Appellant. |
| Court | U.S. Court of Appeals — Federal Circuit |
Appeal from the United States District Court for the District of Delaware in No. 10-CV-0045, Judge Leonard P. Stark.
CHARLES E. LIPSEY, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Reston, Virginia, argued for plaintiffs-appellees. With him on the brief were HOWARD W. LEVINE, SANYA SUKDUANG, CORTNEY B. CASP, and VICTORIA S. LEE, of Washington, DC.
THOMAS P. STEINDLER, McDermott Will & Emery LLP, of Washington, DC, argued for defendant-appellant. With him on the brief were JEFFREY R. GARGANO and KEITH M. STOLTE, of Chicago, Illinois.
Before NEWMAN, BRYSON, and PROST, Circuit Judges.
Opinion for the court filed by Circuit Judge PROST.
In this patent infringement case, Tolmar, Inc. challenges the district court's holding that the claims of U.S. Patent Nos. 7,579,377 ('377 patent); 7,737,181 ('181 patent); 7,834,060 ('060 patent); 7,838,558 ('558 patent); and 7,868,044 ('044 patent), which are owned by Galderma Laboratories, L.P., Galderma S.A., and Galderma Research and Development, S.N.C. (collectively, "Galderma") are not invalid under 35 U.S.C. § 103. We find that the district court erred in finding the claims of the asserted patents not invalid as obvious. Accordingly, we reverse.
This Hatch-Waxman case is based on Tolmar's filing of an Abbreviated New Drug Application ("ANDA") seeking approval to market a generic version of Differin® Gel, 0.3%, which is a topical medication containing 0.3% by weight adapalene approved for the treatment of acne. On January 21, 2010, Galderma sued Tolmar in the United States District Court for the District of Delaware, alleging that Tolmar's ANDA product infringed certain claims of the '377 patent. Galderma subsequently filed amended complaints alleging infringement of each of the asserted patents. After a bench trial, the district court ruled against Tolmar on several issues of which only invalidity under 35 U.S.C. § 103 is at issue in this appeal.
The asserted patents include both composition claims and claims directed to methods of treating acne usingpharmaceutical compositions. At trial, Galderma alleged infringement of claims 35 and 36 of the '181 patent, claims 24 and 27 of the '060 patent, claim 5 of the '558 patent, and claims 40 and 41 of the '044 patent.1 Each of the asserted claims requires an aqueous gel or cream that includes 0.3% by weight of adapalene. The asserted claims also recite one or more inactive excipients included in the gel or cream. Claim 5 of the '558 patent is representative:
5. A topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a topically applicable, pharmaceutically acceptable aqueous gel comprising at least one carbomer gelling agent and wherein the sole antiacne ingredient is adapalene.
Below, Tolmar based its obviousness argument primarily on three pieces of prior art: U.S. Patent No. 4,717,720 ("Shroot '720 patent"), U.S. Reissue No. 34,440 ("Shroot '440 patent"), and the Differin® 0.1% Gel Data Sheet ("Data Sheet").
The Shroot '720 patent specifically discloses and claims adapalene along with other inventive compounds. Col. 3 ll. 9-10; col. 4 ll. 29-37; col. 9 ll. 39-54; col. 19 l.17-col. 20 l. 19. Four of the seven composition examples in the Shroot '720 patent disclose adapalene as the active ingredient, in concentrations of 0.001%, 0.1%, and 1%. Col. 16 ll. 35-53; col. 17 ll. 20-52. The specification of the Shroot '720 patent states repeatedly that the inventivecompounds are useful for the treatment of acne. See col. 4 ll. 53-59; see also col. 5 ll. 49-53. Moreover, the specification states that the inventive compounds can be used in concentrations "preferably between 0.01 and 1 weight percent, based on the total weight of the composition." Shroot '720 patent col. 5 ll. 61-64. Finally, the Shroot '720 patent indicates that the inventive compounds "are less irritating than known retinoids of analogous structure." Col. 4 ll. 48-51. The Shroot '440 patent is largely similar to the Shroot '720 patent, but also contains claim 4, which recites a preferred range of 0.01 to 1% for cosmetic compositions which include the inventive compounds, e.g., adapalene, as the active ingredient. Shroot '440 patent col. 20 ll. 15-18. Notably, prior to their expiration, the Shroot patents were listed in the FDA's Orange Book as covering Galderma's prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.
The Data Sheet is the product insert for Galderma's earlier launched adapalene product. The Data Sheet discloses 0.1% adapalene as a treatment for acne. It also discloses all but one of the inactive ingredients listed in the asserted claims. Other than the dosage of adapalene, the only difference between the claimed formulations and the formulation taught by the Data Sheet is that the Data Sheet discloses "poloxamer 182," while certain asserted claims list "poloxamer 124."
In addition to the Shroot patents and the Data Sheet, Tolmar provided other relevant evidence. For instance, a 1989 article by Jamoulle et al. describes the use of a lotion containing 0.3% adapalene in an animal model to determine whether adapalene was suitable for the treatment of acne. The authors concluded from this test that adapalene was "particularly suitable for the treatment of acne." J.A. 13063. A series of other prior art articles demonstrate that 0.03% and 0.1% adapalene products were effective against acne and well tolerated. These articles include: Verschoore et al., Efficacy and Safety of CD 271Alcoholic Gels in the Topical Treatment of Acne Vulgaris, 124 British J. of Derm. 368-71 (1991) ("Verschoore 1991"); Alirezai et al., Comparative Study of the Effectiveness and Tolerance of 0.1 and 0.03 Percent Adapalene Gels and of a 0.025 Percent Tretinoin Gel in the Treatment of Acne, 123 Ann. Dermatol. Venereol. 165-70 (1996) ("Alirezai 1996"); Allec et al., Skin Distribution and Pharmaceutical Aspects of Adapalene Gel, 35(6) J. Am. Acad. of Dermatol. S119-25 (1997) ("Allec 1997").
The prior art also teaches the use of 0.3% adapalene for other conditions without intolerable irritability. See Verschoore et al., Adapalene 0.1% Gel Has Low Skin Irritation Potential, 36(6) J. Am. Acad. of Dermatol. S104-09 (1997) ("Verschoore 1997"); Goldfarb, Using Adapalene to Treat Photodamage, Supp. to Skin & Aging 4-7 (Nov. 2000) ("Goldfarb Article"); Goldfarb et al., Photographic Assessment of the Effects of Adapalene 0.1% and 0.3% Gels and Vehicle on Photodamage Skin, 14 (Supp. 1) J. Eur. Acad. Dermatol. Venerol. 315 (2000) ("Goldfarb Abstract"); Euvrard, "How Adapalene Can Treat Actinic Keratoses," Supp. to Skin & Aging 12-15 (Nov. 2000) ("Euvrard 2002").2 There was also an indication in the prior art that dermatologists preferred other retinoids to adapalene at least in part because they were available in multiple concentrations whereas adapalene was only available in one. Bershad et al., Topical Retinoids in the Treatment of Acne Vulgaris, 64 (Supp. 2) Cutaneous Med. for the Practitioner 8-19 (Aug. 1999) ("Bershad 1999"). Finally, the prior art indicated that many skilled artisans believed at the time of the invention that 0.1% was the optimal concentration of adapalene for the treatment ofacne. See Verschoore 1997; Allec 1997; Czernielewski et al., Adapalene Biochemistry and the Evolution of a New Topical Retinoid for Treatment of Acne, 15 (Supp. 3) J. Eur. Acad. Dermatol. Venerol. 5-12 (2001) ("Czernielewski 2001").
The determination of invalidity for reasons of obviousness under 35 U.S.C. § 103 is a legal conclusion based on underlying facts. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Following a bench trial, we "review the district court's factual findings for clear error and its conclusions of law de novo." Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1344-45 (Fed. Cir. 2000).
Factual considerations that underlie the obviousness inquiry include the scope and content of the prior art, the differences between the prior art and the claimed invention, the level of ordinary skill in the art, and any relevant secondary considerations. See Graham, 383 U.S. at 17-18. Relevant secondary considerations include commercial success, long-felt but unsolved needs, failure of others, and unexpected results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007); In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). Because patents are presumed valid, Tolmar was required to prove that the asserted claims were obvious by clear and convincing evidence. See Microsoft Corp. v. i4i Ltd. P'ship, 131 S. Ct. 2238, 2242 (2011).
Tolmar presents an obviousness case that is both straightforward and potent. At the time of the invention, adapalene was a known compound and the prior art Shroot patents disclose topical adapalene compositions for the purpose of treating acne in a preferred range of 0.01%-1%, including several exemplary formulations containing adapalene in various concentrations. The asserted claims are directed to 0.3% topical adapalene compositions for the treatment of acne, which fall withinthe concentration range disclosed in the Shroot patents. Thus, the Shroot patents disclose all of the limitations of the asserted claims, except for a precise teaching of 0.3% adapalene and the specific inactive ingredients of the asserted claims. The specific inactive ingredients of the asserted claims are, however, taught by the Data Sheet.
The Data Sheet discloses each of the...
To continue reading
Request your trial