Galderma Laboratories, L.P. v. Tolmar, Inc., 737 F.3d 731

Tolmar alleged patent infringement of Galderma’s 0.3% adapalene gel products in an ANDA case; five Galderma patents ('377, '181, '060, '558, '044) were in suit.
The district court held the asserted claims not invalid under 35 U.S.C. § 103 (obviousness) after a bench trial.
Tolmar appeals, contending the claims are obvious in view of a prior-art range for adapalene and the Data Sheet, and that the district court erred on multiple obviousness factors.
Key prior art includes Shroot '720 and Shroot '440 patents disclosing adapalene within a broad range (including 0.01–1%), and Galderma’s 0.1% Differin Gel Data Sheet disclosing inactive ingredients and compositions.
Additional prior art and articles (e.g., Verschoore, Alirezai, Allec, Czernielewski, Goldfarb, Euvrard, Bershad, Jamoulle) discussed tolerability, irritation, and varying concentrations of adapalene.
The panel reversed the district court’s finding of no obviousness, holding the asserted claims invalid; the dissent would affirm the district court’s decision based on the evidence of teaching away, unexpected results, and commercial considerations.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Was 0.3% adapalene obvious in view of prior art range?	Tolmar—obvious because range taught by Shroot encompassed 0.3%.	Galderma—selection within a disclosed range is not automatically obvious; requires motivation/secondary considerations.	No; the court held the claims invalid as obvious.
Did the district court err on teaching away and related factors?	Tolmar—prior art taught away from 0.3% due to dose-related irritancy.	Galderma—evidence supports teaching away; trial findings are sufficient.	No; the court found the district court erred in concluding teaching away. (For the panel majority, this supports invalidity.)
Do unexpected results and commercial success support nonobviousness?	Tolmar—unexpected tolerability at 0.3% and market success support patentability.	Galderma—these secondary considerations are not enough to overcome strong prior-art range.	No; the court found unexpected results and commercial success insufficient to overcome obviousness.

Graham v. John Deere Co., 383 U.S. 1 (U.S. 1966) (obviousness factors; factual inquiries for §103)
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. 2007) (teaching-suggestion-motivation standard for obviousness in a range)
Cyclobenzaprine Hydrochloride Litigation, 676 F.3d 1063 (Fed. Cir. 2012) (burden-shifting, proper approach to obviousness review)
Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) (commercial success and nexus considerations in obviousness)
In re Cyclobenzaprine, 676 F.3d 1063 (Fed. Cir. 2012) (discusses proper weighting of evidence in obviousness analysis)
In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012) (obviousness includes multiple factual inquiries not resolved by presumption)
Anderson v. Bessemer City, 470 U.S. 564 (U.S. 1985) (trial-level findings; appellate deference for credibility)