Categories: 103 Date: Dec 11, 2013 Title: Golderma Lab v. Tolmar: Obviousness when Prior Art Range Encompasses Claimed Value
|Title||Golderma Lab., LP v. Tolmar, Inc., No. 2013-1034 (Fed. Cir. Dec. 11, 2013).|
|Issue||The relevant dispute in this case is thus not over whether the prior art discloses all of the claim elements or over the motivation to combine the prior art references [since all the features are taught, but for a concentration value that nonetheless falls within a range disclosed in the prior art]. Rather, the dispute is whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.|
Golderma Lab. at *9 (text added).
|Holding||[W]e hold that 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 are invalid as obvious [because: A. the prior art does not actually disparage selection of 0.3% adapalene composition in the disclosed range; B. a percent increase constitutes only a difference in degree from the prior art; and C. evidence of commercial success diminishes when market entry by others is precluded by a blocking patent]. |
Id. at *15 (text added).
|Procedural History||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.|
Golderma Lab. at *2.
|Legal Reasoning (Prost, Bryson)|
|Representative Claim 5 (of U.S. Pat. 7,838,558):||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 anti-acne ingredient is adapalene.|
Golderma Lab. at *3.
|All claim features taught, but for 0.3% value||The asserted claims are directed to 0.3% topical adapalene compositions for the treatment of acne, which fall within the 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.|
Id. at *6-7.
|Obviousness Standard: Prior Art discloses range encompassing claimed value||In these circumstances, where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary con- siderations. See Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346, 1352-54 (Fed. Cir. 2013).|
Id. at *9.
|A. Teaching Away: the Prior Art of Record does Not Disparage or Criticize the claimed 0.3% adapalene concentration|
|Teaching Away sandard||A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. A reference does not teach away, however, if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed. Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009).|
Golderma Lab. at *10.
No Dispragement of claimed 0.3% adapalene concentration
|Alirezai 1996 articles, which show that the increase in adapalene concentration from 0.03% to 0.1% resulted in an increase in side effects. Neither of these articles mentions 0.3% adapalene compositions, nor do they expressly teach away from the claimed invention. The district court inferred that these references taught away from a further tripling of the adapalene concentration. We cannot agree with this inference.|
These articles show increased side effects associated with 0.1% adapalene as compared to 0.03% adapalene, yet they failed to discourage even the use of 0.1% adapalene.
Id. at *11.
|The district court relied on the Allec 1997, Verschoore 1997, and Czernielewski 2001 articles to demonstrate that 0.1% was the standard or optimal concentration of adapalene for the treatment of acne. The court concluded that this fact teaches away from 0.3% adapalene compositions. It does not. […] A teaching that a composition may be optimal or standard does not criticize, discredit, or otherwise discourage investigation into other compositions.|
Id. at *11.
|B. Unexpected Results: A percent Increase Constitutes Only a Difference in Degree from the Prior Art|
|Legal Standard||Unexpected results that are probative of non- obviousness are those that are “different in kind and not merely in degree from the results of the prior art.” […] Results which differ by percentages are differences in degree rather than kind, where the modification of the percentage is within the capabilities of one skilled in the art at the time. […] [W]here an unexpected increase in efficacy is measured by a small percentage, as here, and the evidence indicates that skilled artisans were capable of adjusting the percentage, the result constitutes a difference in degree, not kind. So too, where an increase by a percentage is expected but not found, that result is also likely only a difference in degree.|
Golderma Lab. at *12 (some internal citations omitted).
|In the art, an increase from 0.1% and 0.3% is a difference in degree||In this case, the expected result was an increase, by some percentage, in the prevalence of certain side effects. The failure of that percent increase to materialize, though unexpected, constitutes only a difference in degree from the prior art results. Accordingly, the comparable tolerability of 0.1% and 0.3% adapalene does not indicate that the asserted claims are non-obvious.|
Id. at *12-13.
|C. Commercial Success: Evidence of Commercial Success Diminishes when Market Entry by Others is Precluded by a Blocking Patent|
|Commercial Success and blocking Patents||“Commercial success is relevant because the law presumes an idea would successfully have been brought to market sooner, in response to market forces, had the idea been obvious to persons skilled in the art.” Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir. 2005). Where “market entry by others was precluded [due to blocking patents], the inference of non-obviousness of [the asserted claims], from evidence of commercial success, is weak.” Id. at 1377. This principle applies forcefully to the present case.|
Golderma Lab. at *14.
|The commercial success of patented device is of “minimal probative value" since it was covered by a blocking patent||The now expired Shroot patents blocked the market entry of 0.3% adapalene products until their expiration in 2010, long after Galderma invented 0.3% adapalene compositions of the asserted claims. As such, no entity other than Galderma could have successfully brought to 0.3% to market prior to 2010. Like the commercial success described in Merck & Co., the commercial success of Differin® Gel, 0.3% is of “minimal probative value.” Id. at 1376. Accordingly, we conclude the district court erred in adjudging this factor as confirming its conclusion of non- obviousness.|
Id. at *14-15.
|For the foregoing reasons, we hold that 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 are invalid as obvious. We therefore reverse the district court’s finding that the claims are valid.|
Id. at *15.
|NEWMAN, Circuit Judge, dissenting. Golderma Lab., Newman Op. at *1.|
|Grounds for Dissent, generally||Here, the district court fully explored the evidence relating to whether it would have been obvious to increase by 300% the concentration of the active ingredient adapalene without increasing its known adverse side effects. The district judge held an eight-day bench trial, heard thirteen live witnesses including expert witnesses of stature and experience, and received evidence and argument from both sides. The court issued an opinion with over 50 pages on the issue of obviousness, finding the facts and weighing the evidence and applying the law with thoughtful explanation and reasoning. My colleagues on this panel give scant attention to the district court’s analysis, instead making their own findings, and applying flawed procedural and substantive law. My colleagues do not identify clear error in the district court’s findings; instead they distort the burdens of proof and production, ignore the applicable standard of proof and rely on their own factual determinations and creative theories of law, and eradicate the patent.|
Golderma Lab., Newman Op. at *2.
|A. Teaching Away||The district court also found that Allec (1997), Verschoore (1997) and Czernielewski (2001) “would also have taught away from tripling the concentration of adapalene from 0.1% to 0.3%, which would have been a significant deviation from the then-understood optimal concentration.” DCt. Op. at 642. The court found that the experience of those skilled with other topical retinoids that had been approved for human use, such as tretinoin and tazarotene, further taught away from tripling of the concentration of adapalene. The court explained that both tretinoin and tazarotene faced tolerability problems which required the manufacturers to decrease their concentration in products for the treatment of acne. Clear error has not been shown in these findings.|
Id. at *15.
|B. Unexpected Results||The district court explained that differences in degree occur when the invention is merely a continuation of a trend previously described in the prior art. Id. at n. 14 (citing In re Huang, 100 F.3d 135 (Fed. Cir. 1996); Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1323 (Fed. Cir. 2004)). Here, the prior art showed a trend to increased adverse side effects with increased concen- tration, while Galderma’s products violated that trend. This was a difference in kind, not in degree. Clear error has not been shown in these findings, all of which are discounted or ignored by the panel majority.|
Id. at *16.
|C. Commercial Success||My colleagues discount the factor of commercial suc- cess, arguing that the entry of 0.3% adapalene products, by Tolmar or others, had previously been blocked by the Shroot patents. Maj. op. at 14. However, the evidence in the district court was that the 0.3% product was success-ful against the 0.1% product and other acne medications. The district court did not err in including evidence of commercial success in its evaluation of the question of obviousness.|
Id. at *15.
|Shifting Burdens||My colleagues hold that for inventions “where there is a range disclosed in the prior art, and the claimed invention falls within that range,” the burden falls upon the patentee to support patentability. Maj. op. at 9. This is not just a shift in the burden ofproduction; the majority never requires that Tolmar meet its burden of persuasion. Instead, once Tolmar had demonstrated that the invention fell within a broad range disclosed in the prior art, according to the panel majority, Tolmar met its evidentiary burden. My colleagues do not require that the prior art provide some reason for selec- tion of the patented embodiment. Instead, the court places the burden of “rebuttal” on the patentee, and limits rebuttal to the “secondary considerations.”|
Id. at *18.