Blog May 19, 2023
Legal Alert: Amgen v. Sanofi
The Fed Cir reverses judgment of non-obviousness. The patents-in-suit cover compositions for and methods of treating acne with 0.3% adapalene and other inactive ingredients. The prior art disclosed (1) adapalene for treatment of acne at "preferred" concentrations of 0.01%-1%; (2) all the inactive ingredients or equivalents in the claimed composition; (3) suitability of 0.3% adapalene lotion for treating acne in an animal model; and (4) suitability for 0.3% adapalene for other conditions without intolerable irritability. --more-->
Galderma Labs., L.P. v. Tolmar, Inc., __F.3d__ (Fed. Cir. Dec. 11, 2013) (Newman (dissent), Bryson, PROST) (D. Del.; Stark) (3 of 5 stars)
Obviousness: The relevant issue was whether there was a motivation to select 0.3% adapalene in the disclosed range, not whether there was motivation to triple the concentration of active ingredient in patentee's prior commercial product (0.1% adapalene), as the district court ruled. Slip op. at 8-9. On this legal question, the Fed Cir held that "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 considerations." Id. at 9. The patents were obvious because the patentee's evidence was insufficient on each point.
Teaching Away: Prior art disclosures that increasing adapalene concentration from 0.03% to 0.1% increased side effects did not teach away because they did not mention the claimed amount and did not discourage the use of relevant concentration. Other prior art disclosures that 0.1% adapalene was "optimal" or "standard" for acne treatment did not teach away because "[a] teaching that a composition may be optimal or standard does not criticize, discredit, or otherwise discourage investigation into other compositions." Id.
Unexpected Results: "Unexpected results that are probative of nonobviousness are those that are different in kind and not merely in degree from the results of the prior art." Id. at 12. The increased efficacy of 0.3% adapalene was not probative of non-obviousness because "[r]esults 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." Id. Likewise, that side effects remained the same was not probative because "where an increase by a percentage is expected but not found, that result is also likely only a difference in degree." Id.
Commercial Success: Rejecting the district court's finding of commercial success, the Fed Cir held that "[t]he mere fact that generic pharmaceutical companies are seeking approval to market a generic version of a drug, without more, is not evidence of commercial success that speaks to the non-obviousness of patent claims" because it "tells us very little about the level of commercial success of the patented invention relative to the prior art." Id. at 14. The patentee's quickly rising sales upon introduction of its 0.3% product did not support an inference of commercial success where a blocking patent prevented potential competitors from entering the market.
The Dissent: Judge Newman would have given greater deference to the district court's findings, and criticized the majority's shifting of the burden to the patentee to come forth with objective considerations of non-obviousness. In Judge Newman's view, there was commercial success because the 0.3% drug was successful against other acne medications, and there was a teaching away because formulations of other acne drugs failed when concentrations were increased. And that the 0.3% product did not conform to the trend of dose-dependent side effects suggested by the prior art was an unexpected difference in kind, not in degree.
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