Tuesday, December 07, 2021


: Teva lost its appeal to the CAFC in the case involving mifepristone [here, Korlym, a 300 mg mifepristone tablet ] :

Teva faults the Board for, in its view, committing two legal errors. First, it claims the Board required precise predictability, rather than a reasonable expectation of success, in achieving the claimed invention. That is, Teva argues the Board improperly required it “to show an expectation that the specific dose recited in the claims would have been safe.” Appellant’s Br. at 41. Second, Teva claims the Board ought to have applied our prior-art-range precedents. In Teva’s view, the Board committed legal error when it found Teva had failed to prove the general working conditions disclosed in the prior art encompassed the claimed invention. We do not agree.

As to reasonable expectation of success:

We start by addressing Teva’s reasonable-expectationof-success argument. “The presence or absence of a reasonable expectation of success is . . . a question of fact,” which we review for substantial evidence. Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016). Whether the Board applied the correct standard in assessing reasonable expectation of success, however, is a question of law that we review de novo. See Endo Pharms. Inc. v. Actavis LLC, 922 F.3d 1365, 1377–78 (Fed. Cir. 2019). The Board did not err by requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. The reasonable-expectation-of-success analysis must be tied to the scope of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the . . . claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error . . . .”); see also Intelligent Bio-Sys., Inc., 821 F.3d at 1367. Here, claim 1 of the ’214 patent requires safe administration of a specific amount of mifepristone, 600 mg per day. See Final Decision at *7–9 (construing claims to require safe administration, rather than just administration). Thus, the Board was required to frame its reasonable-expectation-of-success analysis around that specific dosage of mifepristone.

Of overlapping ranges:

We next address the applicability of our prior-art-range cases—i.e., the cases in which a claimed range of values overlap the ranges disclosed in the prior art. The Board declined to apply those cases because it found Teva had failed to prove the general working conditions disclosed in the prior art encompass the claimed invention. The scope and content of the prior art is a question of fact, reviewed for substantial evidence. SIPCO, LLC v. Emerson Elec. Co., 980 F.3d 865, 870 (Fed. Cir. 2020).

“For decades, this court and its predecessor have recognized that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (quotation marks omitted). “A more specific application of this general principle is that a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” Id. (quotation marks and alterations omitted). But overlap is not strictly necessary for a conclusion of obviousness: “obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); accord In re Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018); Valeant Pharms. Int’l, Inc. v. Mylan Pharms. Inc., 955 F.3d 25, 32 (Fed. Cir. 2020).


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