Wednesday, February 17, 2021

Takeda prevails at CAFC in case about alogliptin, a uracil-containing DPP-IV inhibitor useful for treating type II diabetes,

The outcome of the Takeda case was that appellants (Torrent et al.) lost :

Torrent and Indoco (collectively, Appellants) appeal from the district court’s final judgment on Appellants’ invalidity challenges to claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda.1 See Takeda Pharm. Co. Ltd. v. Torrent Pharm. Ltd., No. 2:17-cv-03186-SRC-CLW, 2020 WL 549594, at *26 (D.N.J. Feb. 4, 2020) (Takeda). The claims at issue are directed to alogliptin, a uracil-containing DPP-IV inhibitor useful for treating type II diabetes, and pharmaceutical salts thereof. Following a two-day bench trial and extensive testimony from three different experts, the district court concluded Appellants had failed to prove by clear and convincing evidence that the challenged claims are invalid for either statutory obviousness or non-statutory obviousness-type double patenting. In their appeal, Appellants challenge several different fact findings by the district court. Even assuming some of those challenges have merit, we discern no clear error in the district court’s finding that a skilled artisan would not have been motivated to make Appellants’ proposed scaffold and isosteric replacements with a reasonable expectation of success. On that basis, we affirm. DISCUSSION Relevant to “the assessment of [reasonable] expectation of success” in all three of Appellants’ invalidity theories, Takeda, 2020 WL 549594, at *11, is the undisputed factual finding that “in the relevant art of pharmaceutical development, very small changes in molecular structure can have dramatic effects on the properties of the molecule,”<.b> id. at *10. Indeed, “the more distantly related two chemical structures are, the less probable it will be that they have the same biological effect.” J.A. 33375–76 (Böhm). Against this backdrop, we turn to the details of Appellants’ invalidity theories.

Torrent has not identified anything in the prior art that would have motivated a skilled artisan to dispose of F162’s fluoro-olefin unit, let alone replace it with an amide, given myriad more conservative and predictable modifications that were available for transforming F162 into a “novel” compound. See Takeda, 2020 WL 549594, at *18–19. To the contrary, Torrent’s expert conceded at trial that he was unaware of any prior art disclosing this specific modification, despite citing references that taught the opposite modification—replacing an amide unit with a fluoro-olefin unit. J.A. 942–43. Even the reference Torrent cites to establish that fluoroolefin and amide were known isosteres features fluoro-olefin compounds and is bereft of any suggestion to make the replacement Torrent proposes. J.A. 33349, 33352.

Footnote 6 mentions the issue of factual inaccuracy:

At oral argument, Torrent’s counsel asserted that the district court’s motivation analysis improperly relied on testimony of Takeda’s expert to the exclusion of Torrent’s expert, specifically referencing a footnote in the opinion below. See Oral Arg. at 4:43–6:50 (discussing Takeda, 2020 WL 549594, at *12 n.3, which cites the trial transcript at J.A. 1178–80, 910–11). That footnote refers to testimony from both Takeda’s and Torrent’s experts, including testimony from Torrent’s expert agreeing that “the Kim reference doesn’t say one word about DPP-IV inhibition,” J.A. 910–11. Torrent’s counsel, moreover, could not identify anything factually inaccurate about the footnote.


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