FC panel affirms DC decision that Torrent did not show obviousness of Takeda’s algoliptin claims

Takeda Pharm. Co. et al. v. Torrent Pharm. Ltd., et al.

Docket No. 2020-1552, -1598 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1552.OPINION.2-16-2021_1733600.pdf) (Non-Precedential)

DYK, MAYER, CHEN

February 16, 2021

Brief Summary:  DC holding that Torrent did not show Takeda’s claims related to algoliptin obvious affirmed. Summary:  Torrent appealed DC final judgment that Takeda’s US 7,807,689 “directed to alogliptin, a uracil-containing DPP-IV inhibitor useful for treating type II diabetes” was not proven by clear and convincing evidence to be invalid for obviousness or non-statutory obviousness-type double patenting.  The DC determined “a skilled artisan would not have been motivated to make Appellants’ proposed scaffold and isoteric replacements with a reasonable expectation of success.”  The FC panel wrote that it was undisputed that “very small changes in molecular structure can have dramatic effects on the properties of the molecule” and “the more distantly related two chemical structures are, the less probable it will be that they have the same biological effect.”  Regarding double patenting holding, the FC panel found no clear error in the DC’s holding that “a skilled artisan would not have been motivated to replace F162’s pyrimidinone scaffold with a uracil scaffold with a reasonable expectation of success” (F162 being Torrent’s proposed lead compound) (e.g., “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.”)  The FC panel also agreed with the DC that Torrent did not show invalidity for statutory obviousness since, e.g., “Indoco ‘failed to show that a [skilled artisan] who did so would have [had] a reasonable expectation of success’ with ‘this particular scaffold replacement’” (e.g., “[t]he interchangeability references on which Indoco relies do not pertain to DPP-IV inhibitors or diabetes, nor do they, or any other prior art of record, teach substituting an existing xanthine scaffold for uracil”, “Indoco’s expert, as the district court observed, did not present any testimony or evidence as to the predictability of the resulting properties from replacing DCAX’s scaffold with uracil.”)  Torrent also argued that the DC “materially erred with respect to the level of ordinary skill in the art” (e.g., “improperly ignored the parties’ dispute over whether a skilled artisan must have specific experience developing DPP-IV inhibitors and/or type II diabetes drugs—experience Takeda’s expert did not have”), but the FC panel disagreed, finding the DC “considered the prior art from both perspectives” (e.g., “even if [Appellants] are correct in this, they still fail to provide invalidity by clear and convincing evidence”, “While motivation and reasonable expectation of success need not be expressly disclosed by the prior art itself and may instead come from the background knowledge of the skilled artisan, merely asserting that a given modification would have been obvious to a skilled artisan does not make it so.”)  The DC decision was therefore affirmed.

This entry was posted in Double Patenting, Generics / ANDA, Obviousness. Bookmark the permalink.

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