Sun Pharmaceutical Industries, Inc. (Concert Pharm.) v. Incyte Corp. (USPTO as Intervenor)
Docket No. 2019-2011 (IPR2017-01256) (https://cafc.uscourts.gov/opinions-orders/19-2011.OPINION.8-22-2023_2178325.pdf) (Non-Precedential)
HUGHES, LINN, STARK
August 22, 2023
Brief Summary: Board obviousness conclusions regarding Sun’s ruxolitinib analogs affirmed. Summary: Sun appealed USPTO (Board) IPR final written decision (FWD) finding all claims of US 9,249,149 directed “novel heteroaryl-substituted pyrrolo[2,3-d]pyrimidines” used to treat diseases related to JAK1/JAK-2 (e.g., myelofibrosis) invalid for obviousness. The IPR focused on three of the claimed compounds, an “octo-deuterated” (CTP-543, fast-tracked by the FDA as a “Breakthrough Therapy” for alopecia areata) and two “tetra-deuterated” ruxolitinib analogs. Incyte presented two obviousness grounds but the Board only considered one of the two which is addressed in this appeal. The FC panel explained that it reviews “the Board’s ultimate obviousness determination de novo and underlying fact findings for substantial evidence” (Hologic, FC 2018; Intercontinental, FC 2017; Intelligent Bio-Sys., FC 2016 (“The presence or absence of a motivation to combine prior art references, and a reasonable expectation of success in doing so, are questions of fact.”)) And in an IPR, “it is the petitioner’s burden to prove, by a preponderance of the evidence, that a person of ordinary skill in the art would have been motivated to combine the prior art references the petitioner is relying on in its obviousness grounds” (35 USC 316(e)). Additionally, the “[m]otivation to combine ‘need not be [based on] an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a sufficiently close relationship to create an expectation, in light of the totality of the prior art, that the new compound will have similar properties to the old’” (Aventis, FC 2007; Anacor, FC 2018 (“[T]he greater the structural similarity between the compounds, the greater the motivation to combine and reasonable expectation of success.”)) And objective indicia of obviousness, including commercial success, “can rebut a petitioner’s prima facie showing of obviousness” (Apple, FC 2016; WMS Gaming, FC 2016). For chemical compound claims, a two-step test is used: 1) would “r a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts”? 2) “whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success”? (Otsuka Pharm., FC 2012; Pfizer, FC 2007) Incyte and Sun did “not dispute that a person of ordinary skill would have selected ruxolitinib as the lead compound”, but Sun argued the Board incorrectly considered the second question. Sun argued the Board “failed to consider whether a person of ordinary skill would have been motivated to deuterate ruxolitinib to modify its pharmacokinetic [PK] properties, including its ADME” but the FC panel disagreed based on Incyte’s expert testimony (e.g., “motivation to deuterate ruxolitinib, at its metabolic hotspots” and improve PK properties). Sun also argued the Board ignored “the unpredictable effects of deuterating ruxolitinib and by not considering how that unpredictability would have deterred a skilled artisan”, and there would not have been “a reasonable expectation of achieving what is claimed in the patent-at-issue” (Intelligen Bio-Sys.; Pfizer, FC 2007 (“[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.”)) The FC panel disagreed, again finding Incyte’s expert testimony supportive of the Board’s conclusions. The FC panel also disagreed with Sun regarding its evidence regarding unexpected results (“merely a difference in degree and not in kind” (Bristol-Myers, FC 2014)) and long-felt need (Millenium, FC 2017) regarding CTP-543 as it was not FDA approved as Sun argued (noting it does agree that the “FDA’s designation of CTP-543 for ‘Breakthrough Therapy’ and ‘Fast-Track’ approval are probative of nonobviousness”). Thus, the Board decision was affirmed.