Takeda Pharmaceutical Co. Ltd. v. Array Biopharma Inc.


Docket Nos. 2017-1079 (IPR2015-00754)

MOORE, O’MALLEY, WALLACH
December 26, 2017

Non-precedential

Brief summary: PTAB denial of Takeda’s contingent motion to amend its claims during IPR vacated and remanded as “the PTAB did not provide an opinion as to any of Array’s alternative grounds for affirmance, and therefore did not make factual findings necessary for this court to conduct[] meaningful review”.

Summary: Takeda appealed PTAB denial of its contingent motion to amend its claims due to a lack of written description after finding claims 1-7 and 12-16 of US 8,592,454 anticipated. The ‘454 patent relates to tachykinin receptor antagonists. Tachkinin is “a generic term for a group of neuropeptides, including ‘[s]ubstance P,’ ‘neurokinin A,’ and ‘neurokinin B’” that bind to the receptors NK1, NK2 and NK3. The antagonists are asserted to be “‘useful’ as ‘an agent for the prophylaxis or treatment of various diseases such as lower urinary tract disease, a digestive tract disease[,], or a central nervous system disease.’” Takeda’s contingent amended claims 19-29 (“Asserted Claims”) directed to “method of antagonizing an NK1” or “NK2 receptor” using a particular antagonist (“represented by the formula”) were to replace orginal claims 13-16. Takeda argued the PTAB’s lack of written description finding “was based on an ‘erroneous premise’”. The FC panel explained that it will set aside the PTAB’s denial of motion to amend if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law, and set aside factual findings that are unsupported by substantial evidence” (Proxyconn, FC 2015; Aqua Prods., FC 2017 (en banc); In re Nuvasive, FC 2016 (“substantial evidence is something less than the weight of the evidence but more than a mere scintilla…as a reasonable mind might accept as adequate”)). Furthermore, “[t]he agency tribunal must make findings of relevant facts, and present its reasoning in sufficient detail that the court may conduct meaningful review of the agency action” (In re Van Os, FC 2017), and a patentee’s motion to amend during IPR must “set forth…[t]he support in the original disclosure…for each claim”. Here, the PTAB found that “substitute claim 18 lacked written description support” and denied entry of the Asserted Claims because those “depend from” claim 18 and were therefore “unsupported for at least the same reasons”. Both Takeda and Array acknowledged this was erroneous. But Array argued the FC should still affirm its decision because Takeda failed to comply with 37 CFR § 42.121 “for other reasons”, the Asserted Claims are anticipated and unpatentable for lack of written description and enablement. The FC panel concluded, however, that “the PTAB did not provide an opinion as to any of Array’s alternative grounds for affirmance, and therefore did not make factual findings necessary for this court to conduct[] meaningful review” (“potentially lawful but insufficiently or inappropriately explained”). It therefore vacated and remanded the decision for review.

This entry was posted in Inter Parties Review (IPR), IPR, Written description. Bookmark the permalink.

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