Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. v. Astellas Pharma Inc.

Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. v. Astellas Pharma Inc.

(IPR2018-00079, Pat. Tr. App. Bd.)

Fitzpatrick Successfully Opposes IPR On Behalf Of Astellas

On May 4, 2018, the Patent Trial and Appeal Board ruled in favor of Fitzpatrick’s client Astellas Pharma Inc. (“Astellas”), denying a request by Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. (collectively “Sawai”) to invalidate several claims of U.S. Patent No. 6,346,532 (“the ’532 patent”).  The ’532 patent claims the compound mirabegron, the active pharmaceutical ingredient in Astellas’s marketed pharmaceutical product Myrbetriq®.  The Board agreed with Astellas that Sawai failed to demonstrate by a preponderance of the evidence that claims of the ’532 patent were unpatentable as obvious. 

The Board rejected Sawai’s first obviousness argument which was premised on a “most structurally similar compound” standard, arguing in part that the Federal Circuit’s lead compound analysis was improper in determining obviousness for new chemical compounds.  In reaching its decision, the Board confirmed that the lead compound analysis was indeed the proper standard, as articulated by binding Federal Circuit precedent, and further found that Sawai’s reliance on In re Dillion, 919 F.2d 688 (Fed. Cir. 1990) did not support rejection of that precedent. 

The Board also rejected Sawai’s second obviousness argument, which purported to apply the lead compound analysis in the alternative, by rejecting the rationale for Sawai’s lead compound selection and modification.  The Board noted that the sheer number of modifications needed and the large number of possible substitution options available suggested that Sawai’s analysis was a hindsight reconstruction of mirabegron, rather than a reasoned basis for lead compound modification.

Myrbetriq® is also the subject of an ongoing Hatch-Waxman litigation in the District of Delaware wherein Sawai and others have filed paragraph IV ANDAs against several Orange Book listed patents covering Myrbetriq®. (Civil Action No. 16-905-JFB-CJB).  Trial in that related case is scheduled for June of 2019.

Astellas was represented in this IPR by Fitzpatrick attorneys Robert Baechtold, Scott Reed, Simon Roberts, Jason Leonard, Erica Norey, Chika Seidel, Corinne Atton, Katherine Adams, Vincent Li, and Kyle Coogan.