Upholding the validity of Bayer’s patent covering orally
disintegrating tablet (ODT) formulations of vardenafil
hydrochloride trihydrate, the US District Court for the District of
Delaware rejected Defendant’s arguments that the claims were
invalid as obvious. Notwithstanding, the court also held the
secondary objective indicia points to non-obviousness.
Bayer Pharmaceuticals AG et al. v. Watson Laboratories, Inc. et
al., C.A. No. 12-cv-517, 2016 WL 1703281(D. Del. April 27,
2016)
At issue was Bayer’s US Patent No. 8,613,950, directed to
particular orally disintegrating tablet formulations of vardenafil
hydrochloride trihydrate. Specifically, Claim 9 is directed to a
drug formulation wherein the sugar alcohols are a mixture of
sorbitol and mannitol. Claim 11 is directed to a drug formulation
wherein at least one sugar alcohol is sorbitol. Bayer received
approval from the US Food and Drug Administration (FDA) to market
vardenafil hydrochloride orally disintegrating
