Ready-to-use CARDENE® I.V. Premixed Injection is indicated for the short-term treatment of hypertension and is the only available FDA-approved premixed formulation of nicardipine hydrochloride. Chiesi USA, Inc. owns four patents listed in the FDA’s Orange Book as covering CARDENE® I.V. Premixed Injection—U.S. Patent Nos. 7,612,102, 7,659,291, 8,455,524, and 7,659,290. Upon receiving a paragraph IV notice letter from Sandoz Inc. challenging the four Orange Book patents, Chiesi sued Sandoz Inc. and other Sandoz entities for patent infringement in the District of New Jersey. Chiesi USA, Inc. et al. v. Sandoz Inc. et al, No. 1:13-5723 (NLH) (AMD). Sandoz Inc. filed its four IPR petitions about a year after the District Court litigation commenced.

Sandoz Inc. urged the PTAB to reconsider the validity of Chiesi’s patents based on obviousness allegations relating to four references that are also the focus of Sandoz’s invalidity contentions in the underlying district court litigation. The PTAB ultimately denied all four petitions, ruling that Sandoz Inc. “has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim.” See, e.g.,IPR2015-00006, Paper 20 at 2. In reaching its decision, the PTAB found Chiesi’s proposed claim construction of certain key claim terms “more persuasive.” Id. at 7. After carefully evaluating the cited prior art and Sandoz Inc.’s corresponding arguments, the PTAB was “not persuaded that a skilled artisan, knowing the teachings of [the cited prior art], would have been motivated to select [certain key attributes] for a pre-mixed nicardipine solution as claimed.” Id. at 13. The PTAB further found that Sandoz Inc. failed to present evidence that the prior art nicardipine products would be expected to be stable as claimed. Id. at 14-16, 18-19. Significantly, the PTAB dismissed the testimony of Sandoz Inc.’s expert, finding his opinions “unsupported by persuasive evidence” and characterizing those opinions as “mere conjecture.” Id. at 15.

To view the Decision for IPR2015-00005, please click here.

To view the Decision for IPR2015-00006, please click here.

To view the Decision for IPR2015-00007, please click here.

To view the Decision for IPR2015-00008, please click here.