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.
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