Proving Optical Purity Before PTAB Can be More Difficult Than at FDA
In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, the Fed. Cir. reversed-in-part, vacated-in-part and remanded to the PTAB, their final written decision that petitioners failed to prove obviousness in view of petitioners’ two production lots as evidence. The claims were directed to a method of pupil dilation using an ophthalmic composition comprising R-phenylephrine hydrochloride having an initial chiral purity of at least 95% and a purity of at least 95% of initial purity after 6 months, the composition having been stored between -10 to 10°C. Petitioner had supplied patentee with the active agent in optically pure form, as well as HPLC and optical rotation data in support of the optical purity, which patentee submitted to the FDA in support of their New Drug Application. The Fed. Cir. ruled that the PTAB abused its discretion in dismissing petitioner’s evidence of optical purity for failing to meet the evidentiary standards under 37 CFR 42.65(b), citing patentee’s use of the same evidence in their FDA submission.