PGR2015-00011 (US 8,859,623 B1)
Post-Grant Review Decision
November 14, 2016
Brief Summary: Preamble found not to limit the claim; petition for PGR found not to show unpatentability of the claims by a preponderance of the evidence.
Summary: The grounds for post-grant review (PGR) may included any that could be raised under 35 U.S.C. § 101, 102, 103, or 112 (except for best mode) and must be filed no later than nine months after the date of grant of the patent or issuance of a reissue patent. The only grounds available under IPR, on the other hand, are those raised under 35 U.S.C. § 102 or 103 and only on the basis of patents or printed publications (and the time requirements differ from PGR). In this PGR proceeding, Altaire petitioned for review of claims 1-1 of Paragon Bioteck’s US 8,859,623 B1 relating to methods for using an ophthalmic composition “wherein the composition comprises R-phenylephrine hydrochloride having a chiral purity of at least 95% when administered after storage” (at “between -10 to 10 degree Celsius prior to administration”). Trial was instituted to determine whether the claims would have been obvious over Altaire’s Product. The Broadest Reasonable Construction (BRC) standard applies to PGR (In re Cuozzo, FC 2015). Under that standard, the Board disagreed with Paragon that the method step should be limited “by adding a six-months-cold-storage requirement” even though the preamble to claim 1 indicates “the chiral purity of R-phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6 months”, “consistent with the prosecution history, in which the applicants argued, and the examiner agreed, that claim 1 was patentable” for that reason. The Board reasoned, however, that that requirement “simply describes a property of the composition to be administered” and “does not add a limitation on the duration of storage at cold temperatures recited in the ‘administering’ step”. “In other words, the step of claim 1 defines the chiral purity of the composition at the time of administration after cold storage for an unspecified time period” and claim 1 does not “require an active step of cold storage for six months.” The Board also identified Alaire’s proposed expert witness as only a “fact witness” since no bases was provided for his qualification as an expert which changes on what he may “testify compentently” (e.g., an expert may, but a lay witness may not, testify as to “prior art teachings or the level of ordinary skill”), and denied its attempt to enter his “new” declaration showing his expertise (“improper reply evidence”). Regarding the obviousness challenge, the Board qualified the ophthalmic solution lots Altaire including the package insert with dosing and storage directions (e.g., one drop in each eye for pupil dilation, store at 2-8 degrees Celsius, within the limitations of ‘623 claim 1) submitted as prior art under § 102(a)(1) (“in public use, on sale, or otherwise available to the public”). The parties disputed the accuracy of Altaire’s HPLC-based chiral purity testing. The Board noted that in a PGR, as in an IPR, “the burden of persuasion is on the petitioner to prove unpatentability, and that burden never shifts to the patentee” (35 USC § 326(e), Dynamic Drinkware (FC 2015)) and “[w]here, as here, the only question presented is whether due consideration of the four Graham factos renders a claim or claims obvious, no burden [of production] shifts from the patent challenger to the patentee” (In re Magnum Oils, FC 2016). And while PGR may be instituted on the “more likely than not” standard (35 USC § 324(a)), “the petitioner must prove unpatentability by a preponderance of the evidence” (35 USC § 326(e)). And Altaire was found not to have sufficiently shown that its HPLC data shows the Product “meets the chiral purity limitations of claim 1” (e.g., it “fail[ed] to explain…how the test was performed and how the data was generated” as required under 37 CFR § 42.65, Paragon did not waive its challenge of the sufficiency of the evidence, that Paragon knew the details of Altaire’s testing procedure is not relevant (“it is the Board, not the Patent Owner, who must evaluate patentability”), and it was not satisfied by Altaire’s optical rotation data). Since it determined unpatentability had not been shown, the real-part-in-interest issue was not reached.