In its Decision, the Board concluded that Petitioner had established it more likely than not that claims 1-13 of the ‘623 patent are unpatentable as having been obvious over one of the cited references; thus, the Board instituted post-grant review of these claims with respect to that reference. The Board did not institute post-grant review with respect to any other reference or combination of references asserted in the Petition, however.
The ‘623 patent discloses “methods and compositions of stabilizing phenylephrine formations” relating to pupil-dilating agent. As characterized by the Board, “it was known that R-phenylephrine, but not S-phenylephrine, was useful to dilate the pupil” at the time of the ‘623 patent invention.
The Petition had asserted the following grounds of unpatentability: (1) anticipation (alternatively, obviousness) of claims 1-13 in view of Petitioner’s product (“the Altaire Product”); (2) anticipation (alternatively, obviousness) of claims 1-13 in view of Altaire’s Package Insert, “or alternatively, in view of common knowledge in the art or, alternatively or in addition, in view of U.S. Patent No. 3,966,749 and in further view of Syn-Tech’s Commercially Available product”); (3) obviousness of claims 1-13 “in view of Applicants’ Admitted Prior Art (‘AAPA’), Altaire’s Commercial Product, and/or the common knowledge in the art or, alternatively or in addition, in view of U.S. Patent No. 3,966,749”; and (4) indefiniteness of claims 1-13 “under 35 U.S.C. § 112(b) for failing to particularly point out and distinctly claim the subject matter which the joint inventors regard as the invention.” Petitioner submitted a Declaration of Mr. Assad Sawaya in support of its unpatentability contentions.
The Board first of all considered that the ‘623 patent had issued from an application containing a claim with an effective filing date after March 16, 2013, and that the Petition was filed within 9 months of the grant of the ’623 patent. Thus, the Board concluded that the ’623 patent was eligible for post-grant review consideration.
Patent Owner had requested that the Petition be dismissed because Saw Aque was not identified as a real party in interest. The Board did not agree that Saw Aque was a real party in interest, finding that Saw Aque had not directed or exercised control over the proceeding, that Saw Aque was “unrelated to Petitioner and in a line of business different from Petitioner’s,” and that Saw Aque had not fund the proceeding in any way.
The Board agreed with Petitioner as to asserted ground (1), finding that Petitioner’s products (the Altaire Product) constituted prior art because they were “in public use, on sale, or otherwise available to the public” prior to the effective filing date of challenged claims 1-13. Patent Owner had challenged the reliability of the methodology that Petitioner had relied upon in determining chiral purity of the Altaire Product, but the Board, while sympathetic to Patent Owner’s position on this point, essentially concluded that Petitioner had at least provided enough evidence to justify moving forward with post-grant review based on ground (1). Specifically, the Board concluded that “based on the current record, even though Patent Owner’s argument here may be reasonable, we find Petitioner’s evidence sufficient to go forward with trial.”
The Board agreed with Patent Owner “that Petitioner’s witness, Mr. Sawaya, is a fact witness, and not an expert” because, for example, he did not identify sufficient bases in his Declaration that would qualify him to testify as an expert. Accordingly, the Board did not accord any weight to Mr. Sawaya in his capacity as an expert. Nonetheless, the Board went on to indicate that the lack of expert testimony is not fatal to a Petition and that “[w]here the technology is simple, where the references are easily understandable without the need for expert explanatory testimony, or where the factual inquiries underlying the obviousness determination are not in material dispute, expert testimony, though it might be helpful, may not be indispensable.”
The Board did not institute post-grant review based on either of grounds (2) or (3), agreeing with Patent Owner’s contention that neither was presented with the requisite degree of particularity. As stated by the Board, though each was “presented as a single ground, with language ‘and/or’ and ‘alternatively or in addition,’ each of these grounds actually represented numerous different grounds. For this reason, and others, the Board found that asserted grounds (2) and (3) did not comply with 35 U.S.C. §322(a)(3) and 37 C.F.R. § 42.22(a)(2).
Finally, the Board denied Petitioner’s indefiniteness ground (4). According to the Board, while “perhaps not articulately stated, claim 1 is cast in clear terms.”
Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., PGR2015-00011
Paper 14: Decision on Institution of Post-Grant Review
Dated: November 16, 2015
Patent: 8,859,623 B1
Before: Sheridan K. Snedden, Zhenyu Yang, and Christopher G. Paulraj
Written by: Yang
Related Proceedings: Two District Court cases involving the parties, but not the ‘623 patent at issue in the instant proceeding