Phenylephrine Hydrochloride (resized)The first final written decision in a post-grant review of a patent arising from Art Unit 1600 issued November 14, 2016, in Altaire Pharm. Inc.. v. Paragon Bioteck, Inc., PGR2015-00011.  PGRs allow challenge based on enablement, written description, indefiniteness, and subject matter eligibility, in addition to the novelty and obviousness bases available in IPRs, permitting petitioners to rely on arguments commonly used to invalidate biotechnology and pharmaceutical patents in litigation.  Here, however, the PTAB instituted PGR based only on obviousness grounds, and ultimately determined that the petitioner did not meet its burden in proving the unpatentability of the challenged claims.

The petitioner requested PGR of claims 1-13 of U.S. Patent No. 8,859,623, directed to methods of using an ophthalmic composition formulated to stabilize the chiral purity of the active ingredient, phenylephrine hydrochloride.  The petitioner challenged the claims on four separate grounds based on anticipation, obviousness, and indefiniteness.  The PTAB denied institution on the anticipation and indefiniteness grounds, but instituted trial to review whether the challenged claims were obvious in view of a prior sale of an Altaire product.

The main dispute revolved around whether the Altaire product met the chiral purity limitations recited in the claims.  The petitioner relied upon data generated by two assays that assertedly demonstrated that the product fell within the scope of the claims.  The PTAB disregarded a portion of the evidence because the petition (1) failed to identify with specificity one of the assays used to generate the data and (2) failed to provide sufficient details of the protocol used to generate the data.  Petitioner attempted to remedy the deficiency by submitting a protocol with its Reply.  The PTAB, however, refused to consider the new evidence for being untimely.  As to the remaining data relied upon in the petition, the patent owner successfully challenged the accuracy and reliability of the assay results.  The PTAB ultimately determined that the petitioner failed to establish by a preponderance of the evidence that the challenged claims were unpatentable.

This decision highlights the importance of the petitioner’s initial filing – deficiencies cannot be remedied in the Reply.  Here, the PTAB, despite instituting review based on the petitioner’s evidence accompanying the petition, disregarded petitioner’s key scientific evidence for failure to provide sufficient detail regarding the underlying methodology, and refused to consider the missing information when supplied in the Reply.  Additionally, the PTAB refused to consider petitioner’s only declarant as an expert witness because the initial declaration failed to explain the declarant’s “knowledge, skill, experience, training, or education” that would provide bases for the qualification.  Petitioner attempted to remedy the deficiency in a Reply declaration, but the PTAB refused to “retroactively qualify” the declarant as an expert.

This decision highlights the importance of the petitioner’s initial filing – deficiencies cannot be remedied in the Reply.

This decision is also a reminder that review institution does not always lead to cancelled claims.  The PTAB instituted review based on the record before it and under the more lenient “more likely than not” standard.  The Board ultimately sided with the patent owner, however, based on a complete record developed at trial and the heightened “preponderance of the evidence” standard.  The petitioner filed a Notice of Appeal on January 13, 2017, to challenge the decision.

While indefiniteness was not at issue here, as we discuss earlier, the grounds for institution in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018 included challenges based on lack of written description and enablement, and indefiniteness.  If the B.R.A.H.M.S. proceeding continues through trial, the resulting final written decision may be the first to address these issues in the context of a patent arising out of Art Unit 1600 in post grant review.