Altaire Pharmaceuticals Inc. filed a Petition for a post-grant review of claims 1 to 13 of U.S. Patent No. 8,859,623 (“the 623 patent”) owned by Paragon Bioteck, Inc.  The primary issue was whether Petitioner’s product—which qualified as 102(a) prior art—met the limitations of the ’623 patent claims and therefore rendered the claims obvious.  The Board found the claims were not invalid as obvious over Petitioner’s product because Petitioner failed to meet its burden of proving by a preponderance of the evidence that the testing it relied upon to show its Product met the limitations of the claims was accurate and reliable. Altaire Pharma Inc. v. Paragon Bioteck Inc., PGR2015-00011 (Nov. 14, 2016).

The ’623 patent is directed to methods and compositions of stabilizing formulations of the R-enantiomer of phenylephrine.  Commercially available R-phenylephrine ophthalmic solutions had special storage requirements and could only be used for a short duration due to instability problems.  According to the patentee, the ’623 patent represented an improvement to overcome these instability problems.

The Petition included HPLC and optical-rotation data to show Petitioner’s product met the limitations of the 623 patent claims (e.g., remained stable and in the form of R-phenylephrine for 6-months).  The patentee challenged the sufficiency of this data.  For instance, the Patent Owner argued that the HPLC assay did not reliably distinguish between R and S-isomers, and so failed to show the Petitioner’s product meets the chiral-purity limitations.

The Board found Petitioner’s evidence unpersuasive because the tests and data submitted with the Petition did not meet the requirements of 37 C.F.R. § 42.65.  Section 42.65(b) describes the information a party relying on testing data must provide in an affidavit (e.g., “how the test was performed and the data was generated” and “how the data is used to determine a value”).  The Petition failed to explain, among other things, how the tests were performed and how the data was generated.  The Petitioner also waited until its Reply to provide the testing details, including the protocol.  Thus, the Board refused to consider at least some of the exhibits offered in Petitioner’s Reply on the basis that the patentee never had an opportunity to respond.

The Board also rejected Petitioner’s assertions that because the patentee failed to provide affirmative testing that Petitioner’s product did not meet the limitations of the claims, it was more likely than not that Petitioner’s testing data was reliable and accurate.  But, according to the Board, in a post-grant review, as in an inter partes review, the burden of persuasion is on the petitioner to prove unpatentability and this burden never shifts to the patentee.  Thus, it was not the patentee’s burden to perform testing on Petitioner’s product.

The Board also considered whether the President of Petitioner (Mr. Sawaya), who filed a Declaration in support of the Petition, qualified as an expert witness.  Citing an opinion from the Federal Circuit, the Board refused to accord weight to Mr. Sawaya’s opinion as an expert witness because the patentee never had an opportunity to consider and respond to Mr. Sawaya’s testimony as an expert.  Petitioner did not attempt to introduce Mr. Sawaya as an expert witness until its Reply.  Moreover, the Board stated that 37 C.F.R. § 42.23(b) limits a reply to arguments raised in the corresponding patentee’s response.  The Rule “does not permit Petitioner to depart from the positions originally taken in the Petition and embark in a new direction with a new approach.”

The Board’s decision offers a good lesson in the importance of presenting all evidence upon which a Petitioner seeks to rely in the initial Petition.