To date, only 43 petitions for Post-Grant Review have been filed with the PTAB. Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter. The PTAB recently instituted the third ever PGR for a biotech-related patent in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018.
The petitioner requested PGR of claims 1-12 of U.S. Patent No. 9,091,698, directed to a method for the advanced detection of sepsis in a systemic inflammatory response syndrome (SIRS)-positive subject involving measuring procalcitonin levels and one or more clinical markers over multiple time points, wherein an increase in the amount of procalcitonin from a previous amount over a 24-hour interval detects sepsis. The petitioner challenged the claims on nine separate grounds, three of which were based on Section 112 challenges (lack of written description, lack of enablement, indefiniteness) that are not available to IPR petitioners.
The ’698 patent issued from an application filed March 10, 2014 (post-AIA), but claimed priority to a series of pre-AIA applications. PGRs are available only for post-AIA applications; in order to succeed under these circumstances, a petitioner must first establish that at least one claim is not entitled to the benefit of a pre-AIA priority date. Here, the petitioner argued that neither the ’698 patent specification nor its priority applications include sufficient written support for the feature “wherein an increase in the amount of procalcitonin … detects sepsis;” instead, these specifications merely disclose that a “difference” in amount of the biomarker is associated with sepsis. The PTAB agreed with the petitioner that this disclosure is insufficient to describe an “increase” in the amount of procalcitonin within the specified time frame. The PTAB also concluded that the ’698 specification and the specifications of the underlying priority applications did not enable the challenged claims because the specifications failed to describe, for example, procalcitonin threshold levels or quantifiable increases in the biomarker over the recited timeframe. As a result, the PTAB concluded that the challenged claims were entitled only to the post-AIA filing date, rendering the patent eligible for PGR.
In addition to finding that the claims were more likely than not to be unpatentable for lack of written description and enablement, the PTAB also determined that the petitioner met its burden in establishing that the claims were likely unpatentable for indefiniteness and for being anticipated and obvious in view of certain prior art. Interestingly, the petitioner did not challenge the ’698 patent claims under Section 101, which may have been expected given the diagnostics-related subject matter.
The resulting final decision may be the first to address Section 112 in the context of a patent arising out of Art Unit 1600 in post-grant review.
If the proceeding continues through trial, the resulting final written decision may be the first to address Section 112 in the context of a patent arising out of Art Unit 1600 in post-grant review. Altaire Pharm. Inc.. v. Paragon Bioteck, Inc., PGR2015-00011, also concerned an Art Unit 1600 patent, but that review focused only on obviousness. There is currently one PGR petition pending relating to an Art Unit 1600 patent, Corvus Pharm., Inc. v. United States, PGR2016-00042. Of the remaining six petitions filed against Art Unit 1600 patents, four were denied, one proceeding was terminated prior to institution, and one was terminated after institution but prior to a final written decision. Although the sample size is small, the percentage of PGR petitions filed in the biotechnology and pharmaceutical field is about twice that of IPR petitions (21% vs. 10%, IPR statistics found here). The preference for PGR over IPR is likely to continue for patents arising out of Art Unit 1600 given the availability for challenge based on enablement, written description, and subject matter eligibility.