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.
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As a standard of appellate review, “substantial evidence” is not peculiar to the Federal Circuit’s review of patent decisions from district courts and the Patent Office. All circuit courts are familiar with that review standard. They apply it routinely in deciding appeals. The standard originated with appeals of jury verdicts, in recognition of the role of credibility at trial. Under this standard, a judge determines not whether a jury’s decision was correctly made, but whether its decision could reasonably have been made based on the evidence it received. Recent opinions make apparent, however, that the Federal Circuit judges are divided and disagree on how to apply that standard.