Standards of Review: Implications for Patent Challengers

Originally published in Life Sciences Law & Industry Report on 11/30/2012.

The standard of review is frequently cited but often overlooked as being outcome-determinative in patent cases. A recent trio of decisions by the Federal Circuit illustrates the differences in outcome that result from the standard of review for issued patents, challenged for validity in the Federal Courts, versus that for patent applications examined for patentability by the U.S. Patent and Trademark Office. A renewed consideration of these differences may motivate a patent challenger to proceed proactively under one of the postgrant reexamination procedures within the U.S. Patent Office (i.e., post-grant review (PGR) and inter partes review (IPR)) rather than reactively in the context of an invalidity defense or declaratory judgment action.

Patent applications are examined for patentability using a preponderance of the evidence standard. That is, claims will be allowed if the evidence in favor of patentability is more convincing than the evidence in opposition to it. In contrast, an issued patent enjoys a statutory presumption of validity, under which a challenger must establish invalidity by clear and convincing evidence in the federal courts. The new America Invents Act post-grant reexamination procedures, conducted within the U.S. Patent Office, do not afford the patentee with the same presumption of validity it enjoys within the federal court system. PGR and IPR are conducted under a lower preponderance of the evidence standard, although, unlike initial examination of a patent application, it is the challenger’s burden to prove invalidity. A spate of recent decisions indicates that the U.S. Court of Appeals for the Federal Circuit has its eye firmly on the standard of review issue, which may result in different outcomes based on similar facts.