Patent Strategies: Presentation given by RMSC2 (awarded Top 10 Allowance Rate for Biotechnology and Organic Fields)
Inherently Obvious and Unexpected
Innovators in the chemical and biological arts almost always have data demonstrating that their new polymer, additive, drug or formulation possess novel features or otherwise does the unexpected. This data is often relied upon to get regulatory approval. The need to generate such data is not surprising as the chemical and biological arts have been characterized as unpredictable. After KSR, predictability stands as the "touchstone of obviousness" that renders inventions unpatentable. It would be expected that inventions in the unpredictable chemical and biological arts would necessarily be patentable; especially when data is presented showing that something unexpected happened. As to dismiss the unpredictable nature of chemical and biological inventions, the USPTO and competitors rely on inherency to deny and defeat patents. Likewise, evidence of unexpected results is dismissed by the USPTO and competitors as the result of mere routine testing or optimization of variables. The prevalence of such allegations, as recently noted by the Court of Appeals for the Federal Circuit, is at odds with the limited reach of inherency and the long standing principal that experimentation does not necessarily preclude patentability. During the presentation we will discuss these recent cases and strategies on using data to get patent applications allowed.
RSVP by e-mail to John Morrisset, John.Morrissett@troutmansanders.com