By Dennis Crouch Purdue Pharma v. Epic Pharma (Fed. Cir. 2016)[1] In an important Hatch-Waxman related decision, the Federal Circuit has affirmed the lower court’s holding that Purdue Pharma’s abuse deterrent OxyContin patent claims are invalid as anticipated and/or obvious over the prior art.[2] Of interest, it appears that the patentee was harmed here by the Patent Act’s objective approach to obviousness that, according to the statute, must be considered without regard to the actual “manner in which the invention was made.” In particular, during the process of creating its low-ABUK oxycodone, the innovators first discovered an 8α impurity isomer created during drug manufacture that led to a problematic 14-hydroxy compound. The claimed invention was a product having a reduced 14-hydroxy level. In the appeal, the Federal Circuit noted that, while the 8α impurity may have been a new discovery, it was not necessary…
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