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Groundhog day just passed, and although famed Pittsburg Punxautawney Phil did not see his shadow, it looks like it's going to be a cold winter for Purdue Pharma, maker of the blockbuster drug Oxycontin.
The pharma company lost big when the Federal District Circuit Court sided with Epic Pharma, et al, in this widely watched patent lawsuit. In the opinion of the court, the alleged changes that Purdue made to OxyContin were not significant and Purdue's attempts to couch a toxicity removal of a base form (oxycodone) of its drug actually was not substantial enough to be considered a break from prior art.
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Abridging the legal issues, here is a basic explanation of the issue that was before the court. OxyContin, one of Purdue's best selling drugs, is covered by a handful of patents, three of which essentially spell out how to produce oxycodone.
Prior to Purdue's patented technique, oxycodone was produced (and still is) using a process that yields a product too high in 14-hydroxycodeinone, a chemical compound believed to be toxic in high concentrations. The patents at issue cover a technique Purdue claims to synthesize oxycodone substantially more free of the toxic compound -- including a method of hydrogenation that converts excess 14-hydroxy into the desired oxycodone.
At the district level, the court disagreed with Purdue's argument: that the source of the toxic compound was from one source of toxic impurity versus the next. The circuit court affirmed the lower court and said: So? "The fact that the 14-hydroxy is derived from 8-alpha imparts no structural of functional differences in the low-ABUK hydrocodone API as compared to the prior art products."
In plain English for non-patent lawyers: "No patentable changes are were made."
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