SmithKline Beecham v. Apotex (on petition for writ of certiorari)
The Supreme Court is contemplating hearing this case that questions the standards for inherent anticipation of a patent. The drug in question is Paxil, and the case history has more twists than a Hazzard County road. But, the question now before the Court is simple:
Whether a compound that is inevitably produced by the prior art is inherently anticipated by the prior art, and thus not novel under 35 U.S.C. 102.
Another way to focus on the particular question is whether any human recognition of the inherency is required.
Here, Paxil (a PHC hemihydrate) is inevitably produced by a PHC anhydrate, and PHC anhydrate (A.K.A. Ferrosan) was well known before the Paxil patent.
Judge Posner (sitting by designation) determined that Paxil was not inherently anticipated because its inevitable production from Ferrosan was not a “scientific certainty.” On appeal, the CAFC reversed that particular decision — finding that the patent was inherently anticipated because PHC hemihydrate “inevitably results from production of” PHC anhydrate.
Now, the Solicitor General has provided the government’s views on the case, and supported the CAFC decision:
The court of appeals correctly held that the patent claim is invalid because PHC hemihydrate was inherently anticipated by the prior art that inevitably produced it. . . . a characteristic of a pre-existing product is not patentable even if no one had previously recognized that characteristic.
Because the Gov’t fully supports the CAFC decision, it also recommended against hearing the case.