At trial, Cadence and Pharmatop successfully proved by a preponderance of the evidence that Exela's generic version of OFIRMEV® literally infringed all ten asserted claims of the '222 patent.Despite Exela's arguments to the contrary, the plaintiffs successfully proved that in Exela's generic product, sodium ascorbate acted as a "buffering agent" and mannitol acted as a "free radical scavenger" (i.e., an antioxidant).The present invention refers to the new Na , Mg 2 , Li , K , Ca 2 or N (R)4 salts of the single enantiomers of omeprazole, where R is an alkyl with 1–4 carbon atoms, i.e. That language clearly defines “the present invention” not as salts of omeprazole, or salts of single enantiomers of omeprazole, but as a particular set of “new” salts of enantiomers of omeprazole, limited to the six named cations. The Federal Circuit concluded that the patent was invalid under the public use bar.Na , Mg 2 , Li , K , Ca 2 or N (R)4 salts of ( )-[omeprazole] and (-)-[omeprazole], where R is an alkyl with 1–4 carbon atoms. The Abstract, though not grammatically a sentence, confirms the limiting disclaimer by identifying what Astra Zeneca said was “novel”: “The novel optically pure compounds Na , Mg 2 , Li , K , Ca 2 or N (R)4 salts of ( )-[omeprazole] or (-)-[omeprazole], in particular sodium and magnesium salt form thereof …” Id., Abstract. After the Court concluded that the “ready for patenting” prong of Pfaff had been satisfied, the sole issue was whether there was public access to the invention.The Federal Circuit affirmed as to one claim of the asserted patents, concluding that the defendants had failed to prove by clear and convincing evidence that the claim was obvious.
The Court identified claim 2 of the ’725 patent as representative of the group.
To invalidate the '222 patent, Exela argued that three pieces of prior art—Greek Patent Application No. Exela was similarly unable to win its argument that the '218 patent was invalid as obvious in view of the '222 patent combined with an article from the 1978 .
Importantly, the 1978 article concerned the oxidative degradation of pyrogallol, which is highly sensitive to oxidation, rather than paracetamol, which is not.
A look back at 2013, while limited in sheer number of data points, appears to support this trend. Rather, the dispute is whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.
Of the almost ten Hatch-Waxman based cases that made their way to the Federal Circuit in 2013, 50% of those cases resulted in the claims either being affirmed as invalid or a determination that those patents were invalid on appeal. In these circumstances, where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.