Lumingan ® .01% is a bimatoprost ophthalmic solution used for the reduction of high eye pressure, also called intraocular pressure, in people with open angle glaucoma or ocular hypertension.
Others may find that the Federal Circuit has set the validity bar too high, however…
In the Allergan case, among their arguments, Appellants argued that the patents were obviously over prior art which teaches a compositional range which encompasses the narrower range recited in the patents.
The appeals court cited Galderma stating “where there is a range disclosed in the prior art, and the claimed invention falls within that range, a relevant inquiry is whether there would have been a motivation to select the claimed composition from the prior art ranges.” Galderma Laboratories, L.P. v. Tolmar, 737 F.3d 731, 37-38 (Fed. Cir. 2013). The appeals court reasoned “[i]n those circumstances, ‘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 were other pertinent considerations.” Id. at 738. Ultimately, the appeals court concluded that there was no error in the district court’s finding that Allergan had produced ample evidence of teaching away and unexpected results, and that such evidence fully supported the district court’s conclusion of nonobviousness.
Notably, the cited prior art includes in their range of possible compositions, some compositions which are ineffectual and/or dangerous. Thus, some commentators have opined that the Federal Circuit may have set the bar too high for the proving of non-obviousness. In other words, what happens if prior art teaches a wide encompassing range of compositions which include effectual and/or safe compositions … Can the patent applicant or owner still show that an invention including a narrower range encompassed by the prior art range is not obvious and therefore patentable?
Practitioners may wish to look to the Allergan case for help. The appeals court stated “It may also be true here that ‘the disclosed range[s are] so broad as to encompass a very large number of possible distinctions’, In re Peterson, 315 F.3 1325, 1330 n.1 (Fed. Cir. 2003), such that they do not teach any specific amounts or combinations and that the burden of producing evidence of teaching away, unexpected results, and other pertinent second considerations did not shift to Allergan.” Ultimately, the appeals court did not decide this issue given the ample evidence produced by Allergan, but their dicta leaves the door open to those faced with challenges based upon the wide “all encompassing” prior art reference. Such patent applicants or owners may argue that they do not have to assume the burden of proof when the cited prior art encompasses such a very large number of combinations that the prior art effectively fails to teach anything specific.
