In an interesting decision today, the Board of Patent Appeals and Interferences (BPAI) decided that dosages are, for the most part, obvious. The case of Ex parte Gillis (Appeal 2010-009318) involved method claims for administering a medical therapy. Fundamental to the claims was a recitation of the dosage necessary to appropriately treat the patient. Assuming the medicine itself is prior art, does specific dosage data give your invention enough novelty?
The BPAI provided the following recitation of case law:
It is well settled that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).In general, however, "an applicant may overcome a prima facie case of obviousness by establishing 'that the [claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.'" In re Peterson, 315 F.3d at 1330 (quoting In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997).
That spells it out pretty clearly - discovery of a dosage value for a known medicine is obvious, unless you can show unexpected results. Consequently, the BPAI provided the following decision in the Ex parte Gillis case:
[G]iven the broad range of useful dosages described in Wappler, we are not persuaded that the Examiner has failed to provide an adequate evidentiary basis for concluding that an ordinary artisan practicing Wagemans' continuous delivery method would have optimized the sufentanil dosage. As Appellants point us to no evidence that the dosage recited in claim 28 provides an unexpected result, and is therefore critical, see Peterson, 315 F.3d at 1330, we are not persuaded that the claimed dosage would have been unobvious over the cited references, despite the fact that the two cited references do not appear to describe the same route of drug administration.
Therefore, the Examiner's rejection was affirmed. As an aside, note that even though the prior art disclosed a different drug delivery method, this was not enough to distinguish the claims from the prior art.
What does this mean for patent practitioners? It means that when prosecuting drug therapy patent applications, you should rely on more than dosage data to distinguish the invention over the prior art, unless you can show unexpected results. Without the proper evidence supporting unexpected results, dosage data does not, by itself, provide enough novelty to an otherwise known medicine or therapy.
Mark Terry is a registered patent attorney located in Miami, Florida with over a decade of experience helping companies and individuals protect their inventions using the patent system.
