In determining whether certain patent claims that were the subject of interference were obvious in view of each other, the U.S. Court of Appeals for the Federal Circuit held that unexpected results discovered after a patent has issued can be considered in an obviousness analysis. Genetics Institute LLC v. Novartis Vaccines and Diagnostics Inc., Case No. 2010-1264 (Fed. Cir. Aug. 23, 2011) (Lourie, J.) (Dyk, J., concurring-in-part and dissenting-in-part).
Plaintiff Genetics Institute (GI) filed an “interfering patents” action under 35 U.S.C. §291 against Novartis Vaccines and Diagnostics in order to determine priority of invention between one GI patent and two Novartis patents. The patents are directed to truncated forms of a protein known as Factor VIII, a blood clotting protein used to treat patients with hemophilia. The question at the lower court was whether structural differences between the proteins claimed in the patents would have been obvious to a person skilled in the art. Novartis offered evidence that its truncated Factor VIII protein included an additional amino acid region that, unbeknownst to Novartis at the time of filing its application, rendered its proteins more stable in the bloodstream. The lower court relied, in part, on this evidence in concluding that no interference-in-fact was present.
On appeal, the Federal Circuit affirmed the district court’s holding that there was no interference-in-fact because the claims of the patents were not obvious in view of each other. The Court credited Novartis’ proffered unexpected results as relevant objective indicia of non-obviousness, even though the unexpected results were discovered years after the patent issued. The Court stated that the full range of an invention is not always achieved at the time of filing the patent application, and, thus, evidence of unexpected results developed after a patent issued should not be excluded from consideration.
Judge Dyk dissented from this portion of the majority’s holding. He stated that the structural similarity and overlap of the proteins claimed in the two patents rendered them prima facie obvious, holding that later-discovered, undisclosed benefits cannot be used to defeat this prima facie showing.
Practice Note: Patentees trying to overcome an obviousness attack should note that unexpected results need not be known at the time of filing a patent application to be considered in a secondary considerations analysis. This case is also noteworthy in light of the Court’s holding that patent term extension under 35 U.S.C. §156 does not apply on a claim-by-claim basis but to the patent as a whole; the expiration of a patent in an interference proceeding under 35 U.S.C. §291 does not strip the Court of subject matter jurisdiction; and unexpected results do not require absolute identity of scope with the claims.