Fresh From the Bench: Latest Federal Circuit Court Cases
CASE OF THE WEEK
Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., Appeal Nos. 2017-2078, -2134 (Fed. Cir. Sept. 10, 2018)
The Federal Circuit affirmed the district court’s ruling following a bench trial that asserted claims of four pharmaceutical patents were invalid. The case is a major decision reconciling the effect of blocking patents on an analysis of objective indicia of nonobviousness.
Defendants, all ANDA applicants preparing to market generic versions of the claimed treatment, stipulated to infringement of all five patents. Defendants’ cross-appeal was dismissed as moot because a fifth patent expired before issuance of the Court’s opinion, and with it the injunction entered against Defendants.
The four patents at issue claimed methods of administering 4-aminopyridien (“4-AP,” marketed by plaintiffs as “Ampyra”) to improve walking in patients with multiple sclerosis (“MS”). The district court had found that, as of the patents’ priority date of 2004, a skilled artisan would have been motivated to administer the claimed stable dose of 4-AP twice daily, and would have had a reasonable expectation of success in the objective of improving the walking ability of multiple sclerosis patients. In its analysis, the district court discounted certain evidence of objective indicia of non-obviousness, relying on the fact that plaintiff held an exclusive license to a blocking patent that would have prohibited others from marketing the claimed treatment.
Nobel Biocare Services AG v. Instradent USA, Inc., Appeal No. 2017-2256 (Fed. Cir. Sept. 13, 2018)
In an appeal from an inter partes review, the Federal Circuit addressed whether a catalog was a printed publication under pre-AIA 35 U.S.C. Sec. 102(b). The PTAB held that it was. In a prior case concerning the same patent, the ITC had held that there was insufficient evidence to find pre-critical date public accessibility, as required to satisfy the standard for printed publications. The Federal Circuit had affirmed that opinion. But the burden of proof is different in IPRs than ITC opinions, and the PTAB found a preponderance of evidence that the catalog was a printed publication. The Federal Circuit affirmed.
ParkerVision, Inc. v. Qualcomm Inc., Appeal Nos. 2017-2012, -2013, -2014, -2074 (Fed. Cir. Sept. 13, 2018)
In an appeal and cross-appeal from three decisions of the Patent Trial and Appeal Board (PTAB) invalidating certain claims from a ParkerVision, Inc. patent while maintaining others, the Federal circuit affirmed the PTAB findings. The Federal Circuit reviewed the PTAB legal decisions de novo and its underlying factual determinations for substantial evidence. The Federal Circuit concluded that the Board’s findings were correct because a prior art reference may anticipate or render obvious an apparatus claim—depending on the claim language—if the reference discloses an apparatus that is reasonably capable of operating so as to meet the claim limitations, even if it does not meet the claim limitations in all modes of operation. The Federal Circuit states that the language used in the claims is critical to deciding on which side of this line the claims fall. Here, the Federal Circuit affirmed the Board’s determination that the apparatus claims are unpatentable because Qualcomm was only required to identify a prior art reference that disclosed an apparatus “capable of “ performing the recited functions to prove that apparatus claims would have been obvious. However, in contrast to the apparatus claims, the method claims required more—a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so—as the Board found and the Federal Circuit affirmed.
University of California v. Broad Institute, Inc., Appeal No. 2017-1907 (Fed. Cir. Sept. 10, 2018)
In an appeal from a decision of the Patent Trial and Appeal Board determining there was no interference-in-fact between two patent applications, the Federal Circuit affirmed. The Board determined no interference-in-fact because UC’s claims to the use of a system for the targeted cutting of DNA molecules and Broad’s claims to using such a system in a eukaryotic cell were patentably distinct. The Federal Circuit used a standard of review that mirrored the standard of review in an obviousness review because the question of interference-in-fact turned on whether one set of claims renders obvious the subject matter of another set of claims. As such, the Federal Circuit reviewed the Board’s ultimate conclusion of non-obvious de novo, and the underlying factual findings for substantial evidence. The Federal Circuit concluded that the Board used the correct test for obviousness, and as such affirmed the Board’s judgement of no interference-in-fact.
In an appeal from an IPR, the Federal Circuit affirmed the Board’s decision that claims related to wireless networking technology are invalid under 35 U.S.C. § 103. The Federal Circuit determined that prior art implicitly disclosing the claims was sufficient to lead a person skilled in the art to conclude that the reference teaches the claims. Thus, the Board’s obviousness finding was supported by substantial evidence.
Orexo AB v. Actavis Elizabeth LLC, Appeal No. 2017-1333 (Fed. Cir. Sept. 10, 2018)
In an appeal from the Delaware District Court, the Federal Circuit reversed the District Court’s decision invalidating the asserted claims of Orexo’s patent covering the brand name product Zubsolv® for opioid dependence on the ground of obviousness. The Federal Circuit found that obviousness was not proved by clear and convincing evidence. Specifically, it disagreed with the Court’s conclusion that the prior art would lead a person skilled in the art along the path to the invention of the patent in suit. The Federal Circuit emphasized that “[t]he question is not whether the various references separately taught components of the [patent in suit’s] formulation, but whether the prior art suggested the selection and combination achieved by the [patent in suit’s] inventors.” Finally, the Federal Circuit reiterated its previous comments “that objective indicia is part of the whole analysis and not just an afterthought.” Here, the Federal Circuit found that the objective evidence guided the obviousness analysis and that the Court had erred in discounting Orexo’s evidence of unexpected and beneficial results.