Combination Dosing Regimen Not Obvious Despite Overlapping Prior-Art Ranges
In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of obviousness based on overlapping ranges did not apply.
Janssen sued Teva for infringing patent claims directed to dosing regimens for an injectable form of paliperidone palmitate. Teva stipulated to infringement and challenged validity on grounds of obviousness and indefiniteness. In a prior appeal, the Federal Circuit affirmed the district court’s rejection of the indefiniteness challenge but vacated its obviousness ruling. On remand, after a bench trial, the district court held that Teva had not proved any of the asserted claims invalid for obviousness or indefiniteness.
The Federal Circuit affirmed. First, it declined to apply the presumption of obviousness despite an overlap in the claimed and prior-art dosage ranges. It found the claimed combination included a novel dosing sequence with a higher first dose followed by a lower second dose. The Federal Circuit explained that the presumption typically applies when a single variable overlaps with prior art ranges and when the skilled artisan could optimize it through routine experimentation. The Federal Circuit also upheld findings by the district court that Teva failed to show a motivation to combine the cited references. It agreed with the district court that a skilled artisan would not have expected success with the claimed regimen due to missing safety data and differing drug behavior in the prior art.
Cancellation of a Closely Related Claim During Prosecution Can Trigger Prosecution History Estoppel
In Colibri Heart Valve LLC v. Medtronic Corevalve, LLC, Appeal No. 23-2153, The Federal Circuit reversed a $106 million infringement verdict, holding that Colibri’s doctrine-of-equivalents arguments were barred by prosecution history estoppel because it cancelled a related claim during prosecution.
Colibri sued Medtronic, a manufacturer of replacement heart valves, for infringement of a patented method for implanting an artificial heart valve that gives the surgeon a second chance to get the positioning of the valve right. During prosecution of its patent, Colibri pursued two closely related independent claims reciting the do-over method. The first claim recited “pushing” the valve out from the delivery device, while the second claim covered “retracting” an outer sheath to expose the valve. The examiner rejected the “retracting” claim for lack of written description and Colibri cancelled it.
In the district court, Medtronic argued that its product deployed the valve by retracting, not pushing. Colibri responded that the “pushing” claim covered Medtronic’s procedure under the doctrine of equivalents. The jury agreed and awarded Colibri more than $106 million in damages. Medtronic moved for judgment as a matter of law (JMOL) on the grounds that Colibri’s doctrine-of-equivalents theory was barred by prosecution history estoppel. The district court denied the JMOL motion because the “pushing” and “retracting” claims were separate independent claims and Colibri did not amend the “pushing” limitation during prosecution.
The Federal Circuit reversed the district court’s denial of JMOL. The court explained that when evaluating prosecution history estoppel, a court considers closely related claims, not just the amended claim. Because of the close substantive relationship between the “pushing” claim and the “retracting” claim, Colibri’s cancellation of the “retracting” claim gave rise to prosecution history estoppel as to the “pushing” claim.
Applicant Admitted Prior Art Can (Sometimes) Show Obviousness
In Shockwave Med., Inc., v. Cardiovascular Sys., Inc., Appeal No. 23-1864, the Federal Circuit held that in inter partes review proceedings, applicant admitted prior art may be used as evidence of what a person of ordinary skill in the art would have as background knowledge, and that background knowledge can be used to supply missing claim limitations in an obviousness combination.
Cardiovascular Systems (“CSI”) filed an IPR petition challenging the claims of U.S. Patent No. 8,956,371 (the “’371 patent”), which was directed to angioplasty catheters used to break up plaque in blood vessels. CSI argued that the challenged claims would have been obvious in view of a European patent publication, “Levy,” modified in view of the applicant’s admitted prior art (“AAPA”) discussed in the ’371 patent’s specification. The Board originally treated the AAPA as falling withing the scope of “prior art consisting of patents or printed publications” under 35 U.S.C. § 311(b) and held claims 1-4 and 6-17 would have been obvious. Shortly thereafter, the PTO issued binding guidance that AAPA does not qualify as prior art consisting of patents or printed publications under § 311(b). The Board initiated rehearing to consider the guidance and ultimately held the same claims to be obvious. In the rehearing decision, the Board still considered the AAPA, but this time as evidence of what was known in the art.
Shockwave appealed the Board’s determination of obviousness, arguing that the Board improperly relied on AAPA in violation of the PTO’s guidance and the statute’s language. The Federal Circuit disagreed. The Court explained that AAPA cannot be the “basis of a ground” for a petition but it can still be used as evidence of a skilled artisan’s background knowledge. The Court clarified that a skilled artisan’s background knowledge, in turn, could provide evidence to supply a missing claim limitation. Thus, the Court affirmed the Board’s analysis because the Board relied on AAPA only for the acceptable purpose of showing that a claimed feature was well-known in the art. Shockwave also argued that the Board’s use of the phrase “basis” in its decision meant that AAPA was improperly considered as a basis for obviousness. The Court disagreed, explaining that “what matters for the purposes of § 311(b) is the grounds raised in the petition,” not the phrasing used in the Board’s decision. In this instance, the Court held, the grounds raised in the petition properly used the AAPA to establish well-known general knowledge.
Federal Circuit Holds District Court Abused Its Discretion By Excluding an Authenticating Witness
In Jiaxing Super Lighting Electric Appliance, Co. V. Ch Lighting Technology Co., Ltd., Appeal No. 23-2245, The Federal Circuit reversed the district court’s JMOL of no on-sale bar after holding the district court abused its discretion in excluding a witness who would have authenticated documents on that issue. The Court also directed the district court to assess the reliability of plaintiff’s damages testimony and affirmed the jury’s finding of infringement and no invalidity for another patent.
Super Lighting sued CH Lighting alleging infringement of three patents related to LED tube lamps. Two of the patents relate to purported structural improvements in LED tube lamps (the “tube patents”) and the third relates to a shock-prevention system for use while installing LED tube lamps (“the ’140 patent”). Before trial, CH Lighting conceded infringement of the tube patents. At trial, the district court granted Super Lighting’s motions (1) to exclude evidence relating to invalidity of the tube patents and, subsequently, (2) for judgment as a matter of law (“JMOL”) that the tube patents were not invalid on the ground of an on-sale bar. A jury later found the ’140 patent infringed and not invalid. The Jury awarded damages for infringement of claims of the three patents. CH Lighting appealed.
First, the Federal Circuit reversed the district court’s grant of JMOL that the tube patents were not invalid. The Court held that the district court abused its discretion in excluding CH Lighting’s witness who would have authenticated documents regarding on-sale bar. It noted the district court did not identify any rule or order requiring parties to identify in advance which witnesses would authenticate documents, and that there is no such requirement under Federal or local rule. Second, regarding the ’140 patent, the Court affirmed the jury’s finding of infringement and no invalidity. The Court stated that the jury was free to credit expert testimony offered by Super Lighting over that offered by CH Lighting. Third, the Federal Circuit found the district court should have conducted a more exacting analysis of the testimony of Super Lighting’s damages expert. It directed the district court to assess the reliability of that testimony under the Court’s recent en banc decision in EcoFactor, Inc. v. Google LLC, 137 F.4th 1333 (Fed. Cir. 2025), which noted that “[a]n absence of reviewable reasoning may be sufficient grounds for this court to conclude the district court abused its discretion.” Accordingly, the Federal circuit vacated the jury’s award of damages and remanded for a new trial on the validity of the tube patents and damages for all three patents.
No Shenanigans: IPRs and Interference Estoppel
In IGT v. Zynga Inc., Appeal No. 23-2262, Interference estoppel does not apply when the interference was terminated due to a threshold issue.
Zynga petitioned for inter partes review (IPR) of an IGT patent after having attacked the same patent via an interference proceeding. IGT opposed, arguing interference estoppel under 37 C.F.R. § 41.127(a)(1). Because the interference proceeding was terminated on a threshold issue and the IPR petition relied on a combination of prior art references not used in the interference proceeding, the PTAB declined to apply interference estoppel. The PTAB ultimately concluded that IGT’s claims were obvious. IGT appealed.
The Federal Circuit affirmed, finding that the decision not to apply interference estoppel was related to the decision to institute the IPR and therefore unreviewable. The court reasoned that the PTO Director is afforded discretion regarding whether to institute an IPR. The decision to institute an IPR is generally unreviewable unless the PTO has violated legal constraints or engaged in other “shenanigans.”
The Federal Circuit found the PTAB’s reasoning for not applying interference estoppel sufficient to support a finding of no “shenanigans,” and that no exceptions applied to the general bar on reviewability of institution determinations. The court further affirmed the PTAB’s finding on obviousness.
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