As applied to Morsa’s application, the Court found that the specification made numerous admissions regarding the knowledge of a person of skill at the time of the invention. However, Judge Newman wrote in dissent that enablement of prior art must also come from the prior art, and that the majority improperly used information from the specification of the patent at issue to find that a prior art reference was enabling.
The issue on appeal was whether Applicants antedated the ‘560 reference in accordance with Rule 131. A patent applicant bears the burden of establishing “reduction to practice prior to the effective date of the reference, or conception of the invention prior to the effective date of the reference coupled with due diligence from prior to said date to a subsequent reduction to practice or to the filing of the application.” 37 C.F.R. 1.131(b). The Court concluded that substantial evidence supported a finding that Applicants failed to establish conception and continuing diligence, or actual reduction to practice, before the effective date of the ‘560 reference.
Despite the Supreme Court ruling that laches is no defense to a copyright infringement action brought during the statute of limitations, the Federal Circuit ruled laches can bar recovery of legal remedies in patent infringement. The Federal Circuit explained that the 1952 Patent Act codified the common law rule, meaning that laches was codified as a defense under 35 U.S.C. 282.
The Federal Circuit, sitting en banc, followed the common law principle that, ”[w]hen a statute covers an issue previously governed by the common law, [the Court] must presume that Congress intended to retain the substance of the common law.” The Federal Circuit also ruled that laches does not preclude an ongoing royalty.
Astornet sued NCR Government Systems, MorphoTrust, and BAE Systems Inc., alleging that they supplied the Transportation Security Administration (“TSA”) with certain boarding pass scanning systems, and that TSA’s use of the equipment infringed or would infringe its patent. The complaints alleged that the defendants “induced (and contributed to) direct infringement by TSA by virtue of TSA’s use of equipment supplied by the defendants.” The Federal Circuit affirmed the dismissal based on 28 U.S.C. § 1498 barring the suits by limiting Astornet’s remedy to an action against the United States in the Court of Federal Claims.
The Federal Circuit disagreed, holding that “record evidence establishe[d] a genuine dispute over whether a person of ordinary skill would have been motivated to add a vent to Hoang’s disinfecting cap.” The Court also held that “the tradeoff between the desire to retain cleaning agent and the patents’ disclosure regarding drying is a factual matter left to the factfinder.”
Since the preferred embodiment did not have patentable characteristics that are distinct from other disclosed embodiments, the Court held that “the patentee [was] entitled to claim scope commensurate with the invention that [was] described in the specification.” The Court also held that the doctrine of claim differentiation was applicable here, since the “two severable score lines” limitation only appeared in a dependent claim but not in any independent claims. In other words, the presence of the “two severable score lines” limitation in a dependent claim gave rise to a presumption that such a limitation was not present in the independent claim.
The Federal Circuit affirmed the TTAB, noting that substantial evidence supported the TTAB’s findings. Where, as here, the disputed term is highly descriptive, the TTAB acted within its discretion in refusing to accept evidence of five years’ use as prima facie evidence of distinctiveness.
JVC is a member of two licensing pools for optical disc technology, one for DVD and one for Blu-ray. The asserted patents are included in both pools. The district court adopted JVC’s position that the asserted patents are essential to the licensed DVD and Blu-ray optical discs. Given the patent pool and licensing program, which covers any and all optical disc structures and uses that are essential under the patents, only the use of unlicensed optical discs would be an infringement – regardless of any third-party software used to manipulate the discs. JVC did not argue, and no evidence of record established, that unlicensed discs should be attributed to Nero, or the patent pool license should not encompass discs and end-users that implemented the Nero software.
The en banc Court reversed the previous panel, and expanded the circumstances under which an alleged infringer may be liable under §271(a). In addition to circumstances identified by the panel, liability may arise if “an alleged infringer conditions participation in an activity or the receipt of a benefit upon performance of a step or steps of the patented method, and establishes the manner or timing of that performance.” When that standard is satisfied, the actions of a third party may be attributed to the alleged infringer, who thereby directly infringes under §271(a), even though there was no “mastermind” acting though a formal agent.
Amgen filed a biologics license application (“BLA”) and obtained FDA approval for its filgrastim product, Neupogen. Sandoz subsequently filed an abbreviated BLA (“aBLA”) under 42 U.S.C. § 262(k), seeking approval for a biosimilar (generic) version of Neupogen. Amgen sued Sandoz, asserting claims of (1) unfair competition under state law based on violations of the Biologics Price Competition and Innovation Act (“BPCIA”); (2) wrongful use of Amgen’s approved BLA; and (3) infringement of U.S. Patent No. 6,162,427, which claims a method of using filgrastim. Amgen alleged that Sandoz violated the BPCIA by failing to disclose its aBLA and manufacturing information as required by 42 U.S.C. § 262(l)(2)(A) and by prematurely giving a notice of commercial marketing under 42 U.S.C.§ 262(l)(8)(A), i.e. giving notice before the FDA approved its biosimilar product.
This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during drug approval. However, because of the differences between these two types of drugs, stemming from the increased complexity in manufacturing and patent protection, unique provisions were included in the BPCIA. Unfortunately, as Judge Lourie of the Federal Circuit put it, the BPCIA could win a “Pulitzer prize for complexity or uncertainty.” And, it is these new provisions that could prove the downfall of the BPCIA, at least as it currently exists.
Writing for the panel majority, Judge Dyk, who was joined by Judge Clevenger, explained that regardless of whether the USPTO properly should have instituted an IPR, the decision of the USPTO could not be reviewed or challenged even after a completed IPR proceeding. Further, the CAFC found that the broadest reasonable interpretation standard is appropriate in IPR. Judge Newman dissented.
The district court imposed a fee-shifting sanction as a condition of permitting AntiCancer to supplement the Preliminary Infringement Contentions that the district court found defective under Patent Local Rule 3.1. The district court issued an Order that would have allowed AntiCancer to supplement its infringement contentions, but only if it concurrently pay the attorney fees and costs incurred by the defendants in connection with their motion for summary judgment related to the defective infringement contentions. AntiCancer objected to this condition, and the district court entered summary judgment… It seems fundamentally unfair for a defendant to have to pay for a filing that becomes nullified by amended infringement contentions, whether they appear in an Amended Complaint or in a filing required by a local rule.
The Federal Circuit, per Judge Newman and with Chief Judge Prost and Judge Hughes, found that the Federal Circuit lacked jurisdiction to hear the appeal from a decision to remand the case back to State court, citing 28 U.S.C. 1447(d), which makes unreviewable “[a]n order remanding a case to the State court from which it was removed…” Section 1447(d) seems, and the outcome likely unfair, although no one will likely shed a tear for MPHJ.
In Novartis, this Federal Circuit panel (opinion by Judge Taranto, joined by Judges Newman and Dyk) ruled that the second exclusion from PTA in the “B period” portion (i.e., 35 U.S.C. § 154(b)(1)(B)(ii)) excludes from PTA any time consumed by a Request for Continued Examination (RCE), even if that RCE is filed more than 3 years after the “actual filing date” of the patent application. Not only is this ruling a questionable interpretation of 35 U.S.C. § 154(b)(1)(B)(ii) for reasons I’ll discuss below, but it creates an unfortunate, and surely unintended impact on RCEs specifically, as well as continuation practice generally. And the more I dig into the PTA statute, the more problematical this ruling in Novartis becomes.