Latest Federal Court Cases – June 2022 #3 | Schwabe, Williamson and WyattPC
Novartis Pharmaceuticals. Corp. vs. Accord Healthcare, Inc.Appeal No. 2021-1070 (Fed. Cir. June 21, 2022)
In this week’s case, the Federal Circuit granted the panel a rehearing and reversed its earlier decision in Novartis Pharmaceuticals. Corp. vs. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022). Our write-up of this opinion can be found here. Previously, the Court upheld the district court’s ruling that Novartis’ patent claims for sclerosis treatments were supported by an adequate written description, and its subsequent trial ruling that the claims were infringed by petitioners HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (HEC). With respect to rehearing issues, the Court found that a negative limitation excluding the use of a “loading dose” in the claimed treatment regimen was supported by an adequate written description, notwithstanding the fact that the patent specification was silent as to the presence or absence of a loading dose. (A “loading dose” is a generally higher dose initially administered to elevate the patent’s medication levels.) In reaching this conclusion, the Court credited expert testimony that a skilled craftsman would understand that the specification discloses a regimen excluding a loading dose.
At the rehearing, Circuit Judge Hughes replaced Judge O’Malley on the panel handling the case following Judge O’Malley’s retirement in March 2022. Judge Hughes joined the Chief Justice Moore (who had previously dissented) to conclude that the negative “no loading dose” limit was not adequately supported by the written description of the patent. The Court’s opinion explained that, as with positive claim limitations, “the characteristic of the written description is disclosure”. The Court held that “[s]silence is generally not disclosure”, and although a negative limitation need not be recited in haec verba, there must be something in the description indicating to a person skilled in the art that the inventor intended the exclusion, such as a discussion of the disadvantages of the excluded item or distinctions between the item and the alternatives. In the absence of such disclosures, the Court held that a skilled craftsman must understand that the excluded item is necessarily absent from the claimed method or apparatus.
Here, the loading doses were not mentioned in the specification at all, and the Court found that the district court clearly erred in concluding that the “no loading dose” limitation was sufficiently substantiated. In support of its conclusion, the Court noted that the negative limitation was added in an amendment during the course of the suit to overcome the prior art, which should not have been necessary if the limitation was necessarily understood to be present by a skilled craftsman, and that HEC’s expert testimony has not otherwise established that a person skilled in the art would understand that the specification necessarily excludes a loading dose. The Court also noted tension in the district court’s finding that the limitation was disclosed in the patent but not in the claimed prior art which was also silent as to the presence of a loading dose. On this last point, the Court rejected the reasoning of the district court that, contrary to the state of the art, a patent “is presumed to be complete”, holding that “[a] patent is not presumed to be complete, so that matters not mentioned are necessarily excluded. We only assume that a patent has an adequate written description, not that it is complete.
Because the asserted claims were not supported by an adequate written description, the Court reversed the district court’s judgment that the claims were not invalid. Justice Linn dissented, disapproving of the majority’s adoption of a “necessarily excluded” standard and arguing that a patent holder should only show that a skilled craftsman would understand that he was in possession of the invention claimed on the claimed priority date.
The review can be found here.
By Jason Wrubleski
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Centripetal Networks, Inc. v. Cisco Systems, Inc.Appeal No. 2021-1888 (Fed. Cir. June 23, 2022)
In this case, the Court of Appeals for the Federal Circuit ruled a judge disqualified for a dispute between Centripetal Networks, Inc. and Cisco Systems, Inc. After the judge realized his wife owned $4,687.99 in stock Cisco, he deposited the shares in a store. trust. First, the Federal Circuit found that while placing shares in a blind trust deprived the judge’s wife of control, it did not deprive her of ownership and therefore did not constitute an “assignment” within the meaning of 28 USC § 455(f), as would be necessary to remedy an inadmissible financial interest under § 455(b)(4). Second, with respect to the appropriate remedy, the Federal Circuit deemed vacatur appropriate. Among other factors, the court considered the risk of upholding the judge’s earlier decision, both by signaling to other judges that sitting in a case where a family member had a financial interest was not a serious problem, and undermining public confidence in the judicial process, particularly given the growing concern among the public and the judiciary caused by reports from judges hearing cases in which they have a financial interest. Thus, the Federal Circuit found that the judge’s violation of § 455(b)(4) was not a trivial error and set aside and returned all orders and opinions entered after the date the judge became aware of of his wife’s financial interest.
The review can be found here.
By Tyler Hall