Precedential Federal Circuit Opinions
1. INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A. [OPINION] (2020-2073, 2020-2142, 11/24/21) (Lourie, Linn, Dyk)
Lourie, J. Affirming Board decision in IPR of patent relating to orally dissolvable films. Some claims were found unpatentable because they were not entitled to their alleged priority date and a reference published after that date taught the claimed formulations. Petitioner failed to establish unpatentability of one claim because its formulation was supported by the priority application. "Regarding claim 1, we agree with the Board that there is no written description support in the [priority application] for the range of 'about 40 wt % to about 60 wt %.' First, the range was not expressly claimed in the [priority application]; if it had been, that could have constituted written description support. Furthermore, the values of '40 wt %' and '60 wt %' are not stated in the [priority application]. Most importantly, neither is a range of 40 wt % to 60 wt %... In the case of a claimed range, a skilled artisan must be able to reasonably discern a disclosure of that range. No range of 'about 40 wt % to about 60 wt %' appears in the [priority application]. A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention. The Board upheld the validity of claim 8, which recites 'about 48.2 wt %' as the amount of polymer. We affirm that determination, even though, as [petitioner] argues, the number '48.2 wt %' is not explicitly set forth in the [priority application]. We do so out of deference to the Board's factfinding, even though one might see some inconsistency between this result and our above holding concerning the principal appeal. But, given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board's decision concerning claim 8." Linn, J. concurred-in-part and dissented-in-part.
2. BIOGEN INTERNATIONAL GMBH v. MYLAN PHARMACEUTICALS INC. [OPINION] (2020-1933, 11/30/21) (O'Malley, Reyna, Hughes)
Reyna, J. Affirming decision that claims related to a drug for treating multiple sclerosis are invalid due to lack of written description. "[T]he district court did not clearly err in finding that a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification's only reference to DMF480 was part of a wide DMF-dosage range and not listed as an independent therapeutically efficacious dose. . The district court, as the finder of fact, did not find it necessary or appropriate to distinguish between therapeutic effects and clinical efficacy based on the specification's definition of 'therapeutically effective dose' and the record before it, and such a determination was not clearly erroneous." O'Malley, J. dissented, stating "[t]here is no dispute over whether the district court erred in finding that [patent owner] was judicially estopped from drawing a distinction between clinical and therapeutic effects: it did. [Defendant] calls the error harmless and the majority finds it 'ancillary' to its analysis. I, on the other hand, believe this threshold error impacted the district court's entire written description analysis. I would therefore reverse and remand for reconsideration in light of a proper understanding of the distinction between the two effects and the written descriptions needed for each. . Column 18 provides a sufficient 'blaze mark' by explicitly mentioning the claimed DMF480 dose. How much brighter need a disclosure blaze?"
WilmerHale represented the plaintiffs-appellants, Biogen International GMBG, Biogen MA, Inc.
3. MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION [OPINION] (2020-2329, 12/1/21) (Lourie, O'Malley, Stoll)
Lourie, J. Affirming Board's IPR decision that claims related to stable nucleic acid-lipid particles ("SNALP") are not obvious. The prior art expressly disclosed claimed ranges for all but one component of the claimed SNALP. The Court rejected petitioner's argument that express disclosure of ranges for all but one component effectively disclosed the range for the remaining component. "We have held that a presumption of obviousness typically exists 'when the ranges of a claimed composition overlap the ranges disclosed in the prior art.' . Here, it is undisputed that a range for the phospholipid is not expressly 'disclosed' in the prior art. Yet, [petitioner] argues that the Board should have applied the presumption anyway based on [petitioner's] theory that a phospholipid range can be derived or calculated from the disclosures of the prior art. Before the presumption of obviousness could be applied, [petitioner] would have to first show that, despite the lack of an express disclosure in the references, a person of ordinary skill would have nevertheless understood that the [prior art] teach or suggest a range for the phospholipid component that overlaps with the claimed range." The Court also found that petitioner had standing. "Accordingly, on the record before us, [petitioner] has demonstrated enough of a risk that it will be faced with an infringement suit based on the combination of its own activities in developing the COVID-19 vaccine, [patent owner's] broad public statements about its extensive patent coverage in this area, and [patent owner's] refusal to grant a covenant not to sue. It also bears noting that, if we were to dismiss this appeal for lack of standing, [patent owner] could sue [petitioner] for infringement immediately thereafter. That possibility is easy to envision based on the record, and [patent owner] has done nothing to dispel it. We seek to avoid such a result, which would perversely incentivize a future similarly situated patent owner to remain silent regarding its intentions during the pendency of an appeal and wait to sue for infringement until after the appeal has been dismissed for lack of standing.
WilmerHale represented appellant, Modernatx, Inc., FKA Moderna Therapeutics, Inc.
4. MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION [OPINION] (2020-1184, 2020-1186, 12/1/21) (Lourie, O'Malley, Stoll)
Lourie, J. Affirming Board's IPR decision that some claims related to stable nucleic acid-lipid particles ("SNALP") are anticipated. Also dismissing petitioner's appeal due to lack of standing. "[Petitioner] has provided no evidence as to how, if at all, its obligations under the [sublicenses] would change if it is successful in its attempts to have the [challenged patent] declared invalid while the remaining licensed patents continue to exist. Thus, [petitioner] has failed to meet its burden of demonstrating that it suffers an injury from the existence of the [challenged patent], or that any such injury would be redressed by invalidation of that patent."
WilmerHale represented appellant, Modernatx, Inc., FKA Moderna Therapeutics, Inc.
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