Necessity Is The Mother Of Single Reference Anticipation By Inherency

25 February 2020 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for its discussion of anticipation and inherency in the context of method of treatment claims. The decision shows that even in the context of anticipation, establishing inherency can be a high burden to carry. 

The Patents At Issue

The patents at issue are listed in the Orange Book for Galderma’s Soolantra® product, which is a topical cream containing 1% ivermectin indicated for the treatment of inflammatory lesions of rosacea. Selected claims of U.S. Patent No. 9,089,587, U.S. Patent No. 9,233,117, and U.S. Patent No. 9,233,118 were before the Federal Circuit. As summarized in the panel opinion, the claims at issue “recite methods of treating inflammatory lesions of rosacea through topical administration of 1% ivermectin once daily to patients with inflammatory lesions of rosacea,” and also “recite certain efficacy benchmarks resulting from the treatment methods,” such as “a significant reduction in inflammatory lesion count in the subject,” recited in claim 12 of the ’587 patent and claims 6, 7, 10 and 11 of the ’118 patent. 

The District Court Decision 

The district court invalidated the claims as anticipated by U.S. Patent No. 5,952,372 (“McDaniel”) but also discussed U.S. Patent No. 7,550,440 (“Manetta”) in its opinion. (The parties agreed Manetta disclosed the claimed Soolantra® formulation.) As summarized by the Federal Circuit (internal citations omitted and emphasis added): 

The district court found that McDaniel expressly discloses: methods for treatment of rosacea, … a topical formulation containing about 1–5% ivermectin; and, once-daily application of ivermectin. …. It also found that McDaniel inherently disclosed the claimed efficacy limitations, …. based on the parties’ stipulation that “Manetta enables McDaniel in 2012 as to the formulation.” ….

According to the district court, “as of 2012, before the critical dates of the asserted claims, a person of ordinary skill in the art would have been able to practice McDaniel’s disclosed treatment method with Manetta’s formulation without undue experimentation.” 

The Federal Circuit Decision 

The non-precedential Federal Circuit decision was authored by Judge O’Malley and joined by Judges Moore and Stoll. The Federal Circuit panel found two main errors in the district court decision: First, in its reliance on more than one reference for its anticipation determination; second, in its inherency analysis. 

The Federal Circuit panel agreed with Galderma that the district court erred by looking to Manetta to provide a “specific teaching” necessary to the anticipation rejection, viz., “an ivermectin formulation (such as Soolantra®) that necessarily achieves the claimed efficacy limitations.” Although the parties had stipulated that “Manetta enables McDaniel in 2012 as to the formulation,” the panel explained that enablement does not amount to anticipation (internal citations omitted) (emphasis added):

[T]he parties’ stipulation meant only one thing: in 2012, a POSA would have been able to practice the general formulations disclosed in McDaniel, i.e., 1–5% ivermectin, “formulated into a cosmetically-acceptable topical lotion, cream, or gel.” …. The stipulation cannot mean … that McDaniel discloses the specific Soolantra formulation.

Noting that “Teva’s own expert testified that a 1% ivermectin formulation can be achieved in ‘thousands and thousands of possible’ ways,” the panel disagreed “that a POSA reading McDaniel would at once envisage the … specific Soolantra® formulation [disclosed in Manetta] that satisfies the claimed efficacy limitations.” Thus, the panel concluded “that the district court erred in looking outside McDaniel in its anticipation analysis.”

The Federal Circuit panel also agreed with Galderma that the district court erred by finding that “McDaniel inherently discloses the claimed efficacy limitations” based on “the mere possibility that a POSA would have been able to practice McDaniel’s disclosed method with Soolantra®.” The panel emphasized:

The proper inquiry for inherent anticipation is whether the claimed efficacy limitations “necessarily result” from practicing McDaniel. See, e.g., Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 960–61 (Fed. Cir. 2014) (affirming judgment that claims were not inherently anticipated where the prior art only showed that the limitation might occur, not that it inevitably occurred). What a POSA would have been able to practice based on Manetta’s disclosure is not at issue.

Thus, the panel reversed the district court’s finding of anticipation by McDaniel.

Reining In Reliance On Inherency 

When a prior art reference does not expressly disclose a functional property or result of a claimed product or method, it is tempting to assert that the missing feature is inherent to the product or method that is described. This non-precedential decision and others like it remind that the “necessarily present” and “necessarily result” requirements for an inherency-based determination can be a high burden to carry. It may be particularly difficult where, as here, the prior art reference does not describe a specific product or method that would permit a court to “conclude with certainty” that practicing cited prior art “will inevitably achieve” the claimed invention. 

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