On January 29, 2020, the Federal Circuit reversed and remanded an August 21, 2019 decision (Galderma v. Teva, 390 F.Supp.3d 582 (2019)) handed down by the United States District Court for the District of Delaware in the patent infringement dispute between Galderma Laboratories and generic manufacturer, Teva Pharmaceuticals, relating to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galderma’s Soolantra® (1% ivermectin cream for topical use) for treating inflammatory lesions of rosacea. Galderma Laboratories, L.P. et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2019-2396, 2020-1213 (Jan 29, 2020). Each of the asserted claims recite administering a 1% ivermectin formulation together with the appearance of one or more functional efficacy metrics. In siding with Galderma, the Federal Circuit reversed the district court’s finding that Galderma’s asserted claims were anticipated based on two references (McDaniel-U.S. Patent No. 5,952,372 and Manetta-US Patent No. 7,550,440), contrary to the axiom that “a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention.” According to the Federal Circuit, the district court erred in two ways.
- The district court imported the specific 1% ivermectin formulation required by Galderma’s asserted claims from Manetta into McDaniel based on the faulty rationale that Manetta enabled McDaniel as to the missing specific formulation, thereby confusing the principle of enablement with actual disclosure.
- According to the Federal Circuit, the lower court erred in its finding that the efficacy metrics were inherent in McDaniel because (a) McDaniel did not disclose the specific 1% formulation in the asserted claims, and (b) practicing McDaniel’s disclosed formulations would not have “necessarily resulted” in the claimed efficacy metrics.
In rendering its decision, the Federal Circuit does not change the precedent on inherent anticipation, although it does distinguish over its prior decision in Perricone v. Medicis Pharm. Corp., 432 F.3d 1268 (Fed. Cir. 2005) based on a differing set of facts, thereby adding clarification to the law on inherent anticipation.
The three patents-in-suit are US Patent Nos. 9,089,587 (“the ‘587 patent”), 9,233,177 (“the ‘117 patent”), and 9,233,118 (“the ‘118 patent”), each of which are listed in the FDA’s Orange Book in association with the “patent and exclusivity” information for NDA No. 206255 (owned by Galderma Laboratories, L.P.) as covering Soolantra® (1% ivermectin topical cream indicated for treating inflammatory lesions of rosacea). Teva filed an Abbreviated New Drug Application (ANDA No. 210019) on December 30, 2016 seeking approval for a generic 1% ivermectin topical cream for treating inflammatory lesions of rosacea (“the ANDA product”). Galderma brought an infringement action against Teva on April 21, 2017 under 35 U.S.C. § 271(d)(2)(A) for infringement of the patents-in-suit.
District Court Decision
Judge Richard G. Andrews held a bench trial from June 10-12, 2019 on the issues of validity (written description, anticipation and obviousness) and infringement of the asserted patents. Galderma asserted eight claims in total. Each of the claims “recite methods of treating inflammatory lesions of rosacea through topical administration of 1% ivermectin once daily to patients with inflammatory lesions of rosacea.” See Galderma Fed. Cir. at page 3. In addition, each of the asserted claims recites at least one functional efficacy metric (e.g., “a significant reduction in inflammatory lesion count in the subject,” as recited in claim 12 of the ‘587 patent). Thus, each of the claims are directed to (a) a rosacea treatment method comprising administering a 1% ivermectin formulation that results in (b) the appearance of one or more efficacy metrics. The district court separately analyzed the anticipation of these features.
As to (a) the method, the district court determined that “McDaniel discloses every element of the claimed treatment method.” Galderma 390 F.Supp.3d at 587. Galderma had argued that “McDaniel fails to disclose (1) the use of topical ivermectin for the purpose of treating inflammatory lesions of papulopustular rosacea and (2) the use of 1% ivermectin once daily.” Id. at 588. As to the first point, Galderma specifically argued that McDaniel failed to teach the use of a topical ivermectin formulation for treating inflammatory lesions of rosacea in view of McDaniel’s disclosure that during the initial phase of treatment, the remnants of dead mites can elicit additional lesions, which can be aided by co-administration with conventional anti-rosacea agents. The court reasoned that since these effects were temporary and that the co-administration was not required, McDaniel still anticipated.
As to the second point, Galderma argued that McDaniel’s disclosure of “about 1-5% ivermectin” was not sufficient to anticipate the asserted claim requiring 1% ivermectin once daily. The district court disagreed with Galderma, determining that there is “no ‘consideral difference’ between the 1% ivermectin limitation and the 1-5% ivermectin range in McDaniel” and found “McDaniel’s disclosed range sufficiently specific to anticipate the 1% ivermectin limitation.” Id. at 589.
As to (b) the efficacy metrics, the district court held that “McDaniel anticipates the asserted claims if the efficacy limitations are inherent to the treatment method.” Id. at 589-590. Galderma argued that McDaniel failed to inherently anticipate the efficacy limitations in view of Perricone v. Medicis Pharm. Corp., 432 F.3d 1268 (Fed. Cir. 2005). The court disagreed. In Perricone, the Federal Circuit held that a claimed method for treating a sunburn with a topical composition was not inherently anticipated by a reference describing that use of that topical composition on skin generally to prevent a sunburn. The Federal Circuit reasoned that since the claimed composition and prior art composition were the same, the issue was “whether [the prior art] disclose[d] the application of its composition to skin sunburn.” In other words, the issue Perricone was whether the prior art disclosed the same claimed use. The court in Perricone held that the prior art did not inherently anticipate the claimed method since the claims relate to a method of treatment, whereas the prior art relates to a method of prevention.
Disagreeing with Galderma, the district court distinguished Perricone since the methods of the prior art and the claims are the same (i.e., both are for treating rosacea), unlike in Perricone (treatment versus prevention). Id. at 591. According to the district court, the issue instead was whether “McDaniel also discloses using the same [1%] ivermectin formulation as in the asserted claims.” Id. The court agreed with Teva that since McDaniel discloses a topical formulation having a range of 1-5% ivermectin, and that this genus includes Manetta’s Soolantra® formulation, that Manetta enables McDaniel for the claimed formulation of 1% ivermectin. According to the court, since McDaniel was enabled as to the claimed 1% ivermectin formulation, the recited functional efficacy metrics were an inevitable result that would occur upon practicing the claimed method. Thus, since efficacy limitations were inherently anticipated, the district court found “each of the asserted claims invalid for anticipation by McDaniel.” Id. at 592.
Galderma filed a notice of appeal with the Federal Circuit on September 6, 2019 to challenge the district court’s finding of anticipation of the asserted claims. The main issue on appeal was whether the district court erred in its anticipation analysis, which included a finding of inherent anticipation as to the claimed functional efficacy metrics. According to Judge O’Malley, the district court erred in at least two ways.
First, the district court erred in finding that McDaniel anticipated the specific 1% ivermectin formulation of the asserted claims (“the Soolantra® formulation”) despite McDaniel being devoid of that specific disclosure (instead, it disclosed formulations having “about 1-5%” ivermectin). According to Judge O’Malley, the district court improperly relied on the doctrine of enablement to justify reliance on Manetta’s specific disclosure of the Soolantra® formulation as enabling McDaniel’s more general disclosure of “about 1-5%” ivermectin as a teaching of the missing disclosure of 1% ivermectin. While anticipation requires that a single prior art reference disclose “all of the claim limitation[s],” it must also enable the subject matter of the claims. Decision at 8. On this point, the Federal Circuit, in agreement with Galderma, stated that while “the district court was permitted to look to other references to interpret the allegedly anticipatory reference, it was strictly prohibited from using additional references ‘for a very specific teaching.’” (citing to Studiengessellschaft Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed. Cir. 1984)). The Federal Circuit rejected the district court’s solution of curing McDaniel’s lack of the specifically claimed formulation (i.e., 1% ivermectin) with Manetta’s specific disclosure of the Soolantra® formulation (1% ivermectin) and stated that doing so “runs afoul” of settle principles. Decision at 10. In particular, the court held that Teva “makes the impermissible leap from enablement to disclosure” when it argues that “‘a skilled artisan with McDaniel in hand would envisage’ the Soolantra formulation,” which McDaniel does not specifically disclose.
Second, the Federal Circuit found the lower court erred in finding that the functional efficacy metrics recited in the asserted claims were inherently disclosed in McDaniel when enabled by Manetta’s Soolantra® formulation because the claimed efficacy limitations would not have “necessarily result[ed] from practicing McDaniel” over its disclosed full scope of ivermectin formulations. The court agreed with Galderma’s argument that the district court based its finding of inherency “on the mere possibility that a POSA would have been able to practice McDaniel’s disclosed method with Soolantra®,” and disagreed with Teva, which argued that “McDaniel ‘discloses’ the Soolantra® formulation, and therefore it inherently anticipates the claimed efficacy limitations… .” Decision at 13. The Federal Circuit also found that the district court “mistakenly relied” on Perricone v. Medicis Pharm. Corp., 432 F.3d 1268 (Fed. Cir. 2005) to find inherent anticipation. As explained by the court, McDaniel, unlike in Perricone, “does not disclose the ‘very same composition’ as the patents-in-suit; it [McDaniel] only discloses topical ivermectin formulations generally.” On the question of whether practicing McDaniel’s disclosed general methods would necessarily result in the claimed efficacy metrics, the court said ‘no,’ citing to the following two reasons: (1) McDaniel does not teach the specific Soolantra® formulation, and (2) McDaniel’s general disclosed formulations would have variations, as acknowledged by Teva’s expert, which would affect whether they would achieve the claimed efficacy metrics. Thus, the court held that not all of the 1% formulations “within the scope of McDaniel’s disclosure will inevitably achieve the claimed efficacy limitations.” Decision at 14.
When asserting an infringement defense of invalidity on the basis of inherent anticipation by a prior art reference, it is important not to conflate the principles of anticipation and enablement where a second reference may be needed to show that the disclosure of the first prior art reference is enabling as to some claimed aspect. While it is permissible to rely on the teachings of a second reference to demonstrate that the disclosure of a first reference is, in fact, enabling, it is not permissible to effectively import a specific teaching from a second reference that may be missing from the first reference in order to establish anticipation of a claim by the first prior art reference.