Relevant Documents:
Opinion
Reorg Pharma Recap
- Today, Aug. 21, 2019, a Delaware court issued an opinion finding three key patents covering Galderma’s Soolantra acne cream invalid and not infringed by Teva’s generic product.
- In today’s opinion, Judge Richard Andrews found that three 2034 method of use patents covering Soolantra are anticipated by another patent owned by Galderma.
- The FDA granted tentative approval to Teva’s generic product in March of this year; because of today’s decision, the FDA is now permitted to grant final approval.
- Today’s opinion is favorable for Teva, which may now launch its generic product at risk once it receives final approval from the FDA.
Today, Aug. 21, 2019, a Delaware court issued an opinion finding three key 2034 method of use patents (U.S. Patent Nos. 9,089,587, 9,233,117, and 9,233,118) covering Galderma’s Soolantra (ivermectin) acne cream invalid. Today’s opinion focused on a single piece of prior art referred to as “McDaniel” (U.S. Patent No. 5,952,372), which the court found anticipated all three Soolantra patents. The court found that McDaniel anticipated the method of treatment as well as the claimed efficacies of the three 2034 patents.
Today’s opinion is favorable for Teva, because Teva may now launch its generic product at risk once it receives final approval from the FDA. Teva’s generic product received tentative approval from the FDA in March of this year.
For additional background, please see Reorg Pharma’s coverage of the May 2019 trial
HERE.
Below is a summary of today’s decision:
Summary of August 19, 2019 Decision
Today’s relatively brief 16-page opinion dealt only with the issue of anticipation by McDaniel, an expired patent owned by Galderma that covers methods for the treatment of rosacea. Though Teva had also argued that the patents were invalid for lack of written description and obviousness, today’s opinion did not reach those arguments. Furthermore, today’s opinion contains no analysis of infringement by Teva, as invalidity is an affirmative defense to infringement. Specifically, today’s opinion analyzed McDaniel’s disclosure of (a) the treatment method claimed in the 2034 patents and (b) the efficacies achieved by that treatment method.
Treatment Method
With respect to the treatment method claimed in the 2034 patents, Judge Andrews concluded that, “McDaniel discloses every element of the claimed treatment method.” As
previously reported by Reorg Pharma, Judge Andrews asked pointed questions on the last day of trial about McDaniel’s description of using ivermectin at a strength of 1% to 5% once or twice daily, and took issue with Galderma’s argument that McDaniel taught the dosage strength separately—
i.e., McDaniel never taught a dosage of 1% once daily. Today’s opinion rejects that argument, stating, “The fact that McDaniel also discloses alternatives to the claimed method… does not change the anticipation analysis.”
Most notably, today’s decision questions Galderma’s attempt to rely upon two cases in which courts found no anticipation—
Atofina v. Great Lakes Chemical (a 2006 appeals court opinion) and
Impax v. Lannett (a 2017 opinion written by Judge Andrews himself). Noting that Galderma cited both cases “without explanation,” today’s opinion finds that McDaniel’s disclosed range of 1-5% ivermectin was “sufficiently specific to anticipate the 1% ivermectin limitation” in the 2034 patents, and that “McDaniel provides a clear reason to connect the disclosure of 1% ivermectin with once-daily applications as it explicitly teaches the use of both elements together.”
Efficacies
With regard to the claimed efficacies achieved by applying 1% ivermectin once daily, the court found anticipation based on
Perricone v. Medicis, a 2005 appeals court opinion. In
Perricone, the appeals court found that "[u]sing the same composition claimed by [plaintiff] in the same manner claimed by [plaintiff] naturally results in the same claimed skin benefits." Judge Andrews found that, in this case—as in
Perricone—treating rosacea with 1% ivermectin using the same method of treatment detailed by McDaniel will inherently result in the efficacies claimed by the 2034 patents. Galderma had argued that Perricone supported a finding of no anticipation because the appeals court in
Perricone had found that a claim for use of the same product to treat sunburn was not anticipated because the prior art reference did not disclose such treatment. Similarly, according to Galderma, “McDaniel’s treatment of rosacea generally is insufficient for anticipation because it will not necessarily result in treatment of inflammatory lesions of papulopustular rosacea.” Judge Andrews disagreed, explaining, “the issue is not whether McDaniel’s formulation
if applied would inherently treat [rosacea], but whether McDaniel discloses the application of the formulation to [rosacea].”
Finally, the opinion rejected Galderma’s argument that Teva needed to prove that all 1% ivermectin formulations disclosed in McDaniel would achieve the efficacies claimed in the 2034 patent. Noting that the parties had stipulated that McDaniel was enabled as to the formulation claimed in the 2034 patents by the “Manetta” patent (U.S. Patent No. 7,550,440), the court explained, “Soolantra is the Manetta formulation,” and because the efficacies of applying Soolantra are undisputed, then the efficacies claimed in the 2034 patents are inherently anticipated—“the natural result flowing from the explicit disclosure” of the claims covering the treatment method.
Based on the above analysis, the court found that the 2034 patents were anticipated by McDaniel and therefore invalid. Because invalidity is an affirmative defense to infringement, the court found that Teva had not infringed any of the asserted claims.
Original Story 3:09 p.m. UTC on Aug. 21, 2019
BREAKING: (TEVA) Soolantra: Delaware Court Finds Galderma Patents Invalid; Teva May Launch Generic Version of Soolantra At-Risk Pending FDA Approval
Relevant Documents:
Decision
Today, August 21, 2019, a Delaware court issued a decision finding three key patents (U.S. Patent Nos. 9,089,587, 9,233,117, and 9,233,118) covering Galderma’s Soolantra acne cream invalid and not infringed by Teva’s generic product. As a result of today’s decision, Teva may now launch its generic product at-risk once it receives final approval from the FDA and pending the outcome of a likely appeal. Teva’s generic product received tentative approval from the FDA in March of this year, and the 30-day stay is scheduled to expire on Sept. 14, 2019.