Background of the Litigation
The litigation between Galderma Laboratories LP and Teva Pharmaceuticals USA, Inc. revolves around the validity and infringement of several patents related to Galderma's topical rosacea treatment, Soolantra®. Soolantra® is a 1% ivermectin cream, and the patents in question are listed in the Orange Book, a catalog of FDA-approved drugs and their associated patents[4][5].
The Patents-in-Suit
Galderma asserted infringement of several claims from three patents: U.S. Patents Nos. 9,089,587 ('587 patent), 9,233,117 ('117 patent), and 9,233,118 ('118 patent). Specifically, Galderma claimed infringement of claim 12 of the '587 patent, claims 2, 3, and 6 of the '117 patent, and claims 6, 7, 10, and 11 of the '118 patent[1][4].
Teva's ANDA Filing and Paragraph IV Certification
Teva filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval for a generic version of Soolantra®. As part of this process, Teva submitted a Paragraph IV certification, asserting that the claims of the patents-in-suit were invalid, unenforceable, and/or not infringed by Teva's generic product[3][4].
District Court Proceedings
Following Teva's ANDA filing and Paragraph IV certification, Galderma initiated a lawsuit against Teva in the United States District Court for the District of Delaware. The case, Galderma Labs., L.P. v. Teva Pharm. USA, Inc., C.A. No. 1:17-cv-01783-RGA, involved a three-day bench trial in June 2019 to determine the issues of validity and infringement of the asserted patents[3][4].
Findings of the District Court
The district court found each of the asserted claims invalid for anticipation based on U.S. Patent No. 5,952,372 (McDaniel). The court determined that McDaniel expressly disclosed various claim limitations and inherently disclosed the claimed efficacy limitations. However, the court's decision was criticized for relying on disclosures from multiple references, which is contrary to the settled law that anticipation must be based on a single reference[4][5].
Appeal to the Federal Circuit
Galderma appealed the district court's decision to the United States Court of Appeals for the Federal Circuit. On appeal, Galderma argued that the district court erred by finding the asserted claims anticipated based on disclosures from multiple references, specifically McDaniel and another reference known as Manetta[2][5].
Federal Circuit's Decision
The Federal Circuit reversed the district court's judgment, agreeing with Galderma that the lower court had erred in its anticipation analysis. The Court held that anticipation must be based on a single reference and that turning to another reference for a specific teaching violates this principle. The Court also found that McDaniel does not disclose the specific Soolantra® formulation and that variations in formulation parameters would affect the results, thus the claimed efficacy limitations were not inherently disclosed by McDaniel[5].
The Federal Circuit remanded the case to the district court for consideration of Teva's remaining invalidity defenses, including obviousness, which had not been addressed by the lower court[5].
Injunction and Cross-Appeal
During the appeal process, Galderma sought and obtained an injunction from the district court to prevent Teva from marketing its generic product pending the appeal. Teva cross-appealed this injunction, but the Federal Circuit stayed the district court's injunction, allowing Teva to proceed with marketing its generic product until the appeal was resolved[2].
Key Takeaways
- Single Reference Rule: The Federal Circuit reaffirmed the principle that anticipation must be based on a single reference, emphasizing that using multiple references for specific teachings is not permissible.
- Formulation Specificity: The court highlighted the importance of the specific formulation in patent claims, noting that variations in formulation can significantly affect the results and efficacy.
- Inherent Disclosure: The decision clarified that inherent disclosure must be explicitly supported by the reference and not inferred from external sources.
- Remand for Further Consideration: The case was remanded for the district court to consider other invalidity defenses, such as obviousness, which were not addressed in the initial trial.
FAQs
Q: What was the main issue in the litigation between Galderma and Teva?
A: The main issue was the validity and infringement of several patents related to Galderma's topical rosacea treatment, Soolantra®, in response to Teva's filing of an ANDA for a generic version.
Q: Which patents were at the center of the dispute?
A: The patents-in-suit included U.S. Patents Nos. 9,089,587, 9,233,117, and 9,233,118.
Q: What was the basis of the district court's decision to invalidate the patents?
A: The district court found the patents invalid for anticipation based on disclosures from U.S. Patent No. 5,952,372 (McDaniel), which was later challenged on appeal.
Q: How did the Federal Circuit rule on the appeal?
A: The Federal Circuit reversed the district court's decision, finding that the lower court erred in using multiple references for anticipation and remanded the case for further consideration of other invalidity defenses.
Q: What was the outcome regarding the injunction against Teva?
A: The Federal Circuit stayed the district court's injunction, allowing Teva to market its generic product pending the resolution of the appeal.
Sources
- Galderma Labs. L.P. v. Teva Pharm. U.S., Inc. - Casetext
- Galderma Labs., L.P. v. Teva Pharm. USA, Inc., 2019-2396 - Casetext
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp
- Galderma Labs L.P. v. Teva Pharms. USA, Inc. - Robins Kaplan LLP
- Federal Circuit Reverses District Court Judgment Invalidating ... - Pearl Cohen
