Background and Context
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 pharmaceutical product that contains a 1% ivermectin formulation, and the patents in question are listed in the Orange Book, a catalog of FDA-approved drugs and their associated patents[5].
The Patents in Question
The dispute centers on U.S. Patent Nos. 9,089,587, 9,233,117, and 9,233,118, collectively known as the "asserted patents." These patents claim methods of treating rosacea through the topical administration of a pharmaceutical composition comprising about 1% by weight ivermectin, along with specific efficacy benchmarks resulting from these treatment methods[2][3].
District Court Proceedings
In April 2017, Galderma initiated a lawsuit against Teva under 35 U.S.C. § 271(d)(2)(A) for infringement of the asserted patents. Teva had filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Soolantra®. Following a bench trial in June 2019, the district court found each of the asserted claims invalid for anticipation by U.S. Patent No. 5,952,372, known as the "McDaniel" reference[2][4].
Anticipation Defense
Teva argued that the McDaniel reference anticipated the asserted claims. The district court agreed, finding that McDaniel expressly disclosed the method of treatment and formulation limitations. The court also determined that McDaniel inherently disclosed the claimed efficacy limitations, relying on the parties’ stipulation that another reference, Manetta, enabled the McDaniel formulation. This led the district court to conclude that one of ordinary skill in the art could practice the method of McDaniel with the formulation of Manetta without undue experimentation, thereby inherently disclosing the efficacy limitations[1][2].
Appeal to the Federal Circuit
Galderma appealed the district court’s decision, arguing that the court erred in finding the asserted claims anticipated by McDaniel. The Federal Circuit agreed with Galderma, reversing the district court’s judgment. The Federal Circuit held that while Manetta’s enablement of McDaniel meant a person skilled in the art could practice the formulations in McDaniel, it did not mean McDaniel disclosed the specific formulations necessary to achieve the claimed efficacy limitations. Therefore, McDaniel did not inherently disclose these limitations[1][5].
Key Findings of the Federal Circuit
- Single Reference Rule: The Federal Circuit emphasized that anticipation must be based on the disclosures of a single reference. Using multiple references to establish anticipation violates settled law[5].
- Inherent Disclosure: The court clarified that inherent disclosure requires the anticipating reference to disclose the claimed limitations explicitly or inherently. In this case, McDaniel did not disclose the specific Soolantra® formulation or the claimed efficacy limitations[1][5].
- Expert Testimony: The court noted that Teva’s expert acknowledged that variations in formulation parameters would affect the results, further supporting the conclusion that McDaniel did not inherently disclose the claimed efficacy limitations[5].
Remand and Remaining Defenses
The Federal Circuit remanded the case for further consideration of Teva’s remaining invalidity defenses, including lack of written description and obviousness, which were not addressed by the district court[1][5].
Practice Implications
This case highlights the importance of carefully analyzing prior art references when asserting anticipation defenses. As the Federal Circuit explained, "whether a prior art reference is enabled is a separate question from whether it discloses, expressly or inherently, the claimed limitations at issue." This distinction is crucial in patent litigation, especially when dealing with complex formulations and efficacy claims[1].
Injunction and Market Impact
During the appeal process, Teva launched its generic drug product, but Galderma obtained an emergency motion for a stay pending appeal, which was initially granted by the district court but later stayed by the Federal Circuit. The reversal of the district court’s decision has significant implications for the market, as it allows Galderma to continue enforcing its patents against generic competitors[1][5].
Key Takeaways
- Single Reference Rule: Anticipation must be based on a single prior art reference.
- Inherent Disclosure: The anticipating reference must disclose the claimed limitations explicitly or inherently.
- Formulation Specificity: Variations in formulation parameters can significantly affect the results and efficacy of a treatment method.
- Expert Testimony: Expert opinions can be crucial in determining whether a prior art reference inherently discloses claimed limitations.
- Remand and Further Consideration: The case was remanded for consideration of other invalidity defenses, highlighting the complexity of patent litigation.
Frequently Asked Questions (FAQs)
Q: What was the main issue in the Galderma v. Teva litigation?
A: The main issue was whether the asserted patents were invalid for anticipation by the McDaniel reference.
Q: What is the significance of the single reference rule in patent law?
A: The single reference rule states that anticipation must be based on the disclosures of a single prior art reference, and using multiple references violates this principle.
Q: How did the Federal Circuit differ from the district court in its analysis?
A: The Federal Circuit disagreed with the district court’s finding that McDaniel anticipated the asserted claims, emphasizing that McDaniel did not disclose the specific formulations necessary to achieve the claimed efficacy limitations.
Q: What are the implications of this case for generic drug manufacturers?
A: This case sets a precedent that generic manufacturers must carefully analyze prior art references to ensure they do not infringe on valid patents, and it highlights the challenges in proving anticipation.
Q: What other defenses were not addressed by the district court and are now to be considered?
A: The remaining defenses include lack of written description and obviousness, which will be considered on remand.
