Background and Procedural Posture
The litigation between Forest Laboratories, LLC, and Mylan Pharmaceuticals Inc. revolves around the generic approval of milnacipran hydrochloride, a drug marketed by Forest under the brand name Savella for the treatment of fibromyalgia. Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA to manufacture and sell a generic version of milnacipran hydrochloride, which led Forest to initiate a Hatch-Waxman action alleging patent infringement[3].
Patents-in-Suit
The case involves three U.S. patents held by Forest:
- U.S. Patent No. 6,602,911 (the ’911 patent)
- U.S. Patent No. 7,888,342 (the ’342 patent)
- U.S. Patent No. 7,994,220 (the ’220 patent)
These patents cover the use of milnacipran hydrochloride as a monotherapy for treating fibromyalgia, a specific dosing regimen, and a fast titration schedule, respectively[3].
Monotherapy Claims and Inducement of Infringement
Mylan argued that its proposed labeling did not instruct physicians to use milnacipran solely as a monotherapy, thus it did not intend to induce infringement of the ’911 patent claims. However, the court found that Forest had disclaimed combination therapy during the patent prosecution to overcome rejections. Consequently, the court construed the ’911 patent claims to exclude combination therapy. Given this construction, Mylan’s label was deemed to inevitably lead some consumers to practice the claimed monotherapy, indicating Mylan’s intent to induce infringement[1][3].
Validity of the Patents: Anticipation Arguments
Mylan argued that the Horrobin reference anticipated the claims of the ’911 and ’342 patents. The Horrobin reference discusses using drugs, including milnacipran, in combination with certain amino acids to treat neurologic diseases. However, the court rejected this argument for several reasons:
- The ’911 patent claims only monotherapy, and the ’342 patent does not disclose the specific amino acids described in Horrobin.
- The Horrobin reference teaches away from the claimed inventions.
- The relevant sentence in Horrobin pertains to the treatment of stroke and brain injury, not fibromyalgia.
- The same arguments were raised and considered during the patent prosecution[1][3].
Validity of the Patents: Obviousness Arguments
Mylan also argued that the claimed inventions were obvious based on prior art. For the ’911 patent, Mylan combined the Horrobin reference with other references (Dwight, Barkin, and WO ’223) that discussed the use of serotonin-norepinephrine reuptake inhibitors (SNRIs) for treating fibromyalgia. However, the court found that Mylan failed to provide a meaningful explanation for any motivation to make the claimed combination. The court concluded that altering the Horrobin reference as proposed would alter its teaching[1][3].
For the ’220 patent, Mylan argued that the fast titration schedule was obvious in combination with three references. However, the court found that the claimed fast titration schedule was directly contrary to the prior art and that no single reference encompassed this schedule. The court also noted that Mylan used hindsight to find fast titration in the prior art, which was directed to treating depression, not fibromyalgia[1][3].
Secondary Considerations
Forest presented secondary considerations, arguing that the claimed titration schedule resulted in unexpected tolerability. However, the court did not credit this argument, stating that the result was “a difference in degree rather than a difference in kind”[1][3].
Expert Testimony and Credibility
The court assessed the expertise and credibility of the parties’ experts. Forest’s experts were found to have more relevant and extensive expertise, making their evidence more credible. This assessment further supported the court’s decision in favor of Forest[1][3].
Conclusion on Patent Validity and Infringement
The court ultimately concluded that Mylan’s ANDA filing would induce infringement of the ’911 patent claims due to the labeling, and that the patents were valid against Mylan’s anticipation and obviousness arguments. This decision prevented Mylan from obtaining FDA approval for its generic version of milnacipran hydrochloride until the patents expire[1][3].
Key Takeaways
- Patent Construction and Inducement: The court's construction of the patents to exclude combination therapy was crucial in determining Mylan's intent to induce infringement.
- Validity of Patents: The court rejected Mylan's anticipation and obviousness arguments, affirming the validity of the patents.
- Expert Testimony: The credibility and expertise of Forest’s experts played a significant role in the court’s decision.
- Impact on Generic Approval: The decision prevented Mylan from obtaining FDA approval for its generic version, protecting Forest’s market exclusivity.
FAQs
Q: What was the main issue in the litigation between Forest Laboratories and Mylan Pharmaceuticals?
A: The main issue was whether Mylan’s ANDA filing for a generic version of milnacipran hydrochloride infringed Forest’s patents and whether those patents were valid.
Q: Why did the court find Mylan’s label to induce infringement of the ’911 patent?
A: The court found that Forest had disclaimed combination therapy during patent prosecution, and Mylan’s label would inevitably lead some consumers to practice the claimed monotherapy.
Q: What were Mylan’s arguments regarding the anticipation of the patents?
A: Mylan argued that the Horrobin reference anticipated the claims of the ’911 and ’342 patents, but the court rejected this argument due to the specific claims constructions and the context of the Horrobin reference.
Q: How did the court assess the obviousness arguments presented by Mylan?
A: The court found that Mylan failed to provide a meaningful explanation for any motivation to make the claimed combinations and that Mylan used hindsight in its arguments.
Q: What was the outcome of the litigation for Mylan’s ANDA filing?
A: The court’s decision prevented Mylan from obtaining FDA approval for its generic version of milnacipran hydrochloride, protecting Forest’s market exclusivity.
Cited Sources
- Forest Labs. Holdings Ltd. v. Mylan Inc. | Robins Kaplan LLP
- Forest Labs., Inc. v. Amneal Pharms. LLC - Casetext
- Forest Labs. Holdings Ltd. v. Mylan Inc. | Robins Kaplan LLP Law Firm
- AbbVie subsidiary Forest faces more antitrust litigation over Alzheimer's drug - FiercePharma
