1:24-cv-00847
Allergan Pharma Intl Ltd v. Macleods Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Allergan Pharmaceuticals International Limited (Republic of Ireland) and AbbVie Inc. (Delaware)
- Defendant: Macleods Pharmaceuticals Ltd. (India) and Macleods Pharma USA, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:24-cv-00847, D. Del., 07/19/2024
- Venue Allegations: Venue is asserted based on Macleods USA being a Delaware corporation and Macleods Pharmaceuticals Ltd. being a foreign corporation that may be sued in any judicial district.
- Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' fibromyalgia drug, SAVELLA®, constitutes an act of infringement of a patent covering a method for the drug's long-term administration.
- Technical Context: The dispute is in the pharmaceutical sector and concerns methods of using milnacipran, a norepinephrine-serotonin reuptake inhibitor, for the long-term management of fibromyalgia syndrome, a chronic pain disorder.
- Key Procedural History: The litigation is initiated under the Hatch-Waxman Act, triggered by Defendants' Paragraph IV certification asserting that the patent-in-suit is invalid or will not be infringed by their proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2005-09-28 | Earliest Priority Date for U.S. Patent No. 7,994,220 |
| 2009-01-14 | FDA Approval of New Drug Application No. 022256 for SAVELLA® |
| 2011-08-09 | U.S. Patent No. 7,994,220 Issued |
| 2024-07-19 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,994,220 - Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome, Issued August 9, 2011
The Invention Explained
The patent describes fibromyalgia syndrome (FMS) as a common and debilitating chronic pain condition. It notes a significant "need for an effective, long-term treatment" because, at the time, no compound had been demonstrated to provide a durable therapeutic effect beyond a few months (Compl. ¶ 23; ’220 Patent, col. 5:1-5).
The invention is a method of providing long-term (at least three to six months) treatment for FMS by administering the drug milnacipran, a dual re-uptake inhibitor, according to a specific dosing schedule. The patent presents clinical trial data as evidence of a surprising and unexpected durable effect, distinguishing it from prior short-term treatments (’220 Patent, col. 5:15-24, Abstract).
The claimed method addresses the challenge that many potential FMS therapies fail in longer trials due to a high placebo response rate or a lack of sustained efficacy, representing an attempt to secure patent protection for a durable treatment regimen (’220 Patent, col. 4:55-col. 5:2).
Key Claims at a Glance
- The complaint alleges that Defendants' notice letter identified claims 1-7 as being implicated by the ANDA filing (Compl. ¶ 26).
- Independent Claim 1 recites a method of treating fibromyalgia comprising:
- administering milnacipran, or a pharmaceutically acceptable salt thereof, to the patient according to the following schedule:
- a) administering 12.5 mg milnacipran/day to the patient for 1 day; then
- b) administering 25 mg milnacipran/day to the patient for 2 days; then
- c) administering 50 mg milnacipran/day to the patient for 4 days; then
- d) administering 100 mg milnacipran/day.
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the "Macleods ANDA Products," specifically generic milnacipran hydrochloride tablets in 12.5 mg, 25 mg, 50 mg, and 100 mg strengths, as described in ANDA No. 210944 (Compl. ¶ 11).
Functionality and Market Context
The complaint alleges that Defendants filed ANDA No. 210944 seeking FDA approval to market a generic version of Plaintiffs' SAVELLA® product (Compl. ¶ 1). The statutory act of infringement under 35 U.S.C. § 271(e)(2) is the submission of the ANDA itself, which seeks approval for an indication—the management of fibromyalgia—that is allegedly covered by the ’220 Patent (Compl. ¶¶ 1, 27). The proposed generic product is intended to be a lower-cost, bioequivalent alternative to the branded drug. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The infringement theory is that the proposed label for the Macleods ANDA Products will instruct physicians and patients to administer the generic drug in a manner that practices the method of claim 1 of the ’220 patent.
’220 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating fibromyalgia in a patient suffering from fibromyalgia | The complaint alleges that Macleods' ANDA seeks approval for an indication claimed in the patent, specifically the use of milnacipran for the management of fibromyalgia. | ¶¶ 1, 27 | col. 13:26-28 |
| comprising administering milnacipran, or a pharmaceutically acceptable salt thereof, to the patient according to the following schedule: | The complaint alleges that users of the Macleods ANDA Products will infringe by using them in accordance with the instructions and/or label provided by Macleods. | ¶¶ 29-30 | col. 13:28-col. 14:2 |
| a) administering 12.5 mg milnacipran/day to the patient for 1 day; then | The complaint alleges the ANDA proposes various dosage strengths, including 12.5 mg, which would enable the practice of the claimed titration schedule. | ¶ 11 | col. 14:3-5 |
| b) administering 25 mg milnacipran/day to the patient for 2 days; then | The complaint alleges the ANDA proposes various dosage strengths, including 25 mg, which would enable the practice of the claimed titration schedule. | ¶ 11 | col. 14:6-8 |
| c) administering 50 mg milnacipran/day to the patient for 4 days; then | The complaint alleges the ANDA proposes various dosage strengths, including 50 mg, which would enable the practice of the claimed titration schedule. | ¶ 11 | col. 14:9-11 |
| d) administering 100 mg milnacipran/day. | The complaint alleges the ANDA proposes various dosage strengths, including 100 mg, which would enable the practice of the claimed titration schedule. | ¶ 11 | col. 14:12-13 |
Identified Points of Contention
- Scope Questions: A central issue will be whether the proposed label for Macleods' generic product will instruct the specific, four-step dose-titration schedule recited in claim 1. If the proposed label instructs a different schedule, omits a step, or presents the claimed schedule as merely one of several options, Defendants may argue that the label does not encourage, recommend, or promote an infringing use.
- Technical Questions: The factual question for the court will be a direct comparison of the text in the proposed generic label against the limitations of the asserted claims. The complaint does not include the proposed label, which will be a key piece of evidence as the case proceeds.
V. Key Claim Terms for Construction
- The Term: "administering... according to the following schedule"
- Context and Importance: The entirety of claim 1 is a method defined by a precise, multi-step schedule. The infringement analysis will depend entirely on whether the instructions for use on the accused product's label map onto this claimed schedule. Practitioners may focus on this term because any deviation between the label's instructions and the claimed schedule could support a non-infringement defense.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of arguments for a broader interpretation. A plaintiff might argue the core invention is long-term treatment and the schedule is one way to achieve it, but the claim language is highly specific.
- Evidence for a Narrower Interpretation: The claim language itself provides strong evidence for a narrow, rigid interpretation. The use of "the following schedule" followed by four distinct, sequential steps (a, b, c, then d) with specific dosages and durations suggests that each step is a required limitation. The patent specification reinforces this by describing this exact dosing regimen as the one used in the clinical study that allegedly demonstrated the invention's surprising long-term efficacy (’220 Patent, col. 9:5-11).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that if its ANDA is approved, Macleods will induce infringement by physicians and patients who follow the product's label instructions (Compl. ¶¶ 30, 37). It further alleges contributory infringement, stating that Macleods knows its product will be used to practice the patented method and that milnacipran is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶ 31, 38).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It does, however, allege that Macleods has knowledge of the ’220 patent, which is a required predicate for any future willfulness claim (Compl. ¶ 29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of infringement mapping: Does the language of the proposed product label for Macleods' generic milnacipran instruct, direct, or inevitably lead medical providers and patients to administer the drug according to the exact four-step dosing schedule recited in claim 1 of the ’220 patent?
- A second central question will be one of patent validity: Although not detailed in the complaint, the Defendants' Paragraph IV certification alleges invalidity. The litigation will likely focus on whether the claimed method of long-term administration using a specific titration schedule would have been obvious to a person of ordinary skill in the art at the time of the invention, given the prior knowledge of milnacipran and standard clinical practices for managing chronic conditions.