DCT

3:17-cv-07996

Forest Laboratories Holdings Ltd v. Strides Pharma Global Pte Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-07996, D.N.J., 10/06/2017
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Strides Pharma Inc. being incorporated and having its principal place of business in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic milnacipran hydrochloride tablets, the active ingredient in Plaintiff's Savella® product, constitutes an act of infringement of three patents directed to methods of treating fibromyalgia.
  • Technical Context: The patents relate to pharmaceutical methods of using milnacipran, a serotonin and norepinephrine reuptake inhibitor, for the treatment of fibromyalgia syndrome, a complex chronic pain disorder.
  • Key Procedural History: The complaint states that the asserted patents were previously the subject of litigation in the District of Delaware, which resulted in a final judgment that all asserted claims were valid and infringed by other generic drug manufacturers. The complaint also notes that a parallel suit was filed in the District of Delaware against Strides.

Case Timeline

Date Event
2001-11-05 Priority Date for '911 and '342 Patents
2003-08-05 U.S. Patent No. 6,602,911 Issued
2005-09-28 Priority Date for '220 Patent
2009-01-14 FDA approves NDA for Savella® (milnacipran hydrochloride)
2011-02-15 U.S. Patent No. 7,888,342 Issued
2011-08-09 U.S. Patent No. 7,994,220 Issued
2017-08-23 Strides sends Notice Letter to Plaintiffs regarding ANDA
2017-10-06 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,602,911 - "Methods of Treating Fibromyalgia"

  • Patent Identification: U.S. Patent No. 6,602,911, "Methods of Treating Fibromyalgia," issued August 5, 2003. (Compl. ¶18).

The Invention Explained

  • Problem Addressed: The patent's background section describes fibromyalgia syndrome (FMS) as a widespread and frequent cause of chronic pain, characterized by heightened pain perception (allodynia and hyperalgesia), fatigue, and nonrestorative sleep, for which there was a need for effective treatments. (Compl. Ex. A, '911 Patent, col. 1:16-29; col. 2:10-14).
  • The Patented Solution: The invention is a method of treating FMS by administering a specific subclass of dual serotonin norepinephrine reuptake inhibitor (SNRI) compounds. The patented solution specifies using an SNRI that is non-tricyclic in structure and that inhibits norepinephrine reuptake to an equal or greater extent than it inhibits serotonin reuptake, with milnacipran identified as a particular example of such a compound. (Compl. Ex. A, ’911 Patent, Abstract; col. 2:40-59).
  • Technical Importance: The invention claims to provide a targeted pharmacological approach for FMS by identifying a specific neurochemical profile (greater or equal inhibition of norepinephrine vs. serotonin reuptake) as being particularly effective for the condition, distinguishing it from broader classes of antidepressants. (Compl. Ex. A, '911 Patent, col. 2:40-52).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" and references a notice letter from Strides that discusses claims 1-7. (Compl. ¶¶23, 25). Independent claim 1 is central.
  • Independent Claim 1:
    • A method of treating fibromyalgia syndrome (FMS)
    • comprising administering to an animal subject suffering from FMS,
    • a composition wherein the active ingredient consists of milnacipran, or a pharmaceutically acceptable salt thereof
    • in an amount effective to treat the chronic pain and fatigue associated with FMS.

U.S. Patent No. 7,888,342 - "Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain"

  • Patent Identification: U.S. Patent No. 7,888,342, "Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011. (Compl. ¶32).

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’911 Patent: the lack of effective treatments for FMS and its associated symptoms, such as widespread pain and fatigue. (Compl. Ex. C, '342 Patent, col. 1:26-41).
  • The Patented Solution: The patent claims methods of treating fibromyalgia by administering milnacipran. A key feature of the claims is the use of the transitional phrase "consisting essentially of" and a negative limitation, or "proviso," stating that the method excludes the co-administration of certain amino acid precursors (phenylalanine, tyrosine, or tryptophan). This proviso is based on the discovery that, contrary to some contemporary theories, milnacipran is effective without these precursors. (Compl. Ex. C, '342 Patent, col. 9:43-54, incorporating by reference '911 Patent, col. 7:45-54). The patent also discloses specific clinical trial designs and dosing regimens. (Compl. Ex. C, '342 Patent, Fig. 1).
  • Technical Importance: This patent appears to claim a more specific method of using milnacipran, potentially to distinguish it from prior art that may have suggested combination therapies.

Key Claims at a Glance

  • The complaint references a notice letter from Strides that discusses claims 1-10. (Compl. ¶37). Independent claims 1 and 6 are representative.
  • Independent Claim 1:
    • A method of treating fibromyalgia, the method consisting essentially of administering to a patient in need thereof
    • an effective amount of at least one compound selected from milnacipran, a pharmaceutically acceptable salt of milnacipran, or a combination thereof,
    • with the proviso that the method excludes administering phenylalanine, tyrosine, or tryptophan.
  • Independent Claim 6:
    • A method of treating fibromyalgia, the method consisting essentially of administering to a patient in need thereof
    • a daily dose of about 200 mg of active ingredient,
    • wherein the active ingredient is at least one compound selected from milnacipran, a pharmaceutically acceptable salt of milnacipran, or a combination thereof,
    • with the proviso that the method excludes administering phenylalanine, tyrosine, or tryptophan.

U.S. Patent No. 7,994,220 - "Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome"

  • Patent Identification: U.S. Patent No. 7,994,220, "Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011. (Compl. ¶46).
  • Technology Synopsis: This patent addresses the need for a long-term treatment for FMS, noting the chronic nature of the disease. (Compl. Ex. D, '220 Patent, col. 5:1-5). Based on clinical trial data, the patent claims that administering milnacipran for an extended period (e.g., at least three months) provides durable, sustained relief from FMS symptoms, which it presents as a novel and non-obvious discovery. (Compl. Ex. D, '220 Patent, col. 11:1-13; Fig. 2).
  • Asserted Claims: The complaint references a notice letter alleging claims 1-7 are invalid. (Compl. ¶51).
  • Accused Features: Strides' ANDA is alleged to infringe because its proposed product label will instruct for the long-term administration of milnacipran for the management of fibromyalgia, thereby inducing infringement by physicians and patients. (Compl. ¶¶52-55).

III. The Accused Instrumentality

Product Identification

  • Strides' proposed generic milnacipran hydrochloride tablets in 12.5 mg, 25 mg, 50 mg, and 100 mg dosage strengths, as described in ANDA No. 207399. (Compl. ¶21, 35, 49).

Functionality and Market Context

  • The accused instrumentality is a generic pharmaceutical product intended to be a substitute for Plaintiffs' brand-name drug, Savella®. The complaint alleges that Strides' product, if approved, will be prescribed and used for the management of fibromyalgia. (Compl. ¶¶24, 38, 52). The act of infringement alleged under the Hatch-Waxman Act is Strides' filing of the ANDA itself, which seeks FDA approval to market this generic drug for an indication claimed by the patents-in-suit before their expiration. (Compl. ¶¶25, 39, 53).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'911 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating fibromyalgia syndrome (FMS) Strides' ANDA seeks approval for an indication to use its generic product in the management of fibromyalgia. ¶24 col. 2:40-42
comprising administering to an animal subject suffering from FMS, The proposed product label will instruct physicians to prescribe, and patients to take, the drug for treating FMS. ¶27 col. 2:42-43
a composition wherein the active ingredient consists of milnacipran, or a pharmaceutically acceptable salt thereof Strides' ANDA product contains the active ingredient milnacipran hydrochloride. ¶21 col. 2:56-59
in an amount effective to treat the chronic pain and fatigue associated with FMS. The dosage strengths in the ANDA (12.5 mg, 25 mg, 50 mg, and 100 mg) and the proposed labeling will instruct a dosing regimen that is effective for treating FMS symptoms. ¶¶21, 26 col. 12:16-20
  • Identified Points of Contention:
    • Scope Questions: Infringement of method-of-use claims in an ANDA case often hinges on the language of the proposed product label. While infringement of claim 1 may be straightforward if the label mirrors that of Savella®, the complaint notes Strides alleges non-infringement of dependent claim 4. (Compl. ¶23). Claim 4 of the '911 Patent requires a "sustained release dosage formulation." This raises the question of whether Strides' formulation meets that specific limitation, suggesting a potential dispute over the technical characteristics of the generic product itself.
    • Technical Questions: The primary dispute is more likely to concern validity rather than infringement, particularly given the prior litigation finding the patent valid. A key question for the court will be whether Strides can introduce new prior art or arguments sufficient to challenge the patent's validity on grounds of anticipation or obviousness that were not successfully argued in the prior case.

'342 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating fibromyalgia, the method consisting essentially of administering to a patient in need thereof Strides' ANDA seeks an indication for treating fibromyalgia, and its proposed label will instruct administration to patients. ¶¶38, 41 col. 2:50-53
an effective amount of at least one compound selected from milnacipran, a pharmaceutically acceptable salt of milnacipran, or a combination thereof, The ANDA product is identified as containing milnacipran hydrochloride. ¶35 col. 2:62-65
with the proviso that the method excludes administering phenylalanine, tyrosine, or tryptophan. The complaint implicitly alleges that the standard, labeled use of Strides' product will not involve co-administration of these specific amino acids, thus satisfying the negative limitation. ¶¶41, 42 col. 10:9-14
  • Identified Points of Contention:
    • Scope Questions: The transitional phrase "consisting essentially of" creates a potential area of dispute. Its construction will be critical. The question for the court is what additional, unrecited therapeutic agents or steps would "materially affect the basic and novel characteristics" of the claimed invention. Strides could potentially argue that its proposed label allows for concomitant use of other drugs in a way that falls outside this scope.
    • Technical Questions: Infringement of the negative limitation (the "proviso") depends on the absence of an instruction. A factual question will be whether Strides' proposed label, or the general standard of care it reflects, implicitly or explicitly directs a method that "excludes" the administration of the specified amino acids.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (from '342 Patent, e.g., Claim 1)
  • Context and Importance: This term is a well-known term of art in patent law that is narrower than "comprising" but broader than "consisting of." Its interpretation is critical for determining the scope of infringement. It permits the presence of unrecited elements so long as they do not materially alter the basic and novel properties of the invention. Practitioners may focus on this term because Strides could argue that its proposed product label, by allowing for various concomitant medications, includes elements that materially alter the claimed method, thereby avoiding infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification (via incorporation from the '911 Patent) discloses that milnacipran can be administered adjunctively with other compounds like analgesics and muscle relaxants. (Compl. Ex. A, '911 Patent, col. 7:55-68). A party could argue this suggests that the "basic and novel" property is simply the core efficacy of milnacipran, and many common adjunctive therapies do not materially alter it.
    • Evidence for a Narrower Interpretation: The patent emphasizes the surprising discovery that milnacipran is effective without the need for neurotransmitter precursors like phenylalanine, which is the basis for the claim's proviso. (Compl. Ex. C, '342 Patent, Claim 1). A party could argue that this standalone efficacy is the "basic and novel" property, and the addition of any other psychoactive or pain-modulating agent would be a material alteration.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Strides' product label will actively encourage and instruct physicians and patients to perform the patented methods. (Compl. ¶¶27, 41, 55). Contributory infringement is based on the allegation that milnacipran is a material part of the invention, is not a staple article of commerce with substantial non-infringing uses, and that Strides has knowledge of the infringement. (Compl. ¶¶28, 42, 56).
  • Willful Infringement: The complaint does not use the term "willful," but it lays a factual foundation for such a claim. It alleges that Strides had pre-suit knowledge of the patents-in-suit as well as knowledge of a prior federal court judgment finding the same patents valid and infringed by other parties. (Compl. ¶¶7, 26, 30). In its prayer for relief, Plaintiff seeks a declaration that the case is "exceptional" and an award of attorney fees, which is consistent with an allegation of willful or egregious conduct. (Compl. p. 18(g)).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of judicial precedent: given that the patents-in-suit have already been adjudicated as valid and infringed in a prior case against different generic challengers, a key question is what new evidence or legal arguments, if any, Strides can present to persuade the court to reach a different conclusion on validity.
  • A key infringement question will be one of claim scope: for the '342 and '220 patents, which were not at issue in the earliest phases of litigation against other generics, the interpretation of terms like "consisting essentially of" and "long-term treatment" will be critical in determining whether Strides' proposed product label falls within the bounds of the claims.
  • A final question relates to remedies: should infringement and validity be established, the court will have to consider whether Strides' decision to file its ANDA in the face of a prior adverse judgment against other parties on the same patents constitutes conduct that warrants finding the case "exceptional" and awarding enhanced damages or attorney fees.