DCT

1:17-cv-01394

Forest Laboratories Holdings Ltd v. Strides Pharma Global Pte Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01394, D. Del., 10/05/2017
  • Venue Allegations: Plaintiff alleges venue is proper in Delaware because Defendant Strides Global is a foreign corporation subject to suit in any U.S. judicial district, and Defendant Strides Inc. sells products in Delaware and holds a contract with the State of Delaware through a pharmacy contracting alliance.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug Savella® (milnacipran hydrochloride) constitutes an act of infringement of three patents covering methods of using milnacipran to treat fibromyalgia.
  • Technical Context: The technology at issue is a pharmaceutical method of treatment for fibromyalgia syndrome (FMS), a chronic disorder characterized by widespread pain and fatigue, using the dual serotonin-norepinephrine reuptake inhibitor (SNRI) milnacipran.
  • Key Procedural History: The complaint notes that the patents-in-suit were previously found valid and infringed by other generic drug manufacturers in a prior litigation in the same district, Forest Labs., Inc. v. Apotex Corp., 1:13-cv-1602 (D. Del.). This history may be presented by Plaintiffs to assert the strength and validity of the patents. Defendant sent a Paragraph IV notice letter on August 23, 2017, asserting that the patents are invalid and/or not infringed by its proposed generic product.

Case Timeline

Date Event
2001-11-05 Priority Date for '911 and '342 Patents
2003-08-05 '911 Patent Issued
2005-09-28 Priority Date for '220 Patent
2009-01-14 NDA No. 022256 (Savella®) Approved
2011-02-15 '342 Patent Issued
2011-08-09 '220 Patent Issued
2017-08-23 Strides sends Paragraph IV Notice Letter
2017-10-05 Complaint Filed

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

U.S. Patent No. 6,602,911 - "Methods of Treating Fibromyalgia," issued August 5, 2003 (’911 Patent)

The Invention Explained

  • Problem Addressed: The patent’s background section identifies fibromyalgia syndrome (FMS) as a common cause of chronic, widespread pain for which there was a lack of effective, single-agent pharmacological treatments. (Compl. ¶19; ’911 Patent, col. 1:12-15, col. 2:7-13).
  • The Patented Solution: The invention provides a method for treating FMS by administering a specific subclass of dual serotonin-norepinephrine reuptake inhibitors (SNRIs). The claimed method specifies using SNRIs that are non-tricyclic in structure and that inhibit norepinephrine reuptake to an equal or greater extent than they inhibit serotonin reuptake, identifying milnacipran as a particular example of such a compound. (Compl. ¶19; ’911 Patent, Abstract; col. 2:40-57).
  • Technical Importance: The invention identified a targeted pharmacological approach for FMS, a condition with limited therapeutic options, by isolating a specific subclass of SNRI compounds (NE≥5-HT) hypothesized to be effective for the condition's unique symptomology. (’911 Patent, col. 2:7-13).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims of the ’911 Patent, referencing claims 1-7 in its summary of Defendant's notice letter (Compl. ¶¶ 24, 26). The key asserted independent claim is Claim 1.
  • 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. (’911 Patent, col. 15:12-16).
  • The complaint’s general allegations suggest it reserves the right to assert other claims, including dependent claims.

U.S. Patent No. 7,888,342 - "Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011 (’342 Patent)

The Invention Explained

  • Problem Addressed: Like the ’911 Patent, this patent addresses the need for effective treatments for FMS, which is characterized by chronic widespread pain, fatigue, and disordered sleep. (’342 Patent, col. 1:21-34).
  • The Patented Solution: The patent claims methods of treating FMS by administering specific daily dosages of milnacipran, namely "about 100 mg" and "about 200 mg." The claims employ the transitional phrase "consisting essentially of" and include a proviso that the method excludes the co-administration of neurotransmitter precursors like phenylalanine, tyrosine, or tryptophan. (Compl. ¶33; ’342 Patent, col. 19:2-17, col. 20:2-10). The specification provides detailed clinical trial data supporting these specific dosage regimens. (’342 Patent, Table 1).
  • Technical Importance: This patent refined the therapeutic approach by claiming specific, clinically evaluated daily dosage amounts of milnacipran, providing more concrete instructions for achieving a therapeutic benefit in FMS patients while distinguishing the method from combination therapies involving certain precursors. (’342 Patent, col. 8:42-51).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims, referencing claims 1-10 from Defendant's notice letter (Compl. ¶¶ 38, 40). The asserted independent claims include Claims 1, 2, and 6.
  • Independent Claim 2:
    • A method of treating fibromyalgia, the method consisting essentially of administering to a patient in need thereof a daily dose of about 100 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. (’342 Patent, col. 19:9-17).
  • The complaint reserves the right to assert other claims, including independent claims 1 and 6 and various dependent claims.

U.S. Patent No. 7,994,220 - "Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011 (’220 Patent)

Technology Synopsis

This patent addresses the lack of proven, durable treatments for FMS, noting that prior therapies had not demonstrated long-term efficacy (Compl. ¶47; ’220 Patent, col. 3:1-4:2). The invention is a method for the long-term treatment of FMS, comprising daily administration of milnacipran for at least three months. The patent is supported by clinical trial data showing sustained therapeutic benefit at three and six months. (’220 Patent, Abstract; Fig. 2).

Asserted Claims

The complaint references claims 1-7. Independent claim 1 is the lead asserted claim. (Compl. ¶¶ 52, 54).

Accused Features

Defendant’s proposed generic milnacipran product, intended for the management of fibromyalgia, is alleged to infringe because its label will instruct for continued daily use, thereby inducing performance of the claimed long-term treatment method. (Compl. ¶¶ 50, 53-54).

III. The Accused Instrumentality

Product Identification

Defendant’s generic milnacipran hydrochloride tablets, for which it filed Abbreviated New Drug Application (ANDA) No. 207399 with the U.S. Food and Drug Administration (FDA). (Compl. ¶22).

Functionality and Market Context

The accused instrumentality is the submission of ANDA No. 207399, which is a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A). The ANDA seeks FDA approval to manufacture and sell a generic version of Plaintiff's Savella® product in 12.5 mg, 25 mg, 50 mg, and 100 mg dosage strengths for the management of fibromyalgia prior to the expiration of the patents-in-suit. (Compl. ¶¶ 22, 26). The commercial importance lies in providing a lower-cost generic alternative to the brand-name drug.

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) comprising administering to an animal subject suffering from FMS... Defendant's ANDA seeks an indication to treat fibromyalgia, and the proposed product label will instruct physicians to prescribe and patients to take the drug for this purpose. ¶25 col. 2:40-44
...a composition wherein the active ingredient consists of milnacipran, or a pharmaceutically acceptable salt thereof... Defendant’s ANDA product contains milnacipran hydrochloride as its active ingredient. ¶22 col. 5:65-6:4
...in an amount effective to treat the chronic pain and fatigue associated with FMS. The ANDA seeks approval for dosage strengths (12.5 mg, 25 mg, 50 mg, and 100 mg) that correspond to the established therapeutic regimen for Savella®, which will be prescribed in amounts intended to be effective. ¶22 col. 13:17-21

’342 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating fibromyalgia, the method consisting essentially of administering to a patient in need thereof a daily dose of about 100 mg of active ingredient... Defendant's ANDA includes a 100 mg dosage strength, and the proposed product label will instruct for administration of a 100 mg daily dose for treating fibromyalgia. ¶36 col. 15:46-51
...wherein the active ingredient is at least one compound selected from milnacipran, a pharmaceutically acceptable salt of milnacipran... Defendant’s proposed generic product is milnacipran hydrochloride. ¶36 col. 6:2-4
...with the proviso that the method excludes administering phenylalanine, tyrosine, or tryptophan. The complaint alleges that the instructions on the proposed product label will result in performance of the claimed method, which by its terms excludes co-administration of specified neurotransmitter precursors. ¶42 col. 7:42-51
  • Identified Points of Contention:
    • Scope Questions: The primary dispute in ANDA litigation concerning method-of-use patents often centers on validity rather than direct infringement. However, a potential point of contention regarding infringement is whether the proposed label language will necessarily induce infringement of every claim limitation. For the '342 Patent, this raises the question of whether the label might permit or be silent on co-administration of other drugs in a way that falls outside the scope of "consisting essentially of."
    • Technical Questions: Defendant's notice letter asserts non-infringement of specific dependent claims (’911 Patent claim 4, ’342 Patent claim 10), the basis for which is not detailed in the complaint (Compl. ¶¶ 24, 38). The primary technical questions will likely relate to validity, such as whether the claimed methods were obvious in light of prior art knowledge regarding the use of SNRIs for treating pain conditions.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (’342 Patent, Claim 2)

    • Context and Importance: This transitional phrase is critical for defining the scope of the claimed method. It is more limiting than "comprising" but less limiting than "consisting of." Its construction will determine whether the co-administration of any other active agents, beyond those explicitly excluded by the proviso (phenylalanine, etc.), would place an accused infringer outside the scope of the claim. Practitioners may focus on this term because Defendant could argue that its proposed label does not foreclose adjunctive therapies that would materially alter the claimed method.
    • Intrinsic Evidence for a Broader Interpretation: The specification discloses that milnacipran can be adjunctively administered with other compounds such as analgesics and muscle relaxants, which could support an interpretation that the "essential" character of the invention is solely the administration of milnacipran without the specified precursors. (’342 Patent, col. 8:1-21).
    • Intrinsic Evidence for a Narrower Interpretation: The patent explicitly carves out certain neurotransmitter precursors, suggesting a deliberate focus on milnacipran's standalone effect. This could support an argument that the co-administration of other psychoactive compounds would "materially affect the basic and novel properties" of the invention and therefore fall outside the claim. (’342 Patent, col. 8:42-51).

  • The Term: "long-term treatment" (’220 Patent, Title and Abstract)

    • Context and Importance: Although this term does not appear in independent claim 1 of the '220 Patent, the claim requires administration for "at least three months." The patent's title and purpose are centered on "long-term treatment." The definition of what constitutes effective long-term treatment will be central. Practitioners may focus on this because the dispute could turn on whether the sustained efficacy shown in the patent was non-obvious, or whether any generic administration lasting over three months automatically infringes.
    • Intrinsic Evidence for a Broader Interpretation: The claim itself provides a clear temporal floor: "at least three months." This suggests any continuous administration meeting this duration for the purpose of treating FMS falls within the claim scope. (’220 Patent, col. 13:1-13).
    • Intrinsic Evidence for a Narrower Interpretation: The specification is supported by clinical trial data showing specific responder rates and efficacy measures at 3 and 6 months. A defendant could argue that "long-term treatment" must imply achieving a level of sustained efficacy similar to that demonstrated in the patent's clinical trials, not merely administering the drug for a set duration. (’220 Patent, Fig. 2; Table 1).

VI. Other Allegations

  • Indirect Infringement: The complaint is grounded in theories of indirect infringement. It alleges that Defendant, by seeking approval for a label that instructs for the use of milnacipran to manage fibromyalgia, will actively induce infringement of the patented methods by physicians and patients upon commercial launch. (Compl. ¶¶ 28, 42, 56). It further alleges contributory infringement, asserting that milnacipran is a material component of the invention, is not a staple article of commerce, and has no substantial noninfringing uses for the claimed indication. (Compl. ¶¶ 29, 43, 57).
  • Willful Infringement: The complaint does not use the word "willful" or plead a separate count for willful infringement. However, it alleges that Defendant has knowledge of the patents-in-suit as a result of the ANDA process and the receipt of the Paragraph IV notice letter, which are factual prerequisites for a future claim of willfulness. (Compl. ¶¶ 27, 41, 55).

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

  • A central issue will be one of patent validity: Can Defendant prove by clear and convincing evidence that the claims are invalid, likely on grounds of obviousness? The key question for the court will be whether it was obvious to a person of ordinary skill at the time of the invention to use milnacipran at the claimed dosages for the long-term treatment of fibromyalgia, particularly in light of the patents' prior successful defense in another case.
  • The case will also present a question of claim scope and inducement: Does the specific language of the "consisting essentially of" limitation in the '342 patent preclude infringement if a physician co-prescribes other common FMS medications not explicitly excluded by the claim's proviso? The court's construction of this term will be critical to the infringement analysis.