DCT

2:18-cv-11543

Eli Lilly Co v. Torrent Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-11543, D.N.J., 07/11/2018
  • Venue Allegations: Venue is based on Defendant Torrent Pharma Inc.’s principal place of business in New Jersey, its status as a registered agent in the district, and alleged purposeful business activities within the state. Venue over Torrent Pharmaceuticals Limited is based on its alleged collaboration with its U.S. subsidiary and its purposeful direction of activities toward the U.S. market, including New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Cialis® (tadalafil) constitutes an act of infringement of a patent covering a method of using tadalafil to treat sexual dysfunction.
  • Technical Context: The technology relates to selective phosphodiesterase type 5 (PDE5) inhibitors, a class of compounds used in pharmaceutical compositions for the treatment of erectile dysfunction.
  • Key Procedural History: This lawsuit was filed under the Hatch-Waxman Act, triggered by Defendant's submission of an ANDA containing a "Paragraph IV certification." This certification asserts that U.S. Patent No. 6,943,166 is invalid, unenforceable, or will not be infringed by the proposed generic product. The filing of the complaint within 45 days of receiving Defendant's notice letter triggers a statutory 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
1999-04-30 U.S. Patent No. 6,943,166 Priority Date
2005-09-13 U.S. Patent No. 6,943,166 Issued
2018-07-11 Complaint Filed

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

U.S. Patent No. 6,943,166 - "Compositions Comprising Phosphodiesterase Inhibitors for the Treatment of Sexual Dysfunction"

  • Patent Identification: U.S. Patent No. 6,943,166, “Compositions Comprising Phosphodiesterase Inhibitors for the Treatment of Sexual Dysfunction,” issued September 13, 2005.

The Invention Explained

  • Problem Addressed: The patent describes that prior PDE5 inhibitors, such as sildenafil (the active ingredient in Viagra®), were associated with significant adverse side effects, including facial flushing, vision abnormalities, and a dangerous drop in blood pressure when taken with organic nitrates (’166 Patent, col. 1:57-col. 2:11). These side effects limited the utility of such treatments, particularly for patients with cardiovascular conditions (’166 Patent, col. 2:2-11).
  • The Patented Solution: The invention claims a method of treatment using a specific compound, (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino[2',1':6,1]pyrido[3,4-b]indole-1,4-dione (tadalafil), at a low oral dosage of about 1 to 20 mg (’166 Patent, col. 2:26-33, col. 14:65-col. 15:15). This specific low-dose regimen is described as providing an effective treatment for sexual dysfunction while minimizing or eliminating the side effects associated with earlier PDE5 inhibitors, thereby expanding the treatable patient population (’166 Patent, col. 2:30-49).
  • Technical Importance: The invention provided a therapeutic method with an improved safety and side-effect profile compared to the first-generation PDE5 inhibitors on the market (’166 Patent, col. 2:36-49).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-2, 4, 5, and 7-12 (Compl. ¶35). Independent claim 1 is the focus of the infringement allegations.
  • Independent Claim 1:
    • A method of treating sexual dysfunction in a patient in need thereof
    • comprising orally administering one or more unit dose
    • containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day,
    • of a compound having the structure [of tadalafil].
  • The complaint reserves the right to assert other claims, including dependent claims which further narrow the method to specific dosages, forms (e.g., tablet), and conditions (e.g., male erectile dysfunction) (Compl. ¶35).

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic tadalafil tablets, for which it seeks FDA approval via Abbreviated New Drug Application (ANDA) No. 211839 (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff's Cialis® tablets (Compl. ¶1). Based on admissions in Defendant's notice letter, the product will be a tablet for oral use containing tadalafil as the active ingredient in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths (Compl. ¶37).
  • The complaint alleges that Defendant will market its product for the treatment of sexual dysfunction, consistent with the FDA-approved label for Cialis®, which is indicated for the treatment of male erectile dysfunction (Compl. ¶¶38-39, 41-42). The product is intended to be a lower-cost, bioequivalent substitute for the branded drug upon receiving FDA approval and patent expiration or invalidation (Compl. ¶1).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’166 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a method of treating sexual dysfunction in a patient in need thereof Defendant allegedly intends to market its proposed tadalafil product to treat sexual dysfunction, consistent with the FDA-approved label for Cialis®, which is indicated for male erectile dysfunction (ED). ¶¶38-39, 42 col. 14:65-67
comprising orally administering one or more unit dose Defendant's notice letter allegedly admits that its proposed product will be a tablet for oral use. ¶37 col. 14:67-68
containing about 1 to about 20 mg...of a compound having the structure [of tadalafil] Defendant's notice letter allegedly admits that its proposed product will contain tadalafil as an active ingredient in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths. ¶37 col. 14:68-col. 15:15
up to a maximum total dose of 20 mg per day Defendant will allegedly market its product consistent with the Cialis® label, which includes this maximum daily dosage limitation. ¶¶38-39 col. 15:1-2
  • Identified Points of Contention:
    • Scope Questions: This case involves method-of-use claims. A primary issue will be whether the instructions and indications on Defendant’s proposed product label will inevitably lead physicians and patients to practice the patented method. The dispute may turn on whether "treating sexual dysfunction," as claimed, is broader than or synonymous with "treating male erectile dysfunction," the indication for which Cialis® is approved.
    • Technical Questions: In an ANDA case, the technical operation of the generic drug is typically not in dispute, as it is formulated to be bioequivalent to the branded drug. The central question is a legal one: does the act of filing the ANDA, coupled with the contents of the proposed product label, constitute infringement under 35 U.S.C. § 271(e)(2)? The complaint alleges Defendant's notice letter does not provide a factual or legal basis for its non-infringement assertion, suggesting this will be a key point of contention (Compl. ¶¶38, 41, 48, 50, 52).

V. Key Claim Terms for Construction

  • The Term: "treating sexual dysfunction"
  • Context and Importance: This term defines the scope of the method claim. The entire infringement case hinges on whether Defendant’s proposed product, by being marketed for erectile dysfunction, will be used for "treating sexual dysfunction." Practitioners may focus on this term because if Defendant can successfully argue for a narrow construction that its product label avoids, or if it can "carve out" the patented use from its label, it could potentially avoid infringement of this method claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent is titled "Compositions Comprising Phosphodiesterase Inhibitors for the Treatment of Sexual Dysfunction" and the abstract describes the invention as useful for "the treatment of sexual dysfunction" (’166 Patent, Title; Abstract). Claim 1 uses the general term without limitation. The specification also refers to both "male erectile dysfunction and female sexual dysfunction" as treatable conditions (Compl. ¶3:7-9).
    • Evidence for a Narrower Interpretation: Dependent claim 2 explicitly narrows the method to where "the sexual dysfunction is male erectile dysfunction," and dependent claim 3 narrows it to "female arousal disorder" (’166 Patent, col. 15:16-19). A defendant may argue that the general term in claim 1 should be interpreted in light of these more specific embodiments, or that the specification's primary focus on these two conditions implicitly limits the term's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint is fundamentally based on induced infringement. It alleges that upon approval, Defendant will infringe by marketing its generic product with a label that will instruct physicians and patients to administer the drug in a manner that directly practices the method claimed in the ’166 Patent (Compl. ¶¶39, 42, 56). The act of filing the ANDA to seek approval for such marketing is the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶55).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendant had knowledge of the ’166 Patent, as evidenced by its Paragraph IV certification and the associated notice letter sent to Plaintiffs (Compl. ¶¶31, 34). These allegations of pre-suit knowledge of the patent and the alleged infringing activity could form the basis for a later claim of willfulness. The prayer for relief also seeks relief under 35 U.S.C. § 285 for exceptional cases (Compl. Prayer for Relief ¶E).

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

  • A core issue will be one of inducement: Will the language of Torrent's proposed product label, as submitted in its ANDA, be found to actively encourage or instruct medical professionals and patients to use the generic tadalafil product in a way that directly infringes the method claims of the ’166 patent?
  • A second central question will be one of validity: As this case was triggered by a Paragraph IV certification, the litigation will necessarily involve Defendant's asserted defense that the claims of the ’166 patent are invalid (e.g., as obvious) or unenforceable, a position which Defendant must prove by clear and convincing evidence.
  • Finally, the outcome may depend on a question of label interpretation: Can Torrent successfully "carve out" the patented method of use from its proposed label to the satisfaction of the FDA and the court, or is the approved indication for erectile dysfunction legally inseparable from the patented "method of treating sexual dysfunction"?