DCT

2:18-cv-12385

Eli Lilly Co v. Umedica Laboratories Pvt Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-12385, D.N.J., 08/02/2018
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA, which is asserted to be a significant step purposefully directed at New Jersey, indicating future plans to market its generic drug within the district upon approval.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA seeking approval to market a generic version of Cialis® (tadalafil) constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology concerns a specific low-dosage method of using the compound tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, for the treatment of sexual dysfunction, a major pharmaceutical market segment.
  • Key Procedural History: This action was triggered by Defendant's filing of ANDA No. 211298, which contained a Paragraph IV certification asserting that Plaintiff's patent is invalid, unenforceable, or will not be infringed by the proposed generic product. The patent-in-suit is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") as covering Cialis®. The complaint notes related litigation against other generic drug manufacturers.

Case Timeline

Date Event
1999-04-30 '166 Patent Priority Date
2005-09-13 '166 Patent Issue Date
2018-08-02 Complaint Filing Date

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. (Compl. ¶17; ’166 Patent, p. 1).

The Invention Explained

  • Problem Addressed: The patent's background describes how prior PDE5 inhibitors, such as sildenafil, were associated with significant adverse side effects, including facial flushing, vision abnormalities, and a dangerous drop in blood pressure when combined with organic nitrates, which limited their use in certain patient populations (’166 Patent, col. 1:57 - col. 2:11).
  • The Patented Solution: The invention is a method of treatment using a specific compound, tadalafil, at a low oral dose of about 1 to 20 mg. This specific dosage regimen is claimed to provide effective treatment for sexual dysfunction while minimizing or eliminating the side effects associated with earlier PDE5 inhibitors, thereby providing an improved safety profile and making the treatment available to a broader range of patients, including those on nitrate therapy (’166 Patent, Abstract; col. 2:22-47).
  • Technical Importance: The invention sought to provide a therapy for sexual dysfunction with an improved side-effect profile, potentially allowing for treatment of individuals who were previously untreatable or who suffered unacceptable side effects from existing therapies (’166 Patent, col. 2:40-47).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 4, 5, and 7-12 (Compl. ¶24).
  • 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 asserts dependent claims that further limit the method to, for example, treating male erectile dysfunction, specific dosage strengths within the 1-20 mg range, and administration in tablet form (Compl. ¶¶ 29, 32-36, 38, 40, 42).

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. 211298 (Compl. ¶1).

Functionality and Market Context

  • The accused instrumentality is the future commercial manufacture, use, and sale of a generic version of Plaintiff’s Cialis® drug product (Compl. ¶1). The act of infringement alleged in the complaint is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2) (Compl. ¶44).
  • The proposed product is described as a tablet for oral use containing tadalafil as the active ingredient, to be offered in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths (Compl. ¶¶ 20, 26).
  • Plaintiff alleges that Defendant's product will be marketed for the same indications as Cialis®, namely the treatment of male erectile dysfunction, as would be reflected on its FDA-approved label (Compl. ¶¶ 27-28, 31).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

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’s proposed product will be marketed to treat sexual dysfunction, consistent with the FDA-approved label for Cialis®, which is indicated for male erectile dysfunction. ¶¶27-28 col. 14:65-66
comprising orally administering Defendant's proposed product is a tablet for oral use. ¶26 col. 14:67
one or more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, Defendant's product will be available in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths, falling within the claimed range. ¶26 col. 15:1-4
of a compound having the structure [of tadalafil]. Defendant’s proposed product contains tadalafil as its active ingredient. ¶26 col. 15:4-15

Identified Points of Contention

  • Scope Questions: The complaint alleges inducement of a method claim. A central question will be whether the proposed label for Defendant's generic product instructs or encourages medical professionals and patients to perform all steps of the claimed method. The complaint alleges that Defendant’s Notice Letter does not deny that its product will induce infringement if the patent is valid, which suggests the primary dispute may not be over infringement but validity (Compl. ¶24).
  • Technical Questions: In ANDA litigation, infringement is often stipulated if the patent is found valid, as the generic product must have the same active ingredient, dosage form, and route of administration as the branded drug. The infringement analysis therefore raises the question of what evidence, beyond the ANDA filing itself, will demonstrate that the intended use on the proposed label directly corresponds to the "treating sexual dysfunction" limitation of the claim.

V. Key Claim Terms for Construction

The Term: "about 1 to about 20 mg"

  • Context and Importance: This phrase defines the core inventive dosage range. The breadth of the word "about" is critical, as it determines how close prior art dosages must be to anticipate or render the claim obvious. Practitioners may focus on this term because its construction will be pivotal to the validity analysis, which is often the central dispute in ANDA cases.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification consistently uses the term "about 1 to about 20 mg" when describing the invention, suggesting the inventors intended some numerical flexibility around the stated endpoints (’166 Patent, col. 2:60-61, col. 3:3-5).
    • Evidence for a Narrower Interpretation: The patent presents clinical data showing a dose-related increase in adverse events, with a notable increase at a 25 mg dose, which is outside the claimed range (’166 Patent, col. 14, Table at lines 25-35). This data could be used to argue that the scope of "about 20 mg" is narrowly constrained and does not extend to dosages where the safety profile changes significantly.

The Term: "treating sexual dysfunction"

  • Context and Importance: This limitation defines the purpose and outcome of the claimed method. Its construction is important for the inducement analysis, as the Plaintiff must show that Defendant's proposed label directs users to use the product for this specific purpose.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification explicitly states that conditions to be treated "include, but are not limited to, male erectile dysfunction and female sexual dysfunction" (’166 Patent, col. 3:6-8). This supports a construction that is not limited to a single indication.
    • Evidence for a Narrower Interpretation: The clinical trial data described in the patent focuses on specific efficacy endpoints, such as the ability to "maintain an erection during intercourse" (’166 Patent, col. 13:42-43). This could support an argument that "treating" requires achieving a defined, measurable clinical outcome rather than simply providing a physiological effect.

VI. Other Allegations

Indirect Infringement

  • The complaint's theory of infringement is based on inducement. It alleges that Defendant's proposed product, upon approval and sale, will induce infringement of the method claims because its marketing and FDA-approved label will instruct physicians and patients to administer the drug in a manner that practices the patented method (Compl. ¶¶ 24, 27-28).

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

  • A core issue will be one of validity: As the infringement allegations rely on the statutory framework of ANDA litigation where the generic product mirrors the brand, the case will likely center on whether Defendant can prove by clear and convincing evidence that the claimed method of using a 1-20 mg dose of tadalafil was anticipated or rendered obvious by prior art.
  • A key question for the infringement case will be one of inducement: Assuming the patent is valid, will the evidence, particularly the proposed product label, establish that the Defendant possessed the requisite intent to encourage or promote the specific acts of "treating sexual dysfunction" as recited in the claims, thereby satisfying the legal standard for induced infringement?