DCT

2:17-cv-07024

Eli Lilly Co v. Glenmark Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-07024, D.N.J., 09/12/2017
  • Venue Allegations: Venue is based on Defendant Glenmark USA having a principal place of business in New Jersey, the collaborative activities of both defendants to market products in the state, and specific jurisdiction arising from the filing of an Abbreviated New Drug Application (ANDA) directed at the U.S. market, which includes New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an ANDA to the FDA to market a generic version of the erectile dysfunction drug Cialis® (tadalafil) constitutes an act of infringement of a patent covering a method of using tadalafil in specific low doses.
  • Technical Context: The technology relates to pharmaceutical methods using a specific phosphodiesterase type 5 (PDE5) inhibitor for the treatment of sexual dysfunction, a significant pharmaceutical market.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 210716 with a Paragraph IV certification. This certification asserts that Plaintiffs’ patent is invalid, unenforceable, and/or will not be infringed by Defendant’s proposed generic product. The complaint was filed within the 45-day statutory window, potentially triggering a 30-month stay of FDA approval for the generic drug.

Case Timeline

Date Event
1999-04-30 '166 Patent Priority Date
2005-09-13 '166 Patent Issue Date
2017-08-11 Defendant sends Notice Letter regarding ANDA filing
2017-09-12 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

  • Issued: September 13, 2005 (Compl. ¶30).

The Invention Explained

  • Problem Addressed: The patent’s background section describes the need for improved treatments for sexual dysfunction. It identifies that the then-marketed PDE5 inhibitor, sildenafil (Viagra®), was associated with significant adverse side effects, including facial flushing, vision abnormalities, and a dangerous drop in blood pressure when used in combination with organic nitrates (’166 Patent, col. 1:60-2:8).
  • The Patented Solution: The invention is a method of treatment using a specific compound, tadalafil, administered in a low-dose oral formulation. The patent asserts that administering tadalafil in a unit dose of "about 1 to about 20 mg" provides effective treatment for sexual dysfunction while minimizing or eliminating the side effects associated with other PDE5 inhibitors, including the dangerous interaction with nitrates (’166 Patent, Abstract; col. 2:21-48).
  • Technical Importance: The claimed low-dose method was presented as a way to provide an effective therapy to individuals who previously could not be treated with PDE5 inhibitors, such as those taking nitrate medication or those susceptible to other side effects (’166 Patent, col. 2:44-48).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 4, 5, and 7-12 (Compl. ¶38).
  • Independent Claim 1: The essential elements are:
    • A method of treating sexual dysfunction in a patient in need thereof
    • comprising orally administering one or more unit doses
    • containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day,
    • of a compound with the chemical structure of tadalafil.
  • The asserted dependent claims further limit the method to specific indications (e.g., male erectile dysfunction), dosages (e.g., about 5 mg), dosage forms (e.g., a tablet), and administration frequency (e.g., once per day) (Compl. ¶¶ 42, 46, 47, 49).

III. The Accused Instrumentality

Product Identification

  • Defendant Glenmark's proposed generic tadalafil tablets, which are the subject of Abbreviated New Drug Application (ANDA) No. 210716 (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs’ Cialis® tablets, intended for the treatment of male erectile dysfunction (Compl. ¶¶ 1, 40-41).
  • Based on Defendant's notice letter, the complaint alleges the product will be manufactured as a tablet for oral administration and will contain tadalafil as the active ingredient in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths (Compl. ¶¶ 39, 47).
  • The proposed product is intended to be marketed as a bioequivalent, lower-cost alternative to the brand-name Cialis® drug upon receiving FDA approval (Compl. ¶1).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement allegations are based on Defendant's filing of an ANDA, which is a statutory act of infringement under 35 U.S.C. § 271(e)(2) if the proposed product, once marketed, would infringe the patent.

'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's proposed product will be marketed for the treatment of male erectile dysfunction, a form of sexual dysfunction, consistent with the FDA-approved label for Cialis®. ¶41 col. 2:63-65
...comprising orally administering one or more unit dose... Defendant's proposed product is a tablet product, a unit dose intended for oral administration. ¶47 col. 2:59-62
...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, which fall within the claimed range. The proposed label is expected to instruct administration up to a maximum of 20 mg per day. ¶39, ¶41 col. 3:16-19
...of a compound having the structure [of tadalafil]. Defendant admits in its notice letter that the proposed product will contain tadalafil as its active ingredient. ¶39 col. 3:11-15

Identified Points of Contention

  • Scope Questions: In Hatch-Waxman litigation, the primary dispute often centers on patent validity rather than infringement, especially when the generic product is a direct copy of the brand-name drug. The Defendant has filed a Paragraph IV certification asserting non-infringement and/or invalidity (Compl. ¶36). Given that the accused product's dosages (2.5, 5, 10, and 20 mg) fall squarely within the claimed range of "about 1 to about 20 mg," the infringement argument appears direct. Any non-infringement defense would likely have to rely on a narrow interpretation of a claim term or a deviation in the final approved product label from what is currently anticipated.
  • Technical Questions: The complaint alleges that Defendant's notice letter failed to provide a detailed "factual and legal basis" for its assertion of non-infringement or invalidity (Compl. ¶¶ 40, 43, 50). This suggests the substantive technical and legal disputes over the patent's validity (e.g., obviousness based on prior art) have yet to be detailed and will form the core of the litigation as it proceeds.

V. Key Claim Terms for Construction

  • The Term: "about 1 to about 20 mg"
  • Context and Importance: This phrase defines the central feature of the claimed invention: a specific low-dosage range that allegedly provides efficacy while avoiding side effects. The construction of "about" will be critical to determining the precise scope of the claim. Practitioners may focus on this term because the patent's validity could depend on how much this range differs from any prior art disclosures. For example, if prior art disclosed a 21 mg dose, the meaning of "about 20 mg" would be dispositive for an anticipation analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The repeated use of "about" throughout the specification in connection with the claimed dosage range suggests the patentee did not intend to be limited to the exact numerical endpoints (’166 Patent, Abstract; col. 2:42-43). Parties arguing for a broader scope may point to this consistent language as evidence of intentional flexibility.
    • Evidence for a Narrower Interpretation: The patent includes clinical data showing a marked increase in adverse events at a 25 mg dose (’166 Patent, col. 14, table). A party arguing for a narrower scope could use this data to contend that the term "about 20 mg" was intended to mean a dose that preserves the safety profile described in the patent and does not extend to doses where side effects become more prevalent.

VI. Other Allegations

  • Indirect Infringement: The primary count is for the statutory act of infringement under 35 U.S.C. § 271(e)(2) based on the ANDA submission (Compl. ¶57). The complaint also alleges that upon approval, Defendant will induce infringement by marketing its generic product with a label that will instruct physicians and patients to administer the drug in a manner that directly infringes the patented method (Compl. ¶¶ 41, 58).
  • Willful Infringement: The complaint does not explicitly allege willful infringement or seek enhanced damages. It includes a request for attorney's fees in the event the case is found to be exceptional under 35 U.S.C. § 285 (Compl. Prayer for Relief E).

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

  • A central issue will be the validity of the '166 patent's method claims. The case will likely turn on whether the claimed dosage range of "about 1 to about 20 mg" for tadalafil was obvious to a person of ordinary skill in the art at the time of the invention. The court will need to consider whether this specific range was merely the result of routine dose-optimization studies or if it achieved an unexpected result, such as a superior safety profile, not suggested by the prior art.
  • A secondary, but critical, question will be one of infringement by label. The analysis will focus on whether the final, FDA-approved label for Defendant's generic product will necessarily instruct users to perform every step of the claimed method. While the infringement allegation is based on the ANDA filing, the ultimate determination of induced infringement will depend on the specific language of the approved label for the accused product.