DCT

2:12-cv-05009

Janssen Pharma Inc v. Glenmark Generics Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:12-cv-05009, D.N.J., 08/09/2012
  • Venue Allegations: Venue is alleged based on Defendant Glenmark Generics USA's principal place of business in New Jersey, as well as both Defendants' continuous contacts, sales, and derivation of substantial revenue within the district. The complaint also notes that Defendants have previously submitted to the jurisdiction of the court.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the oral contraceptive ORTHO TRI-CYCLEN® LO constitutes an act of infringement of a patent covering a specific triphasic contraceptive regimen.
  • Technical Context: The technology relates to low-dose combination oral contraceptives, a field focused on minimizing hormone-related side effects while maintaining contraceptive efficacy and predictable cycle control.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 204057 with a Paragraph IV certification, asserting that the patent-in-suit is invalid and/or not infringed. The complaint notes that the patent-in-suit has been the subject of several other litigations against different generic drug manufacturers.

Case Timeline

Date Event
1998-12-23 '815 Patent Priority Date (Provisional Filing)
2001-04-10 '815 Patent Issue Date
2012-07-05 Glenmark Paragraph IV Notice Letter Date
2012-08-09 Complaint Filing Date

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

U.S. Patent No. 6,214,815 - "TRIPHASIC ORAL CONTRACEPTIVE"

  • Patent Identification: U.S. Patent No. 6,214,815, "TRIPHASIC ORAL CONTRACEPTIVE", issued April 10, 2001.

The Invention Explained

  • Problem Addressed: The patent's background section describes a significant challenge with oral contraceptives (OCs) containing low doses of estrogen (less than 30 µg per day). While desirable for reducing serious side effects, these low-dose regimens were associated with poor menstrual cycle control, particularly a higher incidence of "breakthrough bleeding and/or spotting," which could lead to patient non-compliance (’815 Patent, col. 1:25-34).
  • The Patented Solution: The invention claims to solve this problem with a specific triphasic (three-phase) dosing regimen. The method involves administering a constant, low daily dose of an estrogen (25 µg of ethinylestradiol) for 21 days, while the daily dose of a progestogen (norgestimate) is sequentially increased across three 7-day phases ('815 Patent, Abstract; col. 3:15-46). This approach is described as providing cycle control comparable to higher-estrogen products while retaining the safety benefits of a lower estrogen dose ('815 Patent, col. 8:25-30).
  • Technical Importance: The claimed method offered a way to achieve the clinical benefits of low-estrogen formulations without the significant drawback of irregular bleeding, a key factor for patient adherence and the overall success of an oral contraceptive product ('815 Patent, col. 1:30-34).

Key Claims at a Glance

  • The complaint asserts infringement of "the claims of the '815 Patent" without specifying particular claims (Compl. ¶20). The patent contains both method and product claims. Independent claim 1 is representative of the core inventive method.
  • Independent Claim 1 requires:
    • A method of contraception comprising administering a combination of 17a-ethinylestradiol and norgestimate for 21 successive days.
    • Phase 1 (first 7 days): a daily dosage of 25 µg of 17a-ethinylestradiol and 0.180 mg of norgestimate.
    • Phase 2 (next 7 days): a daily dosage of 25 µg of 17a-ethinylestradiol and 0.215 mg of norgestimate.
    • Phase 3 (next 7 days): a daily dosage of 25 µg of 17a-ethinylestradiol and 0.250 mg of norgestimate.
    • Followed by 7 days without hormone administration.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the generic drug product described in Defendants' Abbreviated New Drug Application (ANDA) No. 204057 (Compl. ¶18).

Functionality and Market Context

  • The complaint alleges that the ANDA seeks approval for a generic version of Plaintiff's branded product, ORTHO TRI-CYCLEN® LO (Compl. ¶18). The product is intended to be bioequivalent to the branded drug, meaning it would contain the same active pharmaceutical ingredients and be administered according to the same triphasic dosage schedule to provide oral contraception (Compl. ¶22). If approved by the FDA, the product would compete directly with Plaintiff's product in the market. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2), where the submission of an ANDA for a drug claimed in a patent is a technical act of infringement. The core allegation is that the product for which Glenmark seeks approval, if commercially manufactured and sold, would infringe the ’815 Patent.

'815 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of 17a-ethinylestradiol and norgestimate... Defendants have filed ANDA No. 204057 seeking approval to market a generic version of ORTHO TRI-CYCLEN® LO, a product which contains these active ingredients and whose proposed labeling would instruct for this use. ¶¶18, 23 col. 9:1-4
for the first 7 days in a daily dosage corresponding to 25 µg of 17a-ethinylestradiol and 0.180 mg of norgestimate, The ANDA product is alleged to be a bioequivalent generic that, if approved, would be administered according to the patented three-phase dosage regimen, starting with this specific dose. ¶¶18, 22 col. 9:4-6
for the succeeding 7 days a daily dosage equal to 25 µg of 17α-ethinylestradiol and 0.215 mg of norgestimate; The product specified in the ANDA would allegedly be administered in a second 7-day phase using this specific dose. ¶¶18, 22 col. 9:7-9
and for the next 7 days a daily dosage equal to 25 µg of 17a-ethinylestradiol and 0.250 mg of norgestimate; The product specified in the ANDA would allegedly be administered in a third 7-day phase using this specific dose. ¶¶18, 22 col. 9:9-11
followed by 7 days without estrogen and progestogen administration. The proposed labeling for the ANDA product would instruct for a 7-day hormone-free period to complete the 28-day cycle, consistent with the patented method. ¶¶18, 22 col. 9:11-12
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges that Defendants' ANDA product is a generic version of ORTHO TRI-CYCLEN® LO, which Plaintiff's own product is "covered by the claims of the '815 Patent" (Compl. ¶16). Assuming the ANDA product's formulation and proposed label mirror the branded product, the infringement analysis may be straightforward. The central dispute, as signaled by the Defendants' Paragraph IV certification, will likely concern the patent's validity (Compl. ¶21).
    • Technical Questions: A key question for the court will be whether the specific combination of a constant low estrogen dose with a triphasic, escalating progestogen dose, as claimed, was obvious to a person of ordinary skill in the art at the time of the invention. The analysis will likely involve examining prior art related to both low-dose estrogen OCs and other triphasic OC regimens to determine if the claimed invention represents a non-obvious improvement.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim term disputes. However, should Plaintiff assert broader claims like dependent claim 3, certain terms could become central.

  • The Term: "equivalent in effect to"
  • Context and Importance: This term appears in claim 3, which recites dosages "equivalent in effect to about" specific milligram amounts of norgestimate ('815 Patent, col. 9:38-46). The construction of this phrase would determine whether the claim's scope extends beyond the exact norgestimate formulation to encompass other progestogens or slightly different dosages that achieve a similar clinical outcome. Practitioners may focus on this term because it directly controls the breadth of infringement for claims extending beyond the precise formulation of claim 1.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses a long list of alternative progestogens that "may be employed as a component in the present invention," which could support an interpretation that "equivalent in effect" is intended to cover these chemical alternatives (ʼ815 Patent, col. 4:53-65).
    • Evidence for a Narrower Interpretation: The patent's examples and clinical data focus exclusively on the use of norgestimate and ethinylestradiol ('815 Patent, col. 7:18-col. 8:30). A party could argue that "equivalent in effect" should be narrowly construed to require the specific clinical performance profile demonstrated in the patent's own examples, rather than a general functional similarity.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Defendants commercially sell their generic product, they would induce and contribute to infringement under § 271(b) and (c) (Compl. ¶¶23, 25). The factual basis for this allegation is that Defendants would market and distribute the product with labeling that instructs physicians and patients to administer it according to the patented method (Compl. ¶24).
  • Willful Infringement: The complaint does not explicitly allege "willful infringement" but does assert that the case is "exceptional" and seeks attorney's fees under 35 U.S.C. § 285 (Compl. ¶26). The basis for this appears to be Defendants' alleged infringement by filing an ANDA with knowledge of the patent, as evidenced by the Paragraph IV notice letter sent to Plaintiff (Compl. ¶22).

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

  • A core issue will be one of patent validity, specifically obviousness: Was the claimed invention—a triphasic regimen combining a constant 25 µg dose of ethinylestradiol with three specific, escalating doses of norgestimate—an obvious modification of prior art oral contraceptives to a person of ordinary skill in late 1998? The outcome will depend on whether the patent's claimed solution to the problem of poor cycle control in low-estrogen formulations is deemed an inventive step.
  • A key legal question will be one of exceptionality: Does Defendants' act of filing a Paragraph IV certification, and the subsequent litigation conduct, rise to the level of making this an "exceptional case" warranting an award of attorney's fees to the Plaintiff, particularly in light of the patent's extensive litigation history against other generic manufacturers?