DCT
2:10-cv-00080
Teva Women's HEALTH, INC. v. LUPIN, LTD.
I. Executive Summary and Procedural Information
Parties & Counsel:
- Plaintiff: Teva Women's Health, Inc. (Delaware)
- Defendant: Lupin, Ltd. (India) and Lupin Pharmaceuticals, Inc. (Virginia)
- Plaintiff’s Counsel: Lite DePalma Greenberg, LLC
Case Identification: 2:10-cv-00080, D.N.J., 01/11/2012
Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendants are subject to personal jurisdiction in the district, engaging in the sale of generic pharmaceutical products there.
Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) for a generic version of the oral contraceptive LoSeasonique®, and its subsequent commercial sale, infringes a patent covering an extended-cycle contraceptive method.
Technical Context: The technology relates to extended-cycle oral contraceptives, which are designed to reduce the frequency of menstruation and manage associated symptoms, a significant segment of the women's health market.
Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant Lupin's filing of an ANDA with a Paragraph IV certification, asserting the patent-in-suit is invalid, unenforceable, or not infringed. The complaint notes that Lupin has since received FDA approval and launched its generic product. Critically, the complaint alleges that Lupin has stipulated that its product infringes the asserted claims if those claims are found to be valid and enforceable, focusing the dispute primarily on the patent's validity.
Case Timeline
| Date | Event |
|---|---|
| 2001-12-05 | ’545 Patent Priority Date |
| 2008-10-24 | FDA approves Teva's LoSeasonique® New Drug Application |
| 2009-11-10 | '545 Patent Issued |
| 2009-11-24 | Lupin sends Paragraph IV Notice Letter to Teva |
| 2011-10-26 | FDA approves Lupin's ANDA for generic LoSeasonique® |
| 2011-12-09 | Lupin allegedly begins selling the accused generic product |
| 2012-01-11 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,615,545 - "Oral Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology"
- Patent Identification: U.S. Patent No. 7,615,545, "Oral Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology," issued November 10, 2009 (’545 Patent, p. 10; Compl. ¶9).
The Invention Explained
- Problem Addressed: The patent describes issues with conventional 28-day cycle oral contraceptives, which result in approximately 13 menstrual periods per year. This regular cycling can be associated with premenstrual syndrome (PMS) and the more severe premenstrual dysphoric disorder (PMDD) ('545 Patent, col. 2:45-58). The patent notes that while lower-dose contraceptives exist, they can present increased "bleeding control problems" ('545 Patent, col. 2:40-42).
- The Patented Solution: The invention is a method for an extended contraceptive regimen designed to reduce the number of menstrual cycles to approximately four per year. This is achieved by administering a combination of an estrogen and a progestin for an extended period (e.g., 84 consecutive days), followed by a short interval of administering a low dose of estrogen alone, rather than a placebo or no pill ('545 Patent, col. 4:5-15, col. 4:40-47). The stated rationale is that maintaining a low level of estrogen, rather than having a complete withdrawal, can diminish the symptoms of PMS and PMDD ('545 Patent, col. 4:21-29).
- Technical Importance: This dosing strategy provides a method to maintain contraceptive efficacy while reducing the frequency of menstruation and its associated adverse symptoms, thereby enhancing convenience and quality of life for users ('545 Patent, col. 4:11-15).
Key Claims at a Glance
- The complaint asserts independent claims 1, 18, 19, 20, and 22, as well as several dependent claims (Compl. ¶26). Independent claim 1 is representative of the core method.
- The essential elements of independent claim 1 are:
- A method of contraception in a female,
- comprising administering a combination of estrogen and progestin for a period of 81 to 89 consecutive days,
- followed by administering a dosage "consisting essentially of estrogen" for 2 to 8 consecutive days,
- wherein the estrogen in the combination phase is equivalent to about 10-50 µg of ethinyl estradiol daily,
- the estrogen in the estrogen-only phase is equivalent to about 5-10 µg of ethinyl estradiol daily, and
- the progestin is equivalent to about 50-150 µg of levonorgestrel daily.
- The complaint reserves the right to assert other claims, including dependent claims 2, 4-9, 15, and 17-21 (Compl. ¶26).
III. The Accused Instrumentality
Product Identification
- The "Lupin Product," a generic version of Teva's LoSeasonique® oral contraceptive (Compl. ¶¶14, 21).
Functionality and Market Context
- The accused product is sold as a kit containing 84 tablets of a combination of 100 µg levonorgestrel and 20 µg ethinyl estradiol, followed by 7 tablets containing 10 µg of ethinyl estradiol alone (Compl. ¶14). The product is manufactured and sold by Lupin as a generic alternative to Teva's branded LoSeasonique® product (Compl. ¶¶21, 25).
- The complaint alleges that Lupin's product labeling directs users to take the tablets in a sequence that practices the patented method (Compl. ¶¶24, 26). It further alleges that Lupin began selling its generic product after receiving FDA approval on October 26, 2011 (Compl. ¶¶18, 21).
Visual Evidence
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that Lupin has stipulated to infringement of the asserted claims to the extent the claims are found valid and enforceable (Compl. ¶26). The infringement theory is based on Lupin’s filing of its ANDA and the subsequent commercialization of a product whose composition and directed use map directly onto the patent’s claims.
’545 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...administering... a combination of estrogen and progestin for a period of 81 to 89 consecutive days... | Lupin's product kit contains 84 combination tablets of ethinyl estradiol and levonorgestrel, with labeling that directs their consecutive use. | ¶14 | col. 25:13-17 |
| ...followed by administration of a dosage consisting essentially of estrogen for a period of 2 to 8 consecutive days... | Lupin's product kit contains 7 tablets of ethinyl estradiol, directed for use after the combination tablets. | ¶14 | col. 25:17-20 |
| ...estrogen...in combination...is administered in a daily amount equivalent to about 10 µg to about 50 µg of ethinyl estradiol... | Lupin's combination tablets contain 20 µg of ethinyl estradiol. | ¶14 | col. 25:20-23 |
| ...estrogen...for the period of 2 to 8 consecutive days is administered in a daily amount equivalent to about 5 µg to about 10 µg of ethinyl estradiol... | Lupin's estrogen-only tablets contain 10 µg of ethinyl estradiol. | ¶14 | col. 25:24-28 |
| ...progestin...is administered in a daily amount of about 50 µg to about 150 µg of levonorgestrel. | Lupin's combination tablets contain 100 µg of levonorgestrel. | ¶14 | col. 25:29-32 |
Identified Points of Contention
- Scope Questions: Given the alleged stipulation that infringement hinges only on validity (Compl. ¶26), the primary dispute over infringement appears to be resolved, pending a validity determination. The complaint alleges that Lupin’s ANDA filing contained a certification that the '545 patent is "invalid, unenforceable and/or will not be infringed" (Compl. ¶15). The focus of the case is therefore expected to be on the patent's validity and enforceability, not on the technical details of infringement.
V. Key Claim Terms for Construction
- The Term: "consisting essentially of"
- Context and Importance: This term appears in claim 1 in the phrase "a dosage consisting essentially of estrogen." This transitional phrase is narrower than "comprising" but broader than "consisting of," permitting the presence of unlisted ingredients that do not materially affect the "basic and novel properties" of the claimed invention. Practitioners may focus on this term if the defendant were to argue that the inactive ingredients (excipients) in its estrogen-only tablets materially alter the properties of the dosage form compared to what is disclosed in the patent, thereby avoiding infringement. However, the alleged stipulation on infringement may render this point moot.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's objective is to "avoid[] complete withdrawal of estrogen" ('545 Patent, col. 4:22-23). This suggests the "basic and novel" property is the physiological effect of providing a low dose of estrogen, a function that standard pharmaceutical excipients would not materially alter.
- Evidence for a Narrower Interpretation: The patent describes specific embodiments and dosages ('545 Patent, col. 6:1-8). A party could argue that the "basic and novel properties" include not just providing estrogen, but doing so with a specific safety or side-effect profile, and that different excipients could materially affect that profile.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶30). The factual basis is Lupin's proposed product labeling, which allegedly directs and instructs medical providers and patients to use the generic product in a manner that directly infringes the method claims of the ’545 Patent (Compl. ¶24). The complaint also pleads facts supporting contributory infringement, alleging the Lupin Product is "especially made and adapted for use in infringing" and is "not suitable for substantial non-infringing use" (Compl. ¶29).
- Willful Infringement: While the complaint does not use the word "willful," it alleges that Lupin knew of the '545 patent when it filed its ANDA (Compl. ¶19), acted "without a reasonable basis for believing that they would not be liable for infringement" (Compl. ¶31), and engaged in conduct that makes the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶32). Teva seeks treble damages, which are awarded for willful infringement (Compl. ¶E). The allegation that Lupin launched its product after the lawsuit was filed may support this claim.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of validity: The complaint alleges that Lupin has stipulated to infringement if the patent is valid (Compl. ¶26). This shifts the central dispute of the case from infringement to whether the asserted claims of the '545 Patent are valid and enforceable, likely focusing on questions of obviousness over prior art contraceptive regimens.
- A key question for damages will be one of willfulness: Does Lupin's conduct, particularly its decision to launch its generic product commercially after being sued for infringement, rise to the level of willful infringement? The court's finding on this issue will determine whether the case is "exceptional" and if an award of enhanced damages and attorneys' fees is warranted.