DCT
1:17-cv-01037
Bayer AG v. Mayne Pharma LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bayer AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc. (Germany/Delaware)
- Defendant: Mayne Pharma LLC (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Bartlit Beck Herman Palenchar & Scott LLP
- Case Identification: 1:17-cv-01037, D. Del., 07/27/2017
- Venue Allegations: Venue is asserted as proper in the District of Delaware because the Defendant, Mayne Pharma LLC, is organized under the laws of Delaware and is therefore a resident of the district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the Natazia® oral contraceptive constitutes an act of infringement of a patent covering the drug's specific multi-phasic formulation.
- Technical Context: The technology concerns a multi-phase oral contraceptive that combines a natural estrogen with a synthetic progestin in a specific, timed dosage regimen designed to improve cycle control and reduce side effects.
- Key Procedural History: This litigation was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification. The complaint was filed within the 45-day statutory window after Plaintiff received Defendant's notice letter, which allegedly asserted that the patent-in-suit is invalid but did not contest infringement on other grounds. The patent-in-suit is listed in the FDA's "Orange Book" as covering the Natazia® product.
Case Timeline
| Date | Event |
|---|---|
| 2004-04-20 | '577 Patent Priority Date |
| 2005-04-15 | '577 Patent Application Filing Date |
| 2011-12-06 | '577 Patent Issue Date |
| 2017-06-16 | Defendant Sends Paragraph IV Notice Letter to Plaintiff |
| 2017-07-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,071,577 - Multi-phase Contraceptive Preparation Based on a Natural Estrogen
- Patent Identification: U.S. Patent No. 8,071,577, “Multi-phase Contraceptive Preparation Based on a Natural Estrogen,” issued December 6, 2011.
The Invention Explained
- Problem Addressed: The patent describes a need for an oral contraceptive that, compared to conventional products, offers greater reliability, improved control over the user's bleeding cycle, and a reduction in side effects such as breast tenderness, headaches, and depressive moods ('577 Patent, col. 1:8-15).
- The Patented Solution: The patent discloses a multiphase contraceptive regimen that uses a natural estrogen (estradiol valerate) in combination with a synthetic progestogen (dienogest). The core of the invention is a specific 28-day dosing schedule that varies the amounts of these hormones in four distinct phases to achieve the desired balance of contraceptive efficacy and tolerability ('577 Patent, Abstract; col. 2:9-25). This regimen involves an initial estrogen-only phase, a two-step combination phase with increasing progestogen, a tapering estrogen-only phase, and a final placebo phase.
- Technical Importance: The use of a natural estrogen was intended to provide a more favorable side-effect profile than the synthetic estrogens commonly used in oral contraceptives at the time, while the dynamic, multi-phasic dosing was designed to maintain robust ovulation inhibition and cycle stability ('577 Patent, col. 1:5-15, col. 2:5-10).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the '577 patent (Compl. ¶31). The key independent claims covering the product and its use are Claims 1 and 3.
- Independent Claim 1 recites a "multiphase product for contraception" comprising:
- A first phase of 2 daily dosage units, each with 3 mg of estradiol valerate.
- A second phase composed of two groups: a first group of 5 daily units (2 mg estradiol valerate and 2 mg dienogest) and a second group of 17 daily units (2 mg estradiol valerate and 3 mg dienogest).
- A third phase of 2 daily dosage units, each with 1 mg of estradiol valerate.
- A fourth phase of 2 daily dosage units, each comprising a pharmaceutically acceptable placebo.
- The complaint does not explicitly reserve the right to assert dependent claims, but its general allegation encompasses them.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Mayne Pharma's proposed generic version of Bayer’s Natazia® tablets, which is the subject of ANDA No. 202999 (Compl. ¶¶ 1, 19).
Functionality and Market Context
- The product described in the ANDA is a 28-day oral contraceptive regimen intended for use in a human female (Compl. ¶21).
- The complaint alleges that the composition of Mayne's proposed product is identical to the commercial Natazia® product, containing a 28-day regimen of: 2 tablets of 3 mg estradiol valerate; 5 tablets of 2 mg estradiol valerate and 2 mg dienogest; 17 tablets of 2 mg estradiol valerate and 3 mg dienogest; 2 tablets of 1 mg estradiol valerate; and 2 placebo tablets (Compl. ¶¶ 17, 21). As a generic drug, it is intended to be a therapeutically equivalent and lower-cost alternative to the branded Natazia® product.
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The infringement theory presented in the complaint is based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as an act of infringement. The complaint alleges that the formulation of Mayne's proposed generic product directly maps onto the elements of the claims of the '577 patent.
'577 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first phase of 2 daily dosage units, each comprising 3 mg of estradiol valerate, | The accused 28-day regimen contains "2 tablets comprising 3 mg of estradiol valerate". | ¶21 | col. 6:16-18 |
| a second phase of 2 groups of daily dosage units, a first group comprising 5 daily dosage units, each of which comprises 2 mg of estradiol valerate and 2 mg of dienogest, | The regimen includes "5 tablets comprising 2 mg estradiol valerate and 2 mg dienogest". | ¶21 | col. 6:19-23 |
| ...and a second group comprising 17 daily dosage units, each of which comprises 2 mg of estradiol valerate and 3 mg of dienogest; | The regimen includes "17 tablets comprising 2 mg estradiol valerate and 3 mg dienogest". | ¶21 | col. 6:23-26 |
| a third phase of 2... daily dosage units, each comprising 1 mg of estradiol valerate, and | The regimen includes "2 tablets comprising 1 mg estradiol valerate". | ¶21 | col. 6:27-29 |
| a fourth phase of 2... daily dosage units, each comprising a pharmaceutically acceptable placebo. | The regimen includes "2 placebo tablets". | ¶21 | col. 6:30-32 |
Identified Points of Contention
- Technical Questions: Based on the complaint, there appears to be no significant technical dispute regarding infringement. The formulation of the accused generic product is alleged to be identical to the claimed formulation.
- Primary Dispute: The complaint alleges that Mayne's Paragraph IV letter asserts the '577 patent is invalid, and that its "only statement of non-infringement is based on a presumed finding of invalidity" (Compl. ¶¶ 24, 25). This suggests the central dispute in the case will not be over whether the accused product infringes, but whether the asserted claims of the '577 patent are valid and enforceable.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific claim terms that may be subject to construction disputes. Given that the infringement allegation rests on the identical formulation of the proposed generic product, it is possible that claim construction will not be a central point of contention. The chemical and dosage terms appear to be precise and defined by their plain and ordinary meaning in the pharmaceutical field.
VI. Other Allegations
- Indirect Infringement: The complaint includes standard allegations of induced and contributory infringement (Compl. ¶34; Prayer ¶E). In the context of an ANDA case, these allegations are typically based on the premise that the defendant's product label and instructions will direct physicians and patients to use the drug in a manner that directly infringes the method claims of the patent.
- Willful Infringement: Willfulness is alleged based on Defendant’s purported actual and constructive knowledge of the '577 patent prior to filing its ANDA, including its listing in the FDA Orange Book (Compl. ¶26). The complaint further alleges that Defendant was aware that filing the ANDA for approval prior to patent expiration constituted an act of infringement (Compl. ¶36).
VII. Analyst’s Conclusion: Key Questions for the Case
The filings to date suggest the litigation will center on the following core questions for the court:
- A primary question of patent validity: Is U.S. Patent No. 8,071,577 invalid as obvious or anticipated by the prior art? The complaint indicates that Defendant's defense is centered on invalidity rather than non-infringement, making this the likely focal point of the case.
- A secondary, and likely undisputed, question of statutory infringement: Does the product described in Mayne's ANDA, if approved and marketed, fall within the scope of a valid and enforceable claim of the '577 patent? Based on the complaint, the alleged one-to-one correspondence between the accused product's formulation and the patent's claims suggests this question will be resolved in the affirmative, shifting the case's focus entirely to the validity of the patent.