DCT
3:17-cv-03462
Novo Nordisk Inc v. Glenmark Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk Healthcare AG (Switzerland)
- Defendant: Glenmark Pharmaceuticals Limited (India) and Glenmark Pharmaceuticals Inc., USA (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; White & Case LLP
- Case Identification: 3:17-cv-03462, D.N.J., 05/11/2017
- Venue Allegations: Venue is alleged based on Defendant’s business operations in New Jersey, including deriving revenue, having a presence, and previously consenting to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the estradiol product Vagifem® constitutes an act of infringement of a patent covering a low-dose method of administration.
- Technical Context: The technology relates to low-dose local hormone replacement therapy for treating atrophic vaginitis in postmenopausal women, designed to provide therapeutic benefits while minimizing systemic side effects.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA (No. 210264) to the FDA. The ANDA included a Paragraph IV certification, asserting that U.S. Patent No. 7,018,992, which is listed in the FDA’s Orange Book for Vagifem®, is invalid, unenforceable, or will not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2000-12-15 | ’992 Patent Priority Date |
| 2006-03-28 | ’992 Patent Issue Date |
| 2017-03-31 | Defendant sends Paragraph IV Certification Letter |
| 2017-05-11 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,018,992 - “Hormone Composition,” March 28, 2006
The Invention Explained
- Problem Addressed: The patent addresses the need for a local, topical treatment for urogenital discomfort (atrophic vaginitis) in estrogen-deprived women. The stated goal is to avoid the systemic side effects associated with oral hormone replacement therapy by providing a treatment that is effective locally but results in low systemic absorption of the active hormone (Compl. Ex. A, ’992 Patent, col. 1:12-28).
- The Patented Solution: The invention is a method for treating atrophic vaginitis by administering a low dose of estradiol, specifically "about 10 µg," in a tablet form. This administration is performed vaginally on an infrequent basis, "once or twice per week." This specific low-dose, low-frequency regimen is described as providing a sufficient clinical effect on vaginal symptoms while furnishing "no or only inferior systemic absorption" ('992 Patent, col. 1:60-65; col. 3:11-14). The patent highlights that this approach achieves the desired therapeutic outcome without significant accumulation of circulating estradiol ('992 Patent, col. 4:28-32).
- Technical Importance: The invention provided a method that sought to decouple the local therapeutic benefits of estrogen from the risks of systemic exposure, a primary concern for patients and clinicians in the field of postmenopausal care ('992 Patent, col. 2:5-7).
Key Claims at a Glance
- The complaint asserts infringement of at least claims 7, 8, 9, 11, and 12 (Compl. ¶17). These are dependent on independent claim 1.
- Independent Claim 1:
- A method for treating atrophic vaginitis in a patient in need of such treatment,
- said method comprising administering vaginally to said patient an amount of about 10 µg estradiol,
- wherein administration of said amount occurs once or twice per week
- and wherein said estradiol is administered in tablet form.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is "Glenmark's Product," a generic version of estradiol vaginal tablets in a 10 mcg dosage strength, for which Defendant Glenmark submitted ANDA No. 210264 to the FDA (Compl. ¶12).
Functionality and Market Context
The complaint alleges that Glenmark’s ANDA seeks approval to market a generic drug that is bioequivalent to Plaintiff’s branded product, Vagifem® (Compl. ¶13). The act of infringement alleged is the submission of the ANDA itself, pursuant to 35 U.S.C. § 271(e)(2)(A), for the purpose of obtaining approval to manufacture and sell this generic product before the expiration of the ’992 patent (Compl. ¶16). The proposed product is intended for the same therapeutic indication as Vagifem®, namely the treatment of atrophic vaginitis (Compl. ¶1). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart. The infringement theory is based on the statutory infringement provision of the Hatch-Waxman Act, where filing an ANDA for a drug claimed in a patent is itself an act of infringement. The core allegation is that the product described in Glenmark's ANDA, if approved and marketed, would be used in a way that infringes the asserted claims of the ’992 patent. The following chart summarizes the implied infringement theory for the lead independent claim.
’992 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating atrophic vaginitis in a patient in need of such treatment, | Glenmark's ANDA seeks approval to market a generic drug for the same indication as Vagifem®, the treatment of atrophic vaginitis. | ¶1, ¶12 | col. 18:13-14 |
| said method comprising administering vaginally to said patient an amount of about 10 µg estradiol, | Glenmark's Product is described as "estradiol vaginal tablets in a 10 mcg dosage strength." | ¶12 | col. 18:15-16 |
| wherein administration of said amount occurs once or twice per week | The filing of an ANDA for a generic version of Vagifem® implies that the proposed product label will instruct for a once or twice weekly dosing schedule to establish bioequivalence with the reference listed drug. | ¶1, ¶13 | col. 18:17-18 |
| and wherein said estradiol is administered in tablet form. | Glenmark's Product is identified as "estradiol vaginal tablets." | ¶12 | col. 18:19 |
Identified Points of Contention
- Validity vs. Infringement: In ANDA litigation, the primary dispute is often the patent's validity. Glenmark's Paragraph IV certification alleges that the ’992 Patent is "invalid, unenforceable, or will not be infringed" (Compl. ¶14). This suggests the case will focus heavily on Glenmark's invalidity defenses, such as obviousness over prior art treatments.
- Scope Questions: The infringement analysis may raise the question of whether Glenmark’s proposed product meets every limitation. For instance, a dispute could arise over whether the specific formulation of Glenmark's tablet falls within the scope of the term "tablet form" as contemplated by the patent, particularly if its release characteristics differ from those described in the ’992 Patent specification.
V. Key Claim Terms for Construction
"about 10 µg estradiol"
- Context and Importance: The precise scope of "about" is critical, as the claimed invention is distinguished by its specific low dosage. Practitioners may focus on this term because both infringement and validity (specifically, anticipation or obviousness by prior art disclosing similar dosages) could depend on whether a given dose falls within the claimed range.
- Intrinsic Evidence for a Broader Interpretation: The specification discusses a treatment regimen of "twice weekly about 5 to about 15 µg estradiol" (’992 Patent, col. 3:8-9), which may suggest that "about 10 µg" was not intended to be strictly limited to the exact numeral.
- Intrinsic Evidence for a Narrower Interpretation: The patent's abstract specifically references a tablet containing "10 µg of active material," and the clinical data presented focuses on the 10 µg and 25 µg dosages (’992 Patent, Abstract; col. 4:32-34). This could support an argument that "about 10 µg" refers to dosages sufficiently close to 10 µg to exhibit the same clinical profile of local efficacy with minimal systemic absorption demonstrated in the patent's examples.
"tablet form"
- Context and Importance: This term is key to distinguishing the invention from other delivery methods like creams or gels (’992 Patent, col. 1:22-23). The patent also explicitly differentiates its "tablet" from a prior art composition it claims "cannot be a tablet" (’992 Patent, col. 1:56-58). The construction of this term could be central if Glenmark's generic tablet has a different formulation or release mechanism.
- Intrinsic Evidence for a Broader Interpretation: The claim language itself does not further limit the type of tablet, which could support a plain and ordinary meaning covering any solid dosage form made by compression.
- Intrinsic Evidence for a Narrower Interpretation: The specification describes the Vagifem® tablet as containing a "film-coated hydrophilic cellulose matrix that adheres well to the vaginal mucosa and hydrates slowly to provide a controlled release of E2" (’992 Patent, col. 5:4-8). A party could argue that "tablet form" should be construed to include these controlled-release properties, potentially excluding an immediate-release tablet from the claim's scope.
VI. Other Allegations
Indirect Infringement
The complaint alleges infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶17). The allegation of induced infringement (§ 271(b)) is based on the premise that Glenmark's proposed product labeling will necessarily instruct medical professionals and patients to administer the 10 mcg tablet according to a once or twice weekly schedule, thereby instructing them to perform the patented method.
Willful Infringement
The complaint does not use the term "willful," but it does seek a finding that the case is "exceptional" and requests attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶20, Prayer for Relief ¶E). This allegation is based on Glenmark's filing of its ANDA with knowledge of the ’992 patent, as evidenced by the patent's listing in the FDA Orange Book and Glenmark's service of a Paragraph IV certification letter (Compl. ¶11, ¶14).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of patent validity: will Defendant be able to prove by clear and convincing evidence that the asserted claims are invalid for obviousness? The analysis will likely focus on whether a person of ordinary skill in the art would have been motivated to develop a 10 µg twice-weekly estradiol tablet for atrophic vaginitis with a reasonable expectation of success, based on prior art knowledge of higher-dose formulations and the general trend toward dose reduction.
- A key question for infringement may be one of claim scope: can the term "tablet form" be limited by the specification's description of a controlled-release matrix, or will it be given a broader construction that covers any solid oral tablet? The answer could determine whether Glenmark's specific generic formulation, if different from the embodiment described in the patent, falls within the scope of the claims.