DCT
1:22-cv-02019
Evoke Pharma Inc v. Teva Pharma Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Evoke Pharma, Inc. (Delaware)
- Defendant: Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Saiber LLC
- Case Identification: 1:22-cv-02019, D.N.J., 04/07/2022
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant entities maintain a principal place of business in Parsippany, New Jersey, and are therefore "at home" in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic metoclopramide nasal spray constitutes an act of infringement of two patents covering formulations and methods of use for Plaintiff's GIMOTI® product.
- Technical Context: The technology concerns stable, nasally-administered pharmaceutical formulations of metoclopramide, a drug used to treat diabetic gastroparesis, a condition that impairs gastric emptying and can make oral medications less reliable.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 216931 and a notice letter to Plaintiff dated February 24, 2022, containing a Paragraph IV certification. U.S. Patent No. 11,020,361 is subject to a terminal disclaimer over U.S. Patent No. 8,334,281, linking their enforceability and expiration.
Case Timeline
| Date | Event |
|---|---|
| 2008-12-22 | Priority Date for ’281 and ’361 Patents |
| 2012-12-18 | U.S. Patent No. 8,334,281 Issues |
| 2021-06-01 | U.S. Patent No. 11,020,361 Issues |
| 2022-02-24 | Defendant Sends Notice Letter to Plaintiff |
| 2022-04-07 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,334,281 - “Nasal Formulations of Metoclopramide”
- Issued: December 18, 2012
The Invention Explained
- Problem Addressed: The patent’s background section states that previously-known nasal solutions of metoclopramide tend to become discolored on storage, taking on an undesirable yellow-to-brown color, particularly under accelerated stability conditions designed to simulate long-term storage (ʼ281 Patent, col. 2:26-39).
- The Patented Solution: The invention is a pharmaceutical composition for a metoclopramide nasal spray that remains stable and avoids discoloration over time. This stability is achieved through a specific formulation that includes a citrate buffer at a concentration of at least 10 millimolar and maintains a pH above 4.5, which collectively protect the solution from color change during storage (ʼ281 Patent, Abstract; col. 4:9-20).
- Technical Importance: Developing a chemically stable liquid formulation is critical for the commercial viability and patient acceptance of a nasally delivered drug, ensuring a consistent and safe product over its intended shelf life (ʼ281 Patent, col. 4:35-42).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims of the '281 patent (Compl. ¶38). Independent claim 1 is representative of the patent's composition claims.
- Essential elements of Independent Claim 1 include:
- A pharmaceutical composition comprising metoclopramide, a citrate buffer, and benzalkonium chloride.
- The composition is a nasal solution that remains "clear to pale yellow when compared to standard E, 32 USP <631>" after storage at 40° C. for at least 4 weeks.
- The composition has a citrate concentration of at least about 10 millimolar.
- The complaint reserves the right to assert other claims, including any dependent claims.
U.S. Patent No. 11,020,361 - “Nasal Formulations of Metoclopramide”
- Issued: June 1, 2021
The Invention Explained
- Problem Addressed: The ʼ361 patent addresses the same technical problem as the '281 Patent: the tendency of metoclopramide nasal solutions to become discolored upon storage ('361 Patent, col. 2:30-41).
- The Patented Solution: This patent claims methods of using the stable nasal formulation to treat specific medical conditions. The invention is the act of intranasally administering an effective amount of the stabilized metoclopramide composition (containing a citrate buffer) to treat gastroparesis, with specific claims directed to a dosage of about 15 mg ('361 Patent, Abstract; col. 32:65-col. 33:5). The solution is thus a method of use for the composition described in the parent patent.
- Technical Importance: A non-oral delivery method for treating gastroparesis is clinically significant because the condition itself impairs gastric motility, which can render oral drug administration unreliable ('361 Patent, col. 2:25-29, citing U.S. Pat. No. 6,770,262).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims of the ʼ361 patent (Compl. ¶43). Independent claim 1 is representative of the patent's method of use claims.
- Essential elements of Independent Claim 1 include:
- A method of treating gastroparesis in a patient.
- The method comprises intranasally administering a composition effective to deliver about 15 mg of metoclopramide.
- The composition comprises citrate in a concentration of at least about 10 millimolar.
- The administration is effective to treat gastroparesis.
- The complaint reserves the right to assert other claims, including any dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's proposed generic version of Evoke's GIMOTI® (metoclopramide) nasal spray, identified as "Teva's ANDA Product" (Compl. ¶11). The act of infringement is the submission of Abbreviated New Drug Application (ANDA) No. 216931 to the FDA (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that Teva’s ANDA Product has the same active ingredient (metoclopramide), route of administration (nasal spray), dosage form, and strength (Eq. 15 mg Base/Spray) as Plaintiff's GIMOTI® product (Compl. ¶35).
- Plaintiff’s GIMOTI® is an FDA-approved product for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis (Compl. ¶22). By filing an ANDA for a generic equivalent, Defendant is seeking approval to market its product for the same indication before the expiration of the patents-in-suit (Compl. ¶33).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed claim chart. The infringement theory rests on the allegation that because Defendant’s ANDA product is a generic version of Plaintiff’s GIMOTI® product, which is covered by the patents-in-suit, the ANDA product will necessarily meet the claim limitations upon approval and commercialization (Compl. ¶¶26, 30, 35).
'281 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising metoclopramide, or a pharmaceutically-acceptable salt thereof, a citrate buffer, and benzalkonium chloride; | Defendant’s ANDA product is alleged to be a generic formulation of Plaintiff’s GIMOTI® nasal spray, which contains metoclopramide and is covered by the '281 patent. | ¶35, ¶38 | col. 2:50-55 |
| wherein the composition is a nasal solution that is clear to pale yellow when compared to standard E, 32 USP <631> on storage at a temperature of 40° C. for at least about 4 weeks; | As a generic equivalent seeking approval, the ANDA product must exhibit stability comparable to the GIMOTI® product, which is alleged to meet this limitation. | ¶26, ¶38 | col. 10:35-49 |
| and wherein the composition has a citrate concentration...of at least about 10 millimolar. | The ANDA product is alleged to have the same formulation characteristics as GIMOTI®, which is asserted to be covered by the claims of the '281 patent. | ¶26, ¶35, ¶38 | col. 2:50-65 |
'361 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating gastroparesis in a patient, | Defendant’s ANDA seeks approval for a generic product to be marketed for the same indication as GIMOTI®, which is the treatment of diabetic gastroparesis. | ¶11, ¶22, ¶35 | col. 8:35-40 |
| comprising intranasally administering to the patient an amount of a metoclopramide composition effective to deliver about 15 mg of metoclopramide, | The ANDA product is alleged to have the same dosage strength (15 mg Base/Spray) and route of administration as GIMOTI®. | ¶11, ¶35 | col. 8:46-52 |
| wherein the composition comprises citrate in a concentration of at least about 10 millimolar, | The ANDA product's formulation is alleged to be equivalent to GIMOTI®, which is covered by the '361 patent and its compositional requirements. | ¶30, ¶35, ¶43 | col. 8:65-col. 9:1 |
| and wherein the intranasally administering is effective to treat gastroparesis. | The ANDA filing itself, seeking approval for this indication, is the basis for the infringement allegation under 35 U.S.C. § 271(e)(2). | ¶35, ¶43 | col. 33:3-5 |
Identified Points of Contention
- Scope Questions: A central issue will be whether the specific formulation detailed in Defendant's confidential ANDA submission literally falls within the scope of the asserted claims. For instance, does the term "citrate buffer" as used in the patents read on the specific buffering system used in Defendant’s product?
- Technical Questions: An evidentiary question will be whether Defendant's formulation, as described in its ANDA, actually meets the objective stability requirement of remaining "clear to pale yellow when compared to standard E, 32 USP <631>" under the conditions specified in the claim. The case will likely involve competing expert analyses of the ANDA's chemistry, manufacturing, and controls (CMC) data.
V. Key Claim Terms for Construction
The Term: "citrate buffer" ('281 Patent, Claim 1)
- Context and Importance: The use of a citrate buffer is presented as a core component of the patented solution to the problem of discoloration. The definition of this term will be critical for determining whether Defendant's specific formulation infringes, as alternative stabilizing agents or different forms of citrate could fall outside a narrow construction.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines "[citrate]" broadly to include the sum of all its protonated and ionic forms, which may support an interpretation that the mere presence of these species in sufficient concentration creates the claimed "buffer" ('281 Patent, col. 9:22-34).
- Evidence for a Narrower Interpretation: The description of specific embodiments combining citric acid monohydrate and sodium citrate dihydrate to achieve a stable pH could be used to argue that a "citrate buffer" requires the deliberate combination of both an acid and a conjugate salt, not just the presence of citric acid alone ('281 Patent, col. 12:50-54).
The Term: "clear to pale yellow when compared to standard E, 32 USP <631>" ('281 Patent, Claim 1)
- Context and Importance: This limitation quantifies the required stability and provides the benchmark for infringement. Its construction is crucial, as a dispute may arise over the precise methodology of the comparison and the definition of the color standard.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent explicitly incorporates the USP standard and describes a visual comparison method, which Plaintiff may argue sets forth a clear, objective, and readily ascertainable standard for one skilled in the art ('281 Patent, col. 10:35-49).
- Evidence for a Narrower Interpretation: A defendant could argue that the term is indefinite if the visual comparison against "standard E" is deemed too subjective or if the testing conditions are not specified with sufficient particularity to ensure a reliable and repeatable result.
VI. Other Allegations
Indirect Infringement
- The complaint alleges that Defendant possesses "specific intent to infringe" (Compl. ¶¶40, 45). In the context of an ANDA case, this supports a claim for induced infringement, based on the allegation that Defendant's proposed product label will instruct physicians and patients to use the generic drug in a manner that directly infringes the method claims of the '361 patent.
Willful Infringement
- The complaint does not use the term "willful," but it alleges that Defendant has "actual and constructive knowledge" of the patents and requests a finding of an "exceptional case" under 35 U.S.C. § 285 to award attorneys' fees (Compl. ¶¶40, 45; p. 9, ¶e). This claim is likely predicated on Defendant's knowledge of the patents, which are listed in the FDA's Orange Book, at the time it filed its ANDA.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of formulation equivalence: will discovery into Defendant’s confidential ANDA submission reveal a formulation that literally meets the compositional limitations of the '281 patent, particularly the "citrate buffer" at the required concentration, or will Plaintiff need to rely on the doctrine of equivalents?
- A key evidentiary question will be one of objective stability: does the product described in the ANDA meet the "clear to pale yellow" stability standard of claim 1 of the '281 patent? The resolution will likely depend on expert testimony and a detailed analysis of Defendant's stability data.
- A central legal question for the '361 patent will be whether Defendant's act of filing an ANDA—with a proposed label that mirrors the indication and 15 mg dosage of the patented method—is sufficient to establish infringement of the method-of-use claims under the specialized provisions of 35 U.S.C. § 271(e)(2).