DCT
1:23-cv-01945
Catalyst Pharma Inc v. MSN Laboratories Pvt Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Catalyst Pharmaceuticals, Inc. (Delaware)
- Defendant: MSN Laboratories Private Limited (India) and MSN Pharmaceuticals Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 1:23-cv-01945, D.N.J., 04/05/2023
- Venue Allegations: Venue is asserted in the District of New Jersey based on Defendant MSN Pharmaceuticals Inc.'s principal place of business in Piscataway, New Jersey, and its systematic business contacts within the state.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the anti-epileptic drug Fycompa® constitutes an act of infringement of a patent covering a specific crystalline hydrate form of the active ingredient, perampanel.
- Technical Context: The dispute centers on pharmaceutical polymorphs—different crystalline structures of the same chemical compound—which can significantly impact a drug's stability, manufacturability, and bioavailability.
- Key Procedural History: This action was filed under the Hatch-Waxman Act, following a notice letter dated February 17, 2023, in which Defendants informed Plaintiff of their ANDA filing. This notice included a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by the proposed generic product. The patent is listed in the FDA's "Orange Book" as covering Plaintiff's Fycompa® product.
Case Timeline
| Date | Event |
|---|---|
| 2004-07-06 | '497 Patent Priority Date |
| 2014-07-08 | '497 Patent Issue Date |
| 2023-02-17 | Defendants' ANDA Notice Letter to Plaintiff |
| 2023-04-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,772,497 - "Method for Producing 1,2-Dihydropyridine-2-One Compound"
- Patent Identification: U.S. Patent No. 8,772,497, "Method for Producing 1,2-Dihydropyridine-2-One Compound," issued July 8, 2014.
The Invention Explained
- Problem Addressed: The patent's background section describes challenges with prior art methods for manufacturing the subject compound, noting that they could produce undesirable by-products and were not ideal for industrial-scale production (’497 Patent, col. 3:26-38). Furthermore, it highlights the general problem in pharmaceuticals that different physical forms of a drug substance (polymorphism) can lead to issues with consistency, stability, and manufacturing, creating a need to identify and secure a stable, homogeneous crystal form for reliable therapeutic use (’497 Patent, col. 3:41-col. 4:11).
- The Patented Solution: The invention provides, among other things, specific crystalline forms of the compound 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one, known as perampanel. The asserted claims identify a specific "hydrate" crystal, which is a form that incorporates water molecules into its lattice structure. This hydrate is defined not by its chemical formula but by its unique physical properties, specifically its characteristic absorption peaks when analyzed by infrared (IR) spectroscopy, as depicted in Figure 1 of the patent (’497 Patent, Abstract; col. 8:1-23).
- Technical Importance: Identifying and claiming a specific, stable polymorph of an active pharmaceutical ingredient is critical for ensuring lot-to-lot consistency in drug product manufacturing, which in turn affects the drug's dissolution, bioavailability, and shelf-life (’497 Patent, col. 3:41-48).
Key Claims at a Glance
- The complaint asserts independent claims 4 and 5.
- Independent Claim 4:
- A crystal of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one hydrate
- having an absorption peak at a wavenumber of 1588±1 cm⁻¹
- in an infrared absorption spectrum (KBr method).
- Independent Claim 5:
- A crystal of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one hydrate
- having absorption peaks at wavenumbers of 1588±1 cm⁻¹ and 751±1 cm⁻¹
- in an infrared absorption spectrum (KBr method).
- The complaint alleges infringement of "at least claims 4 and 5," suggesting the right to assert additional claims may be preserved (Compl. ¶37).
III. The Accused Instrumentality
Product Identification
- Defendants' Abbreviated New Drug Application (ANDA) No. 218152 and the proposed generic drug product described therein, which is a generic version of Catalyst's Fycompa® (perampanel) 0.5 mg/mL oral suspension (Compl. ¶1).
Functionality and Market Context
- As an ANDA product, the accused product is one that Defendants have represented to the FDA will have the same active ingredient, dosage form, strength, and administration route as the branded Fycompa® product, and will be bioequivalent (Compl. ¶32). The infringement allegations are based on the assertion that the active pharmaceutical ingredient (perampanel) within the proposed generic product is a specific crystalline form that falls within the scope of the ’497 Patent's claims (Compl. ¶37).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The complaint alleges infringement of at least claims 4 and 5. The following chart summarizes the allegations for the broader of the two, claim 5, which incorporates all elements of claim 4. The complaint does not map specific evidence from the ANDA to the claim elements, instead making a general allegation based on "information and belief."
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystal of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one hydrate | The complaint alleges on information and belief that Defendants' proposed ANDA product contains a crystalline hydrate form of perampanel. | ¶37 | col. 8:16-18 |
| having absorption peaks at wavenumbers of 1588±1 cm⁻¹ and 751±1 cm⁻¹ | The complaint alleges on information and belief that the crystalline form in the ANDA product possesses these characteristic absorption peaks. | ¶37 | col. 8:19-21 |
| in an infrared absorption spectrum (KBr method). | The complaint alleges this is the analytical method by which the claimed characteristics of the infringing crystal are measured. | ¶37 | col. 8:22-23 |
- Identified Points of Contention:
- Technical Questions: A primary question will be factual: does the crystal form of perampanel in Defendants' ANDA product actually possess the specific physical properties required by the claims? This will necessitate expert analysis of spectroscopic data from the accused product, which Plaintiff will seek in discovery.
- Scope Questions: Does the term "hydrate" as used in the claims cover any crystalline form of perampanel containing water in its lattice, or is its meaning limited by the specific examples and embodiments disclosed in the patent specification? The resolution of this question could be dispositive.
V. Key Claim Terms for Construction
- The Term: "hydrate"
- Context and Importance: This term is central to the scope of the asserted claims. The patent discloses multiple anhydrous and hydrated crystalline forms, but the asserted claims are directed only to a "hydrate" (’497 Patent, col. 9:29-65; col. 15:20-43). The definition of this term will determine what types of crystalline structures can infringe. Practitioners may focus on this term because its construction will define the boundary between the patented polymorph and other potential forms of the same compound.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves do not specify a particular stoichiometric ratio of water to perampanel (e.g., monohydrate, dihydrate). A party could argue this suggests the term should be given its plain and ordinary meaning, covering any crystalline form incorporating water molecules.
- Evidence for a Narrower Interpretation: The specification provides detailed examples of preparing specific hydrate crystals, such as the one in Example 5 (’497 Patent, col. 30:50-col. 31:10). A party could argue that these examples implicitly define the term "hydrate" as used in the patent, limiting it to the specific polymorph(s) characterized therein.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that the very act of filing the ANDA to seek approval for a drug claimed in the ’497 Patent constitutes infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶39). It further alleges that upon FDA approval, Defendants' commercial manufacture, use, and sale of the ANDA product would constitute direct infringement, and that by providing product labeling and instructions, they would induce infringement by others (Compl. ¶40).
- Willful Infringement: The complaint alleges that Defendants have had knowledge of the ’497 Patent "since at least the date Defendants submitted Defendants' ANDA" and that this knowledge supports a claim for willful infringement post-approval (Compl. ¶42). The complaint also seeks a finding that the case is "exceptional" under 35 U.S.C. § 285, which would permit an award of attorneys' fees (Compl. ¶43).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this Hatch-Waxman litigation will likely depend on the answers to two central questions:
- A key evidentiary question will be one of technical fact: Does the specific crystalline form of perampanel in Defendants' proposed generic product actually exhibit the infrared absorption peaks at 1588±1 cm⁻¹ and 751±1 cm⁻¹, as required by the asserted claims? This will be determined through a battle of competing expert analyses of the accused product.
- A core issue will be one of definitional scope: How should the term "hydrate" be construed? Will the court determine that it encompasses any crystalline form of the compound containing water, or will it be limited to the specific, exemplified polymorphs described in the patent's specification, potentially narrowing the scope of infringement?