DCT
1:23-cv-01961
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-01961, D.N.J., 04/06/2023
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendant MSN Pharmaceuticals Inc.'s principal place of business in the district and both Defendants' systematic and continuous business contacts, including the marketing and sale of other generic pharmaceutical products. The complaint further notes that Defendants have previously invoked the jurisdiction of the court as counterclaim plaintiffs in other patent matters.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the epilepsy drug Fycompa® constitutes an act of infringement of a patent covering specific crystalline hydrate forms of the active ingredient, perampanel.
- Technical Context: The technology relates to pharmaceutical polymorphism, where a specific crystalline structure of an active pharmaceutical ingredient is claimed to provide stable and desirable properties for formulation and therapeutic use.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a notice letter, dated February 17, 2023, in which Defendants stated they had filed an ANDA with a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed by their proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" for the Fycompa® product.
Case Timeline
| Date | Event |
|---|---|
| 2004-07-06 | '497 Patent Priority Date |
| 2014-07-08 | '497 Patent Issue Date |
| 2023-02-17 | Defendants send ANDA Notice Letter to Plaintiff |
| 2023-04-06 | 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, issued July 8, 2014.
The Invention Explained
- Problem Addressed: The patent's background section notes that while methods for producing the chemical compound known as perampanel were known, they were not ideal for industrial-scale manufacturing due to the creation of by-products and other impurities ('497 Patent, col. 3:20-38). Furthermore, for a compound to be used as a medicine, it is desirable to have a homogeneous and stable crystal form to ensure consistent quality and potency ('497 Patent, col. 3:45-51).
- The Patented Solution: The invention claims to solve these problems by, among other things, identifying and characterizing specific crystalline forms of perampanel, including a stable hydrate form. The patent describes these crystal forms using analytical techniques like infrared (IR) spectroscopy and X-ray diffraction to define their unique physical structures ('497 Patent, Abstract; col. 8:12-24). The detailed description explains that such a well-defined crystal form is desirable to avoid issues with chargeability and to ensure stability during production and storage ('497 Patent, col. 4:4-11).
- Technical Importance: In pharmaceutical development, identifying a stable polymorph (a specific crystal form) of a drug substance is critical for ensuring consistent dissolution rates, bioavailability, and manufacturability of the final drug product ('497 Patent, col. 3:45-51).
Key Claims at a Glance
- The complaint asserts independent claims 4 and 5 (Compl. ¶37).
- 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 notes that Defendants' future actions would also infringe "one or more claims of the '497" patent, reserving the right to assert additional claims (Compl. ¶40).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendants' proposed generic version of perampanel 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets, which is the subject of Abbreviated New Drug Application (ANDA) No. 218178 (Compl. ¶1).
Functionality and Market Context
- The product is a proposed generic equivalent to Plaintiff's branded drug, Fycompa®, which is used for treating certain neurological and neuromuscular diseases (Compl. ¶¶1-2).
- By filing the ANDA, Defendants have represented to the FDA that their product contains the same active ingredient (perampanel), is bioequivalent to, and has the same strength and dosage form as Fycompa® (Compl. ¶32). The complaint alleges, based on the ANDA, that the accused product "contains crystalline forms of perampanel" (Compl. ¶37).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint's infringement allegations are based on information and belief derived from the Defendants' ANDA submission, which is typical for a Hatch-Waxman action at the pleading stage.
'497 Patent Infringement Allegations
| Claim Element (from Independent Claim 4) | 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 that the Defendants' proposed ANDA Product contains a crystalline form of perampanel that is a hydrate. | ¶37 | col. 8:12-14 |
| ...having an absorption peak at a wavenumber of 1588±1 cm⁻¹ in an infrared absorption spectrum (KBr method). | It is alleged that the crystalline form of perampanel in the ANDA product exhibits this characteristic IR absorption peak. | ¶37 | col. 8:14-17 |
| 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 that the Defendants' proposed ANDA Product contains a crystalline form of perampanel that is a hydrate. | ¶37 | col. 8:18-20 |
| ...having absorption peaks at wavenumbers of 1588±1 cm⁻¹ and 751±1 cm⁻¹ in an infrared absorption spectrum (KBr method). | It is alleged that the crystalline form of perampanel in the ANDA product exhibits these characteristic IR absorption peaks. | ¶37 | col. 8:20-24 |
- Identified Points of Contention:
- Technical Question: The central dispute will likely be factual and evidentiary: does the specific crystalline form of perampanel in Defendants' ANDA product possess the exact infrared (IR) absorption spectrum characteristics—namely, a peak at 1588±1 cm⁻¹ and, for claim 5, an additional peak at 751±1 cm⁻¹—as required by the asserted claims? The outcome will depend on the analytical data contained within the ANDA and produced during discovery.
- Scope Questions: The case raises the question of whether the Defendants' product is, in fact, a "hydrate" as that term is used in the patent. This may involve disputes over the amount of water incorporated into the crystal lattice and whether it matches the forms characterized in the '497 patent.
V. Key Claim Terms for Construction
- The Term: "hydrate"
- Context and Importance: This term is fundamental to the scope of the asserted claims. Infringement can only occur if the Defendants' product is a crystalline hydrate of perampanel. If the product is an anhydrous crystal, a different solvate, or an amorphous form, there would be no literal infringement. Practitioners may focus on this term because its precise definition will determine whether the accused product's composition falls within the claim's boundary.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves recite "hydrate" without specifying a particular stoichiometric ratio of water to perampanel (Compl. ¶¶27-28). A party could argue this term should be given its plain and ordinary meaning, covering any crystalline form that incorporates water molecules into its lattice structure, irrespective of the specific ratio.
- Evidence for a Narrower Interpretation: The specification describes and provides data for specific hydrate forms, such as a "3/4 hydrate" and a "monohydrate" ('497 Patent, col. 15:29-35). A party could argue that the term "hydrate" should be construed as being limited to the specific, characterized crystalline structures disclosed in the patent's examples and figures (e.g., FIG. 1, FIG. 4), rather than covering any possible hydrate.
VI. Other Allegations
- Indirect Infringement: The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a patented drug as a statutory act of infringement (Compl. ¶39). It also alleges that the future commercial manufacture and sale of the ANDA product, post-approval, would constitute direct infringement under § 271(a) as well as induced (§ 271(b)) and contributory (§ 271(c)) infringement (Compl. ¶40).
- Willful Infringement: The complaint alleges that Defendants had knowledge of the '497 patent "since at least the date Defendants submitted Defendants' ANDA" and that this submission constituted an act of infringement (Compl. ¶42). Based on this alleged knowledge, the complaint asserts the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶43).
VII. Analyst’s Conclusion: Key Questions for the Case
This dispute, typical of ANDA litigation involving polymorph patents, will likely center on the following key questions for the court:
- A central question will be one of factual identity: Does the crystalline form of the perampanel active ingredient in MSN's ANDA product, as revealed through discovery, exhibit the precise physical characteristics—specifically, the infrared absorption peaks at the wavenumbers defined in claims 4 and 5—of the patented hydrate crystal?
- A related question will be one of claim scope: How should the term "hydrate" be construed? The court may need to determine if the term covers a broad range of water-containing crystalline structures or if it is limited to the specific stoichiometric and structural forms detailed in the '497 patent's specification.
- Finally, stemming from the Defendants' Paragraph IV certification, a critical issue for the litigation as a whole will be patent validity: Can MSN prove by clear and convincing evidence that the specific crystalline hydrate forms, as defined by the asserted claims, were either anticipated or rendered obvious by the state of the art prior to the patent's priority date?