DCT

1:10-cv-00007

Cephalon Inc v. Watson Laboratories Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:10-cv-00007, D. Del., 01/05/2010
  • Venue Allegations: Venue is alleged to be proper based on Defendants' marketing, sales activities, and systematic distribution of generic pharmaceutical products to residents of Delaware. Additionally, Defendant Watson Pharma, Inc. is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to market generic armodafinil constitutes an act of infringement of a patent covering a specific crystalline form of that drug.
  • Technical Context: The technology relates to pharmaceutical polymorphism, which involves identifying and characterizing distinct solid-state crystalline forms of an active pharmaceutical ingredient that can affect a drug's physical properties and performance.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant Watson's filing of ANDA No. 200-156 seeking FDA approval to market a generic version of Plaintiff's Nuvigil® product. As part of its application, Watson filed a "Paragraph IV Certification" alleging that the patent-in-suit is invalid or will not be infringed. Watson sent a formal Notice Letter to Cephalon regarding its ANDA filing on November 24, 2009.

Case Timeline

Date Event
2002-12-20 U.S. Patent No. 7,132,570 Priority Date
2006-11-07 U.S. Patent No. 7,132,570 Issued
2009-11-24 Watson sends ANDA Notice Letter to Cephalon
2010-01-05 Complaint for Patent Infringement Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,132,570

  • Patent Identification: U.S. Patent No. 7,132,570, "Method for the Production of Crystalline Forms and Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006. (Compl. ¶12).

The Invention Explained

  • Problem Addressed: The patent describes prior art methods for producing modafinil and its individual optical enantiomers (molecules that are mirror images of each other). These methods produced what the patent designates as "Form I," which is described as the most thermodynamically stable polymorphic form ('570 Patent, col. 2:42-48). The specification implicitly identifies a need for alternative crystalline forms, which may possess different and potentially advantageous properties.
  • The Patented Solution: The invention provides processes for creating new and distinct crystalline forms (polymorphs and solvates) of the optical enantiomers of modafinil. The patented solution demonstrates that the specific crystalline form obtained "mainly depends on the nature of the crystallisation solvent used" and the conditions of crystallization, such as the rate of cooling ('570 Patent, col. 2:28-30, col. 5:43-62). The patent identifies several new forms (e.g., Forms II, III, IV, and V) and characterizes them by their unique X-ray powder diffraction (XRPD) patterns, which serve as structural fingerprints ('570 Patent, Figs. 9-16).
  • Technical Importance: Different crystalline forms of a drug can exhibit different physical properties such as solubility, stability, and dissolution rate, which are critical factors in designing an effective and reliable pharmaceutical formulation ('570 Patent, col. 3:11-15).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one of the claims" but does not specify which ones (Compl. ¶20). Claim 1 is the first independent claim.
  • Independent Claim 1 elements:
    • A laevorotatory enantiomer of modafinil
    • in a polymorphic form
    • that produces a powder X-ray diffraction spectrum comprising intensity peaks at the interplanar spacings: 8.54, 4.27, 4.02, 3.98 (Å).
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶20, 24).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are "Watson's generic armodafinil products" that are the subject of ANDA No. 200-156. These are proposed in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg dosage strengths (Compl. ¶13).

Functionality and Market Context

The accused products are generic versions of Cephalon's "successful Nuvigil® (armodafinil)" pharmaceutical products (Compl. ¶10). Armodafinil is a prescription drug used to improve wakefulness in patients with sleep disorders such as obstructive sleep apnea, narcolepsy, and shift work sleep disorder (Compl. ¶11). Watson's ANDA seeks approval for the same indications as Nuvigil® (Compl. ¶11, 13). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed factual allegations mapping the accused product to the patent claims, which is common in initial ANDA complaints. The infringement theory is based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA as a technical act of infringement if the product, once commercially marketed, would infringe the patent. The following chart summarizes the implied allegations for a representative claim.

'570 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A laevorotatory enantiomer of modafinil The accused product is identified as "generic armodafinil," which is the common name for the laevorotatory enantiomer of modafinil. ¶13 col. 2:18-22
in a polymorphic form The complaint alleges that Watson's product, if approved and sold, would infringe the patent, which requires the product to be in a specific crystalline polymorphic form. ¶17, 20 col. 2:33-36
that produces a powder X-ray diffraction spectrum comprising intensity peaks at the interplanar spacings: 8.54, 4.27, 4.02, 3.98 (Å). The complaint does not present XRPD data but necessarily alleges that the crystalline form of armodafinil in the product described in Watson's ANDA No. 200-156 will, upon manufacture, produce an XRPD spectrum that includes the characteristic peaks of the claimed Form I polymorph. ¶16, 17, 21 col. 2:49-65
  • Identified Points of Contention:
    • Technical Questions: The central factual question will be whether the crystalline form of armodafinil in Watson’s proposed product, as specified in its ANDA, is in fact the "Form I" polymorph claimed in the ’570 Patent. This determination will rely on scientific evidence, primarily a comparison of the XRPD spectra of Watson's product against the claimed pattern.
    • Scope Questions: The term "comprising intensity peaks" is open-ended, suggesting the product's XRPD spectrum could contain additional peaks. A dispute may arise over how closely the overall pattern of the accused product must match the disclosed pattern for Form I, and what experimental variance is permissible for peak positions and relative intensities.

V. Key Claim Terms for Construction

The complaint does not identify any specific claim construction disputes. However, based on the technology, certain terms are likely to be central.

  • The Term: "polymorphic form"
    • Context and Importance: The distinction between a "polymorphic form" and other solid forms, such as solvates or an amorphous solid, is fundamental to the scope of the claims. Practitioners may focus on this term to determine if the accused product falls outside this definition.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent provides a definition: "an organised structure involving only molecules of the solute, having a characteristic crystalline signature" ('570 Patent, col. 2:33-36). This is a standard, functional definition.
      • Evidence for a Narrower Interpretation: The patent explicitly distinguishes a "polymorphic form" from a "solvate," which involves both solute and solvent molecules ('570 Patent, col. 2:37-41). If Watson's product were shown to be a stable solvate, it might be argued not to be a "polymorphic form" as used in the patent.
  • The Term: "produces a powder X-ray diffraction spectrum comprising intensity peaks at..."
    • Context and Importance: This phrase defines the evidentiary test for infringement. The construction of "comprising" and the required precision of the peak locations will be critical.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The standard legal meaning of "comprising" is "including but not limited to." This would suggest that infringement is established if the accused product's XRPD spectrum contains the recited peaks, even if it also contains other, unlisted peaks.
      • Evidence for a Narrower Interpretation: A party might argue that the identity of a polymorph is defined by its entire characteristic pattern, not just a subset of peaks. They could point to the specification's use of full XRPD tables and figures to distinguish between different forms (e.g., Form I vs. Form II), suggesting that a holistic comparison is necessary and that a product with a substantially different overall pattern does not infringe, even if a few peaks overlap.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement. The factual basis cited is Watson's intent to market its generic product with a product insert that will "direct physicians and patients in the use of Watson's generic armodafinil products" (Compl. ¶19, 21, 24). It also alleges that the various Watson entities acted in concert to encourage and induce the ANDA filing (Compl. ¶18).
  • Willful Infringement: Willfulness is alleged based on Watson's knowledge of the '570 patent (Compl. ¶26). This knowledge is evidenced by Watson's filing of a Paragraph IV certification against the patent and its sending of the November 24, 2009 Notice Letter to Cephalon, both of which occurred pre-suit (Compl. ¶13-14, 16).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of empirical proof: Does the specific crystalline solid form of armodafinil that Watson proposes to market, as defined by the characterization data in its ANDA, actually exhibit the powder X-ray diffraction pattern of the patented "Form I"? The case will likely turn on a battle of scientific experts analyzing this technical data.
  • A second central question, prompted by Watson's Paragraph IV certification, will be one of patent validity: Is the claimed Form I polymorph a patentable invention, or was it anticipated or rendered obvious by prior art methods of preparing armodafinil? This raises the question of whether Form I was an inherent or inevitable result of known processes.