DCT

1:13-cv-01206

UCB Inc v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:13-cv-01206, D. Del., 07/10/2013
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Accord conducts systematic and continuous business in the state, including the sale of pharmaceutical products.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market generic lacosamide tablets constitutes an act of infringement of a patent covering the lacosamide compound.
  • Technical Context: The technology concerns a specific anticonvulsant chemical compound used for the treatment of partial-onset seizures associated with epilepsy.
  • Key Procedural History: The patent-in-suit is a reissue of an earlier patent and has received a patent term extension. The complaint notes that Defendants filed a Paragraph IV certification asserting that the patent is invalid and/or not infringed. Subsequent to the complaint's filing, the patent survived both an ex parte reexamination, which resulted in the cancellation of broader claims while confirming the patentability of the specific compound claim, and an inter partes review, which confirmed the patentability of all then-existing claims.

Case Timeline

Date Event
1996-03-15 ’551 Patent Priority Date
1998-06-30 Original U.S. Patent No. 5,773,475 Issue Date
2004-07-06 U.S. Reissued Patent No. RE 38,551 ('551 Patent) Issue Date
2008-10-28 FDA Approval of NDA for Vimpat® tablets and intravenous solution
2010-04-20 FDA Approval of NDA for Vimpat® oral solution
2013-06-06 Date of Accord's Notice of Certification letter
2013-07-10 Complaint Filing Date
2022-03-17 ’551 Patent Expiration Date (with term extension)

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

U.S. Reissued Patent No. RE 38,551 - "Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004

The Invention Explained

  • Problem Addressed: The patent's background section describes a need for improved anticonvulsant drugs for treating epilepsy, noting that a significant portion of the patient population is poorly managed by existing therapies, which often cause disturbing side effects, including liver toxicity upon chronic administration (RE38,551 Patent, col. 2:61-col. 3:8).
  • The Patented Solution: The invention provides a class of "enantiomeric amino acid derivatives" that are asserted to have high anticonvulsant activity, minimal neurological toxicity, and a high protective index (RE38,551 Patent, col. 3:9-32). A key aspect of the patented solution is the isolation of the R stereoisomer, which the inventor found to be "significantly more efficacious than the corresponding S enantiomer or a racemic mixture thereof" (RE38,551 Patent, col. 5:1-4). This improved safety and efficacy profile is described as making the compounds suitable for long-term (chronic) administration.
  • Technical Importance: By providing a compound with a potentially superior safety and efficacy profile, the invention addressed a critical need for more tolerable and effective long-term treatments for chronic conditions like epilepsy (RE38,551 Patent, col. 3:41-54).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '551 patent without specifying individual claims (Compl. ¶34). A representative independent claim central to the dispute is Claim 8.
  • Independent Claim 8:
    • The compound according to claim 1 which is (R)-N-Benzyl 2-Acetamido-3-methoxypropionamide.
  • The complaint reserves the right to assert other claims, including those directed to therapeutic compositions and methods of treatment (Compl. ¶19).

III. The Accused Instrumentality

Product Identification

The accused products are Defendants' generic lacosamide tablets in 50 mg, 100 mg, 150 mg, and 200 mg dosage strengths, as described in Abbreviated New Drug Application (ANDA) No. 205011 ("Accord's ANDA Products") (Compl. ¶26, ¶27).

Functionality and Market Context

The complaint alleges that the active ingredient in Accord's ANDA Products is lacosamide (Compl. ¶33). The products are intended as generic equivalents to Plaintiffs' Vimpat® tablets, which are used as an adjunctive therapy for partial-onset seizures in people with epilepsy (Compl. ¶15). The filing of the ANDA seeks FDA approval to market these generic products before the expiration of the ’551 Patent (Compl. ¶28).

IV. Analysis of Infringement Allegations

RE38,551 Infringement Allegations

Claim Element (from Independent Claim 8) Alleged Infringing Functionality Complaint Citation Patent Citation
The compound... which is (R)-N-Benzyl 2-Acetamido-3-methoxypropionamide. The complaint alleges that the active ingredient in Accord's ANDA Products is lacosamide, which it identifies chemically as (R)-2-acetamido-N-benzyl-3-methoxypropionamide. The complaint provides a chemical structure diagram of lacosamide, which it alleges is the active ingredient in the accused product (Compl. ¶18). ¶18, ¶33 col. 20:37-39

Identified Points of Contention

  • Scope Questions: In this Hatch-Waxman context involving a claim to a specific chemical compound, the primary infringement question is one of direct correspondence. The central issue is whether the active pharmaceutical ingredient (API) defined in Accord's ANDA is, in fact, the chemical compound recited in Claim 8. The complaint alleges this identity directly (Compl. ¶33).
  • Technical Questions: A key technical question for the litigation will be what analytical evidence confirms the chemical structure, including the specific stereochemistry (the R configuration), of the lacosamide API in Accord's ANDA product. The complaint's allegation of infringement rests on this identification.

V. Key Claim Terms for Construction

Given that the asserted independent claim recites a specific chemical compound by its recognized chemical name, extensive claim construction is not anticipated. The dispute is more likely to center on the validity of the claim rather than the meaning of its terms. Practitioners would likely focus discovery on evidence confirming the chemical identity of the accused product and on prior art relevant to the patent's validity.

VI. Other Allegations

  • Indirect Infringement: The complaint's allegations are centered on direct infringement under 35 U.S.C. § 271(e)(2) based on the ANDA filing. It does not contain specific factual allegations to support separate counts of induced or contributory infringement, such as detailing instructions provided to doctors or patients.
  • Willful Infringement: The complaint alleges that Accord was aware of the ’551 Patent at the time it filed its ANDA (Compl. ¶30). This allegation of pre-suit knowledge may serve as a basis for a willfulness claim. The prayer for relief requests a determination that the case is "exceptional" under 35 U.S.C. § 285, which is consistent with an allegation of willful infringement (Prayer for Relief ¶G).

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

The resolution of this case will likely depend on the answers to a few central questions:

  • A threshold factual question will be one of chemical identity: does Accord's ANDA product specify the exact compound, (R)-N-Benzyl 2-Acetamido-3-methoxypropionamide, as recited in Claim 8 of the ’551 patent?
  • The central legal battle will likely concern claim validity: does the prior art, as may be raised by Defendants in connection with their Paragraph IV certification (Compl. ¶31), render the asserted claims invalid as anticipated or obvious?
  • A key evidentiary issue will be the impact of the patent's prosecution and post-grant history: how will the cancellation of broad claims during reexamination and the subsequent confirmation of the asserted claims in an inter partes review influence the court's analysis of both the scope and validity of the patent?