DCT
1:23-cv-00243
UCB Inc v. Annora Pharma Pvt Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: UCB, Inc. (Delaware) and UCB Biopharma SRL (Belgium)
- Defendant: Annora Pharma Private Limited (India)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Covington & Burling LLP
- Case Identification: 1:23-cv-00243, D. Del., 03/06/2023
- Venue Allegations: Venue is alleged to be proper as Defendant is a foreign corporation that may be sued in any judicial district. The complaint also asserts that Defendant has previously consented to personal jurisdiction in the District of Delaware in other patent litigation.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's anti-epileptic drug Briviact® (brivaracetam) constitutes an act of infringement of a patent covering the drug’s active ingredient and methods of use.
- Technical Context: The technology involves specific 2-oxo-1-pyrrolidine derivatives, a class of chemical compounds developed for the treatment of neurological disorders such as epilepsy.
- Key Procedural History: The complaint notes that the same parties are involved in a prior litigation (UCB, Inc. v. Annora Pharma Private Ltd., C.A. No. 20-987-CFC) concerning the same patent-in-suit but directed to a generic version of Briviact® tablets rather than an oral solution. A bench trial in that earlier case was held in November 2022. The patent-in-suit has also received a five-year Patent Term Extension (PTE) based on the FDA's regulatory review of Briviact®.
Case Timeline
| Date | Event |
|---|---|
| 2000-02-23 | ’461 Patent Priority Date |
| 2005-06-28 | ’461 Patent Issue Date |
| 2020-10-27 | ’461 Patent Term Extension Certificate Issued |
| 2022-11-01 | Bench Trial Held in Prior UCB v. Annora I Litigation (approx. date) |
| 2023-02-17 | Annora Sends Paragraph IV Notice Letter to UCB |
| 2023-03-06 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,911,461 - “2-oxo-1-pyrrolidine Derivatives, Processes for Preparing Them and Their Uses”
- Patent Identification: U.S. Patent No. 6,911,461, “2-oxo-1-pyrrolidine Derivatives, Processes for Preparing Them and Their Uses,” issued June 28, 2005.
The Invention Explained
- Problem Addressed: The patent background discusses the existing anti-epileptic drug levetiracetam and notes that related compounds could offer improved therapeutic profiles (U.S. Patent No. 6,911,461, col. 1:12-24). The patent sought to identify novel analogs of levetiracetam with "markedly improved therapeutic properties" (U.S. Patent No. 6,911,461, col. 1:33-38).
- The Patented Solution: The invention provides a class of chemical compounds, defined by a general formula for 2-oxo-1-pyrrolidine derivatives, that are asserted to be particularly effective for treating neurological disorders, including epilepsy (’461 Patent, Abstract; col. 1:39-44). The claims specifically identify certain stereoisomers of these derivatives.
- Technical Importance: The invention identified a new set of chemical entities with potential for enhanced efficacy and/or safety in the treatment of epilepsy and other central nervous system disorders (’461 Patent, col. 1:33-38).
Key Claims at a Glance
- The complaint asserts independent claims 1, 3, and 5, and dependent claims 2 and 4 (Compl. ¶26).
- Independent Claim 1: A composition of matter claim directed to the "(4R) and (4S) diastereoisomers of (2S)-2-[2-oxy-4-propylpyrrolidinyl]butanamide or a pharmaceutically acceptable salt thereof."
- Independent Claim 3: A method of use claim for treating a list of disorders, including epilepsy, by "administering a therapeutic dose of at least one compound according to claim 1."
- Independent Claim 5 (as corrected): A composition of matter claim directed specifically to "(2S)-2-[(4R)-2-oxo-4-propylpyrrolidinyl]butanamide or a pharmaceutically acceptable salt thereof," which is the chemical compound known as brivaracetam.
III. The Accused Instrumentality
Product Identification
Annora’s proposed generic brivaracetam oral solution (10 mg/mL dosage strength), as described in its ANDA No. 218048 (Compl. ¶1, ¶22).
Functionality and Market Context
The product is a generic equivalent of UCB’s branded drug, Briviact® oral solution, and is intended for the same therapeutic use: the treatment of partial-onset seizures (Compl. ¶1, ¶18). By filing an ANDA, Annora seeks to enter the U.S. market and compete with UCB’s branded product before the expiration of the ’461 Patent (Compl. ¶11).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that by submitting its ANDA, Annora has committed a statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶26). Critically, the complaint states that "In Annora's Notice Letter, Annora has not contested infringement of claims 1–5 of the '461 Patent" (Compl. ¶26). This suggests that the core of the dispute will be patent validity and/or enforceability, rather than claim interpretation or factual infringement. The infringement allegations for the compound itself are summarized below.
'461 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (2S)-2-[(4R)-2-oxo-4-propylpyrrolidinyl]butanamide or a pharmaceutically acceptable salt thereof. | Annora's ANDA product is identified as a "brivaracetam oral solution," and the active pharmaceutical ingredient brivaracetam is the compound recited in the claim. | ¶22, ¶26 | col. 88:24-27 |
- Identified Points of Contention:
- Legal Questions: As infringement is reportedly not contested, the central legal question is whether Annora's defenses, asserted in its Paragraph IV certification, can succeed. The certification alleges that the '461 Patent is "invalid, unenforceable, and/or will not be infringed" (Compl. ¶21). The complaint does not detail Annora's specific invalidity or unenforceability arguments.
- Technical Questions: Since the product described in the ANDA is a generic copy intended to have the same active ingredient as the branded drug, there are no apparent technical mismatches identified in the complaint. The technical dispute, if any, will likely arise in the context of Annora's validity challenges (e.g., comparing the claimed invention to the prior art).
V. Key Claim Terms for Construction
Because the asserted claims recite specific chemical compounds by structure and stereochemistry, and infringement is reportedly not contested, claim construction is not anticipated to be a primary area of dispute based on the allegations in the complaint. The meaning of the terms in the compound claims, such as "(2S)-2-[(4R)-2-oxo-4-propylpyrrolidinyl]butanamide," is defined by established principles of chemical nomenclature, leaving little room for interpretation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Annora will actively induce infringement upon approval of its ANDA (Compl. ¶23). This allegation is directed at the method of use claims (Claims 3 and 4). The basis for inducement would be Annora's proposed product labeling, which would instruct physicians and patients to administer the generic drug for the patented therapeutic indications.
- Willful Infringement: Willfulness is not explicitly pleaded as a separate count. However, the complaint alleges that Annora had knowledge of the '461 Patent, at the latest, by virtue of the prior litigation and its receipt of UCB's Orange Book listing (Compl. ¶12, ¶20). The prayer for relief also seeks a finding that the case is exceptional and an award of attorneys' fees, which can be predicated on litigation misconduct or, in some circumstances, willful infringement (Request for Relief (F)).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of patent validity: Given that infringement is not contested according to the complaint, the case will likely turn on whether Annora can prove by clear and convincing evidence that the asserted claims of the '461 Patent are invalid or otherwise unenforceable, as asserted in its Paragraph IV certification.
- A key procedural question will be the impact of prior litigation: The outcome of this case may be significantly influenced by the earlier lawsuit between the same parties over the same patent. Questions of issue preclusion or persuasive authority from findings in UCB v. Annora I concerning the patent's validity will be a primary focus for the court and the parties.