DCT
1:15-cv-00158
Forest Laboratories LLC v. Alembic Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Forest Laboratories, LLC (Delaware) and Forest Laboratories Holdings, Ltd. (Irish)
- Defendant: Alembic Pharmaceuticals Ltd. (India), Alembic Global Holding SA (Switzerland), and Alembic Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 1:15-cv-00158, D. Del., 02/13/2015
- Venue Allegations: Venue is asserted based on Defendant Alembic Inc. being a Delaware corporation that regularly transacts business in the state. The foreign defendants are alleged to be subject to jurisdiction through their U.S. subsidiary and agent, Alembic Inc., and by having previously availed themselves of the court's jurisdiction in other matters.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the antipsychotic drug Saphris® constitutes an act of infringement of a patent covering a rapidly disintegrating sublingual pharmaceutical formulation.
- Technical Context: The case involves pharmaceutical formulations designed to deliver drugs via sublingual (under the tongue) or buccal (in the cheek) routes, a method intended to improve drug absorption and reduce side effects compared to traditional oral ingestion.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act, triggered by Defendant Alembic's submission of an ANDA with a Paragraph IV certification to the FDA. This certification alleges that the patent-in-suit is invalid and/or not infringed by Alembic's proposed generic product. The patent-in-suit was granted a five-year term extension by the PTO.
Case Timeline
| Date | Event |
|---|---|
| 1994-03-02 | '476 Patent Priority Date |
| 1998-06-09 | '476 Patent Issue Date |
| 2009-08-13 | FDA Approval for Saphris® (NDA No. 22117) |
| 2015-01-03 | Alembic sends Paragraph IV Notice Letter to Plaintiffs |
| 2015-02-13 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,763,476 - “Sublingual or Buccal Pharmaceutical Composition”
- Issued: June 9, 1998.
The Invention Explained
- Problem Addressed: The patent states that conventional peroral (swallowed) administration of the active compound, asenapine, resulted in "serious cardiotoxic effects, e.g. postural hypotension and/or impairment of baroreceptor functioning" (’476 Patent, col. 2:25-28).
- The Patented Solution: The invention is a pharmaceutical formulation for sublingual or buccal administration that allows the active ingredient to be absorbed directly through the mucosal tissues of the mouth. This delivery method was found to cause "substantially less cardiovascular side effects" (’476 Patent, col. 2:31-32). The core of the solution is a solid dosage form, such as a tablet or lozenge, comprising a water-soluble or water-dispersible carrier that allows the composition to "rapidly disintegrate in the mouth" (’476 Patent, col. 2:55-58).
- Technical Importance: This formulation provided a method to safely deliver a therapeutically effective dose of a potent antipsychotic agent by avoiding the metabolic pathways and side effects associated with gastrointestinal absorption.
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" of the ’476 patent and specifically references claim 4 in its allegations of indirect infringement (Compl. ¶23, ¶32). Independent claim 1 is the broadest composition claim.
- Independent Claim 1:
- A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole or a pharmaceutically acceptable salt thereof;
- wherein the composition is a solid composition
- and disintegrates within 30 seconds in water at 37° C.
- The complaint does not specify which, if any, dependent claims are asserted, but reserves the right to do so.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Alembic's Generic Asenapine Product," which is the subject of Abbreviated New Drug Application (ANDA) No. 206098 submitted to the FDA (Compl. ¶18).
Functionality and Market Context
- The ANDA seeks approval to market 5 mg and 10 mg asenapine maleate tablets, which are generic versions of Plaintiff's Saphris® product (Compl. ¶17-18). The act of infringement alleged under 35 U.S.C. § 271(e)(2) is the filing of the ANDA itself, which seeks approval for commercial sale prior to the expiration of the ’476 patent (Compl. ¶23). The complaint alleges Alembic seeks approval for indications claimed in the ’476 patent, specifically the treatment of schizophrenia and bipolar disorder (Compl. ¶16, ¶22).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint alleges that the product described in Alembic's ANDA, if approved and marketed, would infringe the ’476 patent. The analysis below is based on these allegations.
'476 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole or a pharmaceutically acceptable salt thereof; | Alembic's ANDA seeks approval for tablets containing "asenapine maleate," which is a pharmaceutically acceptable salt of the claimed active compound. | ¶18 | col. 1:57-65 |
| wherein the composition is a solid composition | Alembic's product is described as "asenapine maleate tablets." | ¶18 | col. 2:55-60 |
| and disintegrates within 30 seconds in water at 37° C. | The complaint alleges that at least one formulation in the ANDA, if approved, would infringe, implying that to be bioequivalent to the rapidly-disintegrating Saphris® product, Alembic's tablet must also meet this disintegration requirement. | ¶21, ¶23 | col. 2:58-61 |
- Identified Points of Contention:
- Technical Questions: A primary factual dispute will be whether the specific formulation detailed in Alembic's confidential ANDA filing actually "disintegrates within 30 seconds in water at 37° C." The complaint does not provide specific test data, basing its allegation on the premise that a bioequivalent generic would necessarily have this characteristic.
- Scope Questions: The interpretation of the disintegration test itself may be a point of contention. The question may arise whether the test must be performed strictly according to the pharmacopeia methods referenced in the patent specification or if other scientifically valid methods could be used to prove or disprove infringement of this limitation.
V. Key Claim Terms for Construction
- The Term: "disintegrates within 30 seconds in water at 37° C."
- Context and Importance: This quantitative functional limitation is the primary feature distinguishing the claimed solid formulation. Infringement will likely depend entirely on whether Alembic's proposed product meets this specific performance metric. Practitioners may focus on this term because it is a dispositive, measurable, and objective criterion for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not specify a particular measurement methodology, only the conditions (time, liquid, temperature). A party could argue that any scientifically reasonable test that measures disintegration under these conditions is sufficient to meet the claim.
- Evidence for a Narrower Interpretation: The specification provides a specific, extrinsic reference for how to measure this property: "as measured according to the procedure described in Remington's Pharmaceutical Sciences, 18th Edition... pp 1640-1641; see also US Pharmacopeia, Chapter <701>" (’476 Patent, col. 2:61-65). A party could argue this language incorporates that specific testing standard into the claim, thereby narrowing its scope to only results obtained via that protocol.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement on the basis that Alembic's product label and instructions will direct physicians and patients to administer the generic product sublingually, thereby causing direct infringement (Compl. ¶25). Contributory infringement is alleged on the grounds that Alembic's product is a material part of the invention, is not a staple article of commerce suitable for substantial noninfringing use, and will be sold with knowledge that it will be used to practice the patented method (Compl. ¶26).
- Willful Infringement: The complaint does not explicitly plead willfulness. However, it alleges that Alembic has "knowledge of the '476 patent" and filed its ANDA seeking to market its product before patent expiration (Compl. ¶24). The prayer for relief requests a declaration that the case is "exceptional" and an award of attorney fees pursuant to 35 U.S.C. § 285, which are remedies often associated with findings of willful infringement or other litigation misconduct (Compl. p.11, ¶h).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case appears to hinge on two central questions:
A core issue will be one of claim construction: how should the phrase "disintegrates within 30 seconds in water at 37° C." be defined? The outcome may depend on whether the court limits the definition to the specific pharmacopeia standard referenced in the specification or allows a broader interpretation.
A key evidentiary question will be one of technical fact: does the formulation described in Alembic's confidential ANDA, when tested according to the properly construed claim, meet the 30-second disintegration limitation? The case will turn on the technical data and expert testimony related to the performance of the accused generic product.