DCT

2:17-cv-01010

Sumitomo Dainippon Pharma Co Ltd v. MSN Laboratories Private Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-01010, D.N.J., 02/14/2017
  • Venue Allegations: Venue is asserted based on the New Jersey principal places of business for MSN Pharmaceuticals Inc. and Sandoz Inc., as well as their alleged development, marketing, and sales activities within the state.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic lurasidone hydrochloride constitutes an act of infringement of the patent covering the compound and its use as an antipsychotic agent.
  • Technical Context: The technology involves a specific chemical compound, lurasidone, which is the active pharmaceutical ingredient in the brand-name drug LATUDA®, used for the treatment of schizophrenia and bipolar disorder.
  • Key Procedural History: This Hatch-Waxman litigation was triggered by Defendants' filing of ANDA No. 208037 with a Paragraph IV certification, asserting that U.S. Patent No. 5,532,372 is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of their proposed generic product. The complaint notes that other litigations involving the same patent have been filed against different generic drug manufacturers.

Case Timeline

Date Event
1990-07-06 '372 Patent Priority Date
1996-07-02 '372 Patent Issue Date
2014-10-28 Defendants' ANDA No. 208037 Submitted to FDA
2017-01-03 Defendants' Paragraph IV Notice Letter Sent
2017-01-04 Plaintiffs Receive Paragraph IV Notice Letter
2017-02-14 Complaint Filing Date

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

U.S. Patent No. 5,532,372 - Imide derivatives, and their production and use

  • Patent Identification: U.S. Patent No. 5,532,372, Imide derivatives, and their production and use, issued July 2, 1996.

The Invention Explained

  • Problem Addressed: The patent describes a need for new antipsychotic agents that avoid the severe side effects associated with conventional treatments, such as extrapyramidal motor disturbances (e.g., Parkinsonism) and orthostatic hypotension (’372 Patent, col. 2:1-8).
  • The Patented Solution: The invention provides novel imide compounds that exhibit antipsychotic activity with a more favorable side-effect profile. The key structural innovation is a molecule that links an imide group to a piperazine or piperidine ring through an intervening "non-aromatic hydrocarbon ring," a departure from the straight alkylene chain linkers found in prior art compounds (’372 Patent, col. 2:9-18, col. 2:63-68). This structural configuration is credited with providing the desired pharmacological action while suppressing adverse effects.
  • Technical Importance: The invention sought to provide a new therapeutic option for psychotic disorders that improved patient safety and tolerability, a significant clinical goal at the time (’372 Patent, col. 2:9-12).

Key Claims at a Glance

  • The complaint alleges infringement by a generic version of lurasidone hydrochloride, directly implicating claim 15. The complaint does not limit its allegations to specific claims, preserving the right to assert others.
  • Independent Claim 15: This claim recites "The imide compound of the formula: [structure]" as depicted in claim 14, but specifically as a hydrochloride (HCl) salt. The structure in claim 14, known as lurasidone, is comprised of four key moieties:
    • A bicyclo[2.2.1]heptane-2,3-dicarboximide moiety.
    • A trans-1,2-cyclohexanediyl-bis(methylene) linker.
    • A piperazine ring.
    • A 1,2-benzisothiazolyl moiety.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic drug products described in ANDA No. 208037, specifically "generic lurasidone hydrochloride tablets" in 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg dosages (collectively, the "ANDA Products") (Compl. ¶¶18, 30).

Functionality and Market Context

  • The ANDA Products contain the active pharmaceutical ingredient lurasidone hydrochloride and are intended for the same therapeutic uses as Plaintiffs' brand-name drug, LATUDA®: the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (Compl. ¶¶18, 25).
  • The complaint alleges that Defendants seek FDA approval to commercially manufacture, use, and sell the ANDA Products in the United States before the expiration of the ’372 patent, positioning them as direct generic competitors to LATUDA® (Compl. ¶¶18, 30).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The complaint asserts infringement under 35 U.S.C. § 271(e)(2)(A), where the filing of the ANDA is the statutory act of infringement. The core allegation is that the API in the ANDA Products is identical to the compound claimed in the ’372 patent.
Claim Element (from Independent Claim 14, incorporated by Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
A bicyclo[2.2.1]heptane-2-exo-3-exo-dicarboximide moiety The complaint alleges the ANDA Products contain "generic lurasidone hydrochloride," which includes this specific imide structure with defined stereochemistry. ¶18, ¶30 col. 30:5-10
A trans-1,2-cyclohexanediyl-bis(methylene) linker The lurasidone hydrochloride API in the ANDA Products is alleged to contain this linker connecting the imide and piperazine moieties, including the specific trans stereochemistry. ¶18, ¶30 col. 23:3-8
A piperazine ring The lurasidone hydrochloride API in the ANDA Products is alleged to contain a piperazine ring as the central linking heterocycle. ¶18, ¶30 col. 23:59-65
A 1,2-benzisothiazolyl moiety bonded to the piperazine ring The lurasidone hydrochloride API in the ANDA Products is alleged to contain this aromatic heterocyclic group. ¶18, ¶30 col. 23:59-65
...and its hydrochloride salt (from Claim 15) The complaint explicitly identifies the ANDA Products as "lurasidone hydrochloride tablets," alleging they contain the specific acid addition salt claimed. ¶18, ¶30 col. 47:48-61
  • Identified Points of Contention:
    • Scope Questions: As the ANDA seeks approval for a product intended to be bioequivalent to LATUDA®, the dispute is less likely to be about the chemical structure itself. A potential question, however, could be one of "form:" "Does the term "acid addition salt" in the claims read on the specific solid-state form (e.g., polymorph, solvate, or amorphous form) of lurasidone hydrochloride that Defendants intend to market, and is that form enabled by the patent's disclosure?"
    • Technical Questions: A key technical point in chemical cases is stereochemistry. This raises an evidentiary question: "What evidence will confirm that the API to be manufactured under ANDA No. 208037 possesses the exact stereochemical configuration (e.g., the "trans-" cyclohexane and "exo,exo-" bicycloheptane) required by the compound of claim 14, which is synthesized in the patent through stereospecific examples?" (’372 Patent, col. 30:30-36).

V. Key Claim Terms for Construction

  • The Term: "imide compound"
  • Context and Importance: This term defines the genus of the invention. While claim 15 is a picture claim for a specific species, the scope of the broader independent claims (e.g., claim 1) hinges on this definition. Practitioners may focus on this term if Defendants argue their product contains impurities or is formulated in a way that falls outside the patent's definition of the claimed "compound," or to challenge the patent's validity for lack of enablement or written description across the full scope of the term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a generic structural formula (Formula I) and defines the constituent parts (Z, D, G, Ar) with numerous alternatives, suggesting the term covers a wide class of molecules (’372 Patent, col. 3:5-44).
    • Evidence for a Narrower Interpretation: The patent repeatedly emphasizes that the object of the invention is to provide compounds with antipsychotic effects but suppressed side effects (’372 Patent, col. 2:9-12). A party could argue the term should be implicitly limited to compounds that achieve this stated objective, as demonstrated in the pharmacological testing examples.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval of the ANDA, Defendants will indirectly infringe by inducing and contributing to infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶¶41, 43). The alleged acts of inducement include the product's labeling, which will instruct medical professionals and patients to use the generic drug for the patented indications (Compl. ¶25).
  • Willful Infringement: The complaint alleges that Defendants were aware of the ’372 patent on or about the date they submitted their ANDA (October 28, 2014) (Compl. ¶¶32, 33). While not using the word "willful," the prayer for relief requests a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which preserves the issue of enhanced damages for post-suit conduct (Compl., Prayer E).

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

  • A central issue in this ANDA litigation, prompted by the Defendants' Paragraph IV certification, will be one of patent validity. The case will likely focus on whether the Defendants can prove by clear and convincing evidence that the asserted claims of the ’372 patent are invalid, for instance, on grounds of obviousness in light of prior art antipsychotic compounds.
  • The primary infringement question will be one of structural identity. The key evidentiary burden will be to demonstrate that the lurasidone hydrochloride API set forth in ANDA No. 208037 is identical to the chemical structure claimed in claim 15 of the ’372 patent, including its specific stereochemistry, which the patent teaches is achieved through a specific synthetic pathway.