DCT

1:18-cv-01096

OSI Pharma LLC v. Shilpa Medicare Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01096, D. Del., 07/25/2018
  • Venue Allegations: Defendant Shilpa Medicare Limited, through counsel, agreed not to contest personal jurisdiction or venue in the District of Delaware.
  • Core Dispute: Plaintiffs allege that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of the cancer drug Tarceva® constitutes an act of infringement of a patent covering a specific crystalline form of the drug's active ingredient.
  • Technical Context: The case involves pharmaceutical chemistry, specifically the field of polymorphism, where a single chemical compound can exist in multiple crystalline structures with different physical properties, such as stability and solubility.
  • Key Procedural History: The complaint notes that on January 8, 2018, the Patent Trial and Appeal Board (PTAB) found the asserted claims (44-46 and 53) unpatentable in an inter partes review. Plaintiffs state this decision was appealed to the Court of Appeals for the Federal Circuit. An accompanying Inter Partes Review Certificate for the same patent, issued June 4, 2020, indicates that claims 44-46 and 53 were ultimately found to be patentable, suggesting the appeal was successful. This procedural history may significantly impact any invalidity defenses raised by the Defendant.

Case Timeline

Date Event
1999-11-11 ’221 Patent Priority Date
2005-05-31 ’221 Patent Issue Date
2018-01-08 PTAB Final Written Decision finding claims 44-46, 53 unpatentable
2018-05-04 Plaintiff OSI files appeal of PTAB decision to the Federal Circuit
2018-06-13 Shilpa sends Tarceva Notice Letter regarding ANDA No. 211960
2018-06-14 Plaintiffs receive Tarceva Notice Letter
2018-07-25 Complaint Filing Date
2020-06-04 Inter Partes Review Certificate issued finding claims 44-46, 53 patentable

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

  • Patent Identification: U.S. Patent No. 6,900,221, "Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy) -4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof," issued May 31, 2005.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of creating a chemically stable and consistent solid dosage form for the cancer treatment compound erlotinib hydrochloride (’221 Patent, col. 8:26-29). Different physical forms (polymorphs) of a drug can have different properties; a less stable form can degrade or convert over time, affecting drug safety, efficacy, and shelf life, which is a significant issue for oral medications like tablets (’221 Patent, col. 1:56-62).
  • The Patented Solution: The inventors discovered that erlotinib hydrochloride exists in at least two distinct crystalline forms, designated polymorph A and polymorph B (’221 Patent, col. 8:29-32). The invention is the identification and method of producing the "thermodynamically most stable" form, polymorph B, which is more suitable for oral administration in tablets than the less stable polymorph A or a mixture of the two (’221 Patent, Abstract; col. 8:32-40). The patent describes specific X-ray powder diffraction patterns that uniquely identify the stable polymorph B (’221 Patent, FIG. 3).
  • Technical Importance: Identifying a stable polymorph is a critical step in pharmaceutical development, as it ensures product consistency, predictable bioavailability, and compliance with regulatory standards for manufacturing. (’221 Patent, col. 8:15-24).

Key Claims at a Glance

  • The complaint asserts claims 44-46 and 53. (Compl. ¶20). Independent claim 44 is representative.
  • Independent Claim 44:
    • A method for the treatment of specific cancers, including non-small cell lung cancer (NSCLC).
    • The method comprises administering to a mammal a "therapeutically effective amount" of a pharmaceutical composition.
    • The composition comprises at least one of "N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine" or its pharmaceutically acceptable salts.
    • The composition also comprises a carrier.
  • The complaint reserves the right to assert additional claims. (Compl. ¶20).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant Shilpa Medicare’s proposed generic erlotinib hydrochloride tablets in 25 mg, 100 mg, and 150 mg strengths, for which it seeks FDA approval via Abbreviated New Drug Application (ANDA) No. 211960. (Compl. ¶2).

Functionality and Market Context

  • The complaint alleges that Shilpa's ANDA product is a generic version of Plaintiffs’ branded drug, Tarceva®. (Compl. ¶2).
  • By filing the ANDA, Shilpa has represented to the FDA that its product has the same active ingredient, dosage form, and strength as Tarceva®, and that it is bioequivalent. (Compl. ¶14).
  • The complaint alleges that Shilpa seeks approval to market its product for the same medical indications as Tarceva®, which include the treatment of non-small cell lung cancer and pancreatic cancer. (Compl. ¶¶ 11, 15).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or specific factual allegations mapping elements of the accused product to the patent claims. The infringement theory is a statutory one unique to ANDA litigation under the Hatch-Waxman Act, where the filing of an ANDA to market a drug prior to the expiration of a relevant patent is itself an act of infringement (35 U.S.C. § 271(e)(2)). The core allegation is that the product described in Shilpa’s ANDA, if approved and marketed, would infringe the asserted claims. (Compl. ¶¶ 20-22).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Factual Question: The central factual dispute will likely be whether the erlotinib hydrochloride in Shilpa's ANDA product is the specific "polymorph B" form. Although the asserted method claims do not explicitly recite "polymorph B," Plaintiffs may argue that infringement requires the use of this specific form, which they contend is the only stable and effective version of the compound for the claimed methods. This will require discovery into the confidential details of Shilpa's ANDA filing.
    • Scope Questions: A primary legal question will concern the scope of the asserted method claims (e.g., claim 44). Does the term "N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine," when read in light of the patent's specification, implicitly limit the claim to methods using the stable "polymorph B"? Or does the claim’s plain language cover methods using any form of the compound, including the less-stable polymorph A or other forms?

V. Key Claim Terms for Construction

  • The Term: "N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine" (from claim 44)
  • Context and Importance: Practitioners may focus on this term because the entire patent is dedicated to solving a problem related to a specific crystalline form (polymorph B) of this compound. However, the asserted method claim recites the compound without expressly limiting it to polymorph B. The construction of this term—whether it is limited by the specification to a specific polymorph—will likely be dispositive of infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of claim 44 recites the chemical compound and its salts without any explicit limitation to a specific polymorphic form. (’221 Patent, col. 31:40-49). An argument could be made that had the patentee intended to limit the claim to polymorph B, they would have done so explicitly, as they did in other claims (e.g., claim 1).
    • Evidence for a Narrower Interpretation: The patent’s title, abstract, summary of the invention, and detailed description all characterize the invention as the discovery and use of the stable polymorph B. (’221 Patent, Title, Abstract, col. 2:26-47). The specification describes polymorph B as the "thermodynamically most stable and desirable form" and the solution to the problems of instability with prior forms. (’221 Patent, col. 8:32-36). A party could argue that the specification defines the invention as polymorph B, and the claims should be construed consistently with that definition to avoid covering unstable, less effective prior art forms.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Shilpa will induce and contribute to infringement by third parties (e.g., doctors and patients). (Compl. ¶¶ 21, 22). This allegation is based on the premise that Shilpa’s product labeling will instruct users to administer the drug for the treatment of diseases like NSCLC, which is the method recited in the asserted claims. (Compl. ¶¶ 11, 15, 22).
  • Willful Infringement: The complaint does not explicitly allege willfulness. It does, however, request "any appropriate relief under 35 U.S.C. § 285," which pertains to attorney's fees in exceptional cases. (Compl., Prayer for Relief ¶5). The complaint alleges that Shilpa had knowledge of the patent-in-suit at least as of its June 13, 2018 notice letter. (Compl. ¶12).

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

  1. Claim Scope vs. Specification: A central issue will be one of claim construction: are the asserted method claims, which recite the chemical compound generally, implicitly limited by the specification to cover only methods that use the specific, stable "polymorph B" that is the stated focus of the invention? The outcome of this question will define the scope of infringement.
  2. Factual Infringement: A key evidentiary question will be one of technical identity: does the generic drug product described in Shilpa’s confidential ANDA filing in fact contain the erlotinib hydrochloride active ingredient in the crystalline structure of "polymorph B" as characterized in the ’221 patent?
  3. Impact of Prior PTAB Proceedings: While the provided IPR certificate indicates the asserted claims were ultimately upheld, the complex procedural history involving an initial PTAB finding of unpatentability followed by a successful appeal may still inform the parties' strategies regarding validity challenges in this litigation.