DCT
1:17-cv-01868
OSI Pharma LLC v. Accord Healthcare Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: OSI Pharmaceuticals, LLC (Delaware) and Genentech, Inc. (Delaware)
- Defendant: Accord Healthcare Inc., USA (North Carolina)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:17-cv-01868, D. Del., 12/28/2017
- Venue Allegations: Venue is based on the Defendant's agreement, communicated via counsel, not to contest 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 methods of using the drug to treat certain cancers.
- Technical Context: The technology concerns the use of erlotinib, a specific chemical compound that acts as a kinase inhibitor, for the treatment of hyperproliferative disorders such as non-small cell lung cancer.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant’s ANDA filing. The complaint was filed within the 45-day window following receipt of the Defendant's notice letter, triggering a 30-month statutory stay of FDA approval for the generic product. Notably, the specific claims asserted in this litigation (claims 44-46 and 53) were the subject of a subsequent inter partes review (IPR) proceeding, IPR2016-01284, which concluded with a finding that all challenged claims were patentable. This post-grant review outcome may significantly inform the validity analysis in this case.
Case Timeline
| Date | Event |
|---|---|
| 1999-11-11 | ’221 Patent Priority Date |
| 2005-05-31 | ’221 Patent Issue Date |
| 2017-11-17 | Accord sends "Tarceva Notice Letter" regarding ANDA filing |
| 2017-11-20 | Date by which Plaintiffs received Accord's Notice Letter |
| 2017-12-05 | Accord agrees via email not to contest jurisdiction or venue |
| 2017-12-28 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
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"
The Invention Explained
- Problem Addressed: The patent explains that the previously known hydrochloride salt of the active compound, erlotinib, existed as a mixture of different crystalline structures (polymorphs) ('221 Patent, col. 8:43-48). This mixture possessed "partially reduced stability," which made it less than ideal for formulation into solid oral dosage forms, such as tablets, where consistency and stability are critical ('221 Patent, col. 8:45-48).
- The Patented Solution: The invention identifies a specific, "thermodynamically most stable" crystalline form of the hydrochloride salt, designated "polymorph B," and methods for producing it in a "substantially pure" state ('221 Patent, col. 8:34-40). This stable polymorph B is described as being more suitable for tablet and oral administration than the previously known mixture ('221 Patent, col. 1:58-61; col. 8:15-18).
- Technical Importance: The development of a stable, pure polymorph was a key step in creating a reliable and effective solid oral dosage form for erlotinib, a significant targeted cancer therapy ('221 Patent, col. 1:19-25).
Key Claims at a Glance
- The complaint asserts independent claims 44 and 53.
- Independent Claim 44 recites a method with the following essential elements:
- A method for the treatment of a specified list of conditions (including non-small cell lung cancer, pediatric malignancies, and others) in a mammal;
- Comprising the administration of a therapeutically effective amount of a pharmaceutical composition;
- Wherein the composition contains at least one of "N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine" or its pharmaceutically acceptable salts;
- And a carrier.
- Independent Claim 53 recites: "The method of claim 44 for the treatment of non-small cell lung cancer (NSCLC)."
- The complaint reserves the right to assert dependent claims 45 and 46 ('Compl. ¶19).
III. The Accused Instrumentality
Product Identification
- Defendant Accord's generic erlotinib hydrochloride tablets (25, 100, and 150 mg), for which it seeks FDA approval via ANDA No. 211083 (Compl. ¶2).
Functionality and Market Context
- The complaint alleges that Accord's ANDA product is a generic version of Plaintiffs' Tarceva® drug product (Compl. ¶2). It is alleged to contain the same active ingredient, have the same dosage form and strength, be bioequivalent to Tarceva, and be intended for the same approved medical indications, which include the treatment of non-small cell lung cancer (NSCLC) (Compl. ¶¶10, 13, 14). The infringement alleged is a "technical" act under the Hatch-Waxman Act, based on the filing of the ANDA itself for a patented use (Compl. ¶19).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not contain a formal claim chart. The infringement theory is based on 35 U.S.C. § 271(e)(2)(A), where the submission of an ANDA to obtain approval for a use claimed in a patent is an act of infringement. The core allegations are summarized below in a chart format for clarity.
’221 Patent Infringement Allegations
| Claim Element (from Independent Claim 44) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for the treatment of NSCLC (non small cell lung cancer)...in a mammal | Accord's submission of ANDA No. 211083 seeks approval to market its generic product for the same indications as Tarceva®, which include the treatment of NSCLC. | ¶10, ¶14 | col. 35:25-27 |
| comprising administering... a pharmaceutical composition comprised of at least one of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, or pharmaceutically acceptable salts thereof... and a carrier | Accord has represented to the FDA that its ANDA product contains the same active ingredient as Tarceva®, which is erlotinib hydrochloride, the salt form of the claimed compound. | ¶13 | col. 35:34-39 |
| a therapeutically effective amount | Accord seeks to market its product in 25 mg, 100 mg, and 150 mg dosage strengths, which correspond to the dosage strengths of the approved Tarceva® product. | ¶2, ¶13 | col. 4:31-38 |
- Identified Points of Contention:
- Scope Questions: The primary question for the court will be whether the proposed label for Accord's generic product will induce infringement of the asserted method claims. The analysis will focus on whether the indications for use described in Accord's ANDA fall within the scope of the methods recited in claims 44 and 53.
- Technical Questions: While the ’221 patent specification places significant emphasis on the novelty of the stable "polymorph B," the asserted method claims are drafted more broadly to cover the active compound or its salts, without limitation to a specific polymorphic form. This raises the question of whether the specific crystalline form of the active ingredient in Accord's product is relevant to the infringement analysis of these particular method claims.
V. Key Claim Terms for Construction
The Term: "N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, or pharmaceutically acceptable salts thereof in anhydrous or hydrate forms"
Context and Importance: Practitioners may focus on this term because the patent’s inventive contribution is described as the isolation of the stable "polymorph B," yet the asserted claims are drafted broadly to cover the chemical compound or its salts generally. The construction of this term will determine whether the claims are limited to the specific polymorph B or cover any form of the active ingredient, which would make infringement easier to establish.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of claim 44 itself, reciting the compound "or pharmaceutically acceptable salts thereof in anhydrous or hydrate forms," does not contain any explicit limitation to a single polymorphic form (col. 35:36-38).
- Evidence for a Narrower Interpretation: A party might argue that the claims should be interpreted in light of the specification's repeated emphasis on the discovery and advantages of the stable "polymorph B" as the core of the invention, suggesting the claim scope should be implicitly limited to that form (Abstract; '221 Patent, col. 8:31-40).
The Term: "therapeutically effective amount"
Context and Importance: This term is central to any method of treatment claim. The dispute will be whether the dosage strengths proposed in Accord's ANDA (25, 100, and 150 mg) meet the definition of a "therapeutically effective amount" for treating the claimed diseases, such as NSCLC.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses wide dosage ranges, such as "about 0.001 to about 100 mg per kg body weight per day" (col. 24:25-27).
- Evidence for a Narrower Interpretation: The specification also provides more specific and preferred dosage ranges, such as "most preferably 5-200 mg/day" (col. 16:36-37). Furthermore, clinical data described in the patent centers on a 150 mg daily dose, which corresponds to one of the dosage strengths of the accused product (col. 29:60-64).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Accord’s commercialization of its ANDA product would induce infringement by others (Compl. ¶¶20, 21). The factual basis for this allegation is that Accord's product label will instruct physicians and patients to administer the drug for the treatment of patented indications like NSCLC, thereby causing direct infringement by end-users.
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it alleges that Accord provided Plaintiffs with a notice letter on November 17, 2017, which establishes pre-suit knowledge of the ’221 patent (Compl. ¶11).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of induced infringement: Does Accord's ANDA, by seeking approval to market a generic drug for the same indications as Tarceva®, contain a proposed product label that would inevitably instruct medical professionals and patients to perform the patented methods of treatment for NSCLC and other cancers?
- A key legal question will be the impact of the prior IPR decision: How will the finding that the asserted method claims are patentable influence the court's analysis of Accord's invalidity defenses? While not binding, the successful defense of the claims in a post-grant proceeding may present a significant hurdle for the defendant.
- A final question relates to claim scope: Can the asserted method claims, which are drafted broadly to cover the erlotinib compound and its salts, be infringed by Accord's product regardless of its specific crystalline (polymorphic) form, or could the claims be narrowed by the specification's focus on the novel "polymorph B"?