DCT

1:10-cv-00528

Pfizer Inc v. Mylan Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:10-cv-00528, D. Del., 12/09/2011
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Mylan purposefully avails itself of the district by systematically placing goods into the stream of commerce in Delaware, has previously consented to jurisdiction in the district for other patent cases, and maintains a registered agent for service of process in the state.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the cancer drug SUTENT® constitutes an act of infringement of three patents covering the drug's active ingredient and methods of its use.
  • Technical Context: The technology involves small-molecule protein kinase inhibitors, a class of targeted therapy drugs used to treat various cancers by disrupting specific cell signaling pathways that drive tumor growth.
  • Key Procedural History: This action was triggered by Defendant’s May 6, 2010 notice letter, which informed Plaintiff of its ANDA submission containing a Paragraph IV certification. This certification asserts that the patents-in-suit, which are listed in the FDA’s "Orange Book" for SUTENT®, are invalid or will not be infringed by the proposed generic product.

Case Timeline

Date Event
1999-12-22 Earliest Priority Date for ’600 Patent
2000-02-15 Earliest Priority Date for ’293 & ’905 Patents
2003-06-03 ’293 Patent Issue Date
2006-10-24 ’905 Patent Issue Date
2007-05-01 ’600 Patent Issue Date
2010-05-06 Defendant Sends Paragraph IV Notice Letter
2011-12-09 Complaint Filing Date

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

U.S. Patent No. 6,573,293 - "Pyrrole Substituted 2-Indolinone Protein Kinase Inhibitors" (Issued June 3, 2003)

The Invention Explained

  • Problem Addressed: The patent identifies that abnormal activity of protein kinases (PKs) is implicated in a host of diseases, including cancer, caused by disorders in cellular growth, differentiation, and proliferation (’293 Patent, col. 1:21-34). The goal was to develop compounds that could modulate this abnormal PK activity.
  • The Patented Solution: The invention provides a class of chemical compounds, defined as 3-pyrrole substituted 2-indolinones, which are designed to inhibit protein kinase activity (’293 Patent, Abstract). These compounds are believed to function by binding to the catalytic region of protein kinases where ATP normally binds, thereby interfering with the signaling cascade that leads to cell proliferation (’293 Patent, col. 164:50-67).
  • Technical Importance: The invention describes a novel chemical scaffold for creating targeted therapies that can selectively inhibit specific protein kinases, representing a significant approach in the development of modern oncology drugs beyond traditional chemotherapy (’293 Patent, col. 2:5-9).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims (Compl. ¶39). The broadest asserted claim is likely independent Claim 1, which defines a large genus of chemical compounds.
  • Claim 1 recites a compound of Formula (I), which is a "3-pyrrole substituted 2-indolinone" core structure with a wide range of possible substituent groups (R¹, R², R³, R⁴, R⁵) defined in a Markush format.
  • The complaint’s broad allegation of infringing "one or more claims" implicitly reserves the right to assert narrower dependent claims that further define the substituent groups.

U.S. Patent No. 7,125,905 - "Pyrrole Substituted 2-Indolinone Protein Kinase Inhibitors" (Issued October 24, 2006)

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’293 patent, this patent addresses the same general problem of developing treatments for disorders related to abnormal protein kinase activity (’905 Patent, col. 1:19-35).
  • The Patented Solution: The invention claims a specific, pharmaceutically acceptable salt form of one of the compounds covered by the broader genus of the ’293 patent (’905 Patent, Abstract; col. 200:1-2). This strategy is often used to secure patent protection on the particular form of a compound that is ultimately developed into a commercial drug product.
  • Technical Importance: Selecting an optimal salt form is a critical step in pharmaceutical development, as it can significantly affect a drug's stability, shelf-life, and bioavailability, which are crucial for creating a safe and effective commercial product (’905 Patent, col. 14:48-58).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims (Compl. ¶51). The key asserted claim is independent Claim 1.
  • Claim 1 recites two essential elements:
    • A specific compound: 5-[5-fluoro-2-oxo-1,2-dihydroindol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide (the active ingredient known as sunitinib).
    • A specific salt form: the L-malate salt of that compound.

U.S. Patent No. 7,211,600 - "Methods of Modulating C-KIT Tyrosine Protein Kinase Function With Indolinone Compounds" (Issued May 1, 2007)

  • Technology Synopsis: This patent addresses the problem of diseases characterized by the overactivity or inappropriate activity of a specific receptor tyrosine kinase known as c-kit (’600 Patent, Abstract). It claims methods of treating such disorders by administering an effective amount of an indolinone compound, such as sunitinib, to a patient. The patent specifically identifies gastrointestinal stromal tumors (GISTs) and mastocytosis as treatable conditions (’600 Patent, col. 32:1-11).
  • Asserted Claims: The complaint alleges infringement of "one or more claims," which are method-of-use claims (Compl. ¶66). Independent Claim 1, for example, is a method for treating an abnormal condition associated with c-kit kinase by administering a specific indolinone compound.
  • Accused Features: The complaint alleges that Mylan, by seeking approval for a generic version of SUTENT®, will induce doctors and patients to use its product to treat GIST, thereby infringing the patented method (Compl. ¶66, ¶68).

III. The Accused Instrumentality

Product Identification

  • Mylan’s ANDA Product, identified as "Sunitinib Malate Capsules" in 12.5 mg, 25 mg, 37.5 mg, and 50 mg dosage strengths, which is a proposed generic version of Pfizer’s SUTENT® (Compl. ¶35).

Functionality and Market Context

  • The accused product is a generic equivalent of SUTENT®, a "breakthrough cancer treatment product" with annual sales of approximately $1 billion (Compl. ¶1, ¶26). SUTENT® is FDA-approved for treating gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (Compl. ¶24). The complaint alleges that Mylan's business strategy is to challenge patents on high-revenue branded drugs to "capture the entire brand market" (Compl. ¶28). The statutory act of infringement alleged is the submission of the ANDA itself to seek FDA approval prior to patent expiry (Compl. ¶42, ¶54, ¶65).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’293 Patent Infringement Allegations

The complaint does not provide a claim chart. The following table summarizes the infringement theory for the active pharmaceutical ingredient.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of Formula (I) ... wherein [substituents are defined] The active ingredient in Mylan's ANDA Product is sunitinib, which is a specific chemical compound alleged to fall within the genus of compounds described by Formula (I). ¶35, ¶39 col. 247:5-55

’905 Patent Infringement Allegations

The complaint does not provide a claim chart. The following table summarizes the infringement theory for the specific salt form.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound that is the L-malate salt of 5-[5-fluoro-2-oxo-1,2-dihydroindol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide... Mylan's ANDA No. 201275 explicitly seeks approval for "Sunitinib Malate Capsules." The name of the product directly corresponds to the claimed L-malate salt of the specific sunitinib compound. ¶35, ¶51 col. 199:30-200:2

Identified Points of Contention

  • Validity vs. Infringement: For the '293 and '905 patents, the infringement appears to be literal, as Mylan's ANDA product is identified as "Sunitinib Malate" (Compl. ¶35). Mylan's Paragraph IV certification asserts non-infringement or invalidity (Compl. ¶36). Given the direct structural overlap, the central dispute will almost certainly concern the validity of the patents (e.g., arguments of obviousness or lack of written description), rather than non-infringement.
  • Method of Use and "Skinny Labeling": For the '600 patent, the key dispute concerns induced infringement. Mylan asserts its label "will not include any indications related to the treatment of gastrointestinal stromal tumors" (Compl. ¶68). This raises the question of whether a generic manufacturer can avoid infringement of a method-of-use patent by omitting the patented indication from its label (a "skinny label"), even if the drug is known to be used for that purpose. Pfizer contends that other parts of the label will nevertheless "encourage, suggest, teach, and/or induce" the infringing use (Compl. ¶68).

V. Key Claim Terms for Construction

For the '905 Patent

  • The Term: "L-malate salt"
  • Context and Importance: This term defines the specific form of the drug product. While Mylan's ANDA identifies its product as "Sunitinib Malate" (Compl. ¶35), any ambiguity in the product's actual composition (e.g., whether it is purely the L-isomer or a racemic mixture of malate) could be a basis for a non-infringement argument. The specificity of this term is central to the scope of Claim 1.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a general definition of "pharmaceutically acceptable salt" as being formed by reacting the free base with an acid, listing numerous potential acids including malic acid (’905 Patent, col. 14:48-col. 15:16). A party could argue this context suggests "malate" should not be interpreted with hyper-technical rigidity.
    • Evidence for a Narrower Interpretation: Claim 1 explicitly recites the "L-malate salt," not just "malate salt." The specific claiming of a single stereoisomer (L-malate) strongly suggests that other forms, such as the D-malate salt or a racemic mixture, were intentionally excluded from the claim scope.

For the '600 Patent

  • The Term: "treat gastrointestinal stromal tumor"
  • Context and Importance: This method-of-use language is the core of the asserted claims. Mylan’s defense hinges on carving this "indication" out of its proposed label (Compl. ¶68). Practitioners may focus on this term because its construction will determine whether infringement requires an explicit FDA-approved indication on the label, or if it can be established through evidence that the label otherwise encourages or enables such treatment.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines "treating" very broadly to include any therapeutic effect, such as alleviating or abrogating an abnormal condition or its symptoms (’600 Patent, col. 4:28-34). This definition is not tied to an FDA-approved label and could support an argument that infringement occurs if the label provides information that would lead a physician to use the drug for GIST, regardless of the formal "indications" section.
    • Evidence for a Narrower Interpretation: A party could argue that in the context of FDA-regulated pharmaceuticals, the term "treat" a specific disease implies use in accordance with a formal, approved indication. The specification itself discusses the invention in the context of providing therapeutics for specific diseases, including GISTs (’600 Patent, col. 32:9-11), which a party could argue links the term to its formal regulatory meaning.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement for all three patents. The basis is that Mylan's proposed labeling and other corporate documents will direct and encourage physicians and patients to use the ANDA product in an infringing manner (Compl. ¶44, ¶56, ¶68). The complaint also alleges the product is not suitable for substantial non-infringing uses, forming the basis for contributory infringement (Compl. ¶45, ¶57, ¶70).
  • Willful Infringement: Willfulness is alleged based on Mylan having knowledge of the patents-in-suit at the time it filed its ANDA (Compl. ¶40, ¶52, ¶64) and allegedly acting "without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶48, ¶60, ¶73). Pfizer seeks a finding that the case is "exceptional" under 35 U.S.C. § 285, which could permit recovery of attorneys' fees (Compl. ¶(e)).

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

  • A central issue will be one of validity: Since Mylan's proposed generic product appears to be a direct copy of the chemical composition claimed in the '293 and '905 patents, the case for those patents will likely focus not on infringement, but on whether Mylan can prove by clear and convincing evidence that the asserted claims are invalid over the prior art.
  • A key legal question will be one of induced infringement via a "skinny label": For the '600 method patent, the core dispute will be whether Pfizer can show that Mylan's label, even without an explicit indication for GIST, will inevitably and intentionally cause physicians to prescribe the generic for that patented use. This will test the limits of the skinny label defense in ANDA litigation.
  • An overarching evidentiary question will concern Mylan's intent: The allegations of inducement and willfulness depend on proving Mylan's state of mind. The extent to which Pfizer can uncover evidence that Mylan intended to capture the entire SUTENT® market, including for the patented GIST indication, will be critical to these claims.