DCT

1:17-cv-01532

Pfizer Inc v. Breckenridge Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01532, D. Del., 10/30/2017
  • Venue Allegations: Venue is alleged to be proper in Delaware based on Plaintiff Pfizer Inc.’s incorporation in the state, causing foreseeable harm there, and Defendant Breckenridge’s alleged history of consenting to jurisdiction in the district in prior litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug Xeljanz® constitutes an act of infringement of four patents covering the active compound and its use.
  • Technical Context: The technology involves small molecule chemical compounds known as Janus kinase (JAK) inhibitors, which are used as immunosuppressants for treating autoimmune diseases like rheumatoid arthritis.
  • Key Procedural History: The litigation was triggered by Defendant Breckenridge Pharmaceutical, Inc.'s filing of ANDA No. 209633 with the U.S. Food and Drug Administration (FDA), which included a "Paragraph IV" certification asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
1999-12-10 Priority Date for ’041, ’208, ’221, and ’783 Patents
2005-10-18 U.S. Patent No. 6,956,041 Issued
2006-08-15 U.S. Patent No. 7,091,208 Issued
2007-09-04 U.S. Patent No. 7,265,221 Issued
2010-09-28 U.S. Patent No. RE41,783 Issued
2017-09-21 Breckenridge Notice Letter Sent to Pfizer
2017-10-30 Complaint Filed

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

U.S. Patent No. 6,956,041 - Pyrrolo[2,3d]pyrimidine Compounds (Issued Oct. 18, 2005)

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective immunosuppressive agents to treat a range of conditions, including organ transplant rejection and autoimmune diseases like rheumatoid arthritis, where T-cell proliferation plays a key role (ʼ041 Patent, col. 1:11-23). The background section identifies the Janus Kinase 3 (JAK3) enzyme, whose expression is limited to hematopoietic cells, as a critical component in the signaling pathways that drive immune responses (ʼ041 Patent, col. 1:23-36).
  • The Patented Solution: The invention provides specific chemical compounds, based on a pyrrolo[2,3-d]pyrimidine core structure, that are designed to inhibit protein kinases, particularly JAK3. By blocking the JAK3 signaling pathway, these compounds are intended to modulate immune activity and provide therapeutic benefit for T-cell proliferative disorders (ʼ041 Patent, Abstract; col. 1:36-43).
  • Technical Importance: The invention provided a targeted therapeutic approach by focusing on JAK3, offering a distinct mechanism for immunosuppression compared to broader-acting agents.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 and dependent claim 4 (Compl. ¶44, ¶48).
  • Independent Claim 1 recites:
    • A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound.
    • The compound is selected from a group of nine specifically enumerated chemical structures.
    • One of the enumerated compounds is 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile (the compound known as tofacitinib).

U.S. Patent No. 7,091,208 - Pyrrolo[2,3d]pyrimidine Compounds (Issued Aug. 15, 2006)

The Invention Explained

  • Problem Addressed: Similar to its parent, the ’208 Patent addresses the need for therapies to treat T-cell proliferative disorders, specifically identifying rheumatoid arthritis as an indication where immunosuppression would be desirable (ʼ208 Patent, col. 1:16-24).
  • The Patented Solution: The patent claims a method of treating rheumatoid arthritis in a mammal by administering an effective amount of a specific pyrrolo[2,3-d]pyrimidine compound. The claimed compound is the same as one of the key compounds disclosed in the ʼ041 Patent (ʼ208 Patent, Abstract; col. 5:58-60).
  • Technical Importance: This patent specifically claims a method of use for a key compound from the family, tying the chemical structure directly to the treatment of a significant autoimmune disease.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶55, ¶59).
  • Independent Claim 1 recites:
    • A method for treating rheumatoid arthritis in a mammal.
    • The method comprises administering to the mammal a therapeutically effective amount of a compound.
    • The compound is specifically identified as 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile (tofacitinib).

Multi-Patent Capsule: U.S. Patent No. 7,265,221

  • Patent Identification: U.S. Patent No. 7265221, Pyrrolo[2,3d]pyrimidine Compounds, issued Sep. 4, 2007 (Compl. ¶32).
  • Technology Synopsis: Continuing the same inventive theme, this patent claims a specific pyrrolo[2,3-d]pyrimidine compound, tofacitinib, in its free base or pharmaceutically acceptable salt form. The invention is directed to the chemical entity itself, which functions as a JAK3 inhibitor for immunosuppressive therapy.
  • Asserted Claims: The complaint asserts at least claim 1 (Compl. ¶66).
  • Accused Features: The proposed Breckenridge Generic Tablets are accused of infringing because they will contain tofacitinib as the active pharmaceutical ingredient (Compl. ¶36).

Multi-Patent Capsule: U.S. Patent No. RE41,783

  • Patent Identification: U.S. Reissue Patent No. RE41,783, Pyrrolo[2,3d]pyrimidine Compounds, issued Sep. 28, 2010 (Compl. ¶33).
  • Technology Synopsis: This patent is a reissue of U.S. Patent No. 6,627,754 and covers pyrrolo[2,3-d]pyrimidine compounds, including tofacitinib. The patent claims the chemical compound itself, which is useful as a JAK3 inhibitor for treating various immune disorders.
  • Asserted Claims: The complaint asserts one or more claims, including at least claim 1 (Compl. ¶72, ¶74).
  • Accused Features: The infringement allegation is based on the active ingredient, tofacitinib, in Defendant's proposed generic product (Compl. ¶36).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Breckenridge Generic Tablets," a proposed generic version of Pfizer's Xeljanz® for which Breckenridge filed ANDA No. 209633 with the FDA (Compl. ¶2, ¶13).
  • Functionality and Market Context:
    • The complaint alleges the Breckenridge Generic Tablets will contain tofacitinib as the active ingredient (Compl. ¶36). Tofacitinib is an inhibitor of Janus kinases (JAKs) (Compl. ¶24).
    • The proposed labeling for the generic product allegedly copies the indication from Pfizer's Xeljanz® label, specifying use for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (Compl. ¶45, ¶56). The product is formulated as an oral tablet (Compl. ¶13).

IV. Analysis of Infringement Allegations

'041 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising a compound... The Breckenridge Generic Tablets are alleged to be a pharmaceutical composition. ¶13 col. 5:66-67
...wherein said compound is... 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile... The Breckenridge Generic Tablets are alleged to contain tofacitinib as the active ingredient, which has this chemical structure. ¶36, ¶25 col. 5:51-53
...and a pharmaceutically acceptable carrier. The proposed product is an oral tablet, which necessarily includes pharmaceutically acceptable carriers. ¶13 col. 5:66-67

'208 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating rheumatoid arthritis in a mammal comprising administering to said mammal a therapeutically effective amount of a compound... The proposed labeling for the Breckenridge Generic Tablets allegedly directs its use for treating rheumatoid arthritis in adult patients. ¶56 col. 1:18-20
...wherein said compound is 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]-piperidin-1-yl}-3-oxo-propionitrile... The active ingredient in the Breckenridge Generic Tablets is alleged to be tofacitinib, which corresponds to the claimed chemical structure. ¶36, ¶25 col. 5:58-60
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges infringement based on the identity of the active pharmaceutical ingredient (API). A potential point of contention, not detailed in the complaint, may be whether the term "compound" in the claims can be construed to be limited to a specific stereoisomer or crystalline form (polymorph), and whether Breckenridge's proposed API falls outside that narrow scope.
    • Technical Questions: Breckenridge’s Paragraph IV notice asserts non-infringement (Compl. ¶35). The complaint does not specify the factual basis for this assertion. A central question is what technical distinction, if any, Breckenridge will argue exists between its tofacitinib product and the chemical entity recited in the claims.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a deep analysis of claim construction disputes. However, in litigation over a specific chemical compound, the definition of that compound is paramount.

  • The Term: "3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile"
  • Context and Importance: This chemical name defines the active ingredient, tofacitinib. The entire infringement analysis for all four patents depends on whether Defendant's API is properly characterized by this name and its corresponding structure. Practitioners may focus on this term because any structural or isomeric difference in the accused product, however subtle, could form the basis of a non-infringement argument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents' claims and specification generally refer to the "compound" without express limitation to a single crystalline form, which may support a construction covering any form of the molecule with the recited chemical structure.
    • Evidence for a Narrower Interpretation: The patents provide a specific example of how to synthesize this compound (e.g., ’041 Patent, Example 14, col. 19:1-7). A defendant might argue that the claims should be limited to the specific form of the compound produced by the disclosed synthesis methods or characterized by the data provided in the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for the method of use claims. Inducement is alleged based on Defendant’s proposed labeling, which allegedly instructs physicians and patients to use the generic tablets to treat rheumatoid arthritis (Compl. ¶48-49, ¶59-60). Contributory infringement is alleged on the basis that the generic tablets are especially made for this infringing use and have no substantial non-infringing use (Compl. ¶50-51, ¶61-62).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Breckenridge had knowledge of each of the patents-in-suit when it submitted its ANDA, establishing pre-suit knowledge (Compl. ¶46, ¶57, ¶67, ¶73). The prayer for relief requests a judgment that the case is "exceptional" under 35 U.S.C. § 285, which is a related but distinct standard for seeking attorneys' fees (Compl., Prayer for Relief ¶E).

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

  • A core issue will be one of patent validity: The case was initiated under the Hatch-Waxman Act framework following Defendant's Paragraph IV certification, which alleges the patents-in-suit are invalid and/or unenforceable. The central conflict will likely revolve around Defendant's prior art-based challenges, such as anticipation or obviousness, the details of which are not contained in the complaint.
  • A key evidentiary question will be one of infringement defense: As Defendant’s non-infringement theory is not specified, a critical question is on what technical grounds it will attempt to distinguish its proposed tofacitinib product from the claimed compound. This could involve nuanced arguments regarding stereochemistry, purity, or polymorphic form that are not evident from the pleadings.