DCT

1:19-cv-00748

Pfizer Inc v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00748, D. Del., 04/25/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation subject to personal jurisdiction in the district. Venue is alleged as to the foreign defendants based on their subjection to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for generic versions of Plaintiff's IBRANCE® (Palbociclib) capsules constitutes an act of infringement of three U.S. patents related to the Palbociclib compound and its method of use for treating breast cancer.
  • Technical Context: The technology concerns Palbociclib, a small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins involved in cell proliferation, developed for the treatment of certain types of advanced or metastatic breast cancer.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following a March 26, 2019 notice letter from Aurobindo to Pfizer, informing Pfizer of Aurobindo's ANDA submission (No. 213086). In its notice, Aurobindo allegedly did not contest that its product would infringe the patents-in-suit but instead asserted that the patents are invalid and/or unenforceable.

Case Timeline

Date Event
2002-01-22 Earliest Priority Date for ’612, ’489, and '168 Patents
2005-08-30 U.S. Patent No. 6,936,612 Issues
2007-04-24 U.S. Patent No. 7,208,489 Issues
2008-11-25 U.S. Patent No. 7,456,168 Issues
2019-03-26 Aurobindo sends ANDA Notice Letter to Pfizer
2019-04-25 Complaint Filed

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

U.S. Patent No. 6,936,612 - 2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3-D] PYRIMIDIN-7-ONES

  • Issued: August 30, 2005 (’612 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the role of cyclin-dependent kinases (Cdks) in regulating the cell cycle and proliferation (Compl. ¶28; '612 Patent, col. 1:13-20). It notes that increased or abnormal Cdk activity is commonly associated with the development of human tumors, creating a need for potent and selective Cdk inhibitors to treat cell proliferative diseases like cancer ('612 Patent, col. 1:28-41).
  • The Patented Solution: The invention provides a class of substituted 2-aminopyridine compounds that are potent inhibitors of Cdk4, a key regulator of cell division ('612 Patent, Abstract). The patent discloses specific chemical structures, including the compound that would become known as Palbociclib, and describes their utility in treating disorders characterized by abnormal cell proliferation ('612 Patent, col. 2:32-34; col. 10:36-39).
  • Technical Importance: This technology provided a specific chemical entity that selectively inhibits Cdk4, offering a targeted therapeutic approach for cancers driven by aberrant cell cycle progression ('612 Patent, col. 2:1-4).

Key Claims at a Glance

  • The complaint asserts claims 1 and 2 (Compl. ¶37). Claim 1 is an independent claim.
  • Essential Elements of Independent Claim 1:
    • A compound which is specifically named as: 6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-one.

U.S. Patent No. 7,208,489 - 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones

  • Issued: April 24, 2007 (’489 Patent)

The Invention Explained

  • Problem Addressed: Similar to the ’612 Patent, this patent addresses the need for therapeutic agents that can inhibit cyclin-dependent kinases to control abnormal cell proliferation associated with diseases like cancer and inflammation (’489 Patent, col. 1:21-46).
  • The Patented Solution: The invention claims a genus of substituted 2-aminopyridine compounds, defined by a general chemical structure (Formula I), that are potent inhibitors of Cdk4 (’489 Patent, Abstract). This genus of compounds encompasses the specific compound claimed in the ’612 Patent, providing broader protection for the chemical scaffold and its variations (’489 Patent, col. 2:47-64).
  • Technical Importance: The patent claims a broader family of Cdk4-inhibiting compounds, providing a wider scope of intellectual property protection around the core chemical structure effective for treating cell proliferative disorders (’489 Patent, col. 2:7-10).

Key Claims at a Glance

  • The complaint asserts claims 1–7 and 9 (Compl. ¶76). Claim 1 is an independent claim.
  • Essential Elements of Independent Claim 1:
    • A compound of Formula I having a 2-(pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-one core structure.
    • Wherein various positions on the core structure and the pyridine ring are substituted with specified chemical groups (R¹, R², R³, R⁴, X¹, X², X³).

U.S. Patent No. 7,456,168 - 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones

  • Issued: November 25, 2008 (’168 Patent)

  • Technology Synopsis: This patent claims methods of using the compounds disclosed in the earlier patents, which act as Cdk4 inhibitors. The claims are directed specifically to a method of treating breast cancer in a mammal by administering a therapeutically effective amount of these compounds (Compl. ¶111).

  • Asserted Claims: Claims 1-4 are asserted (Compl. ¶115).

  • Accused Features: The accused feature is the future use of Aurobindo's ANDA Product for the treatment of breast cancer, which the complaint alleges will be induced by Aurobindo's proposed product labeling (Compl. ¶119, ¶121).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Aurobindo's ANDA Product," identified as generic Palbociclib capsules (75 mg, 100 mg, and 125 mg) for which Aurobindo seeks FDA approval via ANDA No. 213086 (Compl. ¶2).

Functionality and Market Context

The complaint alleges that Aurobindo's ANDA Product contains the same active pharmaceutical ingredient as Pfizer's IBRANCE® product, which is the compound claimed in the ’612 Patent (Compl. ¶32, ¶37). The product is intended for commercial manufacture, use, and sale in the United States as a generic alternative to IBRANCE® for, among other things, the treatment of breast cancer, upon receiving FDA approval (Compl. ¶2, ¶111). The act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶39, ¶78, ¶116).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’612 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[A] compound which is 6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-one. Aurobindo’s ANDA Product is alleged to be a pharmaceutical composition containing this exact chemical compound, Palbociclib. ¶37, ¶56 col. 41:52-56

’489 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of formula I... having a 2-(pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-one core The compound in Aurobindo's ANDA Product, Palbociclib, is alleged to fall within the genus of compounds described by Formula I, as it possesses the specified core structure and the required substituents as defined in the claim. ¶76, ¶94 col. 41:43-61

Identified Points of Contention

  • Factual Question: The complaint alleges that Aurobindo's notice letter did not contest infringement on grounds other than invalidity (Compl. ¶38, ¶77). This suggests the primary infringement question is a factual one: does Aurobindo's ANDA Product contain the specific compound Palbociclib, which falls within the scope of the asserted claims? Under the framework of an ANDA litigation, this is often stipulated or not heavily contested if the ANDA is for a bioequivalent product.
  • Scope Questions: While not raised in the complaint, future disputes could question whether the specific salt form or polymorph of Palbociclib in Aurobindo’s product is encompassed by the scope of the asserted claims. The complaint does not provide sufficient detail for analysis of this possibility.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of claim construction. The central allegation is that the accused product is a generic version of the specific compound claimed in the ’612 Patent, and the notice letter allegedly focused on invalidity rather than non-infringement, suggesting claim construction may not be a primary area of dispute (Compl. ¶38, ¶77).

VI. Other Allegations

Indirect Infringement

The complaint alleges that Aurobindo will actively induce infringement of all three patents upon ANDA approval (Compl. ¶43, ¶82, ¶120). The basis for this allegation is that Aurobindo's proposed product labeling will direct and instruct medical providers and patients to use the generic product in an infringing manner, specifically for the treatment of breast cancer as claimed in the ’168 Patent (Compl. ¶42, ¶81, ¶119).

Willful Infringement

The complaint alleges that Aurobindo has acted with "full knowledge" of the patents-in-suit and "without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶47, ¶86, ¶124). This allegation is based on Aurobindo's pre-suit knowledge gained through the ANDA certification process required by the Hatch-Waxman Act, which necessitates identifying patents listed in the FDA's Orange Book for the branded drug (Compl. ¶36, ¶75, ¶114).

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

  • A central issue will be one of patent validity: as the complaint alleges infringement was not contested on other grounds, the case will likely focus on whether Aurobindo can prove by clear and convincing evidence that the asserted claims of the patents covering the Palbociclib compound and its method of use are invalid for reasons such as anticipation, obviousness, or lack of enablement.
  • A key question for the method-of-use ’168 Patent will be one of induced infringement: assuming the patent is valid, will the contents of Aurobindo’s proposed product labeling be sufficient to establish the specific intent required to encourage or instruct physicians and patients to use the generic drug for the patented method of treating breast cancer?
  • An underlying evidentiary question is one of chemical identity: what are the precise chemical and physical properties (e.g., salt form, crystalline structure) of the active pharmaceutical ingredient in Aurobindo's ANDA product, and how do those properties map to the scope of the asserted patent claims?