DCT

1:19-cv-00097

Pfizer Inc v. Mylan Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00097, N.D.W. Va., 04/29/2019
  • Venue Allegations: Venue is based on Defendant Mylan Pharmaceuticals Inc. being a corporation organized under the laws of West Virginia with a principal place of business in Morgantown, West Virginia.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of IBRANCE® (Palbociclib) capsules constitutes an act of infringement of three patents related to the Palbociclib compound, compositions, and methods of use.
  • Technical Context: The dispute is in the field of pharmaceutical chemistry and oncology, concerning patents for a cyclin-dependent kinase (CDK) inhibitor used as a cancer therapy.
  • Key Procedural History: This litigation was initiated under the Hatch-Waxman Act following Mylan’s notification to Pfizer, via a letter dated March 18, 2019, of its ANDA filing. Mylan’s ANDA included a Paragraph IV certification, asserting that Pfizer's patents are invalid, unenforceable, and/or will not be infringed by Mylan's generic product.

Case Timeline

Date Event
2002-01-22 Priority Date for ’612, ’489, and ’168 Patents
2005-08-30 U.S. Patent No. 6,936,612 Issued
2007-04-24 U.S. Patent No. 7,208,489 Issued
2008-11-25 U.S. Patent No. 7,456,168 Issued
2019-03-18 Mylan sends Notice Letter to Pfizer regarding ANDA filing
2019-04-29 Complaint Filed

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

U.S. Patent No. 6,936,612

  • Patent Identification: U.S. Patent No. 6,936,612, entitled “2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3-D] PYRIMIDIN-7-ONES,” issued August 30, 2005.

The Invention Explained

  • Problem Addressed: The patent addresses the role of abnormally activated cyclin-dependent kinases (Cdks) in the development of human tumors and other cell proliferative diseases ('612 Patent, col. 1:29-41). It notes the historical difficulty in developing Cdk inhibitors that are selective for specific Cdk proteins, a key factor in creating effective therapies with manageable side effects ('612 Patent, col. 2:18-28).
  • The Patented Solution: The invention provides substituted 2-aminopyridine compounds that are potent and selective inhibitors of Cdk4, which are useful for treating disorders related to uncontrolled cell proliferation, such as cancer ('612 Patent, Abstract; col. 2:3-11). The patent discloses a class of compounds built around a 2-(pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-one core structure ('612 Patent, col. 2:34-47).
  • Technical Importance: The invention provided a specific chemical compound, Palbociclib, which demonstrated high selectivity for Cdk4, addressing a need for targeted cancer therapies that could inhibit cell cycle progression in tumors while reducing the side effects associated with less selective cytotoxic agents ('612 Patent, col. 2:11-18).

Key Claims at a Glance

  • The complaint asserts claims 1 and 2 (Compl. ¶26).
  • Independent Claim 1:
    • 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.
  • Claim 2 is dependent on claim 1 and recites a pharmaceutical composition containing the compound of claim 1 and a pharmaceutical carrier.

U.S. Patent No. 7,208,489

  • Patent Identification: U.S. Patent No. 7,208,489, entitled “2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones,” issued April 24, 2007.

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’612 Patent, the ’489 Patent addresses the same technical problem of uncontrolled cell proliferation linked to abnormal Cdk activity ('489 Patent, col. 1:12-44).
  • The Patented Solution: The patent claims a broader genus of 2-aminopyridine compounds, defined by a Markush structure (Formula I), which act as selective Cdk4 inhibitors ('489 Patent, col. 2:35-51). This genus encompasses the specific compound claimed in the ’612 Patent as well as related chemical structures.
  • Technical Importance: By claiming a chemical genus, the patent provides broader protection for the core inventive concept, potentially covering variations and modifications of the specific Palbociclib compound.

Key Claims at a Glance

  • The complaint asserts claims 1-7 and 9 (Compl. ¶65).
  • Independent Claim 1:
    • A compound of the formula: [Formula I depicted in the patent]
    • wherein the dashed line represents an optional bond;
    • X¹, X², and X³ are independently selected from a list of chemical groups, with the proviso that at least one is hydrogen;
    • R¹, R², R³, and R⁴ are variables representing different chemical groups or atoms that can be substituted at various positions on the core molecular structure.
  • The complaint directly asserts dependent claims 2-7 and 9.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 7,456,168, entitled “2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones,” issued November 25, 2008.
  • Technology Synopsis: The ’168 patent claims a method of treating breast cancer in a mammal. The claimed method comprises administering a compound of a specified formula, which includes Palbociclib (Compl. ¶100).
  • Asserted Claims: Claims 1-4 are asserted (Compl. ¶104). Independent claim 1 recites "[a] method of treating breast cancer in a mammal comprising administering to said mammal an amount of a compound of" the claimed formula (Compl. ¶100).
  • Accused Features: The complaint alleges that Mylan's proposed product labeling for its generic Palbociclib product will direct its use for treating breast cancer, thereby inducing infringement of the claimed method (Compl. ¶108, ¶118).

III. The Accused Instrumentality

  • Product Identification: Mylan’s ANDA Product, which are generic Palbociclib capsules in 75 mg, 100 mg, and 125 mg dosages, intended for commercial manufacture, use, and sale upon FDA approval (Compl. ¶1, ¶2).
  • Functionality and Market Context: The accused instrumentality is a generic version of Pfizer’s branded drug IBRANCE® (Palbociclib) (Compl. ¶1). The filing of ANDA No. 213141 with the FDA, seeking approval to market this generic product prior to the expiration of the patents-in-suit, is the statutorily defined act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶2, ¶28). The complaint alleges that upon approval, Mylan will market the product for uses covered by the patents, including for the treatment of breast cancer (Compl. ¶100, ¶108).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Mylan's notice letter did not contest infringement of the asserted claims of the ’612 and ’489 patents on any basis other than alleged invalidity (Compl. ¶27, ¶66). The infringement analysis for a generic drug under the Hatch-Waxman Act is often straightforward, as the generic product must have the same active ingredient as the branded drug it references.

'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. Mylan’s ANDA Product is a generic version of IBRANCE® (Palbociclib) and contains the active pharmaceutical ingredient Palbociclib, which is this specific compound. ¶21, ¶26 col. 43:6-44:14

'489 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of the formula: [Formula I] Mylan's ANDA Product contains Palbociclib, which the complaint alleges is a compound falling within the scope of the chemical genus defined by Formula I in the patent. ¶61, ¶65 col. 2:35-47
  • Identified Points of Contention:
    • Scope Questions: Because the ’612 Patent claims a single, specific chemical compound, the primary infringement question is one of identity: is the active ingredient in Mylan's ANDA Product the claimed compound? The regulatory framework of ANDA filings suggests this is the case. For the ’489 Patent, a potential question is whether the specific Palbociclib compound meets every limitation of the broad Markush genus claimed in claim 1. The complaint alleges Mylan's own notice letter did not contest infringement of these claims on grounds other than invalidity (Compl. ¶27, ¶66).
    • Technical Questions: The primary technical dispute in this case, as framed by the complaint, appears to be validity, not infringement. A key question for the court will be reconciling Mylan's Paragraph IV certification of non-infringement with the complaint's allegation that Mylan's notice letter only articulated invalidity challenges for the compound and composition patents.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms that may be in dispute. As this is a Hatch-Waxman action where the defendant’s notice letter allegedly focused on invalidity, the central dispute may not turn on the construction of specific claim terms, but rather on the relationship of the claims to the prior art. Claim 1 of the ’612 Patent recites a specific chemical structure by its IUPAC name, which typically leaves little room for construction disputes.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is alleged on the basis that Mylan's proposed product labeling will instruct physicians and patients to use the generic drug for patented methods, such as the treatment of breast cancer claimed in the ’168 Patent (Compl. ¶32, ¶71, ¶109). Contributory infringement is alleged on the grounds that the product is especially made for infringing uses and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶33, ¶72, ¶110).
  • Willful Infringement: The complaint alleges that Mylan acted with full knowledge of the patents-in-suit and without a reasonable basis for believing it would not be liable, which may support a claim for willful infringement (Compl. ¶36, ¶75, ¶113). Knowledge is predicated on the ANDA process, which requires an applicant to address all patents listed in the FDA’s Orange Book for the reference drug.

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

This case presents several central questions characteristic of pharmaceutical patent litigation under the Hatch-Waxman Act.

  • A core issue will be one of validity: can Mylan prove by clear and convincing evidence that the asserted claims of the ’612, ’489, and ’168 patents are invalid (e.g., for anticipation or obviousness over the prior art), as it certified to the FDA?
  • A key question for the method-of-use patent will be one of induced infringement: will Mylan's proposed product labeling, if approved, actively encourage and instruct medical professionals and patients to administer the generic drug in a manner that directly infringes the specific method of treating breast cancer claimed in the ’168 Patent?
  • A procedural and evidentiary question will be one of infringement defense: what basis, if any, beyond its invalidity arguments, does Mylan have for its certification of non-infringement, given the complaint’s allegation that Mylan's notice letter did not contest infringement of the compound patents?