DCT

2:25-cv-11027

Genentech Inc v. Sun Pharmaceutical Industries Ltd

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-11027, D.N.J., 11/24/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Sun Pharmaceutical Industries, Inc. has its principal place of business in New Jersey, and both defendants are subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' cancer drug ERIVEDGE® (vismodegib) constitutes an act of infringement of a patent covering the compound and methods of its use.
  • Technical Context: The patent relates to a class of chemical compounds known as pyridyl inhibitors, which are designed to block the Hedgehog signaling pathway, a key mechanism involved in cell growth and proliferation in certain types of cancer.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 220393, which included a Paragraph IV Certification. This certification asserts that U.S. Patent No. 9,278,961, which is listed in the FDA's Orange Book for ERIVEDGE®, will not be infringed by the proposed generic product and/or is invalid.

Case Timeline

Date Event
2004-09-02 ’961 Patent Priority Date
2016-03-08 ’961 Patent Issued
2025-11-24 Complaint Filed

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

U.S. Patent No. 9,278,961 - "Pyridyl Inhibitors of Hedgehog Signalling," issued March 8, 2016

The Invention Explained

  • Problem Addressed: The patent’s background section describes the role of the Hedgehog (Hh) signaling pathway in cell growth. It notes that inappropriate activation of this pathway is associated with various malignancies, including basal cell carcinoma, and that a need exists for compounds that can effectively inhibit this pathway for therapeutic purposes (Compl. ¶30; ’961 Patent, col. 2:16-52).
  • The Patented Solution: The invention provides a class of novel pyridyl compounds, defined by a general chemical formula (Formula I), that are useful as inhibitors of the Hedgehog signaling pathway. The patent describes these compounds as being useful for treating "hyperproliferative disorders and angiogenesis mediated diseases" (’961 Patent, col. 2:10-16, col. 2:53-62; Abstract).
  • Technical Importance: The development of small-molecule inhibitors of the Hedgehog pathway provided a targeted therapy approach for cancers driven by mutations or aberrant activation of this specific biological pathway (’961 Patent, col. 2:32-52).

Key Claims at a Glance

The complaint asserts infringement of claims 1, 37, 42, 66, and/or 93 (Compl. ¶41). The primary asserted independent claims are 1, 37, and 66.

  • Independent Claim 1: A method of treating cancer in a mammal.

    • comprising administering a compound of formula I
    • wherein A is a carbocycle or heterocycle;
    • X is one of several specified linker groups (e.g., NR4C(O));
    • Y is absent or one of several specified linker atoms/groups (e.g., O, S, NR4);
    • R1 is a substituted or unsubstituted alkyl, carbocycle, or heterocycle;
    • R2, R3, R4 are other specified substituents; and m and n define the number of R3 and R2 substituents.

  • Independent Claim 37: A method of treating cancer in a mammal.

    • comprising administering a compound of a specified formula
    • wherein R3 is H or methyl;
    • R8 is halogen or alkyl substituted with halogen;
    • X is NR4C(O);
    • R4 is H or alkyl; and
    • R1 is an optionally substituted aryl or heteroaryl.

  • Independent Claim 66: A method of treating cancer in a mammal.

    • comprising administering a compound of a specified formula
    • wherein A is substituted benzene;
    • X is NR4C(O) or NR4C(S);
    • Y is absent;
    • R1 is an optionally substituted aryl or heteroaryl;
    • R2 is halogen or alkyl substituted with halogen and is in the o-position relative to pyridyl;
    • R3, R4, m, and n are other specified substituents.

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed generic drug product, identified as "Vismodegib Capsules, 150 mg strength," which is the subject of ANDA No. 220393 ("Sun's ANDA Product") (Compl. ¶1, ¶42).

Functionality and Market Context

  • The complaint alleges that the active ingredient in Sun's ANDA Product is Vismodegib (Compl. ¶43). The complaint provides the chemical structure of Vismodegib, showing a pyridyl group linked to a substituted benzene ring (Compl. ¶43, p. 13). The proposed dosage is a 150 mg capsule intended for oral administration (Compl. ¶44).
  • The proposed product is intended for the treatment of basal cell carcinoma in humans, which is the same indication for which Plaintiffs' ERIVEDGE® is approved (Compl. ¶29, ¶45). The complaint alleges that Defendants intend to market and sell this product in the United States upon receiving FDA approval (Compl. ¶11).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,278,961 Infringement Allegations (Claim 1)

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating cancer in a mammal... Sun's ANDA Product is intended for the treatment of basal cell carcinoma, a type of cancer, in humans. ¶45 col. 301:24-25
...comprising administering a compound of formula I... Sun's ANDA Product contains the active ingredient Vismodegib, which is alleged to be a compound of formula I, and is intended to be administered orally to patients. ¶43, ¶44 col. 301:26-34
...wherein A is a carbocycle or heterocycle... The Vismodegib structure contains a 2-chloro-4-(methylsulfonyl)phenyl group, which is a substituted carbocycle (benzene ring), corresponding to the 'A' moiety of formula I. ¶43 col. 301:35
...X is...NR4C(O)... The Vismodegib structure contains a carboxamide linker (-NH-C(O)-), corresponding to the 'X' moiety where R4 is H. ¶43 col. 301:37-39
...R1 is selected from the group consisting of alkyl, a carbocycle or a heterocycle... The Vismodegib structure contains a 4-chloro-3-(pyridin-2-yl)phenyl group, which is a substituted carbocycle, corresponding to the R1 moiety. ¶43 col. 301:40-45

U.S. Patent No. 9,278,961 Infringement Allegations (Claim 66)

Claim Element (from Independent Claim 66) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating cancer in a mammal, comprising administering a compound of the formula... Sun's ANDA Product, containing Vismodegib, is intended for oral administration to treat basal cell carcinoma, a type of cancer, in humans. ¶44, ¶45 col. 312:48-52
...wherein A is substituted benzene... The Vismodegib structure contains a 4-chloro-3-(pyridin-2-yl)phenyl group, which is a substituted benzene ring, corresponding to the 'A' moiety. ¶43 col. 312:53
...Y is absent... The Vismodegib structure shows the 'X' linker directly attached to the pyridyl ring, meaning the 'Y' moiety is absent. ¶43 col. 312:55
...R1 is aryl or heteroaryl, each of which is optionally substituted... The Vismodegib structure contains a 2-chloro-4-(methylsulfonyl)phenyl group, which is a substituted aryl group, corresponding to the R1 moiety. ¶43 col. 312:56-57
...R2 is halogen...and an R2 is in the o-position on said A benzene relative to pyridyl... The Vismodegib structure shows a chlorine atom ('halogen') on the 'A' benzene ring at the position ortho (o-position) to the point of attachment of the pyridyl group. ¶43 col. 312:58-60
  • Identified Points of Contention:
    • Scope Questions: A central question is whether the specific compound Vismodegib falls within the scope of the Markush groups recited in the asserted independent claims. While the complaint alleges this to be the case, and the existence of claim 42 (which recites the Vismodegib structure) supports this allegation, the precise mapping of Vismodegib to the broader definitions in claims 1 and 66 may be a focus of dispute.
    • Technical Questions: Since this is an ANDA case, infringement is technical and predicated on the filing of the ANDA itself. The primary factual dispute on infringement will likely concern whether Sun's proposed label will instruct users to perform the claimed methods. The complaint alleges that "use of Sun's ANDA Product in accordance with and as directed by Sun's proposed labeling...would infringe" (Compl. ¶54).

V. Key Claim Terms for Construction

  • The Term: "carbocycle or heterocycle" (Claim 1)

  • Context and Importance: This term defines the chemical nature of two key structural components of the claimed compound: the 'A' ring and the R1 substituent. The breadth of this definition is critical to determining the overall scope of the claimed chemical genus and whether Vismodegib falls within it. Practitioners may focus on this term because the definitions provided in the specification are extensive and could be subject to arguments for limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification defines "carbocycle" broadly to include "any stable 3- to 7-membered monocyclic or bicyclic or 7- to 14-membered bicyclic or tricyclic, saturated, partially unsaturated, or aromatic." It provides a similarly broad definition for "heterocycle" (’961 Patent, col. 6:15-28).
    • Evidence for a Narrower Interpretation: A defendant might argue that the numerous specific examples and preferred embodiments, which feature particular types of carbocycles and heterocycles (e.g., substituted benzene, pyridyl), should inform the construction of these terms to be narrower than their plain meaning (’961 Patent, col. 10:23-40; cols. 20-300).

  • The Term: "treating cancer" (Claims 1, 37, 66)

  • Context and Importance: This method step is central to the infringement allegation. In an ANDA context, the dispute will center on whether the proposed label for the generic product instructs or encourages physicians to "treat cancer" as claimed. The term's construction will determine if the intended use on the label falls within the claim's scope.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification lists a wide variety of cancers that may be treated by inhibiting the Hedgehog pathway, including basal cell carcinoma, medulloblastoma, pancreatic adenocarcinoma, and small cell lung carcinoma (’961 Patent, col. 119:18-24).
    • Evidence for a Narrower Interpretation: The complaint itself focuses on the FDA approval for "basal cell carcinoma" (Compl. ¶29, ¶45), and a defendant may argue that the context of the patent or its prosecution history limits the term to specific cancers for which efficacy was demonstrated or contemplated.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that Sun's proposed product label will instruct and encourage physicians and patients to use the generic product to treat basal cell carcinoma, thereby infringing the asserted method claims (Compl. ¶55). Contributory infringement is also alleged, based on the assertion that Sun's product is not a staple article of commerce and is not suitable for substantial non-infringing use (Compl. ¶56).
  • Willful Infringement: The complaint alleges that Sun has acted with full knowledge of the ’961 Patent, as evidenced by the patent's listing in the FDA Orange Book and Sun's submission of a Notice Letter regarding its Paragraph IV certification (Compl. ¶50). This knowledge, coupled with the alleged lack of a reasonable basis for believing its product would not infringe, is the stated basis for willfulness (Compl. ¶50, ¶58).

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

  • A core issue will be one of claim scope: While the complaint asserts that Vismodegib is covered by the claims, the case will depend on the court's construction of the chemical Markush groups in the broad genus claims (e.g., claim 1), particularly terms like "carbocycle" and "heterocycle," which define the foundational structure of the claimed invention.
  • The dispositive question, as is common in ANDA litigation, will likely be patent validity. The complaint acknowledges that Sun's Paragraph IV certification challenges the validity of the ’961 Patent (Compl. ¶38, ¶47). The details of Sun's invalidity contentions (e.g., anticipation, obviousness) are not in the complaint but will form the central battleground of the litigation.