DCT

2:25-cv-19019

Genentech Inc v. Sun Pharmaceutical Industries Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-19019, D.N.J., 12/29/2025
  • Venue Allegations: Venue is alleged to be proper as to Defendant Sun Inc. because it is incorporated and has a principal place of business in New Jersey. Venue is alleged as to Defendant Sun Ltd., an Indian corporation, on the basis that it is a foreign entity subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of the cancer drug ALECENSA® (alectinib) infringes seven U.S. patents related to the alectinib compound, specific formulations, crystalline and amorphous forms, and methods of production.
  • Technical Context: The technology concerns alectinib, a small-molecule kinase inhibitor used as a targeted therapy for certain types of non-small cell lung cancer, a significant segment of the oncology pharmaceutical market.
  • Key Procedural History: This infringement action was filed under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV certification notice from Defendant Sun, which asserted that the asserted patents are invalid, unenforceable, and/or not infringed by its proposed generic product. The complaint notes that three of the patents-in-suit were previously litigated in a case against a different defendant in the District of Delaware, which was dismissed by consent of the parties.

Case Timeline

Date Event
2009-06-10 Earliest Priority Date for U.S. Patent No. 9,126,931
2010-08-20 Earliest Priority Date for U.S. Patent No. 9,365,514
2014-04-25 Earliest Priority Date for U.S. Patent Nos. 10,350,214; 11,433,076; 9,714,229
2014-08-08 Earliest Priority Date for U.S. Patent Nos. 10,344,014; 10,774,067
2015-09-08 U.S. Patent No. 9,126,931 Issues
2015-12-11 FDA approves ALECENSA® (alectinib)
2016-06-14 U.S. Patent No. 9,365,514 Issues
2017-07-25 U.S. Patent No. 9,714,229 Issues
2019-07-09 U.S. Patent No. 10,344,014 Issues
2019-07-16 U.S. Patent No. 10,350,214 Issues
2020-09-15 U.S. Patent No. 10,774,067 Issues
2022-09-06 U.S. Patent No. 11,433,076 Issues
2023-02-09 "Sun Publication II" Published
2023-04-27 "Sun Publication I" Published
2025-01-05 "Sun Publication III" Published
2025-11-21 Date of Sun's Paragraph IV Notice Letter
2025-12-29 Complaint Filed

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

U.S. Patent No. 9,126,931 - "Tetracyclic Compound"

(Issued September 8, 2015; Compl. ¶51)

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective therapeutic agents against diseases associated with abnormalities of Anaplastic Lymphoma Kinase (ALK), such as cancer and cancer metastasis (’931 Patent, col. 1:26-34). The background also notes that compounds with ALK inhibitory activity are often poorly soluble in water, which can negatively affect bioavailability when administered orally ('931 Patent, col. 1:41-44).
  • The Patented Solution: The invention provides a class of novel tetracyclic compounds that exhibit ALK inhibitory activity ('931 Patent, Abstract). The patent discloses a broad genus of related chemical structures and claims specific compounds within that genus, including the compound that is the free base of alectinib, which is claimed to be useful for the prevention or treatment of these diseases ('931 Patent, col. 18:5-20; Compl. ¶52).
  • Technical Importance: The patent discloses a new chemical entity providing a therapeutic agent for targeting ALK-driven diseases. ('931 Patent, col. 1:35-40).

Key Claims at a Glance

  • The complaint asserts infringement of at least claim 15 (Compl. ¶73). Claim 15 is dependent on independent claim 1.
  • Claim 15 recites the specific chemical entity:
    • A compound which is 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile, or a salt or solvate thereof.
  • The complaint states that its infringement allegations include, but are not limited to, claim 15, reserving the right to assert other claims (Compl. ¶88).

U.S. Patent No. 9,365,514 - "Composition Comprising Tetracyclic Compound"

(Issued June 14, 2016; Compl. ¶54)

The Invention Explained

  • Problem Addressed: The patent's background section notes that certain tetracyclic compounds with ALK inhibitory activity are poorly water-soluble, which may result in insufficient bioavailability when administered orally (’514 Patent, col. 1:40-42).
  • The Patented Solution: The invention is a pharmaceutical composition designed for oral administration that improves the solubility of the alectinib compound. The claimed solution combines the active compound with a pharmaceutically acceptable carrier and a specific "dissolution aid," sodium lauryl sulfate (SLS) ('514 Patent, Abstract; Compl. ¶55).
  • Technical Importance: The formulation provides a method for effective oral delivery of a poorly soluble active pharmaceutical ingredient, potentially enhancing its therapeutic efficacy. ('514 Patent, col. 1:59-65).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the patent, citing independent claim 1 as an example (Compl. ¶55, 94).
  • The essential elements of independent claim 1 are:
    • A composition comprising a substance which is 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof,
    • a pharmaceutically acceptable carrier, and
    • a dissolution aid,
    • wherein the dissolution aid is sodium lauryl sulfate.
  • The complaint alleges infringement of "one or more claims," reserving the right to assert others (Compl. ¶94).

U.S. Patent No. 10,350,214 - "Preparation Containing Tetracyclic Compound at High Dose"

(Issued July 16, 2019; Compl. ¶57)

  • Technology Synopsis: The patent addresses the challenge of creating a high-dose oral formulation for the poorly soluble alectinib compound that still provides adequate dissolution (’214 Patent, col. 2:42-51). The claimed solution is a pharmaceutical formulation comprising granules that contain 140 mg to 190 mg of the active compound, which are then blended with carmellose calcium as an external disintegrating agent to improve solubility (Compl. ¶58; '214 Patent, col. 2:52-59).
  • Asserted Claims: Claims 1 and 15 (independent) are asserted as examples (Compl. ¶58).
  • Accused Features: The complaint alleges that Sun's generic product is a formulation containing a high dose of alectinib in a granule blended with carmellose calcium, sodium lauryl sulfate, and hydroxypropylcellulose, thereby infringing the '214 Patent (Compl. ¶116, 119).

U.S. Patent No. 11,433,076 - "Preparation Containing Tetracyclic Compound at High Dose"

(Issued September 6, 2022; Compl. ¶60)

  • Technology Synopsis: This patent claims a pharmaceutical formulation of alectinib focusing on specific physical characteristics of the drug-containing granules. The invention requires the granules to have a mean particle diameter of 150 µm or more, a bulk density of 0.5 g/ml or more, and a tapping density of 0.6 g/ml or more, properties said to improve solubility in high-dose formulations (’076 Patent, col. 5:1-3; Compl. ¶61).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶61).
  • Accused Features: The complaint alleges that Sun's proposed generic alectinib product comprises granules that meet the specific particle diameter, bulk density, and tapping density limitations of the '076 Patent (Compl. ¶151-152).

U.S. Patent No. 9,714,229 - "Crystal of Tetracyclic Compound"

(Issued July 25, 2017; Compl. ¶63)

  • Technology Synopsis: The patent is directed to specific crystalline polymorphic forms of alectinib monohydrochloride. Different crystalline forms of a drug can affect its stability, solubility, and manufacturing properties. The invention identifies and claims these novel crystal forms by their characteristic peaks at specific diffraction angles in a powder X-ray diffraction (PXRD) pattern (’229 Patent, col. 2:13-24; Compl. ¶64).
  • Asserted Claims: Claims 1 and 4 (both independent) are asserted as examples (Compl. ¶64).
  • Accused Features: The complaint alleges that the alectinib hydrochloride in Sun's ANDA product exists in a crystalline form that exhibits the PXRD patterns claimed in the '229 Patent, citing Sun's own scientific publications as evidence for this allegation (Compl. ¶164, 43-44, 46).

U.S. Patent No. 10,344,014 - "Amorphous Form of Tetracyclic Compound"

(Issued July 9, 2019; Compl. ¶66)

  • Technology Synopsis: This patent claims an amorphous (non-crystalline) form of alectinib, which can offer different solubility and bioavailability characteristics compared to crystalline forms (’014 Patent, col. 1:59-65). The invention also covers methods of producing this amorphous form and solid dispersions containing it, which involve combining the amorphous drug with an inert carrier to improve stability and solubility ('014 Patent, col. 10:3-7; Compl. ¶67).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶67).
  • Accused Features: Based on Sun's scientific publications describing amorphous solid dispersions of alectinib, the complaint alleges that Sun's ANDA product contains alectinib in the claimed amorphous form, potentially combined with a carrier such as Soluplus (Compl. ¶184-185, 41).

U.S. Patent No. 10,774,067 - "Amorphous Form of Tetracyclic Compound"

(Issued September 15, 2020; Compl. ¶69)

  • Technology Synopsis: This patent claims a specific method for producing the amorphous form of alectinib covered by the related '014 Patent. The claimed method comprises the steps of: (i) dissolving the compound in a solvent to create a feed solution; (ii) spraying the solution; and (iii) drying the sprayed solution to yield the amorphous form, a process consistent with spray drying (’067 Patent, col. 2:41-51; Compl. ¶70).
  • Asserted Claims: Claim 1 (independent) of the '067 Patent is asserted (Compl. ¶70, 203).
  • Accused Features: The complaint alleges, based on Sun's publications, that Sun manufactures its amorphous alectinib API using a process that includes dissolving, preparing a solution to be dried, and drying it—steps that are alleged to meet the limitations of the claimed method (Compl. ¶207, 42).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Sun ANDA Product," a generic version of ALECENSA® (alectinib) capsules, for which Sun Ltd. and Sun Inc. are seeking FDA approval under ANDA No. 214274 (Compl. ¶1, 28).

Functionality and Market Context

The Sun ANDA Product is described as a hard capsule containing 150 mg of alectinib for oral administration, intended to be a bioequivalent and therapeutically equivalent version of the branded drug ALECENSA® (Compl. ¶31, 95). ALECENSA® is a kinase inhibitor approved for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (Compl. ¶22). The complaint alleges that Sun's product, if approved, will be sold in New Jersey and nationwide, where it will directly compete with and displace sales of ALECENSA® (Compl. ¶13, 18). A chemical diagram provided in the complaint illustrates the hydrochloride salt form of alectinib, the alleged active ingredient in the Sun ANDA Product (Compl. p. 19).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,126,931 Infringement Allegations

Claim Element (from Independent Claim 1, as specified in dependent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound which is 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile, or a salt or solvate thereof. The Sun ANDA Product contains alectinib hydrochloride as its active pharmaceutical ingredient, which is the hydrochloride salt of the claimed compound. ¶74, 77, 83 col. 297:48-54
  • Identified Points of Contention:
    • Factual Questions: The primary question is factual: does the active pharmaceutical ingredient in Sun's ANDA product correspond to the specific chemical structure claimed in claim 15, or a salt or solvate thereof? The complaint alleges that Sun's ANDA copies the ALECENSA® label, which identifies the active ingredient as alectinib hydrochloride (Compl. ¶74, 78).
    • Scope Questions: The complaint states that in its notice letter, Sun has not contested infringement of any claim of the ’931 Patent (Compl. ¶73). This suggests that the scope of the claim as reading on the accused product may not be a central point of dispute for this patent.

U.S. Patent No. 9,365,514 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a composition comprising a substance which is 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof, The Sun ANDA product is a pharmaceutical composition that contains alectinib hydrochloride, the salt of the claimed substance. ¶96, 98 col. 1:47-56
a pharmaceutically acceptable carrier, Sun's product is alleged to contain inactive ingredients such as lactose monohydrate and hydroxypropylcellulose, which function as pharmaceutically acceptable carriers. This is based on the ALECENSA® label, which the Sun ANDA product allegedly copies. ¶95, 99 col. 15:52
and a dissolution aid, The formulation of the Sun ANDA product is alleged to contain sodium lauryl sulfate, which functions as a dissolution aid. ¶95, 104 col. 1:63
wherein the dissolution aid is sodium lauryl sulfate. The ALECENSA® label, which the Sun ANDA product allegedly copies, explicitly lists sodium lauryl sulfate as an inactive ingredient. ¶95 col. 15:53-54
  • Identified Points of Contention:
    • Technical Questions: A potential point of contention may be whether the sodium lauryl sulfate present in Sun's formulation performs the specific function of a "dissolution aid" as required by the claim. A party could argue that an ingredient, while present, serves a different primary function in a given formulation (e.g., as a wetting agent or manufacturing lubricant) and thus does not meet the functional claim limitation.
    • Scope Questions: The complaint's allegation of infringement under the doctrine of equivalents raises the possibility that Sun's product may use a chemically similar but not identical dissolution aid, or that its formulation differs in a way that avoids literal infringement (Compl. ¶98).

V. Key Claim Terms for Construction

  • The Term: 'dissolution aid' (from '514 Patent, Claim 1)
  • Context and Importance: This term is critical because the inventive concept of the '514 Patent is the specific combination of alectinib with sodium lauryl sulfate acting as a dissolution aid to overcome poor solubility. The definition of this term will determine whether the mere presence of SLS is sufficient for infringement, or if Plaintiffs must prove it performs a specific function to a certain degree in the accused product. Practitioners may focus on this term because it links the structural composition of the claim to a functional outcome.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to provide an explicit, restrictive definition of "dissolution aid." The claims are for a "composition," not a method, which may support an interpretation where the presence of the specified ingredients is sufficient, regardless of the precise mechanism or degree of dissolution enhancement.
    • Evidence for a Narrower Interpretation: The patent's background explicitly identifies poor solubility and bioavailability as the problem being solved ('514 Patent, col. 1:40-42). The abstract highlights that the invention provides a composition with "improved solubility" ('514 Patent, Abstract). A party could argue this context requires the "dissolution aid" to be the principal cause of a quantifiable improvement in dissolution characteristics, not merely an incidental component.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all asserted patents. The basis for inducement is the allegation that Sun supplies the ANDA product and "instructs, recommends, encourages, and/or suggests" that another entity combine the components in an infringing manner (Compl. ¶85, 106, 132).
  • Willful Infringement: The complaint alleges that Sun had knowledge of the asserted patents when it filed its ANDA (Compl. ¶80, 90, 101). It further alleges that Sun's assertions of non-infringement and invalidity in its Paragraph IV notification lack a good faith basis, which may form the grounds for a willfulness claim and a request for enhanced damages and attorneys' fees as an exceptional case (Compl. ¶90, 111, 137).

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

  • A core issue will be one of physical form and evidence: For the '229 Patent (crystalline forms) and '014 Patent (amorphous form), can Plaintiffs prove, likely through competing expert analyses of characterization data, that the alectinib active ingredient in Sun's final, to-be-marketed product will necessarily take on the specific physical forms claimed? The complaint's reliance on Sun's own research publications suggests this will be a central evidentiary battleground.
  • A second key question will be one of functional purpose vs. chemical presence: Across the formulation patents ('514, '214), does the presence of standard pharmaceutical excipients like sodium lauryl sulfate and carmellose calcium in Sun's product automatically constitute infringement? Or must Plaintiffs demonstrate that these components perform the specific roles of a "dissolution aid" and "disintegrating agent," respectively, in the context of Sun's overall formulation, a distinction that could be pivotal in the claim construction and infringement analysis.
  • A final question will be one of process infringement: For the '067 method patent, can Plaintiffs produce sufficient evidence to show that Sun's confidential manufacturing process for its amorphous API includes the claimed steps of dissolving, spraying, and drying? This raises the question of whether the process described in Sun's academic publications, cited in the complaint, is the same as the commercial-scale process that will be used to produce the ANDA product.