DCT

1:20-cv-00394

Hoffmann La Roche Inc v. Fresenius Kabi USA LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00394, D. Del., 03/19/2020
  • Venue Allegations: Venue is alleged as proper in the District of Delaware because Defendant Fresenius Kabi USA, LLC is incorporated in Delaware, and the foreign co-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 the cancer drug ALECENSA® constitutes an act of infringement of four U.S. patents covering the active pharmaceutical ingredient, alectinib, and specific formulations thereof.
  • Technical Context: The technology relates to small-molecule kinase inhibitors used in targeted cancer therapy, specifically for treating anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs' receipt on February 5, 2020, of a Paragraph IV certification notice from Defendants. In the notice, Defendants asserted that the asserted patents, which are listed in the FDA's "Orange Book" for ALECENSA®, are invalid, unenforceable, and/or will not be infringed by their proposed generic product.

Case Timeline

Date Event
2009-06-10 Priority Date for ’931 and ’922 Patents
2010-08-20 Priority Date for ’514 Patent
2014-04-25 Priority Date for ’214 Patent
2015-09-08 ’931 Patent Issued
2015-12-11 FDA Approved ALECENSA® (alectinib)
2016-06-14 ’514 Patent Issued
2016-09-13 ’922 Patent Issued
2019-07-16 ’214 Patent Issued
2020-02-05 Plaintiffs Received Defendants’ Paragraph IV Notice Letter
2020-03-19 Complaint Filed

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

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

(Issued on September 8, 2015. Compl. ¶39)

The Invention Explained

  • Problem Addressed: The patent addresses the need for novel compounds that exhibit inhibitory activity against Anaplastic Lymphoma Kinase (ALK), a receptor tyrosine kinase implicated in diseases such as cancer and cancer metastasis. ('931 Patent, col. 1:30-47).
  • The Patented Solution: The invention provides a new class of tetracyclic compounds, based on a benzo[b]carbazole chemical scaffold, that are designed to inhibit ALK activity. ('931 Patent, Abstract; col. 3:9-20). The patent claims the specific chemical compound alectinib, its salts, and its solvates.
  • Technical Importance: The patent discloses a novel chemical entity that provides a therapeutic agent for ALK-positive cancers, a recognized target in oncology. ('931 Patent, col. 1:45-47).

Key Claims at a Glance

  • The complaint asserts dependent claim 15. (Compl. ¶40, ¶62).
  • Claim 15 recites a single element:
    • A compound, salt, or solvate that 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 (the chemical name for alectinib). ('931 Patent, cl. 15).

U.S. Patent No. 9,440,922 - Tetracyclic Compound

(Issued on September 13, 2016. Compl. ¶42)

The Invention Explained

  • Problem Addressed: As a divisional of the application leading to the ’931 Patent, this patent addresses the same problem: the need for effective treatments for ALK-implicated diseases like cancer. (’922 Patent, col. 1:30-47).
  • The Patented Solution: The invention claims a pharmaceutical for treating cancer that comprises one of the tetracyclic compounds disclosed in the shared specification, combined with a pharmaceutically acceptable carrier. (’922 Patent, Abstract; cl. 1). This shifts the focus from the compound itself to its use in a formulated drug product for a specific therapeutic purpose.
  • Technical Importance: The patent protects the application of the novel ALK-inhibiting compounds in a pharmaceutical context for treating cancer. (’922 Patent, col. 17:10-14).

Key Claims at a Glance

  • The complaint asserts dependent claims 8 and 20. (Compl. ¶43, ¶73). The lead independent claim is claim 1.
  • The essential elements of independent claim 1 are:
    • A pharmaceutical for the treatment of cancer or cancer metastasis
    • comprising a compound or salt or solvate thereof represented by Formula (I)
    • and a pharmaceutically acceptable carrier. (’922 Patent, cl. 1).
  • Claim 20 specifies the compound as alectinib, and claim 8 specifies the cancer as lung cancer. (’922 Patent, cl. 8, 20).

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

(Issued on June 14, 2016. Compl. ¶45)

Technology Synopsis

This patent addresses the technical challenge of formulating the poorly water-soluble alectinib compound for effective oral administration. (Compl. ¶46; ’514 Patent, col. 1:33-40). The patented solution is a composition that combines alectinib with a "dissolution aid," specifically identifying sodium lauryl sulfate, to improve its solubility and bioavailability. (’514 Patent, Abstract; cl. 1).

Asserted Claims & Accused Features

  • Asserted Claims: Claim 1 (independent). (Compl. ¶46).
  • Accused Features: The complaint alleges that the formulation of the brand-name drug ALECENSA®, which Defendants' generic product seeks to copy, contains both alectinib and sodium lauryl sulfate, thereby meeting the limitations of the asserted claims. (Compl. ¶98, ¶100).

U.S. Patent No. 10,350,214 - Preparation containing tetracyclic compound at high dose

(Issued on July 16, 2019. Compl. ¶48)

Technology Synopsis

The patent addresses the problem of delivering a high dose of the poorly soluble alectinib compound while maintaining satisfactory dissolution. (’214 Patent, col. 10:40-52). The solution involves a specific pharmaceutical formulation structure: a granule containing alectinib is combined with an external disintegrating agent, carmellose calcium, in a unit formulation containing 140 mg to 190 mg of alectinib. (’214 Patent, Abstract; cl. 1).

Asserted Claims & Accused Features

  • Asserted Claims: Claim 1 (independent), Claim 5, and Claim 6. (Compl. ¶49, ¶128).
  • Accused Features: The complaint alleges that Defendants’ proposed 150 mg generic capsule will infringe because the ALECENSA® label, which the generic product will copy, discloses a formulation containing alectinib and carmellose calcium at the claimed dosage strength. (Compl. ¶119, ¶121).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic 150 mg alectinib capsules, for which Abbreviated New Drug Application (ANDA) No. 213166 was filed with the U.S. Food and Drug Administration. (Compl. ¶14).

Functionality and Market Context

  • The product is a generic equivalent of ALECENSA®, an oral kinase inhibitor indicated for the treatment of ALK-positive metastatic non-small cell lung cancer. (Compl. ¶12, ¶54). The act of infringement alleged under 35 U.S.C. § 271(e)(2)(A) is the filing of the ANDA itself, which seeks approval to market this generic drug prior to the expiration of the patents-in-suit. (Compl. ¶22). The complaint alleges that the proposed generic product will contain the same active ingredient and will have the same labeling as ALECENSA®. (Compl. ¶59, ¶75, ¶98, ¶119).

IV. Analysis of Infringement Allegations

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

Claim Element (from Dependent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound or salt or solvate... 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. The active ingredient in Defendants' ANDA Product is alectinib, which the complaint alleges is the specific chemical compound claimed. The complaint provides the chemical structure of the alectinib hydrochloride salt, which it alleges is covered by the claims. (Compl. p. 15, ¶55). ¶54, ¶55 col. 281:49-65

Identified Points of Contention

  • Scope Questions: The complaint states that Defendants’ Paragraph IV notice letter did not allege non-infringement of claim 15. (Compl. ¶52). This suggests the primary dispute for this patent may concern validity rather than the scope of the claim.
  • Technical Questions: A potential technical question, though likely straightforward in an ANDA case, is whether the active pharmaceutical ingredient specified in Defendants' confidential ANDA is, in fact, the claimed compound, its salt, or its solvate.

U.S. Patent No. 9,440,922

Claim Element (from Independent Claim 1, as narrowed by Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical for the treatment of cancer or cancer metastasis... The proposed label for Defendants’ ANDA Product, copying the ALECENSA® label, will instruct physicians to use the product for treating ALK-positive non-small cell lung cancer. ¶77, ¶82 col. 1:30-34
...comprising 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... The ANDA Product contains alectinib, which is the specified compound. ¶75, ¶76 col. 429:1-20
...and a pharmaceutically acceptable carrier. The ALECENSA® label, which the ANDA Product will allegedly copy, lists inactive ingredients such as lactose monohydrate and hydroxypropylcellulose, which serve as carriers. ¶75 col. 17:10-14

Identified Points of Contention

  • Scope Questions: The complaint alleges that Defendants' notice letter did not contest infringement of claims 8 and 20. (Compl. ¶73). This raises the question of whether the dispute will center on validity challenges (e.g., obviousness of the treatment method) rather than claim construction or non-infringement.
  • Technical Questions: The central technical question is whether the product defined in the ANDA, including its proposed label and instructions for use, meets all limitations of the asserted method-of-use claims.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim construction disputes, particularly as it alleges that infringement of the asserted claims in the ’931 and ’922 patents was not contested in Defendants' notice letter. (Compl. ¶52, ¶73). However, for the formulation patents, certain terms may become points of contention.

  • The Term: "dissolution aid" (from Claim 1 of the ’514 Patent)
  • Context and Importance: This term is critical because infringement requires the presence of sodium lauryl sulfate (SLS) that functions as a "dissolution aid." Practitioners may focus on this term because a defendant could potentially argue that while its formulation contains SLS, it is included for a different purpose (e.g., as a manufacturing lubricant or surfactant) and does not meaningfully "aid dissolution" in the final product, thereby avoiding infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself states, "...and a dissolution aid, wherein the dissolution aid is sodium lauryl sulfate." (’514 Patent, cl. 1). A party could argue this language effectively defines SLS as a "dissolution aid" for the purposes of the claim, regardless of its measured effect in a specific formulation.
    • Evidence for a Narrower Interpretation: The patent's abstract states that the inventors "unexpectedly found that, by allowing a dissolution aid to co-exist with a poorly water-soluble or insoluble substance... solubility of the substance can be significantly improved." (’514 Patent, Abstract). This suggests a functional requirement, and a party could argue that for SLS to be a "dissolution aid," it must be shown to perform this function of significantly improving solubility in the accused product.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The basis for this allegation is that Defendants, by seeking approval for a product with a label that copies the ALECENSA® label, know and intend that physicians and patients will use the generic product for the patented method of treating cancer, thereby directly infringing method claims. (Compl. ¶59-60, ¶82-83).
  • Willful Infringement: The complaint does not use the term "willful infringement" but alleges that Defendants' invalidity and unenforceability assertions in their Paragraph IV notice are "devoid of an objective good faith basis in either the facts or the law." (Compl. ¶69, ¶92, ¶114). This language forms the basis for a request that the case be declared "exceptional" under 35 U.S.C. § 285, which would entitle Plaintiffs to an award of attorneys' fees.

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

  • A core issue will be one of validity versus infringement: given the complaint's assertion that Defendants did not contest infringement of the primary compound and method-of-use claims ('931 and '922 patents), the central dispute for those patents will likely be the strength of Defendants' invalidity challenges, such as arguments based on obviousness or anticipation.
  • A key evidentiary question will be one of formulation equivalence: for the two formulation patents ('514 and '214), the case may turn on whether the specific combination of excipients and manufacturing processes detailed in Defendants' confidential ANDA meets the functional and structural limitations of the claims, such as the precise role of sodium lauryl sulfate as a "dissolution aid" or the claimed granule-disintegrant architecture.
  • A final question for the court will be the objective reasonableness of Defendants' legal positions: Plaintiffs have alleged that Defendants' Paragraph IV certifications lack an objective good faith basis, raising the issue of whether this litigation conduct will be deemed "exceptional" under 35 U.S.C. § 285, potentially leading to an award of attorneys' fees.