DCT

1:19-cv-00211

Biogen Inc v. Hetero Labs Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00211, D. Del., 01/31/2019
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Hetero USA Inc. is a Delaware corporation, and the foreign-domiciled defendants may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic dimethyl fumarate capsules constitutes an act of infringement of a patent covering methods of treating multiple sclerosis.
  • Technical Context: The technology is a pharmaceutical method of use for treating multiple sclerosis, an autoimmune disease, with the active ingredient dimethyl fumarate, which is the active ingredient in Plaintiff's branded drug, Tecfidera®.
  • Key Procedural History: The complaint notes this action follows a "Second Notice Letter" from Hetero regarding its ANDA and the patent-in-suit. A "First Suit" involving the same ANDA but different patents was previously filed by Biogen and consolidated with other litigation. The patent-in-suit has a patent term extension of 811 days.

Case Timeline

Date Event
1998-11-19 '001 Patent Priority Date
2009-11-17 '001 Patent Issue Date
2013-03-27 FDA Approval for NDA No. 204063 (Tecfidera®)
2017-06-01 Date of "First Notice Letter" from Hetero regarding other patents
2017-06-26 Biogen files "First Suit" against Hetero on other patents
2018-12-17 Date of "Second Notice Letter" from Hetero regarding '001 patent
2019-01-31 Complaint Filing Date
2020-06-20 '001 Patent Expiration Date (including patent term extension)

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

U.S. Patent No. 7,619,001 - "Utilization of Dialkylfumarates," Issued Nov. 17, 2009

The Invention Explained

  • Problem Addressed: The patent describes the drawbacks of then-existing treatments for autoimmune diseases and transplant rejection, which relied on immunosuppressive agents like cyclosporine that carried risks of weakening the body's defense against infections and increasing the risk of malignant diseases (’001 Patent, col. 2:56-64). The patent also notes that prior formulations of fumaric acid derivatives could have "unacceptably severe side effects and high toxicity" (’001 Patent, col. 3:26-32).
  • The Patented Solution: The invention is directed to the use of dialkyl fumarates, such as dimethyl fumarate, for treating autoimmune diseases, including multiple sclerosis (’001 Patent, Abstract; col. 4:55-63). The patent describes formulating the active ingredient into specific oral dosage forms, such as enteric-coated micro-tablets, which are theorized to improve patient tolerance by avoiding high local concentrations of the drug in the intestine and thereby reducing gastrointestinal irritation (’001 Patent, col. 5:36-59).
  • Technical Importance: The technology provided a therapeutic option for modulating the immune system in the treatment of autoimmune diseases that could potentially offer an alternative safety profile to existing therapies (’001 Patent, col. 3:42-51).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶47).
  • Independent Claim 1 recites:
    • A method of treating multiple sclerosis comprising administering, to a patient in need of treatment for multiple sclerosis,
    • an amount of a pharmaceutical preparation effective for treating multiple sclerosis,
    • the pharmaceutical preparation comprising at least one excipient or at least one carrier or at least one combination thereof; and
    • dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof.
  • The complaint reserves the right to assert other claims of the ’001 patent (Compl. ¶47).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' "generic dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate" as described in ANDA No. 210500 (Compl. ¶12).

Functionality and Market Context

  • The product is a generic version of Biogen's branded drug, Tecfidera®, and is intended for the treatment of relapsing forms of multiple sclerosis (Compl. ¶¶2, 12). The complaint alleges that Hetero has filed its ANDA to obtain FDA approval to manufacture and sell this generic product in the United States before the expiration of the ’001 patent (Compl. ¶12). The alleged infringement is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2), which is a statutory act of infringement enabling patent litigation before the generic drug is marketed (Compl. ¶48).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'001 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating multiple sclerosis comprising administering, to a patient in need of treatment for multiple sclerosis The ANDA product is intended for treating relapsing forms of multiple sclerosis, and its label will instruct physicians and patients to administer the drug for this indication (Compl. ¶¶12, 51). ¶12, ¶51 col. 4:55-58
an amount of a pharmaceutical preparation effective for treating multiple sclerosis The ANDA product will be available in 120 mg and 240 mg dosage strengths, which are alleged to be therapeutically effective amounts for treating multiple sclerosis (Compl. ¶12). ¶12 col. 4:45-50
the pharmaceutical preparation comprising... dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof. The product described in the ANDA is identified as "dimethyl fumarate delayed-release capsules," which contains the active ingredient specified in the claim (Compl. ¶12). ¶12 col. 4:28-30
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges infringement of at least Claim 1, which broadly recites a "pharmaceutical preparation." The ’001 patent's dependent claims recite more specific formulations, such as "microtablets" (Claim 15) that are "enteric-coated" (Claim 19). A potential point of contention may arise if Plaintiff asserts these dependent claims, raising the question of whether Defendants' "delayed-release capsules" meet those more specific limitations.
    • Technical Questions: In this ANDA context, the primary infringement question is whether the use of Hetero's proposed generic product, according to its proposed label, would infringe the asserted claims. The complaint alleges that Hetero is required to copy the FDA-approved labeling for Tecfidera®, which directs use for treating multiple sclerosis (Compl. ¶51). A key question for the court will be whether the administration of Hetero's ANDA product for its labeled indication will necessarily practice all steps of the claimed method.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutical preparation"
  • Context and Importance: This term defines the physical form of the drug administered to the patient. Its construction is critical because a narrow definition could create a path for a non-infringement defense, whereas a broad definition would encompass a wider range of drug formulations. Practitioners may focus on this term because the specification contains extensive discussion of specific formulations like "micro-tablets" as a solution to the stated problem of gastrointestinal irritation, which Defendants may argue limits the scope of the otherwise broad term in the claims (’001 Patent, col. 5:36-59).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses a wide variety of dosage forms, including "tablets, micro-tablets, pellets or granulates" for oral administration as well as "ointments, plasters, lotions," "suppositories or micro-enemas" for other routes, suggesting the inventors contemplated a broad scope for the term (’001 Patent, col. 4:35-37; col. 5:1-6).
    • Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the advantages of "micro-tablets" and "micro-pellets" in capsules as a preferred embodiment for solving the problem of local irritation in the intestine (’001 Patent, col. 3:9-11; col. 5:41-59). The detailed examples exclusively describe the preparation of enteric-coated micro-tablets (’001 Patent, col. 6-7). A party could argue these specific embodiments define the true scope of the invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval of its ANDA, Hetero will induce infringement by physicians and patients by providing a product with a label that instructs its use for treating multiple sclerosis (Compl. ¶51). The complaint also pleads contributory infringement, alleging that Hetero's product is a material part of the invention, is not a staple article of commerce suitable for substantial non-infringing use, and that Hetero knows of the patent (Compl. ¶52).
  • Willful Infringement: The complaint alleges that Hetero has "actual knowledge of the '001 patent," based on its "Second Notice Letter" that certified its ANDA against the patent (Compl. ¶¶45-46). While the complaint does not use the term "willful," it requests that the case be declared exceptional under 35 U.S.C. § 285 (Compl. p. 12, ¶6).

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

  • A central issue is one of statutory infringement: As this is an ANDA case filed under 35 U.S.C. § 271(e)(2), the dispositive question for infringement will be whether the future marketing of Defendants' proposed generic product, used in accordance with its proposed FDA-approved label, would infringe one or more claims of the ’001 patent.
  • A key legal question will concern claim construction: The litigation may turn on the court's interpretation of the term "pharmaceutical preparation." The central question will be whether the term should be given its broad, plain meaning, or if its scope should be narrowed by the specification's repeated focus on specific "micro-tablet" and "enteric-coated" embodiments as the solution to a stated technical problem.
  • While not detailed in the complaint, the ultimate outcome will almost certainly depend on patent validity. The core dispute in the underlying litigation will likely focus on whether the asserted claims of the ’001 patent are valid over the prior art, an issue that cannot be analyzed from the complaint alone.