DCT

1:19-cv-00333

Biogen Inc v. Cadila Healthcare

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00333, D. Del., 02/15/2019
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic drug constitutes a future act of infringement purposefully directed at Delaware. The complaint also notes that Defendant has not contested venue or jurisdiction in Delaware in two prior, related lawsuits involving the same ANDA.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an ANDA to market a generic version of Plaintiff's multiple sclerosis drug, Tecfidera®, constitutes an act of infringement of a patent covering methods of treating multiple sclerosis with a dimethyl fumarate formulation.
  • Technical Context: The dispute is in the pharmaceutical sector, concerning a patented method of use for a chemical compound (dimethyl fumarate) formulated for treating the autoimmune disease multiple sclerosis.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter from the Defendant regarding its ANDA filing. The complaint notes this is the third wave of litigation between the parties over the same ANDA (No. 210538); prior suits involved U.S. Patent Nos. 8,399,514, 7,320,999, and 6,509,376. The patent-in-suit was granted an 811-day patent term extension by the USPTO.

Case Timeline

Date Event
1998-11-19 Priority Date for U.S. Patent No. 7,619,001
2009-11-17 U.S. Patent No. 7,619,001 Issues
2013-03-27 FDA Approves NDA for Tecfidera®
2017-06-01 Zydus sends First Notice Letter (re '514 & '999 patents)
2017-06-30 Biogen files first suit against Zydus in D.N.J.
2017-07-14 Biogen files first suit against Zydus in D. Del.
2018-03-12 Zydus sends Second Notice Letter (re '376 patent)
2018-04-25 Biogen files second round of suits against Zydus in D. Del & D.N.J.
2019-01-04 Zydus sends Third Notice Letter (re '001 patent)
2019-02-15 Complaint Filed
2020-06-20 Stated Expiration Date for '001 Patent (including term extension)

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

U.S. Patent No. 7,619,001 - "Utilization of Dialkylfumarates"

  • Patent Identification: U.S. Patent No. 7,619,001, “Utilization of Dialkylfumarates,” issued November 17, 2009.

The Invention Explained

  • Problem Addressed: The patent describes the significant drawbacks of existing therapies for autoimmune diseases and organ transplant rejection, which rely on immunosuppressive agents like cyclosporine (’001 Patent, col. 2:31-40). These agents can weaken the body's natural defenses against infection and increase the risk of malignant diseases, creating a need for alternative treatments with better safety profiles (’001 Patent, col. 2:56-59).
  • The Patented Solution: The invention proposes using specific dialkyl fumarates, such as dimethyl fumarate, formulated into pharmaceutical preparations to treat autoimmune diseases (’001 Patent, Abstract). The specification describes formulating these compounds into micro-tablets or pellets, which can be enterically coated, to improve tolerance and reduce gastrointestinal side effects by avoiding high local concentrations of the active ingredient in the intestine (’001 Patent, col. 5:35-54).
  • Technical Importance: The described technology offered a method for modulating the immune system to treat conditions like multiple sclerosis, while potentially avoiding the severe side effects associated with conventional immunosuppressants (’001 Patent, col. 8:5-9).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim including at least claim 1" (Compl. ¶36).
  • Independent Claim 1 of the ’001 Patent recites the following essential elements:
    • 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.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed "generic dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate," which are the subject of Abbreviated New Drug Application (ANDA) No. 210538 (Compl. ¶5).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff’s approved drug, Tecfidera®, and is intended for the treatment of relapsing forms of multiple sclerosis (Compl. ¶2, ¶5, ¶31). As an ANDA product, it is required to have the same active ingredient, dosage form, strength, and route of administration as the reference listed drug, Tecfidera® (Compl. ¶40). The complaint alleges that Defendant, a generic pharmaceutical company, seeks to market this product prior to the expiration of the ’001 Patent (Compl. ¶4, ¶5).

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 Defendant's ANDA seeks approval for a product indicated for treating relapsing forms of multiple sclerosis, and its label will instruct physicians and patients on this use. ¶5, ¶29, ¶40 col. 8:28-29
comprising administering, to a patient in need of treatment for multiple sclerosis, an amount of a pharmaceutical preparation effective for treating multiple sclerosis, The proposed generic product is formulated in 120 mg and 240 mg delayed-release capsules, which are therapeutically effective amounts for administration to patients with multiple sclerosis. ¶5 col. 4:45-50
the pharmaceutical preparation comprising at least one excipient or at least one carrier or at least one combination thereof; As a formulated drug product in capsule form, the accused product necessarily contains pharmaceutical excipients and/or carriers in addition to the active ingredient. ¶5 col. 4:44-45
and dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof. The accused product is described as containing "dimethyl fumarate" as its active pharmaceutical ingredient. ¶5 col. 4:28-30
  • Identified Points of Contention:
    • Scope Questions: A central question may be the proper construction of the term "pharmaceutical preparation." While Claim 1 uses this broad term, the patent specification places significant emphasis on "micro-tablets" or "micro-pellets" as a solution to the problem of gastrointestinal irritation (’001 Patent, col. 5:35-49). This raises the question of whether the claim scope is implicitly limited to such formulations, which could create a potential non-infringement argument for Defendant's "delayed-release capsules."
    • Technical Questions: The complaint does not provide sufficient detail for analysis of specific technical mismatches. An evidentiary question could arise regarding whether the specific combination of excipients and the release profile of the Defendant’s product causes it to function in a way that falls outside the scope of the "pharmaceutical preparation" as claimed and described in the patent.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutical preparation"
  • Context and Importance: The scope of this term is critical to the infringement analysis. Defendant may argue that the repeated and detailed discussion of "micro-tablets" and "micro-pellets" in the specification limits the term "pharmaceutical preparation" to these specific embodiments, especially since they are presented as the solution to a stated problem. Practitioners may focus on this term because its construction could determine whether the claims read on Defendant’s "delayed-release capsules" or are confined to the specific formulations emphasized in the patent's written description.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself uses the broad, unmodified term "pharmaceutical preparation." The doctrine of claim differentiation may suggest that because dependent claims add limitations (e.g., claim 15 recites "microtablets"), the independent claim should be read more broadly. The specification also refers more generally to "tablets, micro-tablets, pellets or granulates" (’001 Patent, col. 4:35-37).
    • Evidence for a Narrower Interpretation: The specification strongly links the invention's success in improving tolerance to the use of "enteric-coated micro-tablets in capsules" (’001 Patent, col. 5:49-54). A defendant could argue that this focus constitutes a disavowal of broader scope or defines the invention. The patent’s detailed working examples exclusively describe preparing "enteric-coated micro-tablets" (’001 Patent, col. 6:24-25, col. 7:1-3), which may be used to argue the inventors viewed this as an essential feature of their invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement.
    • Inducement is alleged based on Defendant’s intent for physicians and patients to use the generic product in an infringing manner, with knowledge and intent established through the product's labeling, which is required to be copied from Tecfidera® and will instruct the patented method of use (Compl. ¶40).
    • Contributory infringement is alleged on the grounds that Defendant’s product is a material part of the invention, is not a staple article of commerce suitable for substantial non-infringing use, and that Defendant knows it will be used to practice the patented method (Compl. ¶41).
  • Willful Infringement: The complaint does not use the term "willful infringement," but it does allege that Defendant received a notice letter and thus has "actual knowledge of the '001 patent" (Compl. ¶34, ¶35). It also requests that the court declare the case "exceptional" under 35 U.S.C. § 285, which provides a basis for seeking enhanced damages and attorneys' fees (Compl., Prayer for Relief ¶6).

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

Given that this is an ANDA case based on a notice pleading, the litigation will almost certainly expand to include defenses not detailed in the complaint. Based on the provided documents, the following questions will likely be central to the dispute:

  1. A core issue will be one of claim construction: Will the term "pharmaceutical preparation" in Claim 1 be interpreted broadly to cover any oral dosage form, or will the court limit its scope to the "micro-tablet" and "micro-pellet" embodiments heavily emphasized in the specification as the solution to a key technical problem?

  2. A key statutory question will be the patent's validity, which is the typical battleground in Hatch-Waxman litigation. The dispositive issue will likely be whether the claimed method of treating multiple sclerosis with a dimethyl fumarate preparation was anticipated or rendered obvious by the prior art existing before the patent's priority date, a defense that Defendant is expected to raise.