DCT

1:19-cv-00303

Biogen Inc v. Accord Healthcare

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00303, D. Del., 02/12/2019
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant has previously agreed not to contest venue in the District of Delaware for related matters involving the same Abbreviated New Drug Application (ANDA). The complaint further alleges that Defendant’s ANDA filing is directed at Delaware and predicts future marketing and sales activities within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application for a generic version of the multiple sclerosis drug Tecfidera® constitutes an act of infringement of a patent covering a method for treating multiple sclerosis using dimethyl fumarate.
  • Technical Context: The technology concerns a pharmaceutical method of use, specifically the administration of dialkyl fumarates to modulate a patient's immune response for the treatment of autoimmune diseases like multiple sclerosis.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s submission of ANDA No. 210499. The complaint notes that this is the second wave of litigation between the parties concerning this ANDA; a prior consolidated suit in Delaware involved different patents. This specific complaint was filed in response to a "Second Notice Letter" from Defendant, dated December 29, 2018, which certified its ANDA against the patent-in-suit. The patent-in-suit, U.S. Patent No. 7,619,001, was granted an 811-day patent term extension by the U.S. Patent and Trademark Office.

Case Timeline

Date Event
1998-11-19 '001 Patent Priority Date
2009-11-17 '001 Patent Issue Date
2013-03-27 FDA Approval of Tecfidera® (NDA No. 204063)
2018-12-29 Date of Accord's "Second Notice Letter" for '001 Patent
2019-02-12 Complaint Filing Date
2020-06-20 Alleged Expiration Date of '001 Patent (with extension)

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

  • 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 challenge of managing medically undesirable immune system reactions, such as graft rejection in organ transplant patients and the self-attack mechanism in autoimmune diseases ('001 Patent, col. 1:64 - col. 2:41). It notes that existing immunosuppressive therapies carry risks of significant side effects, creating a need for alternative treatments ('001 Patent, col. 2:56-63).
  • The Patented Solution: The invention is directed to the use of dialkyl fumarates, such as dimethyl fumarate, for preparing pharmaceutical compositions to treat autoimmune diseases and manage transplant reactions ('001 Patent, Abstract). The patent suggests these compounds work by modulating the immune system, specifically by causing a "shift of the cytokine pattern of the Th1 type to the cytokine pattern of the Th2 type," which represents a specific mechanism of immunosuppression ('001 Patent, col. 8:10-14).
  • Technical Importance: This method provided a therapeutic approach for autoimmune diseases like multiple sclerosis that could potentially offer a different safety and side-effect profile compared to established immunosuppressants ('001 Patent, col. 8:5-9).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 ('001 Patent).
  • Independent Claim 1 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 carrier; and
      • dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof.
  • The complaint alleges infringement of "at least one claim including at least claim 1," thereby reserving the right to assert dependent claims (Compl. ¶32).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant Accord’s filing of ANDA No. 210499 with the FDA (Compl. ¶5). The ANDA seeks approval to market "generic dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate," which are generic versions of Plaintiff's Tecfidera® product (Compl. ¶5, ¶28).
  • Functionality and Market Context: The filing of the ANDA is an act of statutory infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶33). The ANDA product is designed to be a bioequivalent substitute for Tecfidera®, which is approved for the treatment of relapsing forms of multiple sclerosis (Compl. ¶27). The complaint alleges that Accord’s proposed product labeling will instruct physicians and patients on the infringing use of the drug, as it is required to be substantially a copy of the approved Tecfidera® label (Compl. ¶36).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'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... Accord’s ANDA seeks approval for a product indicated for the treatment of multiple sclerosis, and its proposed label will instruct physicians and patients to administer the drug for that purpose. ¶35, ¶36 col. 4:56
...to a patient in need of treatment for multiple sclerosis... The accused generic product is intended for patients with relapsing forms of multiple sclerosis, mirroring the indication for the brand-name drug Tecfidera®. ¶27, ¶36 col. 4:56
...an amount of a pharmaceutical preparation effective for treating multiple sclerosis... The ANDA product is formulated in 120 mg and 240 mg strengths, which are the approved, effective dosages for treating multiple sclerosis. ¶5 col. 4:45-50
...the pharmaceutical preparation comprising... at least one excipient or at least one carrier... Accord’s ANDA product is a "delayed-release capsule," which is a pharmaceutical preparation that by definition contains excipients and/or carriers in addition to the active ingredient. ¶5 col. 4:45-47
...and dimethyl fumarate... Accord's ANDA explicitly identifies the active pharmaceutical ingredient in its proposed generic product as "dimethyl fumarate." ¶5 col. 4:28-30
  • Identified Points of Contention:
    • Legal Questions: In a Hatch-Waxman case involving a method-of-treatment claim, the central dispute typically revolves around induced infringement. The key question for the court will be whether Accord’s proposed product label is sufficient evidence of its specific intent to encourage physicians to prescribe, and patients to use, the generic drug in a manner that directly infringes the claimed method. The complaint alleges that copying the Tecfidera® label satisfies this requirement (Compl. ¶36).
    • Scope Questions: A potential dispute may arise over the construction of "effective for treating." A defendant could argue that this term requires a specific clinical outcome as defined in the patent's specification, raising the question of whether the patent provides a particular definition of efficacy that must be met for infringement to occur.

V. Key Claim Terms for Construction

  • The Term: "effective for treating"
  • Context and Importance: This term links the administration of the drug to the claimed therapeutic result. Its construction is critical because it defines the required outcome of the infringing method. Practitioners may focus on this term because if the patent defines "effective" with a high or specific standard, it could create an avenue for a non-infringement defense. Conversely, a broad definition may make the claim more susceptible to a validity challenge based on prior art.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification uses general, qualitative language, suggesting that "effective" means providing some level of therapeutic benefit. For example, the patent discusses the object of providing a preparation that may "alleviate or heal diseases" and "treat, especially to suppress, weaken and/or alleviate" immune reactions ('001 Patent, col. 3:21; col. 2:60-63). This language may support a construction where any demonstrable, positive therapeutic effect qualifies as "effective."
    • Evidence for a Narrower Interpretation: The patent discloses specific dosage ranges, such as preparations containing an "amount corresponding to 10 to 300 mg of fumaric acid" ('001 Patent, col. 4:47-50). A party could argue that these specific embodiments implicitly limit the scope of "effective" to administration within or equivalent to these disclosed ranges.

VI. Other Allegations

  • Indirect Infringement: The complaint pleads both induced and contributory infringement. The inducement allegation is based on the assertion that Accord's proposed product label will actively and intentionally instruct physicians and patients to perform the patented method of treating multiple sclerosis (Compl. ¶36). The contributory infringement allegation is based on the assertion that Accord's generic product is a material part of the invention, is not a staple article of commerce suitable for substantial non-infringing use, and is being sold with knowledge that it will be used to practice the patented method (Compl. ¶37).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Accord has "actual knowledge of the '001 patent" as a result of its own Notice of Certification letter (Compl. ¶31). This allegation of pre-suit knowledge, combined with the request that the court declare the case "exceptional" and award attorney fees, lays the groundwork for a future argument of willful or egregious conduct (Compl. Prayer for Relief ¶6).

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

  • A central issue will be one of induced infringement: Does Accord's act of filing an ANDA with a proposed label that mirrors the label for Tecfidera®—instructing its use for treating multiple sclerosis—provide sufficient evidence of specific intent to induce infringement of the method claimed in the '001 patent, as required under 35 U.S.C. § 271(b)?
  • The case will also likely involve a significant question of patent validity (though not detailed in the complaint itself). Can the method of treating multiple sclerosis with a known compound, dimethyl fumarate, survive challenges of anticipation or obviousness? The ultimate outcome will depend on whether the claimed method was disclosed or suggested in the prior art before the patent's priority date.