DCT
1:19-cv-02210
Biogen Inc v. Cipla Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen International GmbH (Switzerland)
- Defendant: Cipla Limited (India) and Cipla USA Inc. (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes
- Case Identification: 1:19-cv-02210, D. Del., 11/27/2019
- Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Cipla USA is a Delaware corporation, and Defendant Cipla Ltd., a foreign corporation, is subject to personal jurisdiction in any U.S. judicial district. The complaint further alleges that Defendants’ Abbreviated New Drug Application (ANDA) filing constitutes an act purposefully directed at Delaware.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an ANDA to market a generic version of the multiple sclerosis drug Tecfidera® constitutes an act of infringement of a patent covering a method of treating multiple sclerosis with dimethyl fumarate.
- Technical Context: The technology concerns pharmaceutical methods for treating autoimmune diseases, specifically using dialkylfumarates like dimethyl fumarate in an oral dosage form.
- Key Procedural History: This action follows a prior lawsuit filed in 2017 by Biogen against Cipla concerning the same ANDA but asserting different patents. The current complaint was filed in response to a second notice letter from Cipla identifying U.S. Patent No. 7,619,001. The patent-in-suit has received 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 of NDA No. 204063 (Tecfidera®) |
| 2017-05-25 | Date of First Notice Letter from Cipla |
| 2017-06-28 | Filing Date of First Suit |
| 2018-04-01 | '001 Patent Original Expiration Date (pre-PTE) |
| 2019-10-18 | Date of Second Notice Letter from Cipla |
| 2019-11-27 | Complaint Filing Date |
| 2020-06-20 | '001 Patent Expiration Date (with PTE) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,619,001 - “Utilization of Dialkylfumarates”
The Invention Explained
- Problem Addressed: The patent describes a need for improved treatments for autoimmune diseases and transplant rejection. It notes that conventional immunosuppressive agents, such as cyclosporine, can cause severe side effects, including kidney damage and an increased risk of malignant diseases, which limits their suitability for long-term therapy (’001 Patent, col. 2:56-59).
- The Patented Solution: The invention proposes the use of dialkyl fumarates, such as dimethyl fumarate, for treating autoimmune diseases like multiple sclerosis (’001 Patent, col. 10:28-34). The specification describes a "positive modulation of the immune system" and specifically discusses formulating the active ingredient in enteric-coated micro-tablets to improve gastrointestinal tolerance by releasing the drug incrementally and avoiding high local concentrations in the intestine (’001 Patent, col. 4:46-50, col. 5:41-54).
- Technical Importance: The technology offered a therapeutic approach for autoimmune diseases with a potentially more favorable side-effect profile compared to existing immunosuppressants, addressing a significant limitation of prior therapies (’001 Patent, col. 2:59-64).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶47).
- The essential elements of independent claim 1 are:
- 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
- Defendants’ proposed generic dimethyl fumarate delayed-release capsules in 120 mg and 240 mg dosages, for which approval is sought under ANDA No. 210305 (Compl. ¶9).
Functionality and Market Context
- The accused products are generic versions of Plaintiff's Tecfidera® product, which is approved for the treatment of relapsing forms of multiple sclerosis (Compl. ¶¶2, 41-42). The complaint alleges that Defendants seek to manufacture and sell these generic products in the U.S. prior to the expiration of the '001 patent (Compl. ¶9). The functionality of the accused product is to deliver a therapeutically effective amount of dimethyl fumarate to a patient.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
Claim Chart Summary
| 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... | Defendants' ANDA seeks approval to market a generic drug for the treatment of relapsing forms of multiple sclerosis. The proposed product label is alleged to instruct physicians and patients to administer the drug for this indication. | ¶¶9, 50 | col. 10:28-34 |
| ...an amount of a pharmaceutical preparation effective for treating multiple sclerosis, the pharmaceutical preparation comprising... dimethyl fumarate... | Defendants' ANDA product is described as delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate, an active ingredient and dosage alleged to be effective for treating multiple sclerosis. | ¶9 | col. 10:35-39 |
Identified Points of Contention
- Scope Questions: The '001 patent specification extensively discusses the benefits of enteric-coated micro-tablet formulations to improve tolerance (’001 Patent, col. 5:9-11, col. 5:41-54). The accused product is identified as "delayed-release capsules" (Compl. ¶9). While asserted claim 1 is broad and not limited to a specific formulation, a question may arise as to whether any differences between the accused product's formulation and the patent's disclosed embodiments are legally significant.
- Technical Questions: As is typical in ANDA litigation involving method-of-use claims, a primary issue will be whether Defendants’ proposed product label would induce infringement. The analysis will focus on whether the label's instructions and indications for use direct physicians and patients to perform each step of the method as recited in the asserted claim (Compl. ¶50).
V. Key Claim Terms for Construction
The Term: "treating multiple sclerosis"
- Context and Importance: The scope of this term is central to the infringement analysis. Its construction will determine whether the specific indications for use on the accused product's proposed label fall within the patent's claimed method. Practitioners may focus on this term to argue whether "treating" is limited to alleviating active symptoms or more broadly includes slowing disease progression or providing prophylactic benefits.
- Intrinsic Evidence for a Broader Interpretation: The specification discusses the use of dialkyl fumarates for the "therapy of autoimmune diseases" generally, which may support a broad interpretation of the therapeutic action (’001 Patent, col. 3:9-14).
- Intrinsic Evidence for a Narrower Interpretation: The patent's working examples detail specific dosages and formulations, which a party could argue implicitly define the scope of what the inventors considered to be effective "treating" under the patent (’001 Patent, Examples 1-4, col. 9:24-10:26).
The Term: "pharmaceutical preparation"
- Context and Importance: Asserted claim 1 does not specify a particular formulation. However, the patent specification repeatedly highlights "micro-tablets" and "micro-pellets," often with an "enteric coating," as a key aspect of the invention that improves tolerance (’001 Patent, col. 5:9-11, col. 5:41-43). The construction of this term is critical to determining if the claim's scope is limited to these disclosed embodiments or if it covers any formulation delivering the active ingredient, including the accused "delayed-release capsules" (Compl. ¶9).
- Intrinsic Evidence for a Broader Interpretation: The plain language of claim 1 does not recite any formulation limitations. Dependent claim 15 adds the limitation "formulated as microtablets," which suggests via the doctrine of claim differentiation that independent claim 1 is not so limited.
- Intrinsic Evidence for a Narrower Interpretation: A party may argue that the specification's consistent emphasis on micro-tablets as the solution to the problem of gastrointestinal irritation should limit the scope of "pharmaceutical preparation" to such disclosed embodiments, potentially reading a limitation from the specification into the claim.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that upon approval, Defendants will "take active steps to encourage the use" of their generic product in an infringing manner through its product labeling, which is required to copy the FDA-approved label for Tecfidera® (Compl. ¶50). The complaint also alleges contributory infringement, asserting that the accused product is a material part of the invention, is not a staple article of commerce, and that Defendants know it will be used to practice the claimed method (Compl. ¶51).
- Willful Infringement: The complaint alleges that Defendants have "actual knowledge of the '001 patent," based on a "Second Notice Letter" that referenced the patent (Compl. ¶¶44-45). Plaintiff also requests that the court declare the case "exceptional" under 35 U.S.C. § 285 in its prayer for relief (Compl. Prayer for Relief ¶6).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be patent validity. In ANDA litigation, a primary defense strategy is to challenge the patent's validity. The case will likely involve disputes over whether the claimed method of treating multiple sclerosis with dimethyl fumarate was obvious or anticipated in light of the prior art existing at the time of the invention.
- A key evidentiary question will be one of induced infringement. Assuming the patent is found valid, the focus will shift to whether the language of the accused product's proposed label, by copying the indications of the branded drug, sufficiently instructs and encourages medical professionals and patients to use the generic drug in a manner that performs all steps of the patented method.