DCT
3:18-cv-08323
Biogen Intl GmbH v. Cadila Healthcare
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen International GmbH (Switzerland)
- Defendant: Zydus Pharmaceuticals (USA) Inc. (New Jersey)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 3:18-cv-08323, D.N.J., 04/25/2018
- Venue Allegations: Venue is asserted on the basis that Defendant is incorporated in New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) for a generic version of the multiple sclerosis drug Tecfidera® constitutes an act of infringement of a patent covering specific pharmaceutical formulations.
- Technical Context: The technology relates to oral dosage formulations of dialkyl fumarates, specifically dimethyl fumarate, for the treatment of autoimmune diseases.
- Key Procedural History: The complaint notes that this action follows prior litigation between the parties concerning the same ANDA but different patents (U.S. Patent Nos. 8,399,514 and 7,320,999). This suit was initiated in response to a second notice letter from the Defendant identifying U.S. Patent No. 6,509,376. The asserted patent includes a one-year interim term extension.
Case Timeline
| Date | Event |
|---|---|
| 1998-11-19 | U.S. Patent No. 6,509,376 Priority Date |
| 2003-01-21 | U.S. Patent No. 6,509,376 Issued |
| 2013-03-27 | FDA Approval of NDA No. 204063 (Tecfidera®) |
| 2017-06-01 | Zydus sends First Notice Letter regarding '514 and '999 patents |
| 2017-06-30 | Biogen files First New Jersey Suit against Zydus |
| 2017-07-14 | Biogen files First Delaware Suit against Zydus |
| 2018-03-12 | Zydus sends Second Notice Letter regarding '376 patent |
| 2018-04-25 | Complaint Filed |
| 2019-04-01 | '376 Patent Expiration Date (including interim extension) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,509,376 - “Utilization of Dialkyfumarates,”
- Issued: January 21, 2003
The Invention Explained
- Problem Addressed: The patent describes the significant side effects associated with existing therapies for autoimmune diseases and organ transplantation, including the risks of infection and malignancy from conventional immunosuppressive agents ('376 Patent, col. 2:55-64). It also notes that prior attempts to use fumaric acid derivatives for such treatments were hampered by severe side effects and toxicity, leading to their abandonment ('376 Patent, col. 3:25-30).
- The Patented Solution: The invention is a pharmaceutical preparation of dialkyl fumarates formulated as "micro-tablets or micro-pellets," which may be enterically coated and placed inside capsules ('376 Patent, col. 3:34-38; col. 4:50-52). This formulation is designed to improve patient tolerance by avoiding high local concentrations of the active ingredient in the intestine, which the patent suggests is a cause of gastrointestinal side effects ('376 Patent, col. 5:36-44).
- Technical Importance: The technology proposed a way to deliver the therapeutic benefits of fumaric acid derivatives for autoimmune diseases while mitigating the previously prohibitive side effects, offering a potentially more tolerable long-term treatment option.
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶26).
- The essential elements of independent claim 1 are:
- A pharmaceutical preparation in the form of microtablets or micropellets;
- Comprising one or more dialkyl fumarates of a specified chemical formula;
- Optionally including suitable carriers and excipients;
- For use in the therapy of enumerated autoimmune diseases, including multiple sclerosis and psoriasis.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendant’s generic drug products containing 120 mg and 240 mg of dimethyl fumarate in delayed-release capsules, for which Defendant seeks FDA approval via ANDA No. 210538 (Compl. ¶¶5, 22).
Functionality and Market Context
- The product is a generic equivalent of Plaintiff’s branded drug, TECFIDERA®, intended for the treatment of relapsing forms of multiple sclerosis (Compl. ¶¶20, 21). The filing of ANDA No. 210538 is a statutory act of infringement that allows the patent holder to litigate its patent rights before the generic product enters the market (Compl. ¶5). The complaint alleges that the products described in the ANDA will infringe upon approval and commercialization (Compl. ¶26).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
Claim Chart Summary
- The complaint is a notice-pleading and does not contain a detailed claim chart. The infringement theory, based on the complaint’s allegations, is summarized below.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical preparation in the form of microtablets or micropellets... | The complaint alleges on information and belief that the generic products described in ANDA No. 210538 are or contain a preparation that meets this limitation. | ¶26 | col. 8:8-10 |
| comprising one or more dialkyl fumarates of the formula... | The accused ANDA products contain dimethyl fumarate, which is a species of dialkyl fumarate covered by the claimed formula. | ¶22 | col. 8:11-20 |
| for use in ... the therapy of autoimmune diseases such as ... multiple sclerosis... | The accused ANDA products are intended for the treatment of relapsing forms of multiple sclerosis, an indication covered by the claim. | ¶20, ¶22 | col. 8:22-28 |
Identified Points of Contention
- Scope Questions: A primary dispute may arise over the proper construction of the claim phrase "pharmaceutical preparation in the form of microtablets or micropellets." The key question is whether this limitation reads on a final dosage form of a "delayed-release capsule" (Compl. ¶19) that contains microtablets or micropellets, or if it is restricted to a preparation where the microtablets/micropellets are the final form administered to the patient.
- Technical Questions: A central evidentiary question for the court will be whether the physical composition of Defendant’s ANDA product, once revealed in discovery, actually contains structures that fall within the scope of "microtablets or micropellets" as that term is construed. The complaint does not provide specific factual detail regarding the internal structure of Defendant's proposed capsules.
V. Key Claim Terms for Construction
- The Term: "in the form of microtablets or micropellets"
- Context and Importance: This term is the central structural limitation of the asserted claim and appears to be the most likely point of non-infringement or invalidity arguments. Infringement will depend on whether the Defendant's formulation, described as "delayed-release capsules" (Compl. ¶19), meets this definition. Practitioners may focus on this term because the patent's contribution over the prior art appears tied to this specific formulation for improving drug tolerance.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification explicitly contemplates that these preparations can be part of a larger dosage form. It states that "Preparations in the form of micro-tablets or pellets, optionally filled in capsules or sachets are preferred" ('376 Patent, col. 3:34-36). Example 1 further describes a process where "enteric-coated micro-tablets are filled into hard gelatine capsules" ('376 Patent, col. 4:50-52). This language may support a construction where a capsule containing micro-tablets is an embodiment of the claimed "preparation."
- Evidence for a Narrower Interpretation: The claim preamble itself recites "A pharmaceutical preparation in the form of microtablets or micropellets" ('376 Patent, col. 8:8-10). A party could argue this phrase defines the essential character of the preparation itself, not a component within a different form (i.e., a capsule). The specification also provides size ranges for the pellets/micro-tablets (e.g., "in the range from 300 to 2,000 μm" ('376 Patent, col. 3:49-52)), which could be used to argue that the term has a specific, limited structural meaning that the accused product may not meet.
VI. Other Allegations
Indirect Infringement
- The complaint makes a general allegation of induced and contributory infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶25). The factual basis for inducement would likely be Defendant’s act of filing an ANDA with a proposed label that instructs medical professionals and patients on an infringing use (i.e., treating multiple sclerosis), thereby encouraging infringement by others.
Willful Infringement
- The complaint does not use the term "willful," but it alleges that Defendant has "actual knowledge of the '376 patent" as a result of receiving a notice letter (Compl. ¶24). Plaintiff also requests that the court "declare this to be an exceptional case" under 35 U.S.C. § 285, which provides a basis for seeking attorney fees (Compl., Prayer for Relief ¶6).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: Can the limiting phrase "pharmaceutical preparation in the form of microtablets or micropellets" be construed to cover a finished dosage form of a capsule that contains such micro-tablets/micropellets, or does the claim require the preparation itself to be in that form? The patent's own examples describing filling capsules with micro-tablets will be central to this inquiry.
- The case will also depend on a question of factual infringement: Assuming a claim construction, does the physical formulation of Defendant's generic product, as specified in its confidential ANDA, actually contain structures that meet the definition of "microtablets or micropellets"? The outcome of the case may hinge on technical evidence and expert testimony concerning the exact nature of the accused formulation.