DCT
1:18-cv-01361
Biogen Inc v. Windlas Healthcare Pvt Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen International GmbH (Switzerland)
- Defendant: Windlas Healthcare, Pvt. Ltd. (India)
- Plaintiff’s Counsel: Ashby & Geddes; Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
- Case Identification: 1:18-cv-01361, D. Del., 08/31/2018
- Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation and may be sued in any judicial district. The complaint asserts personal jurisdiction based on Defendant’s activities directed at Delaware and the U.S., including the filing of an Abbreviated New Drug Application (ANDA) with the FDA and alleged intent to market generic drugs in the district.
- 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 two patents covering pharmaceutical formulations of dimethyl fumarate and methods of its use for treating multiple sclerosis.
- Technical Context: The technology concerns pharmaceutical compositions, specifically enteric-coated micro-dosage forms of dialkyl fumarates, and their use in treating autoimmune diseases.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 210284 and a subsequent notice letter to Plaintiff. The complaint notes a prior, separate suit involving the same ANDA but a different patent (U.S. Patent No. 8,399,514), which was consolidated into other litigation. The front pages of the asserted patents indicate that terminal disclaimers were filed in 2017, which may limit the patents' enforceable term.
Case Timeline
| Date | Event |
|---|---|
| 1998-11-19 | Priority Date for '376 and '999 Patents |
| 2003-01-21 | U.S. Patent No. 6,509,376 Issued |
| 2008-01-22 | U.S. Patent No. 7,320,999 Issued |
| 2013-03-27 | FDA Approval of Biogen's Tecfidera® (NDA No. 204063) |
| 2017-05-30 | Windlas's First Notice Letter (concerning a non-asserted patent) sent |
| 2018-07-20 | Windlas's Second Notice Letter (concerning '376 and '999 patents) sent |
| 2018-08-31 | Complaint Filed |
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 challenge of treating autoimmune diseases and transplant rejection, noting that conventional immunosuppressive agents can weaken the body's defenses against infection and increase the risk of malignant diseases ('376 Patent, col. 2:56-64).
- The Patented Solution: The invention proposes using dialkyl fumarates formulated into "micro-tablets or micro-pellets" for oral administration ('376 Patent, Abstract). This specific formulation is intended to improve patient tolerance and reduce the gastrointestinal side effects associated with high local concentrations of the active ingredient, thereby providing a more effective modulation of the immune system ('376 Patent, col. 5:30-55).
- Technical Importance: The technology offered a therapeutic approach for autoimmune diseases that aimed to provide the benefits of immunosuppression with a potentially improved safety profile compared to existing therapies like cyclosporine ('376 Patent, col. 2:41-48).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶30).
- Essential elements of Claim 1 include:
- A pharmaceutical preparation in the form of microtablets or micropellets.
- The preparation comprises one or more dialkyl fumarates of a specified chemical formula.
- The preparation is for use in treating autoimmune diseases, including multiple sclerosis.
- The complaint’s use of "at least one claim including at least claim 1" suggests the right to assert other claims is reserved (Compl. ¶30).
U.S. Patent No. 7,320,999 - "Dimethyl Fumarate for the Treatment of Multiple Sclerosis", Issued January 22, 2008
The Invention Explained
- Problem Addressed: As a divisional of the '376 patent, this patent addresses the same general problem of providing effective and well-tolerated treatments for autoimmune diseases, but with a specific focus on multiple sclerosis ('999 Patent, col. 2:27-34).
- The Patented Solution: The invention claims a specific method of treating multiple sclerosis by administering a pharmaceutical preparation where dimethyl fumarate is the "only active ingredient" ('999 Patent, Claim 1). The claims further specify that the preparation can be in the form of enteric-coated microtablets ('999 Patent, Claims 12-13).
- Technical Importance: This patent provides targeted protection for a specific method of using a single compound (dimethyl fumarate) to treat a specific indication (multiple sclerosis), a common strategy to protect a marketed drug product.
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶44).
- Essential elements of Claim 1 include:
- A method of treating multiple sclerosis.
- The method comprises treating a patient with an effective amount of a pharmaceutical preparation.
- The preparation's "only active ingredient" for treating multiple sclerosis is dimethyl fumarate.
- The complaint’s phrasing suggests the right to assert other claims is reserved (Compl. ¶44).
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, as identified in ANDA No. 210284 submitted to the FDA (Compl. ¶27).
Functionality and Market Context
- The complaint alleges that 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, ¶5). The act of infringement alleged is the submission of the ANDA itself, which seeks FDA approval to market these generic products in the United States prior to the expiration of the patents-in-suit (Compl. ¶5, ¶31). The complaint does not provide specific details on the formulation of the accused products beyond their being "delayed-release capsules" (Compl. ¶5).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint provides a high-level notice pleading of infringement without detailed claim charts. The following tables summarize the apparent infringement theories.
'376 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical preparation in the form of microtablets or micropellets | The accused product is a "dimethyl fumarate delayed-release capsule" (Compl. ¶5). Infringement would require that the contents of the capsule meet the definition of "microtablets or micropellets." | ¶31 | col. 4:50-53 |
| comprising one or more dialkyl fumarates... | The accused generic products are alleged to contain 120 mg and 240 mg of dimethyl fumarate, which is a species of dialkyl fumarate. | ¶27 | col. 3:25-27 |
| for use in ... the therapy of autoimmune diseases such as ... multiple sclerosis... | The ANDA seeks approval for a generic version of Tecfidera®, a drug used to treat multiple sclerosis. The proposed product label would therefore be expected to specify this use. | ¶2, ¶5 | col. 2:24-28 |
'999 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 to market a drug for treating multiple sclerosis. The complaint alleges that the product's label will instruct physicians and patients to perform this method, leading to induced infringement. | ¶47 | col. 8:14-15 |
| wherein the only active ingredient for the treatment of multiple sclerosis present in said pharmaceutical preparation is dimethyl fumarate | The accused generic products are alleged to contain dimethyl fumarate (Compl. ¶27). As a generic equivalent to Tecfidera®, it is expected that dimethyl fumarate would be the sole active pharmaceutical ingredient in the formulation. | ¶45 | col. 8:17-20 |
- Identified Points of Contention:
- Technical Questions: A primary question for the '376 Patent is whether the formulation within the Defendant's "delayed-release capsules" constitutes "microtablets or micropellets" as claimed. The complaint does not provide sufficient detail for analysis of the accused product's physical form.
- Scope Questions: The infringement case for the '999 Patent will depend on the content of the proposed drug label. The analysis will focus on whether the instructions for use on the label will direct or encourage physicians and patients to perform the patented method.
V. Key Claim Terms for Construction
The Term:
"microtablets or micropellets"('376 Patent, Claim 1)- Context and Importance: This term defines the physical structure of the claimed composition. The infringement analysis for the '376 Patent will hinge on whether Defendant's formulation, contained within a capsule, falls within the proper construction of this term.
- Intrinsic Evidence for a Broader Interpretation: The claims do not provide an explicit size or manufacturing definition, which could support an interpretation covering various forms of small, granulated, or compacted solid dosage forms.
- Intrinsic Evidence for a Narrower Interpretation: The specification provides examples with specific mean diameters "in the range from 300 to 2,000 µm" ('376 Patent, col. 4:50-53) and details specific manufacturing processes ('376 Patent, Examples 1-2). A party may argue these embodiments limit the term to particles with similar characteristics.
The Term:
"only active ingredient"('999 Patent, Claim 1)- Context and Importance: This limitation is critical for the '999 method patent, as it defines the composition used in the method. Practitioners may focus on this term because if the accused product contains any other substance that could be construed as an "active ingredient," infringement might be avoided.
- Intrinsic Evidence for a Broader Interpretation (of what could be "active"): A defendant could argue that certain excipients in its formulation provide a synergistic or therapeutic effect, thereby qualifying as a second "active ingredient" and taking the product outside the claim's scope.
- Intrinsic Evidence for a Narrower Interpretation (of "active ingredient"): The patent consistently distinguishes the claimed fumarates from "customary carriers and excipients" ('376 Patent, col. 4:40-42, which is part of the '999 specification). This supports a construction aligning with the standard regulatory definition of an active pharmaceutical ingredient (API), which would likely favor the patentee.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant will induce infringement of the '999 Patent. This is based on the allegation that Defendant's product label, which under FDA regulations must be a copy of the Tecfidera® label, will instruct physicians and patients to use the drug in a manner that directly infringes the claimed method (Compl. ¶47). Contributory infringement is also alleged on the basis that the product is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶48).
- Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Defendant has "actual knowledge" of the asserted patents as of its receipt of Plaintiff's notice letter (Compl. ¶29, ¶43). Plaintiff also requests that the case be declared "exceptional" under 35 U.S.C. § 285, which can be based on findings of willfulness or other litigation misconduct (Compl., Prayer for Relief ¶11).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical scope: Can the term
"microtablets or micropellets"from the '376 patent be construed to read on the specific internal formulation of Defendant’s delayed-release capsules? The resolution will depend heavily on claim construction and factual evidence from the ANDA that is not yet public. - A key question of indirect infringement will be central to the '999 patent: Does the proposed product label for the generic drug, by law a substantial copy of the brand-name label, necessarily instruct users to perform the patented method of treating multiple sclerosis, thereby making the generic manufacturer liable for inducing infringement?
- Finally, an underlying issue in this ANDA litigation will be patent validity. While not detailed in the complaint, Defendant's Paragraph IV certification inherently asserts that the patents are invalid or not infringed, raising the question of whether the '376 and '999 patents can withstand challenges based on prior art or enablement, particularly given their prosecution history and terminal disclaimers.