DCT
1:17-cv-01361
Biogen Intl GmbH v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen International GmbH (Switzerland)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes
- Case Identification: 1:17-cv-01361, D. Del., 09/27/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic version of the multiple sclerosis drug Tecfidera® constitutes an act of infringement of two patents covering pharmaceutical formulations of dimethyl fumarate and methods of its use.
- Technical Context: The technology concerns oral pharmaceutical formulations for treating autoimmune diseases, specifically multiple sclerosis, a significant neurodegenerative disorder.
- Key Procedural History: The complaint states that this lawsuit follows a "Second Notice Letter" from Teva regarding its ANDA. It is related to a "First Suit" (1:17-cv-00829-LPS) filed by Biogen against Teva in the same court based on an earlier notice letter concerning the same ANDA and patents. Plaintiff notes its intent to seek consolidation of the two cases.
Case Timeline
| Date | Event |
|---|---|
| 1998-11-19 | Priority Date for ’376 and ’999 Patents |
| 2003-01-21 | ’376 Patent Issued |
| 2008-01-22 | ’999 Patent Issued |
| 2013-03-27 | FDA Approved NDA No. 204063 for Tecfidera® |
| 2017-05-23 | Teva's First Notice Letter Sent to Biogen |
| 2017-06-26 | First Suit (1:17-cv-00829) Filed |
| 2017-08-18 | Teva's Second Notice Letter Sent to Biogen |
| 2017-09-27 | Complaint Filing Date |
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 challenge of managing immunologically-driven conditions like autoimmune diseases and transplant rejection. It notes that conventional immunosuppressive agents can weaken the body's defenses against infection and increase the risk of malignant diseases (’376 Patent, col. 2:56-59).
- The Patented Solution: The invention claims a pharmaceutical preparation for these conditions using dialkyl fumarates formulated as "micro-tablets or micro-pellets," which may be enterically coated (’376 Patent, Claim 1). This formulation is described as improving patient tolerance by releasing the active ingredient in smaller dosages within the intestine, thereby avoiding the high local concentrations that can cause gastrointestinal irritation and other side effects (’376 Patent, col. 5:30-55).
- Technical Importance: The technology aimed to provide a therapeutic option for serious autoimmune conditions with a potentially more favorable side-effect profile compared to existing powerful immunosuppressants like cyclosporine (’376 Patent, col. 2:60-64).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶36).
- The essential elements of 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 with suitable carriers and excipients
- for use in transplantation medicine or for the therapy of autoimmune diseases, including multiple sclerosis.
- The complaint reserves the right to assert additional claims (Compl. ¶36).
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 application leading to the ’376 Patent, this patent addresses the same need for effective and well-tolerated treatments for autoimmune diseases, but focuses specifically on multiple sclerosis (’999 Patent, col. 2:31-38).
- The Patented Solution: The invention is a specific method of treating multiple sclerosis by administering a pharmaceutical preparation where dimethyl fumarate is the "only active ingredient" (’999 Patent, Claim 1). This narrows the broader teachings of the parent patent to a targeted therapeutic method using a single specified compound for a single disease. The benefits of the micro-tablet formulation described in the parent patent are incorporated by reference and apply to this method of use (’999 Patent, col. 5:29-54).
- Technical Importance: The invention provides a targeted method of use for a specific active ingredient (dimethyl fumarate) to treat multiple sclerosis, an area with significant unmet medical need at the time.
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶50).
- The essential elements of Claim 1 are:
- A method of treating multiple sclerosis
- comprising treating a patient in need of such treatment
- with an effective amount of a pharmaceutical preparation
- wherein the only active ingredient for treating multiple sclerosis in the preparation is dimethyl fumarate.
- The complaint reserves the right to assert additional claims (Compl. ¶50).
III. The Accused Instrumentality
- Product Identification: Defendant Teva’s proposed generic dimethyl fumarate delayed-release capsules in 120 mg and 240 mg strengths, as described in its Abbreviated New Drug Application (ANDA) No. 210290 (Compl. ¶¶ 5, 33).
- Functionality and Market Context: The accused product is a generic version of Biogen’s branded drug, Tecfidera®, and is intended for the treatment of relapsing forms of multiple sclerosis (Compl. ¶¶ 2, 5). Under the Hatch-Waxman Act, Teva's ANDA filing is a technical act of infringement that allows for adjudication of the patents before the generic product enters the market (Compl. ¶¶ 5, 37). The ANDA product is required by regulation to have the same active ingredient, dosage form, and labeling as Tecfidera® (Compl. ¶53). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’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 | Teva’s ANDA describes generic "dimethyl fumarate delayed-release capsules," which the complaint alleges infringe this limitation. | ¶¶ 33, 37 | col. 4:34-40 |
| comprising one or more dialkyl fumarates | Teva’s ANDA product contains dimethyl fumarate, which is a species of dialkyl fumarate. | ¶33 | col. 3:25-28 |
| for use in...therapy of autoimmune diseases such as...multiple sclerosis | Teva’s ANDA product is intended for the treatment of relapsing forms of multiple sclerosis and its label will reflect this indication. | ¶¶ 5, 31, 53 | col. 2:65-col. 3:3 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether Teva's specific formulation, as detailed in its confidential ANDA submission, constitutes "microtablets or micropellets" as that term is used and defined in the patent. The patent provides size ranges (e.g., 300 to 2,000 µm) and manufacturing examples that may be used to argue for a specific construction of the term (’376 Patent, col. 3:49-53).
- Technical Questions: The complaint pleads infringement both literally and under the doctrine of equivalents (Compl. ¶37). This suggests a potential dispute over whether Teva's formulation, including its excipients and release mechanism, is structurally identical to the claimed invention or merely performs the same function in substantially the same way to achieve the same result.
’999 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating multiple sclerosis | Teva’s product is a generic version of Tecfidera®, a drug for multiple sclerosis. Teva's product label will allegedly instruct physicians and patients to use the drug for this purpose. | ¶¶ 52, 53 | col. 4:55-58 |
| wherein the only active ingredient...is dimethyl fumarate | Teva’s ANDA is for a product whose sole active ingredient is identified as dimethyl fumarate. | ¶33 | Claim 1 |
- Identified Points of Contention:
- Scope Questions: The interpretation of "only active ingredient" will be critical. The dispute may focus on whether any of the excipients in Teva’s formulation could be characterized as having a therapeutic or "active" effect, which would place the product outside the literal scope of the claim.
- Technical Questions: As this is a method claim, infringement will be indirect. The primary evidence will be Teva's proposed product label. The key question is whether the instructions on that label will inevitably lead physicians and patients to perform each step of the claimed method (Compl. ¶¶ 52, 53).
V. Key Claim Terms for Construction
The Term:
"microtablets or micropellets"(’376 Patent, Claim 1)Context and Importance: This term defines the core physical structure of the claimed pharmaceutical composition. Whether Teva’s product embodies this structure will be a primary issue for determining infringement of the ’376 patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification presents micro-tablets and pellets as preferred forms for oral administration, alongside conventional tablets and granulates, suggesting the term could be interpreted functionally to mean any small, pelletized form designed to improve gastrointestinal tolerance (’376 Patent, col. 3:31-33).
- Evidence for a Narrower Interpretation: The patent provides specific embodiments, including a "preferred embodiment" where the mean diameter of the pellets or micro-tablets is "in the range from 300 to 2,000 µm," and provides detailed manufacturing examples. A party could argue the term should be limited by these specific disclosures (’376 Patent, col. 3:49-53; Examples 1 & 2).
The Term:
"only active ingredient"(’999 Patent, Claim 1)Context and Importance: This limitation is potentially case-dispositive for the ’999 patent. If Teva’s product can be shown to contain any other component that qualifies as an "active ingredient," it would not infringe this method claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (of what constitutes an "active ingredient"): A defendant might argue that an excipient that materially affects the drug's bioavailability or has a synergistic therapeutic effect could be considered an "active ingredient" in the context of the claim, even if not classified as such by the FDA. The patent does not provide an explicit definition.
- Evidence for a Narrower Interpretation (of what constitutes an "active ingredient"): A plaintiff would likely argue that in the context of pharmaceutical patents, "active ingredient" has a well-understood meaning: the substance responsible for the primary therapeutic effect, as designated in regulatory filings. Other components are "excipients," which are by definition inert or used to facilitate drug delivery.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced infringement (35 U.S.C. § 271(b)) and contributory infringement (35 U.S.C. § 271(c)) of the ’999 patent. The factual basis for inducement is that Teva’s product label will instruct physicians and patients to use the generic drug to treat multiple sclerosis, with Teva’s knowledge and intent that this use infringes (Compl. ¶53). The basis for contributory infringement is that Teva's product is a material part of the invention, not a staple commodity suitable for substantial non-infringing use (Compl. ¶54).
- Willful Infringement: The complaint alleges that Teva has "actual knowledge" of the patents-in-suit as a result of the notice letters it sent to Biogen (Compl. ¶¶ 35, 49). While not using the term "willful," this allegation of pre-suit knowledge, combined with the request for a declaration of an "exceptional case" under 35 U.S.C. § 285, lays a foundation for a potential future claim for enhanced damages (Prayer for Relief, ¶11).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term
"microtablets or micropellets", as described in the ’376 patent with specific size ranges and examples, be construed to read on the specific formulation of Teva’s proposed generic product as detailed in its ANDA? - A second key question will involve the exclusivity of the active ingredient: for the ’999 patent, the case will turn on whether
"only active ingredient"is strictly limited to the FDA-designated active pharmaceutical ingredient (dimethyl fumarate), or if Teva can argue that one of its chosen excipients has a functional effect that qualifies it as a second "active ingredient" for claim construction purposes, thus avoiding infringement. - Finally, a central evidentiary question for the ’999 patent’s method claim will be one of induced infringement: does Teva’s proposed product label, which by law must largely mirror the brand-name label, contain instructions that will necessarily and intentionally cause physicians and patients to practice every element of the claimed method of treatment?