DCT
3:19-cv-05987
Biogen Inc 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: 3:19-cv-05987, D.N.J., 02/15/2019
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Zydus Pharmaceuticals (USA) Inc. is incorporated in New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic dimethyl fumarate capsules constitutes an act of infringement of a patent covering methods of treating multiple sclerosis.
- Technical Context: The technology concerns oral pharmaceutical formulations of dialkyl fumarates for the treatment of autoimmune diseases, specifically multiple sclerosis.
- Key Procedural History: This action follows two previous rounds of litigation between the same parties concerning the same ANDA but involving different patents. The complaint states that those prior suits were dismissed in favor of litigation in the District of Delaware. This case was initiated in response to a third notice letter from the Defendant concerning the patent-in-suit. The asserted patent’s term has been extended by 811 days via Patent Term Extension.
Case Timeline
| Date | Event |
|---|---|
| 1998-11-19 | ’001 Patent Priority Date |
| 2009-11-17 | ’001 Patent Issue Date |
| 2013-03-27 | FDA Approval of New Drug Application for Tecfidera® |
| 2019-02-15 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 7,619,001, “Utilization of Dialkylfumarates,” issued November 17, 2009 (’001 Patent).
- The Invention Explained:
- Problem Addressed: The patent describes a need for therapies for autoimmune diseases and transplant rejections that can avoid the significant side effects associated with then-current immunosuppressive agents, such as cyclosporine. (’001 Patent, col. 2:56-63).
- The Patented Solution: The invention is the use of certain dialkyl fumarates, such as dimethyl fumarate, to prepare pharmaceutical compositions for treating autoimmune diseases, including multiple sclerosis. (’001 Patent, Abstract; col. 4:1-17). The patent describes formulating these compounds into enteric-coated micro-tablets, which are purported to improve patient tolerance by releasing the active ingredient incrementally in the intestine, thereby avoiding high local concentrations that can cause gastrointestinal irritation. (’001 Patent, col. 5:36-55).
- Technical Importance: The technology provided a potential oral treatment for multiple sclerosis with a different mechanism of action and side-effect profile from the injectable and infusion-based therapies common at the time. (’001 Patent, col. 4:47-51).
- Key Claims at a Glance:
- The complaint asserts at least independent claim 1. (Compl. ¶28).
- Essential elements of independent claim 1:
- 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 does not explicitly reserve the right to assert dependent claims but alleges infringement of "at least one claim including at least claim 1." (Compl. ¶28).
III. The Accused Instrumentality
- Product Identification: Defendant’s generic dimethyl fumarate delayed-release capsules, in 120 mg and 240 mg strengths, for which Defendant submitted ANDA No. 210538 to the FDA. (Compl. ¶5).
- Functionality and Market Context: The accused products are generic versions of Plaintiff’s Tecfidera® drug, which is approved for the treatment of relapsing forms of multiple sclerosis. (Compl. ¶¶ 5, 23). As an ANDA product, its proposed use is necessarily the same as the branded drug. (Compl. ¶32). The complaint alleges that upon approval, the Defendant’s generic products will be manufactured, marketed, and sold for this purpose throughout the United States. (Compl. ¶30). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’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, to a patient in need of treatment for multiple sclerosis, | Defendant's ANDA seeks approval to market a generic drug for the treatment of relapsing forms of multiple sclerosis. The product's label will instruct physicians and patients to administer the drug for this purpose. | ¶¶5, 23, 32 | col. 10:28-30 |
| an amount of a pharmaceutical preparation effective for treating multiple sclerosis, | Defendant's ANDA is for 120 mg and 240 mg delayed-release capsules, which are the dosages of the FDA-approved branded drug, Tecfidera®. | ¶5 | col. 10:30-32 |
| the pharmaceutical preparation comprising at least one excipient or at least one carrier or at least one combination thereof; and | The complaint does not provide sufficient detail for analysis of the specific excipients in Defendant's product, though such components are a necessary element of any pharmaceutical capsule. | ¶5 | col. 10:33-35 |
| dimethyl fumarate, methyl hydrogen fumarate, or a combination thereof. | Defendant's ANDA filing is for "generic dimethyl fumarate delayed-release capsules," identifying dimethyl fumarate as the active pharmaceutical ingredient. | ¶5 | col. 10:36-38 |
- Identified Points of Contention:
- Validity vs. Infringement: The complaint alleges that Defendant’s notice letter "did not allege non-infringement as to at least one claim of the '001 patent." (Compl. ¶26). This suggests the primary dispute may center on the validity of the ’001 Patent’s claims (e.g., based on obviousness or lack of written description), rather than on whether the proposed generic product meets the claim limitations.
- Technical Questions: A potential evidentiary question is whether the administration of Defendant's proposed generic product, according to its proposed label, results in a method that is "effective for treating multiple sclerosis" as that term would have been understood by a person of ordinary skill in the art at the time of the invention. In ANDA litigation, this is typically established by the FDA's approval of the branded drug's label, which the generic applicant must copy.
V. Key Claim Terms for Construction
- The Term: "an amount ... effective for treating multiple sclerosis"
- Context and Importance: This term appears in independent claim 1 and links the administration of the drug to a functional outcome. Its construction is important because it defines the required level of therapeutic efficacy. Practitioners may focus on this term if there is a dispute over whether the dosages disclosed in the ANDA achieve the level of "effectiveness" contemplated by the patent, or if the meaning of "treating" itself is contested.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the therapy of "autoimmune diseases" generally, which could support a construction where "effective" means demonstrating any measurable, positive therapeutic effect against the disease. (’001 Patent, col. 4:15-17).
- Evidence for a Narrower Interpretation: The patent’s detailed examples describe specific formulations and dosages, such as capsules containing 120 mg of dimethyl fumarate. (’001 Patent, Example 1, col. 6:25-26). A party could argue that an "effective amount" should be construed in light of these specific embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegation is based on the assertion that Defendant’s product label will, by law, copy the Tecfidera® label and therefore instruct physicians and patients to perform the patented method of treatment. (Compl. ¶32). The contributory infringement allegation is based on the assertion that Defendant's product is a material part of the invention, is specifically labeled for the infringing use, and is not a staple article of commerce suitable for substantial non-infringing use. (Compl. ¶33).
- Willful Infringement: The complaint does not contain a separate count for willfulness. However, it alleges that Defendant has "actual knowledge of the '001 patent" based on its "Third Notice Letter" sent to Plaintiff. (Compl. ¶¶26-27). This allegation of pre-suit knowledge could form the basis for a later claim of willfulness. The prayer for relief also requests a finding that the case is "exceptional" under 35 U.S.C. § 285. (Compl., Prayer for Relief ¶6).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central question appears to be one of patent validity. Given the complaint's allegation that Defendant is not asserting non-infringement, the case will likely turn on Defendant's anticipated invalidity defenses (e.g., obviousness, written description, enablement), which are the common focal point of ANDA litigation.
- Another key issue will be one of indirect infringement and intent. The court will need to determine if the act of filing the ANDA with a proposed label that mirrors the branded drug's instructions is sufficient to establish the specific intent required for induced infringement, particularly in light of the extensive litigation history between the parties.
- Finally, a procedural and remedial question will be the significance of the prior litigation. The court may need to consider whether the history of suits involving the same ANDA and parties affects the analysis of whether this case is "exceptional" for the purposes of awarding attorney fees under 35 U.S.C. § 285.