DCT
1:17-cv-00855
Biogen Intl GmbH v. Pharmathen SA
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biogen International GmbH (Switzerland) and Biogen MA Inc. (Massachusetts)
- Defendant: Pharmathen S.A. (Greece)
- Plaintiff’s Counsel: Ashby & Geddes; Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
- Case Identification: 1:17-cv-00855, D. Del., 06/28/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation (organized in Greece) and may be sued in any judicial district. The complaint asserts personal jurisdiction in Delaware based on Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA, which allegedly constitutes a formal act purposefully directed at Delaware and predicts future marketing and sales activities within the district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff’s Tecfidera® product constitutes an act of infringement of six U.S. patents related to dimethyl fumarate formulations and methods for treating multiple sclerosis.
- Technical Context: The technology concerns pharmaceutical compositions of dimethyl fumarate, an oral therapeutic used to treat relapsing forms of multiple sclerosis, a chronic autoimmune disease affecting the central nervous system.
- Key Procedural History: The action arises under the Hatch-Waxman Act, triggered by Defendant’s filing of ANDA No. 210436 and its associated Notice Letter to Plaintiff dated June 9, 2017. The complaint does not reference prior litigation or post-grant proceedings. Public records indicate that terminal disclaimers were filed for U.S. Patent Nos. 6,509,376 and 7,320,999, which may limit their effective patent terms to align with other patents in the family.
Case Timeline
| Date | Event |
|---|---|
| 1998-11-19 | Earliest Priority Date ('376, '999, '001, '840, '393 Patents) |
| 2003-01-21 | '376 Patent Issued |
| 2007-02-08 | Priority Date ('514 Patent) |
| 2008-01-22 | '999 Patent Issued |
| 2009-11-17 | '001 Patent Issued |
| 2010-09-28 | '840 Patent Issued |
| 2013-03-19 | '514 Patent Issued |
| 2013-03-27 | FDA Approved Tecfidera® (NDA No. 204063) |
| 2014-06-24 | '393 Patent Issued |
| 2017-06-09 | Defendant Sent Notice Letter to Plaintiff |
| 2017-06-28 | 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 significant risks associated with conventional immunosuppressive agents used to treat autoimmune diseases and prevent transplant rejection, including a weakened immune system and an increased risk of malignant diseases (’376 Patent, col. 2:56-59).
- The Patented Solution: The invention is a pharmaceutical preparation containing dialkyl fumarates formulated into "micro-tablets or micro-pellets" (’376 Patent, col. 8:1-3). This formulation is designed to reduce gastrointestinal side effects by avoiding the high local concentrations of the active ingredient that occur with conventional tablets, instead distributing the release over a larger area of the intestine (’376 Patent, col. 5:30-52).
- Technical Importance: This formulation technology sought to enable the therapeutic use of fumaric acid derivatives for serious autoimmune conditions by improving their tolerability and safety profile compared to previous formulations and other systemic therapies (’376 Patent, col. 3:20-30).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶30).
- 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 including suitable carriers and excipients;
- For use in treating autoimmune diseases, including multiple sclerosis.
U.S. Patent No. 7,320,999 - "Dimethyl Fumarate for the Treatment of Multiple Sclerosis"
- Issued: January 22, 2008
The Invention Explained
- Problem Addressed: The patent addresses the same problem as its parent '376 Patent: the need for a treatment for autoimmune diseases, such as multiple sclerosis, that avoids the significant disadvantages of conventional immunosuppression (’999 Patent, col. 2:55-64).
- The Patented Solution: Rather than claiming the formulation itself, this patent claims a method of treating multiple sclerosis. The claimed method involves administering a pharmaceutical preparation where dimethyl fumarate is the "only active ingredient" for the treatment of the disease (’999 Patent, col. 8:15-20). The specification describes the same benefits of using micro-tablet or micro-pellet formulations to improve patient tolerance as the parent patent (’999 Patent, col. 5:29-54).
- Technical Importance: This patent shifts the focus from the composition to the specific therapeutic application, aiming to protect the use of a monotherapy of dimethyl fumarate for treating multiple sclerosis.
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶44).
- The essential elements of claim 1 are:
- A method of treating multiple sclerosis;
- Comprising treating a patient with an effective amount of a pharmaceutical preparation;
- Wherein the only active ingredient for treating multiple sclerosis in the preparation is dimethyl fumarate.
U.S. Patent No. 7,619,001 - "Utilization of Dialkylfumarates"
- Patent Identification: U.S. Patent No. 7,619,001, issued November 17, 2009.
- Technology Synopsis: This patent claims a method of treating multiple sclerosis by administering a pharmaceutical preparation that comprises both dimethyl fumarate and its metabolite, methyl hydrogen fumarate, addressing the in-vivo conversion of the drug (’001 Patent, col. 8:30-36).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶59).
- Accused Features: The complaint alleges that Defendant’s generic dimethyl fumarate product will, upon administration, necessarily practice the claimed method of treatment (Compl. ¶58, ¶60).
U.S. Patent No. 7,803,840 - "Utilization of Dialkylfumarates"
- Patent Identification: U.S. Patent No. 7,803,840, issued September 28, 2010.
- Technology Synopsis: This patent claims a method for treating a specific set of autoimmune diseases, including multiple sclerosis, where the only active ingredient administered for the condition is dimethyl fumarate, similar to the '999 Patent but with a slightly different scope of recited diseases (’840 Patent, col. 8:30-41).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶74).
- Accused Features: The complaint alleges that Defendant’s generic product, when used as directed by its label for treating multiple sclerosis, will infringe the claimed method (Compl. ¶73, ¶75).
U.S. Patent No. 8,759,393 - "Utilization of Dialkylfumarates"
- Patent Identification: U.S. Patent No. 8,759,393, issued June 24, 2014.
- Technology Synopsis: This patent claims a specific pharmaceutical preparation in the form of enteric-coated microtablets where the active ingredient consists of dimethyl fumarate. This narrows the scope of the earlier '376 Patent by excluding other dialkyl fumarates and explicitly requiring an enteric coating (’393 Patent, col. 8:43-51).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶89).
- Accused Features: The complaint alleges that Defendant’s generic dimethyl fumarate delayed-release capsules meet the limitations of the claimed preparation (Compl. ¶88, ¶89).
U.S. Patent No. 8,399,514 - "Treatment for Multiple Sclerosis"
- Patent Identification: U.S. Patent No. 8,399,514, issued March 19, 2013.
- Technology Synopsis: This patent is directed to a specific dosage regimen, claiming a method of treating multiple sclerosis by orally administering a pharmaceutical composition that provides about 480 mg per day of dimethyl fumarate, monomethyl fumarate, or a combination thereof (’514 Patent, col. 28:57-65).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶102).
- Accused Features: The complaint alleges that Defendant’s product, which will be dosed according to the approved label for Tecfidera®, infringes this claimed dosage method (Compl. ¶101, ¶103).
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed generic "dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate," which is the subject of ANDA No. 210436 (Compl. ¶6, ¶26).
Functionality and Market Context
- The accused product is a generic equivalent of Plaintiff’s branded drug, Tecfidera®, and is intended for the same therapeutic use: the treatment of relapsing forms of multiple sclerosis (Compl. ¶3, ¶24). By filing an ANDA, Defendant seeks FDA approval to market its product as a bioequivalent and substitutable alternative to Tecfidera® before the expiration of the patents-in-suit (Compl. ¶6).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,509,376 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... | Defendant's ANDA product is a pharmaceutical preparation alleged to infringe this claim. The specific form is not detailed in the complaint. | ¶30 | col. 5:9-12 |
| ...comprising one or more dialkyl fumarates of the formula... | Defendant's product contains dimethyl fumarate, which is a species of the claimed dialkyl fumarates. | ¶26 | col. 4:15-28 |
| ...for use in... the therapy of autoimmune diseases such as... multiple sclerosis... | Defendant seeks approval to market its product for treating multiple sclerosis, mirroring the indication for Tecfidera®. | ¶24, ¶30 | col. 3:55-59 |
Identified Points of Contention
- Scope Questions: A central question for the '376 patent will be whether Defendant’s "delayed-release capsules" meet the claim limitation "in the form of microtablets or micropellets." The analysis will depend on the physical composition of the capsule's contents, which is not described in the complaint.
U.S. Patent No. 7,320,999 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating multiple sclerosis comprising treating a patient... with an amount of a pharmaceutical preparation... | The label for Defendant's product will instruct physicians and patients to administer the drug to treat multiple sclerosis. | ¶45, ¶46 | col. 8:15-17 |
| ...wherein the only active ingredient for the treatment of multiple sclerosis present in said pharmaceutical preparation is dimethyl fumarate. | Defendant's product is identified as containing dimethyl fumarate, and as a generic equivalent, it is not expected to contain other active ingredients for MS. | ¶26 | col. 8:17-20 |
Identified Points of Contention
- Technical Questions: For the '999 patent, infringement is contingent on the actions of physicians and patients following the product's label. The key question will be whether the instructions on that label, once approved, will direct users to perform all steps of the claimed method.
V. Key Claim Terms for Construction
The Term: "microtablets or micropellets" ('376 Patent, claim 1; '393 Patent, claim 1)
- Context and Importance: The definition of this term is critical to the infringement analysis for the asserted composition patents. If Defendant's formulation does not meet this structural limitation (e.g., if it is an enteric-coated powder or granule that falls outside the scope of the term), there may be no literal infringement of these claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition that limits the term's scope. A party may argue that it should encompass any small, unit-dosed solid forms within a capsule designed to achieve the specification's stated goal of distributing the active ingredient.
- Evidence for a Narrower Interpretation: The specification provides detailed examples for producing "convex tablets having a gross weight of 10.0 mg and a diameter of 2.0 mm" (’376 Patent, col. 6:29-32) and for preparing "micro-pellets" by coating nonpareil beads (’376 Patent, col. 7:12-25). A party may argue these examples define the term’s scope, limiting it to discrete, manufactured solid units rather than less structured forms like coated granules or powders.
The Term: "about 480 mg per day" ('514 Patent, claim 1)
- Context and Importance: This term defines the dosage regimen. The infringement analysis for the '514 patent will turn on whether the dosing instructions on Defendant's proposed label fall within the scope of "about 480 mg."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the word "about" suggests the claim is not limited to exactly 480 mg per day and encompasses a range of values close to it. The patent specification does not define the bounds of "about."
- Evidence for a Narrower Interpretation: While "about" allows for some flexibility, a party may argue that the range should be narrow, particularly if the prior art discloses similar but distinct dosages. The prosecution history, though not provided in the complaint, may contain statements that limit the scope of this term.
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced and contributory infringement for all asserted method claims ('999, '001, '840, and '514 patents). The basis for these allegations is that Defendant, by law, must copy the FDA-approved labeling for Tecfidera®, which allegedly instructs physicians and patients to use the generic product in a manner that directly infringes the method claims (Compl. ¶46, ¶61, ¶76, ¶104). The complaint further alleges that the dimethyl fumarate delayed-release capsules are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶47, ¶62, ¶77, ¶105).
Willful Infringement
- The complaint does not contain a formal count for willful infringement. However, it alleges that Defendant has had "actual knowledge" of each patent-in-suit since receiving a Notice Letter on June 9, 2017 (Compl. ¶28, ¶42, ¶57, ¶72, ¶87, ¶100). This allegation establishes a basis for potential future claims of post-suit willful infringement. The prayer for relief also requests the case be declared "exceptional" under 35 U.S.C. § 285, which is often associated with findings of willfulness or litigation misconduct (Request for Relief, ¶31).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of formulation scope: do the contents of Defendant’s "delayed-release capsules," as specified in its ANDA, meet the structural limitation of "microtablets or micropellets" required by key composition claims in the '376 and '393 patents? The case may turn on whether the accused product contains discrete, manufactured solid units or a formulation that falls outside a proper construction of that term.
- A second central question will be one of methodological scope: does the proposed label for the generic product, by instructing a specific dosage and use for treating multiple sclerosis, induce infringement of the various method claims? This will involve a careful mapping of the label's instructions to the elements of claims covering the method of use ('999, '840 patents), the in-vivo metabolic process ('001 patent), and the specific daily dosage ('514 patent).