Details for Patent: 11,007,167

Which drugs does patent 11,007,167 protect, and when does it expire?

Patent 11,007,167 protects TECFIDERA and is included in one NDA.

This patent has thirty-seven patent family members in thirteen countries.

Summary for Patent: 11,007,167

Title:	Methods of treating multiple sclerosis
Abstract:	Provided herein are methods of treating multiple sclerosis with a fumarate, wherein the fumarate is a dialkyl fumarate, a monoalkyl fumarate, a combination of a dialkyl fumarate and a monoalkyl fumarate, a prodrug of monoalkyl fumarate, a deuterated form of any of the foregoing, or a pharmaceutically acceptable salt, clathrate, solvate, tautomer, or stereoisomer of any of the foregoing, or a combination of any of the foregoing. The methods provided herein improve the safety of treatment by informing and monitoring patients undergoing treatment regarding progressive multifocal leukoencephalopathy, and/or by monitoring lymphocyte count.
Inventor(s):	Mark Novas, Rui (Ray) Zhang
Assignee:	Biogen MA Inc
Application Number:	US17/071,740
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 11,007,167: Claim Scope, Tecfidera Exclusivity, Litigation Risk, and Patent Landscape

U.S. Patent No. 11,007,167 is a Biogen method-of-treatment patent directed to safety monitoring for fumarate therapy in multiple sclerosis. Its independent claim requires a specific treatment protocol: administration of dimethyl fumarate (DMF), monomethyl fumarate (MMF), or both; scheduled complete blood counts and lymphocyte monitoring; treatment interruption after prolonged severe lymphopenia; and monitoring for progressive multifocal leukoencephalopathy (PML).

The patent does not broadly claim DMF, MMF, fumarate chemistry, or the treatment of multiple sclerosis alone. Its commercial significance is concentrated in labeled use of Tecfidera and generic DMF products, particularly where product labeling instructs healthcare professionals to follow the claimed monitoring and interruption protocol.

What does U.S. Patent 11,007,167 protect?

The patent protects a cumulative clinical-management protocol for a patient with multiple sclerosis. Claim 1 requires every one of the following elements:

Required element	Claim limitation
Disease	Patient has multiple sclerosis
Active ingredient	DMF, MMF, or a combination of DMF and MMF
Composition exclusions	No fumarate salt and no additional fumarate
Monitoring timing	CBC, including lymphocyte count, after six months of repeated administration
Ongoing monitoring	CBC every six to 12 months thereafter
Treatment interruption	Interrupt administration if lymphocyte count is below 0.5 × 10^9/L for more than six months
Neurologic safety monitoring	Monitor for a sign or symptom suggestive of PML

The claim is narrow in subject matter but commercially relevant because the claimed monitoring language tracks important Tecfidera prescribing information. The claim is not limited to Biogen-branded Tecfidera. On its face, it covers a qualifying method performed with any pharmaceutical composition containing the specified fumarate active ingredients.

What products fall within the claim?

The principal product within the commercial scope is oral delayed-release DMF, including Tecfidera and generic DMF capsules. The dependent claims also expressly cover:

• DMF and MMF combinations;
• DMF alone;
• MMF alone;
• oral administration;
• total fumarate dosing of no more than 480 mg daily;
• DMF at 240 mg twice daily;
• DMF titration at 120 mg twice daily for seven days, followed by 240 mg twice daily;
• specified neurologic symptoms associated with PML;
• withholding treatment and conducting diagnostic evaluation for PML; and
• informing the patient that PML has occurred in a patient treated with DMF.

The exclusions in claim 1 are important. A composition containing a fumarate salt or another fumarate compound could fall outside the literal wording of the claim. The exclusions do not, however, exclude excipients, stabilizers, coatings, or other non-fumarate ingredients.

How do the 22 claims divide the patent scope?

Claim 1 is the only independent claim. Claims 2 through 22 add narrower limitations.

Claims	Added subject matter
1	Core treatment, CBC monitoring, lymphocyte threshold, PML monitoring
2	DMF/MMF combination
3	DMF
4	MMF
5	Oral administration
6	240 mg DMF twice daily orally
7	No more than 480 mg total fumarates daily
8	Specific PML symptoms
9	Withholding treatment and PML diagnostic evaluation
10	Patient counseling regarding DMF-associated PML
11	DMF titration followed by maintenance dosing
12	Oral administration plus specified PML symptoms
13	Oral administration plus withholding and diagnostic evaluation
14-19	The same PML and diagnostic limitations combined with claims 6, 7, or 11
20	Oral DMF/MMF combination
21	Oral DMF
22	Oral MMF

Claims 12 through 19 and 20 through 22 contain substantial overlap with earlier claims. Their practical purpose is to preserve narrower fallback positions if broader claims are invalidated or construed narrowly.

What is the strongest infringement theory for Tecfidera and generic DMF?

The strongest theory would be induced infringement based on a product label that instructs healthcare professionals to perform the claimed protocol. A generic manufacturer does not necessarily perform every claimed step itself. The alleged direct actors may include:

• the patient, who takes the fumarate;
• the prescribing physician, who orders or interrupts therapy;
• the laboratory, which performs the CBC;
• the physician or healthcare team, which monitors for PML and evaluates symptoms.

A generic label can create infringement exposure if it affirmatively instructs the steps required by claim 1. The Federal Circuit has recognized inducement theories involving instructions, labeling, and treatment protocols, although liability depends on proof that the accused party intended to encourage the infringing conduct and that the encouraged conduct would satisfy the claim limitations.[1]

The most exposed limitations are the ones expressly included in product labeling:

• CBC monitoring after six months;
• periodic lymphocyte monitoring;
• interruption for prolonged severe lymphopenia; and
• PML symptom monitoring.

The least straightforward limitations are patient counseling under claim 10 and the specific composition exclusions. A label may warn about PML without using the exact claim language. A claimant would need to establish that the label or related conduct encourages the claimed patient-information step.

How does the patent compare with the Tecfidera core patents?

Patent 11,007,167 is a regimen and safety-monitoring patent. It differs from earlier Tecfidera patents that addressed fumarate compositions, dosage forms, or the therapeutic use of DMF.

Patent category	Typical protected subject matter	Relevance to generic DMF
Composition patents	DMF, MMF, fumarate formulations, or related chemical compositions	Often expire earlier and may be challenged through Paragraph IV
Formulation patents	Delayed-release capsules, enteric coatings, excipient systems, dissolution profiles	Can restrict a particular dosage form even after active-ingredient patents expire
Method-of-treatment patents	Use of fumarates for multiple sclerosis	May cover the approved indication or dosing regimen
Safety-monitoring patents	CBC, lymphocyte thresholds, PML monitoring, treatment interruption	Creates label-based inducement risk
Manufacturing patents	Processes, intermediates, purification, crystallization, or scale-up	May affect supply economics without necessarily blocking finished-product sale

Biogen’s most important earlier Tecfidera patent was U.S. Patent No. 8,399,514. In litigation involving Mylan, the Federal Circuit affirmed a judgment that the patent claims were invalid for obviousness, removing a major obstacle to generic DMF entry.[2] That decision reduced the value of the earlier Tecfidera patent estate, but it did not automatically invalidate later continuation patents such as 11,007,167.

A continuation patent may share specifications and priority claims with an earlier application while presenting different claims. The invalidity of one patent does not, by itself, establish invalidity of every related patent. The later claims must be assessed independently for anticipation, obviousness, written description, enablement, and claim-construction issues.

What is the likely patent expiration date?

The statutory term is generally 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.[3]

Patent 11,007,167 appears to belong to a continuation family associated with Biogen’s fumarate multiple-sclerosis program. Its effective expiration should be determined from the patent’s continuity data and the USPTO term calculation rather than from the issue date. A continuation normally does not receive a fresh 20-year term from its own filing date.

The relevant commercial analysis is:

Exclusivity component	Practical significance
FDA new chemical entity exclusivity	Prevents ANDA filing for the statutory period but is separate from patent term
Orange Book-listed patents	Can support Paragraph IV litigation and a 30-month stay
Patent-term adjustment	Can extend the nominal expiration date
Patent-term extension	May extend a qualifying regulatory patent, although only within statutory limits
Pediatric exclusivity	Can add six months to qualifying listed protections
Method-of-use patent	May support a restricted label or inducement claim even after composition patents expire

The patent’s exact terminal date should be taken from the USPTO patent record and the FDA Orange Book listing in force for the relevant product and edition. The issue date, May 18, 2021, is not the expiration date.[4]

Is Patent 11,007,167 an Orange Book patent?

An issued method-of-use patent can be submitted for Orange Book listing if it claims an approved method of using the drug and satisfies FDA listing requirements. Listing is product-specific. A patent’s existence does not establish that it is listed for every DMF product.

For Tecfidera, the relevant questions are:

1. Whether Biogen submitted Patent 11,007,167 for listing against the approved product.
2. Whether FDA accepted the patent under the applicable listing category.
3. Whether the listed use corresponds to the approved labeling.
4. Whether the patent remained listed when a generic applicant filed its ANDA.
5. Whether the generic applicant carved out the protected use or certified under Paragraph IV.

The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is the controlling public source for listed patents and exclusivity codes.[5] A later patent may have less practical value if it was not listed before an ANDA certification date or if the approved labeling does not contain the claimed use.

What Paragraph IV risks exist for generic DMF?

A generic applicant seeking approval of DMF capsules may address listed patents through:

• Paragraph I certification, when no patent information is listed;
• Paragraph II certification, when the listed patent has expired;
• Paragraph III certification, when the applicant will wait until patent expiration;
• Paragraph IV certification, asserting that the patent is invalid, unenforceable, or not infringed; or
• a section viii statement, carving out a patented method of use from the proposed labeling.[6]

For Patent 11,007,167, a Paragraph IV challenge would likely focus on five issues.

Anticipation by the Tecfidera label

The Tecfidera label has long included CBC monitoring, lymphocyte monitoring, treatment interruption for prolonged severe lymphopenia, and PML warnings.[7] If the relevant label or clinical materials predate the patent’s effective filing date, an accused party could argue that the claimed protocol was already publicly disclosed.

The principal question would be whether one prior-art reference discloses every limitation in the claimed combination, including:

• the six-month CBC timing;
• the six-to-12-month recurring schedule;
• the precise lymphocyte threshold;
• persistence for more than six months;
• treatment interruption; and
• PML monitoring.

A general warning about lymphopenia or PML may not anticipate the complete claimed sequence. A label that recites the full protocol would present a materially stronger anticipation case.

Obviousness

The claim combines known elements: administration of DMF, CBC monitoring, lymphocyte monitoring, interruption for severe lymphopenia, and PML surveillance. An ANDA filer could argue that a skilled clinician would have combined those elements based on the known safety profile of DMF and standard multiple-sclerosis monitoring practice.

Biogen could respond that the precise threshold, persistence period, monitoring interval, and PML response constituted a clinically selected protocol with a safety benefit. The strength of that response would depend on the prosecution record, contemporaneous clinical evidence, and whether the patent identifies an unexpected result.

Written description and enablement

The claim covers DMF, MMF, and their combination, while most commercial activity concerns DMF. A challenger could test whether the specification adequately supports each claimed active ingredient and the full monitoring regimen across the claimed composition range.

The written-description issue is stronger against the broad combination and MMF-alone alternatives if the disclosure focused primarily on DMF. The enablement issue is less significant if the specification provides clinical or regulatory support for the claimed dosing and safety protocol.

Claim construction

The phrase “after 6 months of repeated administering” may generate disputes over whether the six-month measurement must occur exactly at six months or within a reasonable interval after six months. “Persisting for more than six months” may also require a continuous period below the threshold or could be argued to encompass repeated low counts over the period.

The composition exclusions may affect products containing trace fumarate-related substances, metabolites, or additional fumarate ingredients. The patent’s specification and prosecution history would control the interpretation.

Label carve-out

A generic applicant may attempt to omit the protected monitoring instructions from its label under section viii. That strategy is difficult if the omitted language is integral to safe use of the approved drug or is embedded in the FDA-required labeling. FDA-approved safety instructions can create practical limits on a skinny-label strategy.

What patent litigation affects Tecfidera generic entry?

The most significant public litigation involved Biogen’s U.S. Patent No. 8,399,514 and generic DMF applicants, including Mylan. The district court and Federal Circuit decisions removed that patent as a barrier to generic entry after the court found the asserted claims obvious.[2]

That litigation matters to Patent 11,007,167 for two reasons:

1. It demonstrates that Biogen’s fumarate patent estate has faced successful validity challenges.
2. It shows that generic applicants have commercial incentives to challenge Tecfidera patents rather than wait for every listed patent to expire.

The existence of earlier litigation does not establish a settlement or invalidity finding concerning Patent 11,007,167. A separate action would require its own complaint, ANDA certification, claim construction, and validity record.

What is the biosimilar risk for this patent?

Biosimilar risk is effectively irrelevant. DMF is a synthetic small-molecule drug, not a biologic. Generic applicants use the ANDA pathway rather than the abbreviated biologics license application pathway.

The competitive risk comes from:

• generic DMF delayed-release capsules;
• alternative fumarate products;
• authorized generic supply;
• payer-driven substitution; and
• potential products with labeling that omits or narrows the claimed method of use.

MMF products may create a separate competitive position, but an MMF product would still face claim 1 if its composition and clinical protocol satisfy the claim limitations.

How strong is the patent estate for Patent 11,007,167?

The estate has meaningful commercial relevance but presents material validity and enforcement risk.

Strength factor	Assessment
Direct link to approved safety labeling	Strong
Coverage of generic DMF clinical use	Strong if the generic label includes the full protocol
Composition breadth	Moderate; limited to DMF, MMF, or both and subject to exclusions
Dose coverage	Moderate to strong for 480 mg/day DMF regimens
Anticipation risk	Material because the Tecfidera label publicly disclosed similar monitoring
Obviousness risk	Material because the protocol combines known safety-management steps
Divided-infringement risk	Material because multiple actors perform different steps
Biosimilar relevance	None
Manufacturing leverage	Limited; the claims do not cover manufacturing
Geographic coverage	United States only

The patent is stronger as a label-based litigation asset than as a broad product-blocking patent. It does not prevent manufacture of DMF as such. It targets performance of a specific method under particular clinical and monitoring conditions.

What generic launch scenarios exist?

Scenario 1: Full label with claimed monitoring

A generic applicant retains the complete DMF safety language, including CBC monitoring, lymphocyte thresholds, treatment interruption, and PML surveillance. This creates the clearest inducement theory if the patent is listed and unexpired.

Scenario 2: Section viii carve-out

The applicant removes the protected method-of-use language while retaining approval for non-protected uses. This may reduce patent exposure but can be difficult where the safety information is necessary for safe administration or required by FDA labeling.

Scenario 3: Paragraph IV litigation

The applicant certifies that the patent is invalid, unenforceable, or not infringed. Litigation can trigger the Hatch-Waxman 30-month stay if statutory conditions are met. The applicant may launch at risk after the stay or after a favorable court decision.[6]

Scenario 4: Non-infringing clinical protocol

A product sponsor could argue that its label does not require every element, such as the exact six-month threshold, the specified interruption rule, or the listed PML symptoms. This strategy may narrow infringement exposure but may conflict with FDA safety-label requirements.

Does the patent cover formulations or manufacturing?

Patent 11,007,167 is not principally a formulation or manufacturing patent. The claims are directed to a method of treating a patient and monitoring therapy. They do not claim:

• a delayed-release capsule;
• an enteric coating;
• a specific excipient system;
• a dissolution profile;
• a polymorph;
• a manufacturing process;
• a synthetic intermediate; or
• a purification method.

A generic manufacturer may therefore avoid this patent only if it avoids the claimed method or defeats the patent. It cannot avoid the claims merely by using a different capsule supplier or manufacturing process if its product label induces the claimed clinical protocol.

What is the geographic coverage?

The patent provides U.S. protection only. Equivalent applications or patents in Europe, Canada, Japan, and other jurisdictions would require separate analysis of:

• national-phase status;
• granted claims;
• prosecution amendments;
• patent-term adjustments;
• opposition or revocation proceedings;
• regulatory linkage; and
• local infringement standards.

A U.S. patent does not restrict generic sale outside the United States and does not establish protection for the same protocol in foreign markets.

Key Takeaways

• U.S. Patent 11,007,167 claims a clinical monitoring and treatment-interruption protocol, not DMF chemistry or a capsule formulation.
• Claim 1 requires all major elements: fumarate administration, six-month CBC monitoring, recurring lymphocyte testing, interruption after prolonged severe lymphopenia, and PML monitoring.
• Tecfidera and generic DMF products are the principal commercial products implicated.
• The strongest infringement theory is likely induced infringement based on generic labeling and healthcare-provider instructions.
• The patent faces potential anticipation and obviousness challenges because comparable monitoring and PML language appeared in Tecfidera labeling.
• Generic DMF applicants may use Paragraph IV certification or attempt a section viii label carve-out.
• Biosimilar risk does not apply because DMF is a small-molecule drug.
• The patent does not directly create manufacturing or formulation barriers.
• The patent’s enforceable term must be calculated from the patent family’s earliest effective filing date, including any patent-term adjustment or terminal disclaimer.
• Orange Book listing must be confirmed against the FDA product-specific patent record; issuance alone does not establish listing.
• The patent is commercially stronger as a label and clinical-practice patent than as a molecule or product patent.

FAQs About U.S. Patent 11,007,167

Can a generic DMF product launch if Patent 11,007,167 remains unexpired?

Yes, potentially. The applicant could prevail in Paragraph IV litigation, obtain a judgment of noninfringement or invalidity, or obtain approval with a compliant section viii carve-out. An unexpired patent does not automatically prevent FDA approval.

Does using MMF instead of DMF avoid the patent?

No. Claim 1 expressly covers MMF alone and DMF/MMF combinations. An MMF product must be assessed against every limitation, including the monitoring schedule and lymphocyte-interruption requirement.

Does a different delayed-release formulation avoid Patent 11,007,167?

Not necessarily. The claims do not require a particular formulation technology. A different formulation could still infringe if the administered composition and clinical protocol satisfy the claim limitations.

Is the 240 mg twice-daily dose the only infringing DMF dose?

No. Claim 1 is not limited to that dose. Claim 6 narrows the method to 240 mg twice daily, while claim 1 can reach other dosing regimens if the remaining limitations are met.

Does a PML warning alone infringe the patent?

Not necessarily. The claim requires more than a PML warning. The accused method must also satisfy the fumarate administration, CBC timing, lymphocyte threshold, treatment-interruption, and other applicable limitations.

References

1. Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011).

2. Biogen International GmbH v. Mylan Pharmaceuticals Inc., 18 F.4th 1333 (Fed. Cir. 2021).

3. 35 U.S.C. § 154.

4. U.S. Patent No. 11,007,167, “Methods of treating multiple sclerosis,” issued May 18, 2021.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.

6. 21 U.S.C. § 355(j)(2)(A)(vii); 21 U.S.C. § 355(j)(5)(B)(iii).

7. U.S. Food and Drug Administration. (2023). Tecfidera (dimethyl fumarate) delayed-release capsules: Prescribing information.

Drugs Protected by US Patent 11,007,167

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No						METHOD OF TREATING MULTIPLE SCLEROSIS
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes						METHOD OF TREATING MULTIPLE SCLEROSIS

International Family Members for US Patent 11,007,167

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015350213
Australia	2020239734
Australia	2021269298
Australia	2024203437
Australia	2026204454
Canada	2967619
China	107106530