US Patent 10,028,940: Claims, Patent Scope, Expiration and Multiple Myeloma Landscape

US Patent 10,028,940 is a narrow, method-of-treatment patent directed to administering dexpramipexole for multiple myeloma. Its strongest protection is claim 1, which covers use of dexpramipexole or a pharmaceutically acceptable salt in treating multiple myeloma. The dependent claims add dose ranges, twice-daily dosing, induction and maintenance regimens, selected combination agents, and oral or topical administration.

The patent does not claim dexpramipexole as a chemical compound, a solid dosage form, a formulation, a manufacturing process, or a diagnostic biomarker. Its commercial value therefore depends on whether dexpramipexole obtains regulatory approval for multiple myeloma and whether the claims survive validity challenges based on enablement, written description, obviousness, and utility.

What does US Patent 10,028,940 protect?

The patent protects a treatment method using dexpramipexole in a patient with multiple myeloma. The core claim is:

Administering a therapeutically effective amount of dexpramipexole, or a pharmaceutically acceptable salt thereof, to a subject in need of treatment for multiple myeloma.

The claims can be divided into five technical groups.

Claim group	Claims	Subject matter
Core treatment	1	Dexpramipexole treatment of multiple myeloma
Dose and frequency	2-6, 16-17	Daily dose ranges and twice-daily administration
Induction combinations	7-15	Dexpramipexole administered after or with specified agents
Initial and maintenance regimens	18-26	Separate initial and maintenance dosing
Route of administration	27-28	Oral or topical administration

The broadest practical protection is claim 1. A party practicing dexpramipexole treatment for multiple myeloma could potentially fall within claim 1 even if it uses a dose, schedule, formulation, or combination not recited in the dependent claims.

How broad is claim 1 of US Patent 10,028,940?

Claim 1 is broad in three respects.

First, it does not limit the disease to a stage, cytogenetic subtype, treatment line, refractory population, or measurable disease burden. It covers multiple myeloma generally.

Second, it does not impose a specified dose, route, dosing frequency, treatment duration, biomarker, response criterion, or combination partner.

Third, it covers dexpramipexole and pharmaceutically acceptable salts. The salt language can prevent a design-around based solely on converting the active ingredient into a conventional salt form.

The principal limitation is disease-specific use. The claim does not cover all therapeutic uses of dexpramipexole. It is also a method claim, so infringement generally requires conduct involving administration to a patient, or inducement or contributory activity tied to that use.

What does claim 1 not cover?

Claim 1 does not expressly cover:

Dexpramipexole composition of matter
Dexpramipexole tablets, capsules, solutions, or other dosage forms
A specific polymorph or crystalline form
A pharmaceutical excipient system
A manufacturing process
A method of diagnosing multiple myeloma
A method of selecting patients based on a biomarker
A method of treating diseases other than multiple myeloma
A defined combination therapy requirement

This distinction materially limits the patent's value compared with a composition-of-matter patent or a formulation patent.

What dose ranges are protected?

Claims 2 through 6, 16, and 17 create overlapping dose protection.

Claims	Dose or schedule
2	About 1 mg to about 1,000 mg per day
3	About 50 mg to about 600 mg per day
4	About 150 mg to about 300 mg per day
5	Divided dosing, half-dose twice daily, or every 12 hours
6	About 150 mg twice daily
16	About 75 mg twice daily
17	About 300 mg twice daily

Claim 2 is the widest numerical range. Claims 3 and 4 are nested within it. Claims 6 and 17 correspond to total daily doses of approximately 300 mg and 600 mg, respectively. Claim 16 corresponds to approximately 150 mg per day.

The use of "about" creates a boundary dispute risk. The patent does not establish a single fixed tolerance for "about" in the claims themselves. A court would likely assess the term through the specification, examples, technical context, and ordinary meaning to a skilled person.

How strong are the dosing claims?

The dosing claims add useful fallback positions but do not materially expand the core disease-use right. Their value depends on whether the claimed ranges are supported by clinical or preclinical data and whether the ranges would have been obvious based on prior dexpramipexole pharmacology.

The most commercially important dose claims are claims 6 and 17 because they identify fixed twice-daily regimens. Their strength would depend on evidence that those schedules produce a multiple myeloma benefit, rather than merely reflecting routine dose optimization.

What combination therapies are protected?

Claim 7 adds an induction step involving a broad set of agents. Claims 8 through 15 identify specific agents or subclasses.

Claim	Combination or induction agent
8	Imatinib
9	Mepolizumab or reslizumab
10	Benralizumab
11	Lebrikizumab
12	Dupilumab
13	Omalizumab
14	Infliximab, adalimumab, certolizumab pegol, or golimumab
15	Etanercept

The combination claims are unusual in the multiple myeloma context. Several listed agents are principally associated with asthma, allergic disease, or inflammatory disorders rather than standard myeloma treatment. The claim language also includes broad categories covering glucocorticoids, corticosteroids, NSAIDs, tyrosine kinase inhibitors, monoclonal antibodies, chemotherapeutics, anti-proliferative drugs, and anti-inflammatory agents.

What are the principal risks in claims 7 through 15?

The combination claims face several potential validity and enforcement issues.

Written description. The specification must demonstrate possession of the full breadth of the combinations, not merely list them. A long list of unrelated antibodies and anti-inflammatory agents may create a written-description vulnerability if the disclosure does not provide representative examples or a coherent mechanistic basis.

Enablement. The patent must enable the full scope of the claimed combinations without undue experimentation. Enablement concerns increase where the claims cover numerous drug classes, disease settings, doses, and treatment sequences without supporting data.

Indefiniteness. Claim 7 uses "induction step," but the claims provided do not define the timing, duration, clinical purpose, or relationship between induction and dexpramipexole administration. A dispute could arise over whether the induction therapy must precede dexpramipexole, overlap with it, or merely be part of the patient's treatment history.

Clinical plausibility. The listed antibodies are not conventional multiple myeloma induction agents. If the patent lacks disease-specific data for those combinations, an accused infringer could challenge whether the full claim scope is credible and enabled.

How are the initial and maintenance claims structured?

Claims 18 through 26 divide treatment into an initial dosing regimen and a maintenance dosing regimen.

Claims	Initial regimen	Maintenance regimen
19, 23	About 50 mg to about 1,500 mg/day	About 50 mg to about 1,500 mg/day
20, 24	About 150 mg to about 300 mg/day	About 150 mg to about 300 mg/day
21, 25	About 300 mg to about 500 mg/day	About 300 mg to about 500 mg/day
22, 26	About 300 mg to about 600 mg/day	About 300 mg to about 600 mg/day

The claims do not require the initial regimen to differ numerically from the maintenance regimen. Claims 19 and 23, for example, permit the same range for both stages. The patent therefore provides broad regimen coverage but limited structural differentiation between induction and maintenance.

A central claim-construction issue is whether "initial dosing regimen" and "maintenance dosing regimen" require a clinically meaningful transition. The specification and prosecution history would be important in determining whether any loading dose, stabilization period, response assessment, or duration is required.

Does the patent cover oral and topical dexpramipexole?

Claim 27 covers oral administration. Claim 28 covers topical administration.

Oral administration is technically and commercially coherent for a systemic multiple myeloma therapy. Topical administration raises a significant enablement question because multiple myeloma is a systemic hematologic malignancy and the claim does not identify a topical dosage form, penetration technology, target tissue, systemic exposure level, or clinical rationale.

A topical product could also face regulatory and scientific barriers independent of the patent. Unless the specification provides data supporting topical delivery of therapeutically effective dexpramipexole concentrations for multiple myeloma, claim 28 is more vulnerable than the oral route claim.

When does US Patent 10,028,940 lose exclusivity?

US Patent 10,028,940 was granted on June 26, 2018. Its effective patent term is governed by the earliest applicable nonprovisional or international filing date in the priority chain, subject to patent-term adjustment and any terminal disclaimer recorded by the USPTO.

The patent appears to belong to a priority family directed to dexpramipexole treatment methods. The nominal 20-year term is therefore expected to run into the mid-2030s, subject to the official USPTO expiration calculation. The grant date alone does not establish the expiration date.

Event	Date or status
Patent grant	June 26, 2018
Patent type	Utility patent
Core technology	Dexpramipexole treatment of multiple myeloma
Expected term basis	Earliest effective nonprovisional or PCT filing in the priority chain
Expected nominal expiry	Mid-2030s, subject to PTA and terminal disclaimer review
Patent-term extension	No verified regulatory extension identified
Pediatric exclusivity	No verified pediatric exclusivity identified

A definitive expiration analysis requires the USPTO continuity data, priority documents, patent-term adjustment calculation, and any terminal disclaimer. The patent should not be treated as expiring 20 years from its grant date.

What is the Orange Book status of dexpramipexole?

Dexpramipexole does not have an FDA-approved multiple myeloma product identified in the claims or patent record. Without an approved NDA for dexpramipexole in that indication, US Patent 10,028,940 is not an Orange Book-listed patent protecting an approved multiple myeloma product.

Regulatory issue	Assessment
FDA approval for dexpramipexole in multiple myeloma	No approved product identified
Orange Book listing	No verified listing identified
Hatch-Waxman patent certification	Not presently relevant without an approved reference product
Paragraph IV exposure	No conventional ANDA Paragraph IV pathway identified
Regulatory exclusivity	No verified FDA exclusivity for this indication
Biosimilar pathway	Not applicable because dexpramipexole is a small molecule

The patent could become commercially relevant if a sponsor obtains approval for dexpramipexole in multiple myeloma. Even then, Orange Book listing would depend on FDA listing requirements and whether the patent claims the approved method of use.

Are Paragraph IV challenges likely?

A conventional Paragraph IV challenge is unlikely to be commercially relevant before approval of a dexpramipexole reference product. ANDA applicants rely on an approved reference listed drug. If dexpramipexole remains unapproved for multiple myeloma, a generic company cannot ordinarily use this patent alone to create an ANDA-based market-entry dispute.

If an NDA is later approved and the patent is listed, an ANDA applicant could challenge the patent through a Paragraph IV certification. The likely arguments would include:

Anticipation: Prior art may disclose dexpramipexole, myeloma treatment, or overlapping dosing.
Obviousness: A skilled person may have considered dexpramipexole a candidate for hematologic or inflammatory disease based on its known pharmacology.
Lack of enablement: The broad treatment claim may exceed the supporting data.
Lack of written description: The specification may not support all doses, routes, combinations, and treatment populations.
Indefiniteness: Terms such as "therapeutically effective amount," "induction step," "maintenance dosing regimen," and "about" could be contested.
Lack of utility or plausibility: The claims may be challenged if the disclosure does not establish a credible multiple myeloma benefit.

Does the patent face biosimilar risk?

No direct biosimilar risk exists. Dexpramipexole is a small molecule, not a biologic. The relevant competitors would be generic or follow-on small-molecule manufacturers, not biosimilar sponsors.

A future dexpramipexole product could face:

Generic competition after patent expiry
A 505(b)(2) product with a different formulation or route
A new NDA relying partly on published literature
Method-of-use challenges if the patent is listed
Off-label competition from established myeloma therapies

What other patents protect dexpramipexole?

The relevant patent estate should be separated into four categories:

Patent category	Relevance to US 10,028,940
Composition of matter	Protects dexpramipexole itself; materially stronger if unexpired
Therapeutic use	Covers disease-specific administration, including the present patent
Formulation	Covers tablets, capsules, salts, release profiles, or excipients
Manufacturing	Covers synthesis, resolution, purification, or solid-state processing

US 10,028,940 is principally a therapeutic-use patent. It does not, based on the claims provided, create a formulation or manufacturing barrier.

A complete freedom-to-operate review would need to examine the full dexpramipexole family, including US continuations, divisionals, national-stage applications, abandoned applications, foreign counterparts, and terminal disclaimers. The claims alone do not establish whether related patents remain pending or enforceable.

How does the patent compare with standard multiple myeloma patent estates?

The patent is weaker than the estates surrounding approved myeloma products that combine composition-of-matter claims with formulation, dosage, method-of-use, and regulatory exclusivity rights.

Product or class	Typical protection profile	Relative position of US 10,028,940
Lenalidomide	Composition, method, formulation, and regulatory history	Narrower
Pomalidomide	Composition and method-of-use protection	Narrower
Proteasome inhibitors	Composition, formulation, dosing, and combination claims	Narrower
Anti-CD38 antibodies	Biologic composition, formulation, method, and manufacturing claims	Substantially narrower
CAR-T products	Biologic construct, manufacturing, and treatment claims	Substantially narrower
Dexpramipexole MM use	Disease-specific method claims	Limited to use

Established myeloma products also benefit from clinical adoption, guideline inclusion, manufacturing scale, and reimbursement. US 10,028,940 provides none of those commercial assets by itself.

What generic launch scenarios exist?

Scenario 1: No approved dexpramipexole product

There is no immediate ANDA-driven launch pathway. The patent remains a blocking asset only against unapproved practice of the claimed method, subject to enforcement and validity.

Scenario 2: Approval before patent expiry

A sponsor could seek approval for dexpramipexole in multiple myeloma. The patent holder could pursue Orange Book listing if statutory requirements are met. Generic entry would then depend on patent certifications, litigation, settlement, and any exclusivity.

Scenario 3: Approval with a non-infringing indication

A product approved for another disease may avoid direct infringement of claim 1 if it is not marketed for multiple myeloma and the sponsor does not induce the claimed use. The risk would depend on labeling, promotional conduct, clinical trial activity, and physician prescribing patterns.

Scenario 4: Post-expiry generic entry

After expiration of the relevant patent family, a generic could compete on the active ingredient, subject to any separate composition, formulation, or manufacturing patents. This patent alone would not block a non-myeloma dexpramipexole product.

What litigation and settlement issues affect the patent?

No verified litigation or settlement involving US Patent 10,028,940 is established by the claim text alone. The principal litigation questions would be:

Whether the patent is listed in the Orange Book
Whether a dexpramipexole NDA exists
Whether any ANDA applicant has filed a Paragraph IV certification
Whether a declaratory-judgment action has been filed
Whether a continuation patent claims overlapping dosing or combination methods
Whether a license restricts enforcement or field of use
Whether the patent has been challenged at the Patent Trial and Appeal Board

The absence of a verified approved product substantially reduces near-term Hatch-Waxman litigation risk. Any future dispute is more likely to involve validity, induced infringement, clinical-trial activity, or a 505(b)(2) product than a conventional generic launch.

How strong is the patent estate?

The patent has a strong conceptual blocking position through claim 1 but a narrower practical value than a composition-of-matter patent.

Factor	Assessment
Core claim breadth	Broad for multiple myeloma use
Chemical exclusivity	None apparent from the claims
Dose fallback claims	Useful but overlapping
Combination claims	Broad, but vulnerable to support and plausibility challenges
Oral route	Commercially coherent
Topical route	More exposed to enablement challenge
Regulatory leverage	Limited without an approved product
Generic challenge pathway	Dormant until an approved reference product exists
Manufacturing barrier	None apparent from the claims
Geographic coverage	US only unless corresponding foreign rights exist
Overall commercial strength	Moderate as a use patent; weak as a standalone product estate

Key Takeaways

US Patent 10,028,940 is a method-of-treatment patent for dexpramipexole in multiple myeloma.
Claim 1 is the principal commercial claim and does not require a specific dose, route, treatment line, or combination.
Claims 2 through 6 and 16 through 17 protect overlapping daily and twice-daily dosing regimens.
Claims 7 through 15 cover unusually broad induction combinations, including several agents not established as standard multiple myeloma therapies.
Claims 18 through 26 cover initial and maintenance dosing but do not clearly require different doses between the two phases.
Oral administration is the strongest route claim; topical administration is more exposed to enablement and clinical-plausibility challenges.
The patent does not claim dexpramipexole composition of matter, formulations, manufacturing, or solid-state forms.
No conventional Paragraph IV or biosimilar risk is apparent without an approved dexpramipexole reference product.
The patent's nominal term is expected to extend into the mid-2030s, subject to the USPTO priority chain, patent-term adjustment, and any terminal disclaimer.
The patent is materially weaker than the integrated estates protecting approved myeloma products.

FAQs

Can a company sell dexpramipexole for a non-multiple-myeloma indication?

Potentially. Claims 1 through 28 are directed to multiple myeloma treatment. A non-myeloma product would not automatically practice these claims, although promotional activity or clinical development could create inducement issues.

Does US Patent 10,028,940 block generic dexpramipexole tablets?

Not by itself. The patent claims a multiple myeloma treatment method, not tablets or dexpramipexole as a compound. A generic product approved for another use would require a separate infringement analysis.

Can a competitor avoid the patent by using a dexpramipexole salt?

Not necessarily. Claim 1 expressly covers dexpramipexole and pharmaceutically acceptable salts.

Are the anti-IL-5 and anti-IgE combination claims commercially important?

They have limited practical value unless the patent specification supports those combinations with credible multiple myeloma data and a sponsor develops the combinations clinically. Their breadth may create validity and enablement exposure.

Is a topical dexpramipexole product a realistic design-around?

It could avoid some oral-route dependent claims, but not necessarily claim 1, which is route-neutral. Claim 1 covers administration without limiting the route, while claim 28 specifically identifies topical administration.

References

United States Patent and Trademark Office. (2018). US Patent No. 10,028,940, Methods of treating multiple myeloma.
United States Patent and Trademark Office. (n.d.). Patent Center: US Patent No. 10,028,940.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations.
U.S. Food and Drug Administration. (n.d.). Purple Book: Database of licensed biological products.
United States Code, 35 U.S.C. §§ 154, 271, 282, and 283.

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	August 24, 1998	⤷ Start Trial	2037-03-16
Immunex Corporation	ENBREL	etanercept	For Injection	103795	November 2, 1998	⤷ Start Trial	2037-03-16
Immunex Corporation	ENBREL	etanercept	For Injection	103795	May 27, 1999	⤷ Start Trial	2037-03-16
Immunex Corporation	ENBREL	etanercept	Injection	103795	September 27, 2004	⤷ Start Trial	2037-03-16
Immunex Corporation	ENBREL	etanercept	Injection	103795	February 1, 2007	⤷ Start Trial	2037-03-16
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,028,940

Summary for Patent: 10,028,940