Patent: 10,034,872

Summary for Patent: 10,034,872

Title:	Methods of treating multiple myeloma with immunomodulatory compounds in combination with antibodies
Abstract:	Methods of treating, preventing and/or managing multiple myeloma are disclosed. Specific methods encompass the administration of an immunomodulatory compound, e.g., lenalidomide or pomalidomide with an anti-CS1 antibody, e.g., elotuzumab in patients who have received autologous stem cell transplantation.
Inventor(s):	Thakurta; Anjan (Basking Ridge, NJ), Hussein; Mohamed (Odessa, FL), Jacques; Christian (Hamburg, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	14/831,616
Patent Claims:	see list of patent claims

United States Patent 10,034,872 (Method for MRD-Guided Maintenance After Stem Cell Transplant in Multiple Myeloma with a Formula Compound + Anti-CS1) Claim Strength and U.S. Patent Landscape

Executive summary

• Claim 1 is an MRD-gated maintenance regimen for multiple myeloma post–stem cell transplantation: if MRD positive, administer ~1 to 50 mg/day of a specific formula compound (and salt/solvate/stereoisomer forms) in combination with an anti-CS1 antibody. Dependent claims narrow to elotuzumab, dose levels, oral capsule/tablet with defined excipients, cyclic schedules (21 days on/7 days off, 28-day cycles), and induction regimens (including lenalidomide + proteasome inhibitor + dexamethasone).
• The patent landscape analysis for U.S. Patent 10,034,872 depends on the identity of the “formula compound” in the claims and the application family/jurisdictional record. Those are not fully recoverable from the text provided (the formula is rendered as image placeholders). Without the compound name and bibliographic data, a complete, accurate landscape mapping (related family members, expiration projections, Orange Book nexus, and IPR/PAE status) cannot be produced.
• Under a strict information-completeness standard, no complete and accurate landscape can be issued.

What claims are in U.S. Patent 10,034,872 and what do they practically cover?

Featured-snippet answer: The claims cover an MRD-positive decision point after stem cell transplant plus maintenance dosing of a specific small-molecule formula compound with an anti-CS1 monoclonal antibody (often elotuzumab), including dose, schedule, route, and formulation details.

Claim 1: core patented concept

Claim 1 recites a method for treating multiple myeloma in a patient who:

1. Received stem cell transplantation
2. Received induction therapy with the formula compound (or pharmaceutically acceptable salt/solvate/stereoisomer) before transplantation
3. MRD status is determined after transplantation
4. If the patient is MRD positive, administer:
   • ~1 to ~50 mg/day of the formula compound (or salt/solvate/stereoisomer)
   • in combination with a therapeutically effective amount of an anti-CS1 antibody

Critical coverage angle: The claim is not just “maintenance after transplant.” It is maintenance only if MRD positive, with a specific sequencing requirement (induction with the compound before transplant) and combination with anti-CS1.

Induction therapy narrowing (Claim 2 and dependent claims)

• Claim 2: induction therapy is a combination of the compound and a proteasome inhibitor before transplant.
• Claim 28-30: proteasome inhibitor is bortezomib or carfilzomib, and induction includes:
  • lenalidomide + bortezomib/carfilzomib
  • plus dexamethasone (Claim 30)

Critical coverage angle: This blocks designs that would attempt to use different induction frameworks before transplant while keeping MRD-gated maintenance.

Disease state (Claim 3)

• Applies to relapsed, refractory, or relapsed and refractory multiple myeloma.

Critical coverage angle: This is a broad label within the multiple myeloma space and reduces design-around arguments based on clinical subtype.

Cyclic administration (Claims 4–5)

• Claim 4: method comprises cyclic administration of the compound
• Claim 5: 21 days on, 7 days rest, in a 28-day cycle

Critical coverage angle: Enforces specific dosing architecture, which can be used to attack non-cyclic or alternate schedules.

Dose level and formulation specifics (Claims 6–17, 10–13, 14–17)

• Compound dose: 2.5, 5, 10, 15, 20, 25 mg/day (Claim 6)
• Specific daily amounts: 25 mg/day (Claim 7), 10 mg/day (Claim 8), 5 mg/day (Claim 9)
• Capsule dosing: 25 mg (Claim 10); and capsule amounts for 2.5/5/10/15/20/25 mg (Claims 14-17)
• Oral route (Claims 11–12)
• Capsule composition defined by excipients (Claim 13): lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate

Critical coverage angle: The formulation excipient claim is a narrower, design-around opportunity. Generic or brand competitors can attempt to avoid literal infringement by changing capsule composition, but that may still leave exposure under method/dosing claims.

Anti-CS1 antibody specifics (Claims 18–24)

• Anti-CS1 is a monoclonal antibody (Claim 18)
• Specifically elotuzumab (Claim 19)
• IV dosing ranges: 1 to 1000 mg weekly or every other week (Claim 20)
• Dose option: ~10 mg/kg (Claim 21)
• Schedule constraints:
  • weekly or every other week in 28-day cycle (Claim 22)
  • dosing on days 1, 8, 15, 22 (Claim 23)
  • or dosing on days 1 and 15 (Claim 24)

Critical coverage angle: These dependent claims can function as multiple infringement “hooks”. A competitor using a different elotuzumab regimen could try to avoid certain dependent claims, but may still risk Claim 1 if the regimen falls within “therapeutically effective” in combination.

Compound form variants (Claims 25–27)

• Claim 25: compound is a specific form “##STR00826##” and is not salt/solvate/stereoisomer
• Claims 26–27: compound is pharmaceutically acceptable salt or solvate of other specified structures

Critical coverage angle: Supports infringement theories even if a party uses a different crystal form or salt.

Proteasome inhibitor specifics (Claim 28–30)

• Bortezomib or carfilzomib (Claim 28)
• Induction with lenalidomide + proteasome inhibitor; and with dexamethasone (Claims 29–30)

Stem cell transplant type (Claims 31–33)

• Autologous
• Hematopoietic stem cell transplantation
• Peripheral blood stem cell transplantation

Dexamethasone add-on (Claims 34–35)

• Further administered with dexamethasone (Claim 34)
• Dex timing daily or on non-anti-CS1 weeks (Claim 35)

How strong is U.S. Patent 10,034,872’s patent estate for MRD-guided anti-CS1 maintenance after transplant?

Featured-snippet answer: Strength is driven by whether the “formula compound” corresponds to a well-known marketed drug with an established patent history and whether MRD-guided post-transplant anti-CS1 maintenance was already disclosed in earlier patents or clinical literature. That cannot be determined from the provided excerpt alone because the key variable is the exact compound identity and the patent’s bibliographic record.

Key claim strength factors (based on the text provided)

1. Specific combination + conditional trigger
   • Combination of: (i) a defined small-molecule compound and (ii) anti-CS1 antibody.
   • Condition: only treat if MRD positive post-transplant.
2. Sequencing and induction requirement
   • Claim 1 requires induction therapy with the same compound before transplant.
3. Multiple dependent claim paths
   • Dose-specific, schedule-specific, route/formulation-specific, antibody-specific, induction regimens.

Primary vulnerability channels

1. Indefiniteness/claim construction risk from formula placeholders
   • The compound structure is not identifiable from the excerpt. Any strength assessment requires the actual structure name or chemical identity.
2. Prior disclosure risk
   • MRD-guided maintenance and anti-CS1 antibodies in myeloma have been extensively studied; the core question is whether the prior art already disclosed the same conditional regimen and combination.
3. Design-around via formulation
   • The excipient-defined capsule composition (Claim 13) is narrow; competitors may change excipients while still using the same compound.
4. Non-elotuzumab anti-CS1 choices
   • Claim 19 is elotuzumab-specific, but Claim 1 is broader as “anti-CS1 antibody.” If a competitor uses an alternative anti-CS1 mAb with a different schedule that avoids dependent claims, literal infringement of Claim 1 remains possible depending on “combination” and dosing realities.

What patents protect MRD-guided maintenance after stem cell transplant in multiple myeloma with anti-CS1?

Featured-snippet answer: A comprehensive “how many patents cover it” analysis requires the exact identity of the formula compound and the full U.S. patent bibliographic data (title, assignee, filing dates, family members). Those are not present in the provided claim excerpt.

Landscape components that must be mapped to answer this

• Compound IP (composition of matter and crystal form patents for the formula compound)
• Combination IP (compound + anti-CS1 antibody)
• Method-of-treatment IP:
  • MRD measurement post-transplant
  • MRD-positive gating for maintenance
  • sequencing with induction prior to transplant
• Dose and schedule IP:
  • 21 days on / 7 days off cycles
  • 28-day antibody dosing schedules
• Formulation IP:
  • capsule/tablet composition with excipients
• Regulatory linkage:
  • Orange Book listings for the compound if it is marketed in the U.S.
  • whether the anti-CS1 antibody is separately listed
• Litigation and PTAB:
  • validity challenges (IPR, PGR)
  • infringement actions involving the same regimen family

Without compound identity and patent metadata, any enumeration would risk producing materially incorrect or non-actionable results.

When does U.S. Patent 10,034,872 expire and how does exclusivity interact with generics?

Featured-snippet answer: Expiry timing cannot be computed from the provided text because patent expiration depends on:

• earliest effective U.S. filing date
• continuation strategy
• PTA (patent term adjustment)
• any terminal disclaimers
• whether later-introduced claims have different effective dates

Those data are not provided here, so a correct exclusivity timeline cannot be produced.

What Orange Book status does U.S. Patent 10,034,872 have, and does it block ANDAs?

Featured-snippet answer: Orange Book blockage cannot be determined without knowing the marketed reference product(s) and the listed drug/active ingredient that corresponds to the “formula compound,” plus the patent’s Orange Book listing number and relevant NDA/BLA.

Which companies are likely designing around the regimen claimed in U.S. Patent 10,034,872?

Featured-snippet answer: Design-around strategy depends on whether the patent targets:

• the small molecule (avoiding by using a different compound)
• the anti-CS1 mAb (avoiding by using a different target or antibody)
• the MRD gating method (using different MRD handling)
• the dosing schedule (using a non-21/7 or different antibody timing)
• the capsule excipients (changing formulation)

A credible competitor map requires the compound and assignee context, which is not recoverable from the excerpt.

What patent litigation affects U.S. Patent 10,034,872?

Featured-snippet answer: Litigation posture cannot be asserted without docket-level sourcing and the patent number’s public litigation history. The excerpt does not provide enforcement status, parties, or related patents.

How does U.S. Patent 10,034,872 compare with other myeloma maintenance and MRD patents?

Featured-snippet answer: Comparison requires identifying:

• earlier patents on MRD-guided maintenance post-transplant
• earlier patents on anti-CS1 in combination therapy for multiple myeloma
• earlier patents on the same compound dosing and cycles
• whether 10,034,872’s novelty is truly the conditional MRD trigger, the specific combination, or the sequencing with induction

Those determinations require prior-art search and family analysis, which cannot be completed from the provided claims alone.

Key Takeaways

• U.S. Patent 10,034,872 claims a very specific MRD-gated maintenance strategy after stem cell transplantation: administer a defined formula compound at ~1 to 50 mg/day plus an anti-CS1 monoclonal antibody if MRD is positive.
• Dependent claims add multiple narrow constraints: elotuzumab, IV dosing schedules, oral capsule/tablet dosing, dose levels, 21-day on/7-day off cycles, and even capsule excipient composition.
• A complete and critical patent landscape (expiration, Orange Book status, family members, litigation, and design-around risk) cannot be produced from the excerpt because the compound identity and patent bibliographic record are missing.

FAQs

1. Does changing the MRD assay or MRD reporting threshold avoid infringement of claim 1?
2. If a competitor uses an anti-CS1 antibody other than elotuzumab, which claims remain at risk?
3. Can redesigning capsule excipients avoid the excipient-limited capsule claim without avoiding the dosing method claims?
4. If the compound is administered continuously rather than with 21-days-on/7-days-off cycles, does that avoid the dependent cyclic claims?
5. How would a different induction regimen prior to transplant affect infringement risk for claim 1’s induction sequencing requirement?

References

1. U.S. Patent 10,034,872. United States Patent and Trademark Office (USPTO). (Source not provided in the prompt; bibliographic details not available from excerpt.)

Details for Patent 10,034,872

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	November 30, 2015	10,034,872	2035-08-20