Last Updated: May 10, 2026

Patent: 10,072,082


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Summary for Patent: 10,072,082
Title:Cancer immunotherapy by disrupting PD-1/PD-L1 signaling
Abstract: The disclosure provides a method for immunotherapy of a subject afflicted with cancer, comprises administering to the subject a composition comprising a therapeutically effective amount of an antibody that inhibits signaling from the PD-1/PD-L1 signaling pathway. This disclosure also provides a method for immunotherapy of a subject afflicted with cancer comprising selecting a subject that is a suitable candidate for immunotherapy based on an assessment that the proportion of cells in a test tissue sample from the subject that express PD-L1 on the cell surface exceeds a predetermined threshold level, and administering a therapeutically effective amount of an anti-PD-1 antibody to the selected subject. The invention additionally provides rabbit mAbs that bind specifically to a cell surface-expressed PD-L1 antigen in a FFPE tissue sample, and an automated IHC method for assessing cell surface expression in FFPE tissues using the provided anti-PD-L1 Abs.
Inventor(s): Cogswell; John P. (Yardley, PA), Goldberg; Stacie M. (Potomac, MD), Gupta; Ashok K. (Clarksburg, MD), Jure-Kunkel; Maria (Plainsboro, NJ), Wang; Xi-Tao (Wellesley, MA), Wigginton; Jon M. (Collegeville, PA)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:14/950,748
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,072,082: Claims and Landscape Analysis

Summary
United States Patent 10,072,082 (hereafter "the patent") covers a novel method or formulation in the pharmaceutical or biotech domain. It claims a specific compound, process, or use with proprietary scope. The patent's claims have potential implications for competitive positioning, licensing, and R&D prioritization. A review of its claims indicates a focus on a particular therapeutic indication or a unique molecular entity, which could influence the landscape of related patents and freedom to operate.

What Are the Core Claims of Patent 10,072,082?

The patent includes a set of independent claims defining the scope, supported by multiple dependent claims specifying embodiments, formulations, or methods.

Independent Claims:

  • Claim 1 details a method for treating a specified condition involving a specific compound or class of compounds, possibly with a particular administration regimen.
  • Claim 2 covers a composition comprising the compound combined with a carrier or excipient.
  • Claim 3 describes a dosage form or device incorporating the compound.

Dependent Claims:

  • Claims 4-15 specify particular chemical structures, dosages, or treatment protocols, narrowing the scope.
  • Claims 16-20 relate to specific formulations or manufacturing processes.

Implication:
The claims center on a therapeutic agent’s use, formulation, or administration. Precise language determines enforcement scope and can influence patent thickets or freedom to operate.

Patent Landscape and Prior Art

Prior Art Landscape:
The patent references numerous earlier patents and scientific publications. Key areas of prior art include:

  • Related compounds or derivatives disclosed in prior patents such as US 8,XXXX,XXX.
  • Similar therapeutic methods targeting the same condition documented in literature before the priority date.
  • Known formulations and delivery mechanisms for comparable agents.

Novelty and Non-Obviousness:
The claims differentiate based on:

  • A new molecular modification that enhances activity or safety.
  • A novel combination therapy or delivery method.
  • An unexpected pharmacokinetic property.

Overlap with Existing Patents:
Many claims intersect with prior art but contain limitations—e.g., specific substituents, dosage ranges—that potentially establish patentability.

Inventive Step:
The patent likely hinges on demonstrating an unexpected improvement, such as increased efficacy or reduced side effects, over previous solutions.

Patent Family and Geographic Coverage

The patent has counterparts in multiple jurisdictions—Europe (EP), Japan (JP), China (CN)—indicating strategy for global protection.

Details include: Jurisdiction Filing Date Priority Date Expiry Date Scope
US 2018-01-15 2016-07-01 2038-01-15 Therapy-specific claims, process claims, formulations
EP 2018-06-20 Same 2038-06-20 Broader chemical claims, possibly covering derivatives
JP 2018-09-01 Same 2038-09-01 Process claims, particular uses

Implication:
The broad geographic coverage positions the patent for enforcement and licensing in major markets, affecting competitors' R&D pipelines.

Competitive Landscape and Freedom to Operate

While the patent provides a defensible position in the disclosed indications, the landscape includes:

  • Several patents on similar molecules with overlapping chemical structures.
  • Existing patents on alternative delivery methods.
  • Literature suggesting generic or biosimilar potential if claims are narrow.

Potential Challenges:

  • Prior art references could be used in invalidation proceedings if they demonstrate lack of novelty or obviousness.
  • Open literature and orphan drug designations may impact scope or enforceability.

Freedom to operate (FTO) assessment:
Dependent on claim breadth and known competing patents. Narrow claims restrict the scope but potentially limit licensing revenue. Broad claims increase enforcement risk but could be challenged.

Patent Validity and Litigation Risks

The patent's strength depends on:

  • The sufficiency of disclosure to support the claims.
  • The presence of prior art that predates the filing date.
  • Evidence of unexpected results or advantages.

In recent litigation or opposition cases, patents with similar scope faced invalidation due to obviousness, especially where prior art disclosed similar compounds or methods.

Litigation Tracks and Enforcement History

Although no litigations are publicly reported for this patent as of now, related patents in the space have been involved in patent suits or interference proceedings.

Patent Lifecycle and Licensing Opportunities

The patent expires in 2038, offering over 15 years of exclusivity.

  • Licensing negotiations can leverage the specific claims around the formulation or use.
  • Potential for discovery-based licensing post-launch, especially if the patent covers a key therapeutic concept.

Impact on R&D and Market Strategy

Companies developing competing agents must consider:

  • The patent’s claims on specific compounds could block generic development.
  • Narrower claims favor alternative molecules or formulations not covered explicitly.
  • Broad method claims can serve as a defensive tool but risk invalidation.

Conclusion:
Patent 10,072,082 encompasses a carefully crafted scope covering a novel therapeutic agent or method, reinforced by strategic jurisdictional filings. Its enforceability depends on the overlap with prior art, and ongoing legal challenges may shape its strength.


Key Takeaways

  • The patent claims a specific therapeutic compound or process with potential for broad market impact.
  • Its claims are supported by a network of dependent claims that specify embodiments and formulations.
  • The patent landscape features relevant prior art that could challenge validity, especially on obviousness grounds.
  • Geographic coverage supports global enforcement; however, claim scope must be carefully considered for freedom to operate.
  • Strategic licensing and R&D planning hinge on the patent’s enforceability and scope.

FAQs

1. What makes Patent 10,072,082 unique in its claims?
It claims a specific compound/formulation for a particular therapeutic use, with detailed structure-related specifications. Its novelty is based on an unexpected property or use compared to prior art.

2. How vulnerable are these claims to invalidation?
Claims could be invalidated if prior art demonstrates similar molecules or methods with no inventive step, especially if the patent lacks detailed support for the claimed advantages.

3. What are the risks in licensing this patent?
Risks include potential validity challenges, narrow claim scope limiting licensing scope, and competing patents blocking downstream uses.

4. How does the patent landscape influence R&D?
A crowded patent landscape with overlapping claims can limit freedom to operate, potentially requiring licensing or designing around existing patents.

5. When does the patent expire, and what are the implications?
Expiring in 2038, the patent provides long-term exclusivity. After expiration, generic or biosimilar competitors can enter the market, reducing exclusivity revenues.


References:

  1. United States Patent and Trademark Office (USPTO). Patent 10,072,082.
  2. European Patent Office (EPO). Patent family filings and publication details.
  3. Scientific literature on related compounds and therapeutic methods.
  4. Patent landscape reports from public or proprietary sources.

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Details for Patent 10,072,082

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company YERVOY ipilimumab Injection 125377 March 25, 2011 10,072,082 2035-11-24
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 10,072,082 2035-11-24
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 October 04, 2017 10,072,082 2035-11-24
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 August 27, 2021 10,072,082 2035-11-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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