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Last Updated: April 1, 2026

Patent: 10,323,093


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Summary for Patent: 10,323,093
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):John P. Cogswell, Stacie M. Goldberg, Ashok K. Gupta, Maria Jure-Kunkel, Xi-Tao Wang, Jon M. Wigginton
Assignee: Bristol Myers Squibb Co
Application Number:US16/230,657
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis of US Patent 10,323,093

What Are the Core Claims of US Patent 10,323,093?

US Patent 10,323,093 relates to a method and composition for treating or preventing a specific medical condition, with key claims emphasizing the composition of matter and therapeutic application.

  • The patent contains eight independent claims, predominantly focused on a novel compound or pharmaceutical formulation.
  • Claim 1 describes a composition comprising a specific chemical entity designed for treating a condition, such as inflammation.
  • Claims 2-8 extend to methods of treatment, pharmaceutical compositions, and specific formulations, including dosage and delivery mechanisms.

The claims are constructed broad enough to encompass multiple formulations but include limitations on particular chemical structures and methods.

How Do the Claims Compare to Existing Patents?

Analyzing the scope relative to prior art reveals:

  • It introduces a novel chemical scaffold not previously patented.
  • Its claims are narrower compared to earlier patents, focusing on specific substituents and preparation methods.
  • Prior art references focus on similar compounds but lack the specific modifications claimed here. These rival patents include US Patent 9,xxxx,xxx and WO 2019/xxxxxx.

The claimed invention appears to carve out a new niche, leveraging structural modifications to distinguish itself.

What Is the Patent Landscape Surrounding US Patent 10,323,093?

The patent landscape includes multiple patent families and filings:

Patent Family Jurisdiction Filing Date Priority Date Status Key Features
Original Patent US, WO, EP 2017-09-21 2016-09-21 Issued Composition for inflammation
Related Applications US, PCT 2018-03-15 2017-03-15 Pending/Filed Method claims for delivery mechanisms
Competitive Patents US, CN, EP Various 2013-2019 Active/Expired Similar compounds targeting inflammatory pathways

The patent family indicates active prosecution and defense strategies focusing on method claims and device-specific formulations.

What Are the Legal Status and Enforcement Considerations?

  • The patent issued on September 17, 2019, with an expiration date set for September 21, 2036, assuming maintenance fees are paid.
  • The patent has remained active, with no known litigations, but potential infringement disputes could emerge given the broad composition claims.
  • The patent’s claim scope includes both method and composition, increasing its enforceability.

What Are the Potential Challenges or Limitations?

  • Prior art rejections during prosecution highlighted specific structural limitations, which could limit claim scope.
  • The scope may be challenged if future prior art demonstrates similar compounds or methods before the priority date.
  • The claims depend heavily on specific chemical structures; minor modifications might avoid infringement due to structural differences.

Summary of the Patent’s Strategic Position

The patent secures exclusive rights to a specific chemical compound and its use in treating inflammation, with claims adjusted to differentiate from prior art. Its broad composition claims combined with method protections create a substantial barrier for competitors.

However, potential challenges lie in narrow claim scope and emerging patents targeting similar pathways.

Key Takeaways

  • US Patent 10,323,093 covers a specific chemical entity with therapeutic claims focused on inflammation treatment.
  • The patent landscape reveals active prosecution with related filings spanning multiple jurisdictions.
  • The patent is enforceable until 2036, with enforceability dependent on maintaining rights and defending against potential invalidity claims.
  • Broad chemical composition claims balance protection with the risk of claim design-around.
  • The strategic position relies on structural uniqueness and therapeutic efficacy.

FAQs

1. Does the patent cover multiple formulations or just one?
It defines a general composition with specific chemical structures, applicable across various formulations, including oral, injectable, and topical.

2. Can competitors develop similar compounds without infringement?
Yes, if they modify the chemical structure sufficiently to avoid the scope of the claims.

3. Are method-of-treatment claims enforceable?
Yes, especially when paired with specific compositions, but enforceability depends on established use and infringement.

4. Has the patent been litigated or challenged?
No public records indicate litigation, but challenges could be mounted given potential patentability issues within the scope.

5. What is the likelihood of patent expiry affecting exclusivity?
Given the expiration date of September 21, 2036, the patent provides over a decade of exclusivity, assuming maintenance fees are paid.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,323,093.

[2] WIPO. (2018). Patent Family Data and Application Status.

[3] European Patent Office. (2020). Patent Landscape Reports for Inflammatory Therapeutics.

More… ↓

⤷  Start Trial

Details for Patent 10,323,093

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 ⤷  Start Trial 2038-12-21
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 October 04, 2017 ⤷  Start Trial 2038-12-21
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 August 27, 2021 ⤷  Start Trial 2038-12-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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