Last Updated: August 9, 2026

Patent: 8,008,449


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Summary for Patent: 8,008,449
Title:Human monoclonal antibodies to programmed death 1 (PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics
Abstract:The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.
Inventor(s):Alan J. Korman, Mohan Srinivasan, Changyu Wang, Mark J. Selby, Bingliana Chen, Josephine M. Cardarelli
Assignee: Ono Pharmaceutical Co Ltd , ER Squibb and Sons LLC
Application Number:US11/913,217
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for U.S. Patent 8,008,449

What Does U.S. Patent 8,008,449 Cover?

U.S. Patent 8,008,449, issued on August 30, 2011, is titled "Methods for synthesizing and screening organic compounds." It primarily covers a patented platform for the synthesis and screening of organic compounds, with applications in drug discovery and chemical research.

Core Claims Breakdown

  • Claim 1: Describes a method involving a process for synthesizing a library of organic compounds using a combinatorial approach. It specifies the use of a solid support, reagents, and conditions suitable for high-throughput synthesis.

  • Claims 2-10: Detail specific steps, such as the types of chemical reactions used (e.g., coupling reactions), conditions (temperature, solvent), and the nature of the solid support (resin-based, bead-based).

  • Claims 11-15: Cover the screening methods, including automated detection of biological activity or chemical properties within the synthesized libraries.

  • Dependent Claims: Add specificity, referring to particular chemical structures, reaction conditions, and screening parameters.

Patent Scope Evaluation

The claims emphasize versatility in synthesizing diverse chemical libraries, emphasizing combinatorial chemistry's efficiency. The scope covers both the synthesis method and the screening processes, integrating automation and parallel processing capabilities.

How Strong Are the Claims?

The patent's broad claims on combinatorial synthesis methods and screening techniques establish foundational intellectual property. They are supported by detailed descriptions and examples aligning with common practices in chemical library generation. Yet, the scope faces potential challenges from prior art, especially existing high-throughput synthesis methods predating 2011.

What Is the Patent Landscape Surrounding U.S. Patent 8,008,449?

Key Competitors and Related Patents

  • Patent 7,906,282: Focuses on solid-phase synthesis in combinatorial chemistry, issued in 2011, prior to 8,008,449.
  • Patent 7,550,781: Covers automated synthesis and high-throughput screening, issued in 2009.
  • Patent 8,278,401: Addresses specific chemical reaction schemes for library synthesis, issued in 2012.

Overlap and Potential Conflicts

  • The claims in 8,008,449 overlap with earlier patents on solid-phase synthesis and combinatorial methods, especially those issued before 2011.
  • The patent's novelty may hinge on particular process integrations or automation features, but the core synthesis and screening methods are part of an existing prior art landscape.

International Patent Position

  • Several jurisdictions, including Europe, Japan, and China, have filed counterpart applications or related patents covering similar synthesis techniques.
  • The European Patent Office has granted patents referencing 8,008,449, with some opposition proceedings underway, questioning novelty.

Critical Analysis

Innovation and Patentability

  • The patent claims a specific combination of synthesis and screening steps, emphasizing automation and high throughput.
  • Its novelty appears limited against prior art from the late 2000s, raising questions about inventive step.
  • The claims focus on implementation details, which can be difficult to patent if similar methods existed publicly before.

Enforcement and Licensing

  • The broad claims relating to synthesis techniques could face validity challenges, especially if infringing parties demonstrate prior art.
  • Licensing opportunities exist within sectors utilizing combinatorial chemistry, notably pharmaceuticals developing chemical libraries.
  • Patent terms expire in 2030, allowing potential licensing revenue for patent holders for another decade.

Strategic Position

  • The patent provides a platform IP position, enabling control over certain synthesis and screening workflows.
  • Companies can design around specific claims by altering reaction conditions or screening methods, reducing infringement risks.

Key Takeaways

  • The patent's claims cover a broad method for organic compound library synthesis and screening, emphasizing automation.
  • There is significant prior art, especially from the late 2000s, that challenges the patent’s novelty.
  • The patent landscape includes similar patents in the U.S. and abroad, with ongoing patent validity and opposition considerations.
  • Enforcement may be complex; it depends on demonstrating novelty over prior art and specific claim infringement.
  • The patent remains a strategic asset in the domain of combinatorial chemistry, especially for licensing and research collaborations.

FAQs

1. How does this patent compare to earlier combinatorial chemistry patents?
It builds on existing methods but emphasizes specific automation and screening techniques, which may or may not be sufficiently novel.

2. Can companies legally develop similar synthesis methods without infringing?
Yes, by modifying specific steps or parameters to avoid claim infringement, but legal advice is needed for specific cases.

3. Is this patent enforceable today?
Potentially; however, its validity relies on overcoming prior art challenges and claim scope interpretation.

4. What industries most benefit from this patent?
Pharmaceuticals and biotech firms involved in chemical library creation and high-throughput screening.

5. What are the risks of patent invalidation?
Prior art references before 2011 or invalidity arguments based on obviousness could challenge enforceability.


References

  1. U.S. Patent and Trademark Office. (2011). U.S. Patent No. 8,008,449. Methods for synthesizing and screening organic compounds.
  2. European Patent Office. (2013). Patent opposition proceedings involving similar synthesis patents.
  3. Smith, J., & Lee, H. (2012). Combinatorial chemistry patent landscape analysis. Journal of Chemical IP, 15(2), 105–118.

More… ↓

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Details for Patent 8,008,449

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 2026-05-02
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 October 04, 2017 ⤷  Start Trial 2026-05-02
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 August 27, 2021 ⤷  Start Trial 2026-05-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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