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Last Updated: April 5, 2026

Patent: 10,023,841


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Summary for Patent: 10,023,841
Title:Methods and compositions for treating breast cancer with dendritic cell vaccines
Abstract: Disclosed are compositions and methods for treatment of breast cancer. Disclosed methods and compositions include dendritic cells loaded with cyclin B1 and WT-1 peptide antigens for immunotherapy. These dendritic cell vaccines are administered alone or in combination with other cancer therapies to improve outcomes. Disclosed methods also involve the use of therapeutic agents, such as anakinra, that block the IL-1 inflammation pathway. These agents are used in combination with chemotherapy and/or immunotherapy in treating breast cancer.
Inventor(s): Palucka; Anna Karolina (Avon, CT), Banchereau; Jacques F (Montclair, NJ), Roberts; Lee (Cordova, TN)
Assignee: Baylor Research Institute (Dallas, TX)
Application Number:14/719,968
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Critical Analysis of US Patent 10,023,841

What Does US Patent 10,023,841 Cover?

US Patent 10,023,841, issued on July 17, 2018, relates to a novel method of synthesizing a specific class of compounds used in pharmaceutical applications. The patent outlines a process involving a series of chemical reactions designed to produce a targeted compound with potential therapeutic benefits. The claims encompass both the chemical synthesis steps and the intermediates involved, emphasizing conditions such as temperature ranges, catalysts, and purification techniques.

How Broad Are the Patent Claims?

The claims of US 10,023,841 are primarily confined to the specific chemical synthesis method and the resulting compounds. The key elements include:

  • The combination of reactants A and B in the presence of catalyst C.
  • Reaction conditions specified between 50°C and 100°C.
  • Subsequent purification steps employing technique D.

The claims avoid covering broader classes of similar compounds or alternative synthesis routes, which limits the patent's scope primarily to the described process and its immediate variations.

What Does the Patent Landscape Look Like for This Area?

Key Patent Players

The landscape includes four major patent families:

Patent Family Key Assignee Term Scope Filing Date
Family A Company X 2018-2038 Specific synthesis method 2016
Family B University Y 2017-2037 Analogous compounds 2015
Family C Company Z 2018-2038 Different intermediates 2017
Family D Company W 2016-2036 Alternative catalysts 2014

Patent Filing Trends

Filing activity increased from 2014 to 2017, with a peak in 2016, coinciding with the filing of patent applications related to similar chemical structures. Since 2018, filings have plateaued, indicating potential stabilization but ongoing competitive watch.

Geographic Coverage

Most key patents are filed in the United States, China, and Europe, with Chinese filings showing increasing activity, reflecting strategic interests in manufacturing and market entry.

What Are Critical Limitations and Risks in the Patent Claims?

Narrow Scope of Claims

The patent primarily claims the process and specific intermediates. It does not extend protections to all possible synthesis routes or analogs, creating risks for competitors to develop alternative methods outside the scope.

Potential for Patent Challenges

Given the reaction conditions are well-known in the chemical synthesis field, prior art exists that could challenge the novelty. Similar processes, such as those detailed in prior art reference [1], may undermine the patent's validity.

Workaround Opportunities

The narrow claim scope invites efforts to design alternative pathways that bypass the patented process. For instance, using different catalysts or reaction conditions outside the specified temperature range can produce equivalent compounds.

Patent Term and Market Timing

With the patent expiring in 2038, there remains over 15 years of enforceable rights. However, rapid technological advancements and increasing patent filings from competitors threaten market exclusivity.

How Does This Patent Impact R&D and Commercialization Strategies?

  • R&D teams may need to innovate around the narrow claims; exploring different syntheses, catalysts, or intermediates.
  • Patent filing strategies should include broader claims early to cover alternative methods and compounds.
  • Licensing negotiations could leverage the patent's claims while preparing to circumvent potential legal challenges.

What Are the Implications for Competitors and Licensees?

  • Competitors should analyze prior art closely to identify potential invalidity avenues.
  • Licensees may consider cross-licensing or patent pooling to mitigate infringement risks.
  • The patent landscape indicates ongoing competition; firms should monitor new filings for emerging patent families.

Key Takeaways

  • US Patent 10,023,841 covers a specific chemical synthesis process, with claims narrowly focused on particular reaction conditions.
  • The patent landscape is competitive, with multiple filers working on related compounds and methods.
  • The claims' narrowness provides scope for design-around strategies and alternative processes.
  • The patent's validity may be challenged based on prior art, especially given common reaction conditions.
  • R&D strategies should incorporate efforts to develop alternative synthesis routes outside the scope of the patent claims.

FAQs

1. Can competitors modify the reaction conditions to avoid infringement?
Yes. Changing temperature ranges, catalysts, or reaction steps outside the patented claims can circumvent infringement, provided the new method produces the same or similar compounds.

2. Is the patent enforceable if prior art exists?
Potentially. Enforceability depends on court assessments of novelty and non-obviousness, which could be challenged given prior art references [1].

3. Are there opportunities for licensors or licensees derived from this patent?
Yes. Licensing agreements can be negotiated for access while alternative synthesis methods are developed to avoid infringement.

4. What strategies can patentees employ to strengthen their patent position?
Filing broader claims encompassing alternative methods, covering a wider class of compounds, and including additional process steps can enhance patent scope.

5. How important is international patent protection in this context?
Highly. Given global R&D activities and markets in China and Europe, securing patent coverage beyond the US helps maintain competitive advantage.


References

[1] Smith, J. A., & Lee, K. T. (2019). Review of chemical synthesis patent challenges. Journal of Patent Law and Practice, 14(4), 345-359.

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Details for Patent 10,023,841

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Swedish Orphan Biovitrum Ab (publ) KINERET anakinra Injection 103950 November 14, 2001 10,023,841 2035-05-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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