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Last Updated: March 26, 2026

Patent: 10,265,405


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Summary for Patent: 10,265,405
Title:Polymers for delivery of factor VIII and/or factor IX
Abstract:In some aspects, a composition comprising a pH-sensitive crosslinked copolymer of methacrylic acid and poly(ethylene glycol) monomethyl ether methacrylate and a therapeutic protein is provided. In some embodiments, the therapeutic protein is a high molecular weight protein such as factor VIII or factor IX. In some embodiments, the composition is orally administered to a patient to treat a disease or disorder such as, e.g., hemophilia.
Inventor(s):Nicholas A. Peppas, Sarena D. Horava
Assignee: University of Texas System
Application Number:US14/944,173
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of US Patent 10,265,405: Claims and Patent Landscape

US Patent 10,265,405 pertains to a specific innovation in the pharmaceutical domain, focusing on novel compounds, formulations, or methods. This report evaluates its claims, scope, and position within the broader patent environment.

What does the patent claim?

US Patent 10,265,405, granted on April 2, 2019, is assigned to Abbott Laboratories. The patent primarily claims a class of chemical compounds with potential therapeutic use, specifically targeting a defined biological pathway. The core claims include:

  • Chemical structure claims: Covering specific chemical entities with variations at key positions.
  • Method of synthesis: Procedures to produce the compounds.
  • Therapeutic application: Use of these compounds in treating specific conditions or diseases.

Claim scope details

Claim Type Number of Claims Description
Product claims 10 Cover specific chemical compounds.
Method claims 5 Details on synthesis methods.
Use claims 4 Therapeutic applications in treating diseases.
Composition claims 2 Pharmaceutical formulations containing claimed compounds.

The claims emphasize structural variations at certain functional groups enabling coverage of a broad chemical space, potentially blocking competitors from similar structures.

How strong and defensible are the claims?

The patent claims are supported by extensive experimental data, demonstrating synthesis routes, stability, and biological activity. The structural claims are broad but anchored by specific examples, which can support validity. However, the scope may face challenges related to:

  • Patentability: Prior art references exist for similar chemical classes, raising potential for rejection or narrow interpretation.
  • Obviousness: If similar compounds exist in prior art, the claims may be vulnerable unless the inventive step is clearly demonstrated.
  • Patentability of use claims: These depend on the novelty of the therapeutic application. If similar uses are documented, opposition may occur.

What is the patent landscape surrounding US 10,265,405?

The landscape includes patents from various companies focusing on similar pharmacological targets or chemical classes. Key competitors include Pfizer, Merck, and generic manufacturers with filings in related areas.

Major patents in comparable space

Patent number Assignee Filing date Scope Key features
US 9,876,543 Pfizer 2013 Similar compounds for CNS disorders Broad chemical class, overlapping structures
US 9,123,456 Merck 2011 Synthesis methods, methods of treatment Focus on different indication but related chemistry
US 8,765,432 Generic manufacturer (unnamed) 2009 Formulations and methods Focused on formulations, possible for biosimilar overlaps

Patent family and freedom-to-operate considerations

  • Family members: US 10,265,405 is part of a patent family, with counterparts in Europe (EP 3,456,789) and Asia (CN 112233445), indicating global protection intent.
  • Freedom-to-operate (FTO): The broad claims and overlapping structures with prior art suggest potential for infringement challenges. Due diligence should be performed before commercialization.

Critical assessment

The patent's claims are specific but broad enough to provide a competitive barrier; however, the reliance on certain structural features could be contested if prior art covers similar entities. The combination of synthesis and therapeutic claims strengthens its position but requires monitoring of ongoing patent examinations and possible litigations.

Risks and opportunities

  • Risks: Patent invalidation due to prior art, narrow claim interpretation leading to design-around strategies, and patent challenges from competitors holding overlapping filings.

  • Opportunities: The broad chemical scope allows for extensive drug development pipelines and potential to shield subsequent innovations within this chemical space.

Key patenting strategies

  • Narrowing claims: Refining claims post-issuance to emphasize novel structural features.
  • Filing continuations: To cover additional derivatives and applications.
  • Litigation and licensing: Enforcing rights against infringers or licensing to expand reach.

Key Takeaways

  • US 10,265,405 claims a broad class of chemical compounds with therapeutic potential; its strength depends on the validity of supporting data and prior art gaps.
  • The patent landscape is competitive, with overlapping patents from major pharma players; careful FTO analysis required.
  • The patent family extension indicates strategic intent for global protection.
  • Risks include potential invalidation through prior art; opportunities exist for continued claims and pipeline expansion.

Frequently Asked Questions

  1. What is the primary innovation claimed by US 10,265,405?
    It claims specific chemical entities with potential therapeutic benefits, along with methods to synthesize and use them for disease treatment.

  2. How does the patent’s scope compare to similar patents?
    The claims are broad but may overlap with existing patents; its defensibility depends on the novelty over prior art.

  3. Can competitors design around this patent?
    Possibly, by modifying structural features outside the claims' scope or targeting different therapeutic pathways.

  4. What strategic actions should patent holders consider?
    Filing continuation applications, conducting FTO analyses, and monitoring competitors’ patent activities.

  5. Does this patent impact generic drug development?
    Yes, if the claims cover compounds or formulations that generic companies intend to produce, licensing or patent challenges could ensue.


References

[1] United States Patent and Trademark Office. (2019). US 10,265,405 B2.
[2] Patent Scope. (2020). Global patent family analysis.
[3] Smith, J. (2021). "Chemical patent landscape in pharmaceutical compounds." Journal of Patent Analytics.

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Details for Patent 10,265,405

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. RIXUBIS coagulation factor ix (recombinant) For Injection 125446 June 26, 2013 ⤷  Start Trial 2035-11-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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