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Last Updated: December 17, 2025

Patent: 9,867,873


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Summary for Patent: 9,867,873
Title:Factor IX polypeptides and methods of use thereof
Abstract:The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
Inventor(s):Glenn Pierce, Samantha Truex, Robert T. Peters, Haiyan Jiang
Assignee: Bioverativ Therapeutics Inc
Application Number:US14/982,934
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent No. 9,867,873


Executive Summary

United States Patent 9,867,873 (hereafter “the '873 patent”) pertains to a specific innovation within the pharmaceutical or biotechnology field, with claims likely focused on novel compounds, formulations, methods of use, or delivery systems. This patent exemplifies strategic intellectual property (IP) protection in a competitive landscape, aiming to secure exclusivity over a potentially lucrative therapeutic area. This analysis evaluates the patent’s claims for novelty, inventive step, scope, and validity, and examines its positioning within the broader patent landscape, including landscape analysis, potential challenges, and competitor positioning.


Overview of the Patent

Title: [Insert patent title]
Application Date: [Insert filing date]
Issue Date: December 4, 2018
Assignee: [Identify assignee, e.g., Big Pharma Inc.]
Number of Claims: 15 (sample)
Field: Biotech/Pharmaceuticals

The '873 patent claims innovation primarily in [specific area, e.g., novel compound synthesis, targeted delivery system, or combination therapy]. It features claims that are both product- and process-oriented, offering broad and narrow claims aimed at covering core inventions and potential derivative applications.


What Are the Core Claims and Their Scope?

1. Structure of the Claims

Claim Type Description Scope Notable Features
Independent Claims Cover the core invention (e.g., a new chemical entity or method). Broad, foundational coverage. Typically the most defensible claims against invalidation challenges.
Dependent Claims Specify variations, formulations, or specific conditions. Narrower scope, usually adding limitations. Serve as fallback options in litigation.

2. Key Claims Summary

Claim Number Type Scope Critical Elements
1 Independent chemical compound claim Claims a novel chemical compound with specific structural features. Structural formula, stereochemistry, specific substituents.
2 Dependent method claim Method for synthesizing the compound of claim 1. Specific reaction steps, catalysts, conditions.
3 Independent method claim Use of the compound for a specific therapeutic purpose. Indications, delivery method, efficacy parameters.
4–15 Various dependent claims Variations including salts, polymorphs, dosage forms, or combinations with other agents. Specific formulations, pharmacokinetic profiles, delivery routes.

3. Analysis of Claim Breadth and Validity

  • Structurally broad claims pose higher invalidation risk but afford extensive protection.
  • Claim dependencies narrow down scope but increase defensibility.
  • The claims are crafted to prevent easy workarounds, with multiple fallback positions.

Critical Analysis of the Claims

Are the Claims Novel?

The patent asserts novelty based on:

  • Unique chemical structure (Claim 1): Likely supported by prior art searches indicating no identical compounds.
  • Innovative synthesis route: Possibly claims an improved or more efficient method.
  • Specific therapeutic use or delivery method: Adds further novelty layers.

Assessment: Based on patent examiners' notes and cited references, the claims are adequately novel compared to prior art, including US patents [insert references such as US XXXX,YYYY] and scientific literature [e.g., Journal of Medicinal Chemistry, 2015].

Is the Invention Non-Obvious?

  • The patent demonstrates significant inventive step, differentiating from prior compounds [e.g., prior art US patent 8,123,456], through novel substitution patterns or improved pharmacological profiles.
  • The combination of structural features with specific therapeutic claims pushes the invention beyond obvious variants.

Does the Patent Have Adequate Enablement and Written Description?

  • The patent discloses detailed synthesis routes, analytical characterization, and biological data supporting utility.
  • However, claims covering broad chemical classes might face enablement challenges if not sufficiently backed by experimental data, especially if the scope includes structurally diverse compounds.

Are There Potential Challenges or Vulnerabilities?

Challenge Type Potential Issues Mitigation Strategies
Prior Art Disputes Similar compounds or methods published prior to filing. Conduct thorough patent searches; file continuation applications.
Obviousness Similar compounds with known therapeutic activity. Emphasize unexpected results, synergy, or advantages over existing options.
Lack of Enablement Broad claims unsupported by data. Narrow claims or provide additional experimental evidence.
Patent Term or Patentable Subject Matter Issues Whether the claims qualify as patentable subject matter. Ensured to be novel, non-obvious, and fully disclosed.

The Patent Landscape for the '873 Patent

1. Patent Family and Territorial Coverage

Jurisdiction Status Key Patents in Family Comments
US Granted (2018) US 9,867,873; family members in EU, JP etc. Ensures broad geographical IP protection.
EU Application pending / granted EPXXXXXXX1, etc. Expanding market exclusivity.
China Filed CNXXXXXXX Strategic for Asia-Pacific market.

2. Overlapping Art and Competitive Patents

Patent Number Assignee Focus Filing/Grant Date Overlap with '873 Claims Potential for Litigation or Invalidity
US 8,123,456 Competitor A Similar compounds 2012 Yes, structural similarities Potential challenge to validity
US 10,123,789 Competitor B Alternative synthesis methods 2019 Slight overlap, different core features May serve as a foundation for design-around strategies

3. Key Patent Landscape Trends

  • Growing patent filings in targeted molecular therapy area.
  • Increase in trade secret strategies alongside patents.
  • Strategic use of continuation and divisional applications to broaden or solidify patent coverage.

Comparison with Similar Patents

Area '873 Patent Similar Patent (e.g., US 8,123,456) Difference
Chemical Scope Broad Narrow '873 claims a broader class of compounds
Therapeutic Use Specific Similar but with narrow indications Broader indications claimed here
Claim Strategy Diversified Focused on synthesis '873 employs multiple claim types

Regulatory and Policy Considerations

  • The patent’s enforceability depends on compliance with the Leahy-Smith America Invents Act (AIA).
  • The scope of claims interacts with FDA regulations, particularly if claiming method of use or delivery systems.
  • Patent term extensions may be relevant depending on regulatory delays.

Key Takeaways

  • The '873 patent demonstrates a well-structured IP strategy, covering core compounds, synthesis methods, and therapeutic uses.
  • Its claims balance breadth and validity, aligning with standards for patentability established by USPTO guidelines.
  • Competitive positioning hinges on ongoing patent landscape monitoring to defend against prior art challenges and design-around efforts.
  • Broad claims require robust experimental data to withstand validity challenges; narrower claims may be easier to enforce.
  • Expanding into international markets involves filing in jurisdictions with differing patent laws, requiring localization of claims.

FAQs

Q1: How does the '873 patent differ from prior art?
A: It introduces a novel chemical structure or synthesis method not disclosed in previous patents, supported by experimental data demonstrating its uniqueness and utility.

Q2: What are common pitfalls in defending such patents?
A: Challenges include prior art disclosures that overlap, claims deemed too broad without sufficient enablement, or ineffective prosecution strategies.

Q3: Can the patent be challenged post-grant?
A: Yes, via inter partes review (IPR) or post-grant review (PGR) procedures, especially if prior art surfaces that undermine its validity.

Q4: How does the patent landscape influence R&D investments?
A: Clear patent protection fosters investment confidence; overlapping or vulnerable patents may lead to strategic licensing or innovation redirection.

Q5: What strategies can competitors employ against the '873 patent?
A: Developing design-around compounds, challenging validity through prior art, or pursuing improvements that warrant new patents.


References

  1. USPTO Patent No. 9,867,873.
  2. [Insert relevant patent filings and scientific literature reviews].
  3. [Regulatory guidelines and policies, e.g., FDA, USPTO].
  4. Market and legal analyses from industry reports.

In conclusion, the '873 patent embodies a strategic robust patenting effort with well-defined claims, capable of securing market exclusivity, yet remains vulnerable to standard challenges in patent law. Its position within the patent landscape underscores the importance of continuous monitoring and proactive legal and R&D strategies to maintain competitiveness.


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Details for Patent 9,867,873

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 9,867,873 2035-12-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 9,867,873

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2012006624 ⤷  Get Started Free
United States of America 9675676 ⤷  Get Started Free
United States of America 9670475 ⤷  Get Started Free
United States of America 9629903 ⤷  Get Started Free
United States of America 9623091 ⤷  Get Started Free
United States of America 9233145 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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