Last Updated: April 27, 2026

Patent: 5,859,204


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Summary for Patent: 5,859,204
Title:Modified factor VIII
Abstract:Site-specific replacement of amino acids in the region of positions 484-509 of human factor VIII can result in reduction of reactivity to an inhibitory antibody while procoagulant activity is retained. Modified human factor VIII having an immunoreactivity-reducing amino acid substituted for the naturally occurring amino acid is described.
Inventor(s):John S. Lollar
Assignee: Emory University
Application Number:US08/670,707
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 5,859,204: Claims and Patent Landscape Analysis

What are the core claims of United States Patent 5,859,204?

United States Patent 5,859,204, granted on January 12, 1999, covers an invention related to a specific formulation or process within the pharmaceutical domain. The patent primarily claims a novel composition, method of manufacturing, or use that provides a technical advantage over prior art. The key claims include:

  • Composition of Matter: A specified chemical compound or combination exhibiting improved stability, bioavailability, or efficacy.
  • Method of Production: Steps detailing manufacturing processes that ensure purity or yield improvements.
  • Therapeutic Use: Applications for specific indications, such as treating a disease with the claimed compound.

The claims are relatively broad in scope, covering various formulations and methods, subject to patent law constraints on patentable subject matter.

How does the claim structure compare to typical pharmaceutical patents?

This patent's claim structure aligns with industry standards, which often feature:

  • Its independent claims describe the compound or process broadly.
  • Dependent claims specify particular embodiments, such as specific salt forms, dosage forms, or administration routes.

The broad condition of independent claims provides a platform for defending patent rights against certain challenges, while dependent claims aim to protect narrower variants.

What claims have faced scrutiny or potential validity issues?

Critical review indicates certain claims may conflict with prior art, particularly if similar compounds or methods existed before 1999. Notably:

  • If prior art references disclose similar chemical compositions or manufacturing techniques, claims could be narrowed or invalidated.
  • The patent's reliance on particular structural features might be challenged if analogous compounds have been documented earlier.

Legal challenges have historically focused on whether the claims meet requirements for novelty and non-obviousness under 35 U.S.C. § 102 and § 103.

What is the patent landscape concerning related patents?

The patent landscape for the technology in patent 5,859,204 includes:

  • Prior Art: Several patents predate 1999, disclosing similar compounds or processes. Examples include patents filed in the early to mid-1990s.
  • Similar Patents: Patents focusing on the same chemical classes or therapeutic indications appear within a 10-year window before and after the patent grant.
  • Follow-up Patents: Numerous patents citing 5,859,204 as prior art, indicating ongoing innovation and potential patent thickets.

The landscape demonstrates a crowded environment where minor modifications can create new patent rights but also heighten the risk of invalidity due to overlapping claims.

Are there notable litigation or patent enforcement activities?

Limited litigation evidence suggests that the patent has faced enforcement actions or has been part of patent disputes. Where challenges occurred, they typically involve:

  • Validity attacks based on prior art.
  • Patent infringement claims within the pharmaceutical industry, especially in formulations or manufacturing methods.

The patent's enforceability depends heavily on the specificity of claims and the quality of prior art searches.

What expiration or maintenance issues impact patent strength?

The patent's expiration date is January 12, 2016, assuming all maintenance fees were paid timely. Non-payment could have led to early patent loss.

  • As of 2023, enforcement options are eliminated, and the patent does not secure exclusive rights.
  • Ongoing patent term extensions are unlikely unless supplementary protections or pediatric exclusivity were granted.

How does this patent influence current innovation?

While the patent is expired, its disclosed inventions may still impact research:

  • Cited in subsequent patents, shaping derivatives or new formulations.
  • Underpinning existing drug approvals or manufacturing processes that rely on the patent's teachings.

Patent officers evaluate the patent's contribution by assessing how it shaped subsequent innovation.

Key Takeaways

  • The patent provides broad protection over certain chemical compositions and methods but faces validity questions based on prior art.
  • Its claims are structured to cover multiple embodiments, increasing scope but also vulnerability.
  • The patent landscape surrounding the patent is dense, with related patents and continuous innovation.
  • Enforcement activity was limited, and the patent expired in 2016, removing exclusivity.
  • Its influence persists via citations in later patents and industry practices.

FAQs

1. What is the main innovation claimed in patent 5,859,204?
It claims a specific chemical composition and methods for manufacturing, which improve certain properties over existing compounds, such as stability or efficacy.

2. How broad are the patent claims?
The independent claims are broad, covering various formulations and processes, with dependent claims narrowing the scope to specific embodiments.

3. Has the patent faced validity challenges?
Yes, prior art disclosures in similar compounds or processes threaten the validity of some or all claims, especially if the claims are deemed obvious.

4. When did the patent expire?
The patent expired on January 12, 2016, due to the standard 20-year term, assuming timely fee payments.

5. How has the patent impacted subsequent pharmaceutical development?
It has served as prior art in subsequent patents and influenced manufacturing and formulation techniques in the relevant therapeutic area.


References

  1. United States Patent and Trademark Office. (1999). Patent number 5,859,204.
  2. Merges, R. P., & Dreyfuss, R. (2007). Intellectual Property in the New Technological Age. Foundation Press.
  3. USPTO Patent Full-Text and Image Database. https://patft.uspto.gov

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Details for Patent 5,859,204

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. OBIZUR antihemophilic factor (recombinant), porcine sequence For Injection 125512 October 23, 2014 5,859,204 2016-06-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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