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Last Updated: December 17, 2025

Patent: 5,824,784


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Summary for Patent: 5,824,784
Title: N-terminally chemically modified protein compositions and methods
Abstract:Provided herein are methods and compositions relating to the attachment of water soluble polymers to proteins. Provided are novel methods for N-terminally modifying proteins or analogs thereof, and resultant compositions, including novel N-terminally chemically modified G-CSF compositions and related methods of preparation. Also provided is chemically modified consensus interferon.
Inventor(s): Kinstler; Olaf B. (Thousand Oaks, CA), Gabriel; Nancy E. (Newbury Park, CA), Farrar; Christine E. (Newbury Park, CA), DePrince; Randolph B. (Raleigh, NC)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:08/321,510
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 5,824,784

Introduction

United States Patent 5,824,784 (the '784 patent) was granted on October 20, 1998, and pertains to innovations in the pharmaceutical or biotech sectors, often focusing on specific drug formulations, delivery mechanisms, or biological methods. Understanding the scope of this patent, its claims, and the surrounding patent landscape is crucial for stakeholders involved in drug development, licensing, and patent strategy. This analysis aims to dissect the patent's claims critically, evaluate its novelty and inventive step, and contextualize its role within the broader intellectual property environment.

Overview of the '784 Patent

The '784 patent appears to relate to a specific composition, method, or device—although the exact nature hinges on the claims—aimed at improving a therapeutic or diagnostic process. Given the patent's age, it likely played a foundational or pioneering role at its time of issuance, but the subsequent patent landscape has evolved to either narrow or expand its scope.

Claims Analysis

Claim Structure and Scope

The "claims" section defines the legal boundaries of the patent. The '784 patent contains a series of independent claims (broad coverage) and multiple dependent claims (specific embodiments or refinements).

Independent claims likely encompass:

  • A unique chemical composition with defined active ingredients.
  • A novel method of administration or formulation.
  • A specific device or apparatus for delivery.

Dependent claims narrow these to particular embodiments, such as specific concentrations, carriers, or delivery routes.

Critical assessment:

  • Breadth: The strongest patents often have broad independent claims. If the '784 patent's independent claims cover a wide array of compositions or methods, they could significantly limit competitors.
  • Validity concerns: Overly broad claims risk invalidation if prior art predates the invention. The examiner's allowance suggests the claims demonstrated novelty and inventive step at the time.
  • Enabling language: The claims must be supported by detailed description; ambiguous language can invite challenge.

Novelty and Inventive Step

When issued in 1998, the '784 patent likely distinguished itself from prior art by specific features or unexpected results. Critical analysis must confirm whether the claims:

  • Involved an inventive step over prior art references, such as earlier patents or scientific publications.
  • Offered a non-obvious improvement, such as increased efficacy, reduced side effects, or simplified manufacturing.

If subsequent citations or litigation analyses reveal overlapping prior art, the patent's validity in broad claims might be questionable.

Legal Status and Patent Landscape

Post-Issuance Litigation and Challenges

Patent durability can be compromised through litigation, reexaminations, or inter partes reviews. While specific legal history of the '784 patent requires ongoing monitoring, common challenges include:

  • Obviousness attacks: Arguing that the patent's claims are an obvious variation of prior art.
  • Lack of utility or enablement: Claiming insufficient disclosure or functional non-operability.
  • Post-grant reviews: Tests of validity based on new prior art.

Competitive Landscape and Related Patents

The patent landscape around the '784 patent likely includes:

  • Follow-on patents: Subsequent filings that attempt to carve out narrower niches or improve upon the original invention.
  • Citations: Both backward to prior art and forward to newer patents citing the '784 patent, indicating influence and technological lineage.
  • Patent thickets: Dense clusters of overlapping patents that may hinder freedom-to-operate.

The positioning of the '784 patent within this landscape impacts licensing strategies and litigation risks.

International Patent Rights

While U.S. patents are territorial, counterpart filings in Europe, Japan, and China could affect global commercialization. Given the patent's age, its foreign counterparts' statuses vary.

Critical Evaluation of the Patent’s Valuation

The value of the '784 patent depends on:

  • Its enforceability and validity.
  • The breadth of claims and their resistibility to challenge.
  • Its position within a competitive patent landscape.
  • Whether it has been maintained, enforced, or licensed.

Historically, patents from the late 20th century in biotech often face obsolescence due to evolving science, but if the claims cover foundational technology, they may still hold strategic value.

Implications for Stakeholders

  • Pharmaceutical companies: Must analyze the claims to avoid infringement or consider licensing opportunities.
  • Patent owners: Need to monitor potential challenges and consider maintaining or broadening claims via continuations.
  • Patent examiners and litigators: Use comprehensive prior art searches and technical assessments to evaluate validity.

Conclusion

The '784 patent embodies a strategic intellectual property asset from the late 1990s, with claims likely centered on innovative compositions or methods. Critical considerations include the claims’ scope, validity challenges, and their role within a complex patent ecosystem. Stakeholders should continually monitor related patents, ensure ongoing validity, and strategically leverage its enforceability or licensing potential.


Key Takeaways

  • Claims scope: The strength of the '784 patent hinges on precise, well-supported claims that balance breadth and robustness against prior art.
  • Validity considerations: Overly broad claims may be vulnerable; ongoing patent prosecution and litigation history should inform strategic decisions.
  • Patent landscape: An evolving sphere of related patents and citations necessitates vigilant monitoring for freedom-to-operate and licensing opportunities.
  • Global implications: International patent rights can extend the patent’s influence but require tailored strategies.
  • Strategic value: Despite age, the '784 patent may possess foundational significance, especially if it covers core technology with limited patent equivalents.

FAQs

  1. What exactly does United States Patent 5,824,784 cover?
    It covers specific compositions, methods, or devices related to a particular therapeutic or diagnostic innovation, with the precise scope detailed in its claims (refer to the patent document for specifics).

  2. Has the '784 patent been challenged or contested?
    Throughout its lifecycle, it may have faced validity challenges or litigation, but specific legal proceedings would need review to assess its current enforceability.

  3. Can this patent be licensed or enforced today?
    Assuming maintenance fees are current and no successful invalidation, the patent may still be enforceable, presenting licensing or enforcement opportunities.

  4. How does the patent landscape influence the value of the '784 patent?
    A dense patent landscape can either protect or hinder its value; overlapping patents or prior art can limit enforceability, while key foundational patents bolster strategic leverage.

  5. Are there international equivalents of this patent?
    Similar patents may exist in jurisdictions like Europe, Japan, or China, but their scope and validity depend on local filings and examinations.


References

  1. U.S. Patent No. 5,824,784.
  2. Patent Examination and Legal Databases.
  3. Patent Citation and Litigation Records.
  4. Industry Patent Landscaping Reports.
  5. Scholarly Articles on Patent Strategies in Pharmaceuticals.

More… ↓

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Details for Patent 5,824,784

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. NEULASTA pegfilgrastim Injection 125031 January 31, 2002 5,824,784 2014-10-12
Amgen Inc. NEULASTA ONPRO pegfilgrastim Injection 125031 December 23, 2014 5,824,784 2014-10-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 5,824,784

Country Patent Number Estimated Expiration
South Africa 951008 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 9611953 ⤷  Get Started Free
United States of America 8258262 ⤷  Get Started Free
United States of America 7662933 ⤷  Get Started Free
United States of America 7090835 ⤷  Get Started Free
United States of America 6956027 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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