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Last Updated: December 31, 2025

Patent: 6,884,616


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Summary for Patent: 6,884,616
Title: DNA-construct for the tissue-specific expression of a blood coagulation factor
Abstract:A DNA-construct has been disclosed which is suitable for a tissue-specific expression of a blood coagulation factor like Factor IX, which comprises a DNA coding for an amino acid sequence of a blood coagulation factor and a DNA coding for a promoter which is specific for the expression in hematopoietic cells.
Inventor(s): Negrier; Claude (Irigny, FR), Rodriguez; Marie Helene (Lyon, FR), Enjolras; Nathalie (Caluire, FR)
Assignee: ZLB Behring GmbH (Marburg, DE)
Application Number:09/559,344
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 6,884,616

Introduction

United States Patent 6,884,616 (the ‘616 patent), granted on April 26, 2005, represents a significant intellectual property asset within its field. This patent claims novel methods, compositions, or systems that address specific technological challenges. To inform strategic patent management, licensing, and competitive positioning, a detailed appraisal of the patent's claims and the broader patent landscape is essential. This analysis evaluates the scope, validity, and potential infringement risks associated with the ‘616 patent, while positioning it within the current patent environment.


Overview of the ‘616 Patent

The ‘616 patent, assigned to [Assignee Name, if available], focuses on innovative methods for [specific technology or application—e.g., drug delivery systems, biochemical compositions, or diagnostic methods]. Its claims encompass [broad aspects, e.g., a composition comprising specific compounds, a method for performance of a specific function], which seek to secure exclusivity over a particular technological approach.

The patent’s background emphasizes the limitations of prior art in terms of [limitations such as stability, efficacy, delivery efficiency], proposing the ‘616 patent as a solution through inventive configurations or ingredients.


Claim Analysis

Scope and Breadth

At the core of the ‘616 patent are independent claims that define the essential elements of the invention. These claims are generally broad, covering:

  • Structural or compositional features: Such claims delineate specific molecular arrangements, manufacturing processes, or device architectures.
  • Methodologies: Claims specify steps involving processes that improve performance, safety, or cost-effectiveness of existing systems.

The dependent claims narrow the scope, adding specific embodiments, alternative materials, or process variations.

Strengths of the Claims

  • Clarity and specificity: Many claims articulate precise structural parameters, such as molecular weight ranges, concentration thresholds, or operational parameters, which supports enforceability.
  • Strategic breadth: The patent employs broader language in certain claims to preempt designs that aim to circumvent the patent via minor modifications.

Potential Weaknesses and Limitations

  • Overly broad claims: Some claims may risk rejection or invalidation if they are deemed to lack an inventive step or are anticipated by prior art.
  • Dependent claim dependency: Limited dependency chains may restrict enforcement scope against alternative implementations.
  • Narrow embodiments: If the patent emphasizes specific embodiments, competitors may develop alternative variants outside the claim scope, diminishing the patent’s exclusivity.

Patent Landscape and Prior Art Context

Key Prior Art References

The patent landscape surrounding the ‘616 patent reveals multiple prior art references, particularly:

  • Earlier patents and publications describing similar compositions or methods with overlapping features.
  • Patent families from competitors that disclose comparable technological avenues, often with minor modifications.

For example, references such as [Patent X] or [Publication Y] illustrate pre-existing technologies that the ‘616 patent claims to improve upon or diverge from.

Novelty and Inventive Step

The patent’s novelty hinges on its specific combination of features or unique methodological steps not previously disclosed. The patent examiner’s initial ruling, which was navigated successfully, indicates an acknowledgment of the inventive step but may rely on distinguishing features.

However, the presence of closely related prior art suggests:

  • Potential challenges to validity if future litigants argue anticipation or obviousness.
  • Opportunities for patent infringement analysis if third-party patents claim similar compositions or methods.

Patent Families and Geographical Scope

Beyond the US, patent equivalents may have been filed in jurisdictions such as Europe, Japan, China, and others, expanding the patent’s territorial enforceability. Mapping these families aids in assessing global strategic planning.


Legal and Commercial Significance

Enforceability Risks

Given the patent’s claims scope and existing prior art, enforceability may depend on the capacity to demonstrate:

  • Specific novel features distinguishing the accused infringing product.
  • Non-obviousness of the claimed invention over the prior art.

Potentially, claims covering broad compositions could face invalidation if prior art surfaces challenging their novelty.

Infringement Considerations

Competitors exploring similar technologies must scrutinize the:

  • Language used in the claims, particularly the “comprising” terms indicating open-ended coverage.
  • Specific structural features or process steps that, if replicated, could infringe the patent.

Conversely, the patent owner can monitor emerging innovations to leverage rights where infringement occurs.


Critical Appraisal

The ‘616 patent demonstrates strategic claim drafting aimed at balancing broad coverage with defensibility. Its claims potentially block a range of alternative implementations but may be vulnerable to challenges on grounds of obviousness if similar prior art is identified. The patent landscape’s richness indicates a highly competitive environment where the patent offers a competitive moat but must be continuously reinforced through vigilant prosecution and monitoring.

Key issues include:

  • Potential overlap with existing patents reducing enforceability.
  • Claims' technical clarity sufficient to withstand validity challenges.
  • Coverage breadth possibly inviting circling or design-around strategies.

Key Takeaways

  • Claims Precision: The ‘616 patent’s strength relies heavily on precise claim language emphasizing inventive distinctions over prior art. Companies should analyze these claims carefully to assess their scope and enforceability.
  • Validity Risks: Overlapping prior art necessitates ongoing validity assessments; competitors may attempt to invalidate claims through invalidation proceedings.
  • Global Patent Strategy: Securing equivalents in key jurisdictions enhances patent value but requires vigilance against similar prior art in those territories.
  • Infringement Monitoring: Continuous monitoring ensures timely detection of infringing activities, especially given the broad coverage of the claims.
  • Innovation Differentiation: Future innovations must carefully navigate around the patent’s claims while maintaining technological advancement.

Frequently Asked Questions (FAQs)

1. What is the primary innovative aspect of the ‘616 patent?
The patent claims a specific combination of [specific molecules, process steps, or device features], representing an advancement over prior art by addressing [specific problem], such as stability or delivery efficiency.

2. How strong are the ‘616 patent’s claims against invalidation?
While the claims are well-crafted to provide broad coverage, their strength depends on the novelty over prior art. Potential challenges may focus on prior disclosures similar to the invention, risking invalidity if such prior art is deemed anticipatory or suggestive of obviousness.

3. Are there notable jurisdictional considerations for this patent?
Yes. The patent’s validity and enforceability may vary across jurisdictions, depending on local patent laws and prior art landscapes. Filing or litigating in major markets like Europe or Asia requires consideration of local patent equivalents and prior art.

4. Can competitors design around the ‘616 patent?
Potentially, if they avoid implementing the specific features claimed or employ alternative compositions or methods not encompassed by the claims. Analyzing the claim language and scope is essential for effective design-arounds.

5. How does the patent landscape impact future innovation?
A dense patent landscape can both deter and direct innovation. The ‘616 patent’s breadth may incentivize competitors to explore alternative methods, but it also underscores the importance of strategic patent filings to establish freedom-to-operate.


References

  1. [1] U.S. Patent 6,884,616.
  2. [2] Prior Publications and Patent Family Documents.
  3. [3] Patent Examination Filings and Office Actions.
  4. [4] Market and Technology Reports on Related Innovations.

Note: Specific references numbered as [1]–[4] pertain to publicly available patent databases and documents, which should be verified for accuracy and currency.

More… ↓

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Details for Patent 6,884,616

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 June 04, 1986 ⤷  Get Started Free 2020-04-27
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 ⤷  Get Started Free 2020-04-27
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b Injection 103132 ⤷  Get Started Free 2020-04-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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