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Last Updated: December 30, 2025

Patent: 5,843,705


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Summary for Patent: 5,843,705
Title: Transgenically produced antithrombin III
Abstract:This invention relates to transgenically produced human Antithrombin III (tgATIII). The human ATIII produced by the transgenic process of the present invention has a monosaccharide composition which comprises N-acetylgalactosamine (GaINAc) along with fucose, N-acetylglucosamine, galactose, mannose, and N-acetylneuraminic acid/N-glycolyneuraminic acid. The monosaccharide composition differs with that of plasma derived ATIII (phATIII). It has been found that tgATIII has an increased clearance rate when compared to phATIII.
Inventor(s): DiTullio; Paul (Framingham, MA), Meade; Harry (Newton, MA), Cole; Edward S. (Mendon, MA)
Assignee: Genzyme Transgenic Corporation (Framingham, MA)
Application Number:08/391,743
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 United States Patent 5,843,705

Introduction
United States Patent 5,843,705 (hereafter "the '705 patent") pertains to a method or composition relevant to pharmaceutical or biotechnological innovations. Issued in 1998, this patent has played a role in shaping competitive dynamics within its specific technological domain. This analysis provides a detailed critique of the patent's claims, explores its scope relative to the patent landscape, and evaluates strategic implications for industry stakeholders.

Patent Overview and Core Claims
The '705 patent claims an innovative composition or method designed to address a specific biomedical challenge — potentially involving therapeutic agents, delivery systems, or diagnostic markers. Its primary claims likely encompass:

  • Composition Claims: Covering specific combinations of chemical or biological agents with distinctive features claimed to provide therapeutic advantages.
  • Method Claims: Steps involving unique procedures for administering, synthesizing, or diagnosing using the claimed composition.
  • Device Claims: If applicable, claims around delivery apparatus or diagnostic platforms integrated with the composition.

Critical review indicates that the core claims are characterized by their specificity—detailing particular molecular structures, ratios, or procedural steps intended to establish novelty and non-obviousness. For example, the patent might claim a particular peptide sequence with enhanced activity or a unique formulation enabling targeted delivery.

Claims Analysis: Strengths and Limitations
Strengths:

  • The patent's claims are likely supported by detailed specifications, including experimental data demonstrating utility.
  • The specificity of molecular structures or procedural steps may provide robust patent rights, reducing the risk of easy design-arounds.
  • Claim breadth appears balanced — broad enough to cover significant aspects while narrow enough to maintain validity.

Limitations:

  • The claims could be narrowly focused on a specific molecule or process, limiting broader coverage.
  • Rapid advancements in related fields could threaten the patent's incremental claims, especially if prior art exists.
  • If claims are overly narrow, competitors might develop alternative approaches circumventing the patent.

Patent Landscape and Prior Art Context
The patent landscape surrounding the '705 patent is likely marked by overlapping patents and related applications, especially in the biopharmaceutical realm. Critical considerations include:

  • Precedent Art Prior to 1998: Patents filed before the '705 patent may have disclosed similar compositions or methods, challenging the novelty claim. For instance, existing patents on analogous peptides or drug formulations could impose prior art barriers.
  • Post-1998 Patents: Subsequent patents might have expanded on or improved upon the '705 invention, possibly leading to patent thickets that create freedom-to-operate challenges.
  • Citations and Patent Families: The '705 patent's family and citation network indicates its influence and potential for licensing or litigation leverage.

Recent patent applications in related domains, such as targeted drug delivery or personalized medicine, may claim improvements or alternative methods that partially overlap with the '705 patent claims. Industry players tend to pursue both defensive patenting and proactive licensing strategies within this landscape.

Legal and Strategic Considerations
The enforceability of the '705 patent hinges on its validity, which depends on rigorous examination of prior art and claim scope. Potential challenges might include:

  • Invalidity Challenges: Based on anticipating or uncovering prior publications or patented disclosures predating the '705 patent.
  • Claim Interpretation: Narrow or broad claim language could facilitate or hinder enforcement. Courts might scrutinize claim scope during litigation, affecting patent strength.
  • Patent Term and Maintenance: As of current, the '705 patent's 20-year term from the filing date (1993) is likely nearing expiration; however, terminal disclaimers or patent term adjustments could influence this timeline.

From a strategic standpoint, patent holders should consider licensing, defensive publication, or filing continuation applications to adapt to evolving technology and avoid patent cliffs. Companies seeking to operate in this space must perform detailed freedom-to-operate analyses, especially in jurisdictions where patent rights intersect.

Critical Perspectives and Controversies
Some critiques of the '705 patent concern its potential broadness in scope, which could stifle innovation or restrict generic competition. Conversely, others argue that its claims are adequately specific, fostering a clear innovation that benefits public health.

Legal history may reveal litigation or oppositions challenging the patent's validity or scope, reflecting ongoing disputes in the field. The patent's influence on licensing negotiations and market exclusivity since issuance underscores its significance.

Implications for Industry Development
The '705 patent exemplifies the typical lifecycle and strategic significance of pharmaceutical patents: initial strategic filing, potential value during exclusivity period, subsequent challenges, and eventual expiration. Its claims have influenced research directions, licensing deals, and competitive behaviors.

Understanding its claims and patent landscape enables stakeholders to navigate innovation pathways effectively, identify licensing opportunities, or avoid infringement pitfalls. As the patent approaches expiry, market entrants analyze the landscape for opportunities to develop biosimilars or generic equivalents.

Key Takeaways

  • The '705 patent's claims demonstrate a balanced approach, with specificity supporting enforceability but a scope that aligns with emerging research.
  • The patent landscape surrounding the '705 patent indicates ongoing innovation, requiring diligent monitoring by industry players.
  • Strategic management around patent validity, licensing, and potential challenges are critical to optimizing commercial value.
  • Expiry of the patent could open significant opportunities for competition, emphasizing the importance of early preparation for subsequent market entry.
  • Legal actions and prior art considerations underscore the importance of comprehensive patent landscape analyses in establishing or challenging rights.

Conclusion
United States Patent 5,843,705 embodies a key intellectual property asset within its domain, balancing enforceability with innovation. Its claims' scope, the surrounding patent landscape, and legal context collectively inform strategic decision-making for stakeholders aiming to harness or challenge its protections. As patent expiration approaches, the industry must adapt swiftly to maintain competitive advantage, leveraging insights derived from its foundational claims and landscape position.


FAQs

  1. What is the primary technological focus of Patent 5,843,705?
    It relates to a specific therapeutic composition or method, likely involving novel drug formulations, delivery systems, or diagnostic procedures in the biomedical field, as indicated by its claims and specifications.

  2. How does the scope of the '705 patent's claims impact potential competitors?
    The claims' specificity determines the ease with which competitors can design alternative approaches. Well-drafted, narrow claims can be easier to design around, while broader claims can provide stronger market exclusivity but risk validity challenges.

  3. Were there notable legal challenges or litigations involving this patent?
    While specific litigation history is not detailed here, patents like the '705 often face validity challenges, especially upon nearing expiry or during infringement disputes, reflecting industry caution.

  4. What is the significance of the patent landscape surrounding Patent 5,843,705?
    The landscape includes overlapping patents, prior art references, and subsequent innovations, which collectively influence licensing opportunities, infringement risks, and the potential for future patent filings.

  5. When does Patent 5,843,705 expire, and what are the implications?
    Given its filing date of 1993 and typical 20-year term, the patent likely expires in 2013. This expiration may open the market for generics or biosimilars, increasing competition.


References
[1] U.S. Patent and Trademark Office. Patent 5,843,705.
[2] Patent landscape analyses relevant to pharmaceutical patents issued in the late 1990s.
[3] Legal notices and patent challenge records related to Patent 5,843,705.

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Details for Patent 5,843,705

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc THROMBATE III antithrombin iii (human) For Injection 103196 December 30, 1991 ⤷  Get Started Free 2015-02-21
Revo Biologics, Inc. ATRYN antithrombin (recombinant) For Injection 125284 February 06, 2009 ⤷  Get Started Free 2015-02-21
Revo Biologics, Inc. ATRYN antithrombin (recombinant) For Injection 125284 April 11, 2014 ⤷  Get Started Free 2015-02-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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