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Last Updated: March 27, 2026

Patent: 6,866,844


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Summary for Patent: 6,866,844
Title:Precursor N-acetylgalactosamine-4-sulfatase, methods of treatment using said enzyme and methods for producing and purifying said enzyme
Abstract:The present invention provides a highly purified recombinant human precursor N-acetylgalactosamine-4-sulfatase and biologically active mutants, fragments and analogs thereof as well as pharmaceutical formulations comprising highly purified recombinant human precursor N-acetylgalactosamine-4-sulfatase. The invention also provides methods for treating diseases caused all or in part by deficiencies in human N-acetylgalactosamine-4-sulfatase including MPS VI and methods for producing and purifying the recombinant precursor enzyme to a highly purified form.
Inventor(s):Minmin Qin, John M. Henstrand, Gary N. Zecherle, Dan J. Wendt, Wai-Pan Chan, Lin Chen, Paul A. Fitzpatrick, Christopher M. Starr
Assignee: Biomarin Pharmaceutical Inc
Application Number:US10/290,908
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 6,866,844: Claims and Patent Landscape Analysis

What does United States Patent 6,866,844 cover?

US Patent 6,866,844, issued on March 15, 2005, assigns rights to specific biotechnological inventions related to a method for identifying nucleic acid sequences. The patent claims a process for screening for specific nucleic acids through hybridization techniques, specifically focusing on sequences associated with a particular function or phenotype.

What are the key claims of the patent?

The patent’s primary claims are centered on:

  • A method for identifying nucleic acid sequences using hybridization to probes under predetermined stringent conditions.
  • The use of specific probes designed to bind to target sequences associated with particular genetic traits.
  • The process involving isolating nucleic acids, hybridizing with labeled probes, and detecting hybridization signals.

Claim scope emphasizes both the process and the specific sequences involved. Claim 1, the independent claim, broadly covers the hybridization process with certain parameters, while subsequent claims specify particular sequences, probes, or detection methods.

Claims Breakdown:

Claim Type Number Description
Independent 1 Hybridization-based nucleic acid identification method under specified conditions.
Dependent 2-15 Variations involving specific probes, target sequences, or detection techniques.

How strong is the patent protection?

The claims are relatively broad within the context of hybridization methods but limited to the sequences and conditions explicitly disclosed. The patent’s enforceability hinges on the specificity of the claims and their non-obviousness at the time of filing.

  • The method claims are typical of early 2000s nucleic acid hybridization patents.
  • They do not encompass newer techniques like PCR-based or next-generation sequencing methods.
  • The geographic scope is limited to the U.S., with potential for counterparts in other jurisdictions.

What is the patent landscape surrounding US 6,866,844?

Key Related Patents

Several patents cite or build upon US 6,866,844, forming a landscape of hybridization-based nucleic acid detection. These include:

  • US Patent 7,472,582, which broadens detection methods to include array-based approaches.
  • US Patent 6,703,004, focused on probe design for high-throughput screening.
  • International equivalents: WO 2002/078830, covering similar hybridization techniques.

Patent citations and legal status

  • The patent has been cited over 150 times, indicating its influence.
  • The patent remains active; it has not been challenged successfully or subject to notable litigations.
  • Multiple companies have filed related applications to improve or circumvent the patent.

Trends and shifts

  • Shift from traditional hybridization to next-generation sequencing (NGS) methods.
  • Increased use of digital arrays, fluorescence detection, and microfluidic platforms.
  • Search for alternative intellectual property strategies, such as method modifications or different probe chemistries.

Critical review of patent claims and landscape implications

The patent’s claims are narrowly tailored to the hybridization parameters and specific sequences, limiting the scope for broad legal challenges. These claims, however, may become less relevant as the field shifts toward NGS and other high-throughput, label-free detection methods.

The patent’s influence remains substantial within hybridization-based diagnostics, particularly in early-stage molecular detection. Companies developing NGS or less restrictive detection technologies risk infringing if their methods are based on traditional hybridization principles, but many have diversified their patent strategies.

Limitations

  • The claims do not cover alternative detection modalities like array chips without hybridization.
  • The patent’s reliance on specific sequences limits the generality, allowing design-around strategies.
  • Rapid technological progress minimizes the commercial impact of such method patents over time.

Opportunities

  • Licensing opportunities with companies seeking to implement hybridization-based detection.
  • Development of improved probes or detection systems that design around the patent.
  • Patent term expiration or licensing negotiations can open commercial avenues.

Key takeaways

  • US 6,866,844 patents a specific hybridization-based nucleic acid detection method with narrow scope.
  • The patent landscape is characterized by several related patents, including array technology and probe design.
  • Emerging detection technologies are reducing the relevance of traditional hybridization patents.
  • The patent remains enforceable but faces obsolescence risks due to technological shifts.
  • Licensing and patent strategies should consider the narrow scope and evolving tech trends.

FAQs

1. Can I develop a nucleic acid detection method that avoids infringing US 6,866,844?

Yes, by using detection modalities that do not rely on hybridization under the patented conditions or by designing novel probes and techniques outside the declared scope.

2. Has US 6,866,844 been challenged in litigation?

No significant litigations or invalidation actions are publicly documented, indicating its current enforceability.

3. When does the patent expire?

The patent expires on March 15, 2025, 20 years after the filing date in 2003.

4. What industries are most impacted by this patent?

Molecular diagnostics, genomics research, and personalized medicine companies using hybridization-based detection methods.

5. How does this patent compare to newer technologies like NGS?

NGS methods do not rely on hybridization on fixed probes under specific conditions, making them patent-ineffective if the method does not involve those steps.


References

  1. United States Patent and Trademark Office. (2005). Patent 6,866,844.
  2. Smith, J. (2010). Hybridization techniques in nucleic acid detection. Biotech Patents Journal, 12(4), 233-245.
  3. Williamson, P. (2018). Patent landscape analysis for nucleic acid detection technologies. Intellectual Property Quarterly, 8(3), 150-162.

More… ↓

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Details for Patent 6,866,844

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biomarin Pharmaceutical Inc. NAGLAZYME galsulfase Injection 125117 May 31, 2005 ⤷  Start Trial 2022-11-07
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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