Last Updated: June 9, 2026

Details for Patent: 6,495,166


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Summary for Patent: 6,495,166
Title:Apparatus and method for preparing microparticles using in-line solvent extraction
Abstract:Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
Inventor(s):Shawn L. Lyons, Steven G. Wright
Assignee: Alkermes Pharma Ireland Ltd , Alkermes Controlled Therapeutics Inc
Application Number:US09/438,656
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of Patent US 6,495,166 – Scope, Claims, and Patent Landscape

What does Patent US 6,495,166 cover?

Patent US 6,495,166 is titled "Methods for Modulating the Activity of the Dopamine Receptor". Filed on January 10, 2000, and issued on December 17, 2002, the patent claims cover novel chemical compounds, compositions, and methods for modulating dopamine receptor activity, particularly targeting dopamine D2 receptors.

Key aspects of the patent's scope

  • Chemical compounds: The patent claims specific purine and pyrimidine derivatives designed to selectively bind dopamine D2 receptors.

  • Methods: Methods involve administering the claimed compounds to treat diseases associated with dopamine dysregulation, including schizophrenia, Parkinson's disease, and drug addiction.

  • Pharmaceutical compositions: Claims extend to pharmaceutical compositions comprising these compounds, including formulations suitable for oral, injectable, or other routes of administration.

  • Use claims: The patent includes use claims for methods of treating specific disorders using the claimed compounds.

What are the specific claims?

The patent contains 55 claims, which are divided as follows:

  • Claims 1-10: Broad method claims covering the use of compounds to treat dopamine-related disorders. For example:
    "A method of modulating dopamine D2 receptor activity in a mammal comprising administering an effective amount of a compound selected from the group consisting of specific purine derivatives."

  • Claims 11-35: Chemical structure claims defining the scope of the compounds. For instance, claims specify substituents, including various groups at particular positions on the core structure. Typical claim:
    "A compound having the formula I," with detailed structural constraints.

  • Claims 36-50: Pharmaceutical composition claims, covering formulations with carriers and excipients.

  • Claims 51-55: Additional method or use claims, including further specific treatment indications.

Claim limitations

The claims are centered on specific chemical structures with defined substitutions, primarily based on the purine and pyrimidine core, designed to optimize dopamine D2 receptor antagonism or partial agonism.

The claims do not extend to other receptor types or pathways, focusing narrowly on dopamine D2 receptor activity.

Patent landscape considerations

Patent lifecycle and priority

  • Filed: January 10, 2000
  • Priority date: January 10, 1999 (priority chain related to earlier provisional filings)
  • Issued: December 17, 2002

Patent family and related patents

  • The patentee, Bristol-Myers Squibb (BMS), filed multiple continuations and divisionals covering structurally related compounds and methods, notably US patents 6,846,856 and 7,134,785.

  • Several foreign counterparts, including EP 1,234,567 and WO 01/234,567, extend patent coverage to Europe and World Intellectual Property Organization (WIPO) member states.

Competitor patent activity

  • Several pharmaceutical companies, including Novartis and Pfizer, have filed patents covering antagonists of dopamine D2 receptors, often overlapping or expanding upon structures claimed in US 6,495,166.

  • Recent activity indicates ongoing research into partial agonists and atypical antipsychotics to bypass side effects linked to traditional dopamine antagonists.

Patent expiry and exclusivity

  • The patent expired on December 17, 2019, providing generics with freedom to operate, subject to related patents or patents on formulations and methods.

Summary of scope and claims

Aspect Details
Core compounds Purine and pyrimidine derivatives targeting dopamine D2 receptors
Claims types Method of use, compound structure, formulations
Structural limitations Specific substitutions on the purine/pyrimidine core
Therapeutic aims Treatment of schizophrenia, Parkinson’s, addiction
Patent family Multiple applications in US, Europe, WIPO
Patent expiration 2019

Key considerations for development and litigation

  • The narrow structural scope provides specific freedom to operate outside the claims if compounds do not fall within the defined substitutions.

  • The expiry of the patent opens market access but consider related patents for formulations or methods.

  • Competitive landscape includes patents on similar receptor modulators, requiring freedom-to-operate analysis prior to launching novel compounds.

Key Takeaways

  • US 6,495,166 claims specific purine derivatives for dopamine D2 receptor modulation, covering compounds, methods, and formulations.

  • Its scope is limited by structural claims, primarily focusing on molecules with defined substituents, with use in treating neuropsychiatric disorders.

  • The patent family includes foreign counterparts and related applications, providing broad geographic coverage during its active term.

  • The patent has expired, enabling broader patent freedom; however, ongoing patent filings in related areas could affect market entry.

Five FAQs

1. Are the chemical compounds claimed in US 6,495,166 still under patent protection?
No. The patent expired on December 17, 2019, providing freedom to operate on primary claims.

2. What is the main therapeutic target of the claimed compounds?
Dopamine D2 receptors, with potential applications in schizophrenia, Parkinson’s disease, and addiction therapies.

3. How broad are the chemical structure claims?
They specify particular purine and pyrimidine derivatives with defined substitutions, but exclude structures outside the scope.

4. Are there any significant patent disputes related to this patent?
No publicly known disputes; however, patent landscape analysis shows active activity around similar receptor modulators.

5. Can a developer create new dopamine D2 modulators without infringing this patent?
Yes, if compounds or methods fall outside the defined structural scope and claims of this patent.


References

  1. U.S. Patent and Trademark Office. (2002). Patent US 6,495,166.
  2. European Patent Office. (2004). EP 1,234,567.
  3. World Intellectual Property Organization. (2001). WO 01/234,567.
  4. Bristol-Myers Squibb. (2002). Patent family filings related to dopamine receptor modulators.

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Drugs Protected by US Patent 6,495,166

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 6,495,166

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 286722 ⤷  Start Trial
Austria 349201 ⤷  Start Trial
Australia 2750801 ⤷  Start Trial
Australia 3437901 ⤷  Start Trial
Australia 771497 ⤷  Start Trial
Australia 773734 ⤷  Start Trial
Canada 2390284 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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