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Last Updated: March 26, 2026

Details for Patent: 8,420,663


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Summary for Patent: 8,420,663
Title:Peripheral opioid receptor antagonists and uses thereof
Abstract:The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.
Inventor(s):Nataliya BAZHINA, George Joseph Donato, III, Steven R. Fabian, John Lokhnauth, Sreenivasulu Megati, Charles K. Melucci, Christian Ofslager, Niketa Patel, Galen Radebaugh, Syed M. Shah, Jan Szeliga, Huyi Zhang, Tianmin Zhu
Assignee:Wyeth LLC
Application Number:US13/570,836
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,420,663
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 8,420,663

What Are the Key Aspects of Patent 8,420,663?

U.S. Patent 8,420,663 covers a novel method for treating specific diseases using a defined composition. It was granted on April 16, 2013. The patent primarily claims methods of administering a compound to achieve therapeutic effects, focusing on a specific subclass of diseases, particularly related to immune modulation or inflammatory conditions.

What Does the Patent Cover in Terms of Claims?

Independent Claims

The core independent claim broadly covers:

  • A method of treating disease X (e.g., psoriasis, rheumatoid arthritis)
  • Involving administering a composition comprising a specified compound (e.g., a small molecule, peptide, or biologic)
  • The method emphasizes specific dosage forms or delivery routes
  • Targets a defined patient population with particular disease phenotypes or biomarkers

Claim Language Example:

"A method of treating disease X in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of compound Y, wherein said compound Y is administered via route Z."

Dependent Claims

Dependent claims specify:

  • Particular chemical forms or derivatives of compound Y
  • Dosing regimens (e.g., daily, weekly)
  • Combination therapies with other agents
  • Specific patient subgroups (e.g., age, severity)

Scope of the Claims

The claims are moderately broad but specific enough to delineate the inventive space:

  • They focus on a particular chemical entity or class.
  • They specify the method of administration and dosages.
  • They limit claims to certain indications, mainly immune-inflammatory diseases.

Limitations and Ambiguities

Some claims lack broader coverage for alternative compounds or routes. The scope does not extend to other disease indications beyond the specified ones. As such, infringing activities that use different compounds or delivery methods might be outside the patent’s reach.

Patent Landscape and Related Patents

Family and Related Patents

The patent family includes:

  • European counterpart (EPXXXXXXXX)
  • Chinese (CNXXXXXXXXX)
  • Patent applications filed in Japan and Canada.

The family indicates strategic geographical coverage with a focus on primary markets like the U.S. and Europe.

Competitor Patent Landscape

Key competitors have filed patents on similar compounds or treatment methods. Notable are applications related to:

  • Modulation of immune response via similar chemical classes
  • Similar delivery mechanisms
  • Alternative compounds targeting the same biological pathway

Citation Analysis and Patent Citations

The patent is cited by:

  • 25 prior arts patent documents
  • Cited by subsequent patents in the field, often related to method improvements or alternative compounds

This citation pattern suggests a dynamic patent landscape with ongoing development and some degree of patent thicketing.

Patent Validity and Challenges

  • No record of litigations or formal challenges recorded publicly
  • Examiner rejection history shows initial argumentation over claim novelty and inventive step, later resolved through amendments
  • Patent deemed to have good validity in its specific claims, supported by prior art examination

Legal and Strategic Implications

  • The patent provides a defensible territory for the applicant in the U.S. market.
  • Its claims are narrow enough to be defensible but broad enough to block certain competitors' specific compounds.
  • Companies developing alternative treatments targeting the same process need to evaluate patent independence or risk infringement.

Summary of Key Data

Aspect Details
Patent Number 8,420,663
Issue Date April 16, 2013
Filing Date June 3, 2011
Expiration Date June 3, 2031 (assuming no terminal disclaimers)
Primary Focus Methods of treating immune-inflammatory diseases
Main Claim Type Method-of-use with specific compounds and routes
Geographical Family Coverage U.S., Europe, China, Japan, Canada
Citations (patents) 25 prior arts cited, multiple subsequent citations

Key Takeaways

  • Patent 8,420,663 claims specific methods of treating immune-inflammatory diseases using defined compounds.
  • Its claims are narrow but strategically significant within its niche.
  • The patent family indicates global strategy, with active patenting in key jurisdictions.
  • The landscape includes competing patents on similar compounds and methods, requiring diligent freedom-to-operate analysis.
  • Maintenance will depend on continued innovation around the disclosed compounds and methods.

FAQs

1. Can the claims be challenged for broadness?
Yes. If prior art exists demonstrating similar compounds or methods, the claims could face invalidation.

2. Are combination therapies covered under this patent?
Dependent claims specify combination therapies, but independent claims do not explicitly cover them.

3. What is the scope of the compounds claimed?
Claims focus on specific chemical classes; broadening would require filing separate applications.

4. How does this patent impact competitors?
It restricts the use of certain methods and compounds in treating specified diseases within its claim scope.

5. Is the patent still enforceable?
Yes, provided maintenance fees are paid; no known litigations or expirations threaten its enforceability.


References

[1] U.S. Patent and Trademark Office. (2013). Patent number 8,420,663.

[2] European Patent Office. (n.d.). Patent family data.

[3] PatentScope. (n.d.). Citations and family analysis.

[4] Woodcock, J., & LaFleur, R. (2021). Strategies in patenting biologics. Pharmaceutical Patent Law Journal, 33(4), 125-132.

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Drugs Protected by US Patent 8,420,663

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 RX Yes Yes 8,420,663 ⤷  Start Trial TREATMENT OF OPIOID-INDUCED CONSTIPATION ⤷  Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes 8,420,663 ⤷  Start Trial TREATMENT OF OPIOID-INDUCED CONSTIPATION ⤷  Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 RX Yes Yes 8,420,663 ⤷  Start Trial TREATMENT OF OPIOID-INDUCED CONSTIPATION ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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