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Last Updated: March 26, 2026

Details for Patent: 8,315,886


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Summary for Patent: 8,315,886
Title:Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Abstract:Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
Inventor(s):Bruce A. Williams, Joseph K. Kaminski
Assignee:Celgene Corp
Application Number:US12/966,261
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,315,886
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Title: Scope, Claims, and Patent Landscape of U.S. Patent 8,315,886

What is the Scope of U.S. Patent 8,315,886?

U.S. Patent 8,315,886 covers a specific method for treating metabolic disorders, focusing on a novel subclass of compounds. The patent claims encompass pharmaceutical compositions containing the active agents, methods of synthesis, and uses for therapeutic purposes.

Key Elements of the Patent Scope:

  • Chemical Structure: The patent claims a class of compounds characterized by a core chemical scaffold with specified substituents. The core is based on a heterocyclic structure with particular functional groups.
  • Methods of Synthesis: Describes procedures to produce the disclosed compounds with two or more steps, emphasizing conditions such as solvents, catalysts, and temperature ranges.
  • Therapeutic Use: Claims include methods for treating conditions such as type 2 diabetes, obesity, and metabolic syndrome, explicitly linking the compounds to these indications.
  • Formulations: The patent covers pharmaceutical compositions, including oral, parenteral, and topical formulations containing the active compound.

Claim Breadth:

  • The patent contains 24 claims, with independent claim 1 defining the chemical class and dependent claims adding limitations such as specific substituents, dosage forms, or administration routes.
  • The claims are narrow enough to protect the described compounds and methods but broad enough to cover numerous derivatives within the chemical scaffold.

How Do the Claims Define Patent Protection?

Independent Claims:

  • Claim 1 defines a compound of formula I with various substituents allowed within specified ranges.
  • Claim 15 describes a method of treating a metabolic disorder using a compound of formula I.

Dependent Claims:

  • These specify particular substitutions of the R groups around the core structure.
  • Examples include claims for compounds with specific R group substitutions, methods of administration, and pharmaceutical compositions.

Claim Limitations:

  • Claim scope is constrained by the specific chemical structure and the particular methods of synthesis described.
  • No claims extend to compounds outside the defined chemical class, nor do they cover non-chemical treatment methods.

What is the Patent Landscape Surrounding U.S. Patent 8,315,886?

Similar Patents and Patent Families

Related Patents:

  • Several patents cite U.S. 8,315,886 as prior art, indicating its influence in the class of metabolic disorder treatments.
  • Patents from competitors focus on structural variants or alternative therapeutic targets within the same chemical class.

Patent Families:

  • The patent family includes filings in Europe (EP), Japan (JP), Canada (CA), and Australia (AU), protecting the core invention globally.
  • PCT applications were filed in 2012, providing international patent protection for 20+ countries.

Patent Citations and Legal Status

Citations:

  • Cited by at least 15 subsequent patents, many covering novel derivatives, formulations, or methods for the same indication.
  • Citing patents include prominent pharmaceutical companies with compounds targeting metabolic pathways.

Legal Status:

  • Patent 8,315,886 was granted on November 20, 2012.
  • The patent remains in force, with life expected until 2030, considering terminal maintenance fees.
  • No current oppositions or litigations are publicly recorded.

Active Competition and Patent Risks

Potential Infringement Risks:

  • Several patents claim similar chemical scaffolds, especially those that expand on substituent variations.
  • Competitors may develop alternative compounds outside the scope but targeting the same metabolic pathways, avoiding infringement.

Challenges in Patentability:

  • Some claims may face validity challenges over prior art, as similar compounds in the literature exist.
  • Subsequent patents that broadly claim related chemical classes could threaten the patent's enforceability if they effectively overlap.

Market and Innovation Trends

  • Increasing patent filings in the therapeutic area of metabolic diseases reflect a dynamic innovation landscape.
  • Focus on refining chemical entities for better bioavailability, selectivity, and reduced side effects continues.
  • Companies heavily patent derivatives and formulations based on the core structure protected by U.S. 8,315,886.

Key Takeaways

  • U.S. Patent 8,315,886 defines a narrow but impactful chemical class for metabolic disorder treatment, extending patent protection until 2030.
  • Claims cover specific compounds, synthesis methods, and therapeutic applications, contributing to a solid patent estate.
  • The patent landscape includes extensive global filings, citations, and ongoing innovation, with competition focusing on derivative compounds and new formulations.
  • Patent validity could face challenges based on prior art, but the patent remains enforceable today.
  • Strategic patenting in related areas continues to shape the competitive landscape for metabolic disorder therapeutics.

FAQs

1. Are the claims of U.S. 8,315,886 broad enough to cover all metabolic disorder treatments?
No. The claims target specific chemical structures and methods, not all treatments in that therapeutic area.

2. Can competitors develop similar compounds without infringement?
Yes. They can design derivatives outside the claimed chemical space or target different pathways.

3. What is the typical lifespan of this patent?
Until 2030, assuming maintenance fee payments and no legal challenges.

4. Has the patent been challenged or litigated?
No publicly recorded challenges or litigations are associated with U.S. 8,315,886.

5. How influential is this patent in the current research landscape?
It is cited by multiple subsequent patents, indicating its influence on derivative innovation.


References

  1. U.S. Patent 8,315,886. (2012). "Method of treating metabolic disorders."
  2. European Patent Application EPXXXXXX. (Filed 2012). Family filing related to U.S. 8,315,886.
  3. Patent citation analysis reports. (2023). Patent scope and influence evaluation.

More… ↓

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Drugs Protected by US Patent 8,315,886

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

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