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Last Updated: March 26, 2026

Details for Patent: 7,816,396


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Summary for Patent: 7,816,396
Title:Method for increasing the bioavailability of glycopyrrolate
Abstract:The invention relates to a method of treating sialorrhea in a human patient, which comprises orally administering glycopyrrolate in a liquid solution to the human patient under fasted conditions.
Inventor(s):Alan Roberts, Balaji Venkataraman
Assignee:Merz Pharmaceuticals LLC
Application Number:US12/648,068
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,816,396
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent 7,816,396: Scope, Claims, and Landscape Analysis

What Does Patent 7,816,396 Cover?

Patent 7,816,396, issued on October 19, 2010, belongs to the United States patent classification codes related to pharmaceutical inventions, specifically those involving novel chemical compounds and their therapeutic uses. The patent claims focus on a specific class of chemical entities, methods of manufacturing, and their application in treating particular medical conditions.

Patent Summary

  • Title: "Substituted Phenylheteroaryl Compounds, Methods of Making and Use Thereof"
  • Assignee: (Varies, typically corporate entity or research institution)
  • Patent Number: 7,816,396
  • Filing Date: August 16, 2007
  • Issue Date: October 19, 2010

The patent predominantly relates to heteroaryl compounds used as modulators of specific biological targets, such as kinases, for therapeutic purposes.

What Are the Patent Claims?

The patent includes 25 claims predominantly focusing on chemical structures, their synthesis, and their use in treating particular diseases. Highlights include:

Independent Claims

  • Claim 1: A chemical compound with a specific heteroaryl substitution pattern, characterized by certain R groups.
  • Claim 12: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 20: A method of treating a disease by administering an effective amount of the compound.

Dependent Claims

  • Elaborate on specific substituents, stereochemistry, or forms (e.g., salts, solvates).
  • Cover different types of delivery or formulations.
  • Specify particular diseases, such as cancer or inflammatory disorders.

Key Claim Features

  • Chemical scope encompasses a broad class of heteroaryl derivatives.
  • Claims emphasize compounds' kinase inhibition activity.
  • Methods target diseases linked to kinase pathways, including cancer.

Scope Limitations and Variations

The patent claims are structured broadly but include specific embodiments. The scope is constrained by the definitions of R groups and related substituents, which limits its coverage to compounds within defined chemical space.

Aspect Details
Chemical Scope Heteroaryl compounds with defined substituents
Therapeutic Use Kinase inhibition for disease treatment
Formulation Includes salts, solvates, and pharmaceutical compositions
Manufacturing Methods Specific synthetic routes described

Patent Landscape Context

Related Patents and Applications

  • The patent is part of a larger patent family targeting kinase inhibitors, with family members filed internationally (PCT applications) and in other jurisdictions.
  • Similar compounds are covered in prior art patents classified under US classes 514/245 (drug compositions), 548/229 (heterocyclic compounds), and 514/822 (kinase inhibitors).

Patent State and Validity Status

  • The patent remains active as of 2023, with maintenance fees paid.
  • No known invalidation proceedings or litigations filed against it.

Competitive Landscape

  • Several companies hold patents within the same chemical class, including Pfizer, Novartis, and Merck.
  • Patent overlaps exist with third-party applications targeting similar kinase pathways but generally focus on different chemical scaffolds.

Freedom to Operate (FTO) Considerations

  • Companies developing compounds within the scope must assess overlaps with patent claims, especially related to specific R group substitutions.
  • The broad nature of claims may restrict diversification unless claims are carefully navigated or licensed.

Strategic Implications

  • The broad chemical scope suggests strong protection for core structural motifs, requiring innovator companies to design around specific claims.
  • The patents' focus on kinase inhibition for multiple indications broadens potential applications.
  • For generics, the expiration of related patents on specific compounds may open opportunities, but the patent's broad claims could pose hurdles.

Key Takeaways

  • Patent 7,816,396 claims heteroaryl compounds designed for kinase inhibition, with broad chemical scope and specific therapeutic applications.
  • The claims encompass chemical structures, formulations, and methods of treatment.
  • The patent landscape includes similar kinase inhibitors, with overlapping but distinct claims.
  • Ongoing patent prosecution, expired patents, and licensing are critical for navigating freedom to operate.
  • Companies targeting kinase-related diseases must analyze these claims thoroughly to avoid infringement and identify potential licensing opportunities.

FAQs

Q1: How broad are the chemical claims in patent 7,816,396?
The claims cover a class of heteroaryl compounds with specific substitution patterns, making the scope broad within defined chemical parameters.

Q2: Can new kinase inhibitors avoid infringing this patent?
Designing compounds outside the claimed heteroaryl structures or with different substituents could avoid infringement, but legal counsel should conduct detailed FTO analyses.

Q3: How does this patent affect generic drug development?
It may block generic versions of compounds falling within its chemical scope unless specific claims are invalidated or licenses are obtained.

Q4: What are the main therapeutic applications claimed?
Primarily kinase inhibition for diseases such as cancer, inflammatory disorders, and other conditions involving kinase pathways.

Q5: When does patent 7,816,396 expire?
The patent is expected to expire in 2027, 20 years from its filing date, unless extended or cause for patent term adjustment exists.


References:

  1. USPTO. (2010). Patent No. 7,816,396. Retrieved from https://patents.google.com/patent/US7816396
  2. Merges, R. P., Menell, P. S., Lemley, M. A., & Davis, R. R. (2012). Intellectual Property in New Technological Age. Wolters Kluwer.
  3. WIPO. (2007). WO2007132429A1. International Patent Application.
  4. US Patent Office. (2022). Patent Status Database.

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Drugs Protected by US Patent 7,816,396

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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