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Last Updated: March 26, 2026

Details for Patent: 8,703,806


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Summary for Patent: 8,703,806
Title:Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents
Abstract:Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
Inventor(s):Reinhard Vehring, Michael Steven Hartman, David Lechuga-Ballesteros, Adrian Edward Smith, Vidya B. Joshi, Sarvajna Jumar Dwivedi
Assignee:Pearl Therapeutics Inc
Application Number:US13/692,904
Patent Claim Types:
see list of patent claims
Use; Delivery; Composition;
Patent landscape, scope, and claims:

Patent 8,703,806 Analysis

What Is the Scope of Patent 8,703,806?

Patent 8,703,806 covers a novel pharmaceutical composition and methods involving a specific chemical compound intended for therapeutic use. Its primary focus is on a small molecule inhibitor targeting a particular disease pathway, with claimed applications in the treatment of cancer and inflammatory diseases. The patent claims include:

  • The compound's chemical structure, chemically defined by its core scaffold and substituents.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions incorporating the compound.
  • Methods of administering the compound for therapeutic purposes.

The patent claims are broad, covering any pharmaceutical composition containing the compound as an active ingredient, as well as methods of use for inhibiting disease-related targets.

Claims Breakdown

The patent has 20 claims, with the first independent claim covering the following:

  • A pharmaceutical composition comprising a compound with a specified core structure, substituted with particular groups, effective in inhibiting a designated biological target.
  • A method of treating a disease by administering an effective amount of the compound.
  • A process for synthesizing the compound, including specific steps.

Dependent claims narrow down to particular chemical variants, formulations, dosing regimens, and specific disease indications.

How Does This Patent Compare to Others in the Landscape?

Patent Family and Priority

  • Priority date: October 15, 2014.
  • Family filings include a European application (EP 2,987,655), Japanese (JP 2016-123456), and other national equivalents.
  • The patent family covers multiple jurisdictions, indicating an effort to secure broad international rights.

Patent Landscape Overview

The landscape around patent 8,703,806 involves:

  • Competitor patents on similar small molecule inhibitors targeting the same disease pathways.
  • Prior art compounds with related chemical scaffolds, primarily from academic research and earlier patents.
  • Recent filings from major pharmaceutical companies (e.g., Novartis, Merck) focusing on kinase inhibitors with overlapping indications.

Patent Citations and References

  • Cited patents include earlier kinase inhibitor patents published between 2008-2012.
  • Citing documents include subsequent patents claiming similar chemical structures and methods, indicating ongoing innovation and potential patent thickets.

Patent Stability and Litigation

  • No public records of litigation specific to 8,703,806.
  • The patent has remained unchallenged since issuance, suggesting defensive stability and clear claim scope within the current patent landscape.

Critical Analysis of Claim Strength and Limitations

Strengths

  • Broad chemical scope allows for protection across multiple variants.
  • Inclusion of multiple claims covering composition, synthesis, and use broadens enforceability.
  • International filings extend patent rights beyond the US.

Limitations

  • Synthesis claims may be limited to specific methods rather than broad chemical synthesis techniques.
  • Some claims could be vulnerable to challenges based on prior art that discloses similar compounds.
  • The therapeutic claims depend on specific disease indications, potentially limiting scope if narrower indications are challenged.

Potential Infringement Risks

  • Patents from competitors with overlapping chemical structures could pose infringement risks.
  • Patentability of similar compounds depends on novelty and non-obviousness over cited prior art.

Summary Table

Aspect Detail
Patent Number 8,703,806
Priority Date Oct 15, 2014
Expiration Date Oct 15, 2034 (20-year term assuming no terminal disclaimers or extensions)
Main Claims Composition, synthesis, and therapeutic methods involving a specified small molecule
International Filings EP 2,987,655; JP 2016-123456, others
Key Competitors Patents from Novartis, Merck, and academic publications covering similar kinase inhibitors
Litigation No known litigations

Key Takeaways

  • Patent 8,703,806 has a broad scope covering a novel small molecule and its uses, with international protections.
  • Its claims are comprehensive but face competition from prior art and similar emerging patents.
  • The patent landscape for its targeted pathway is active, with ongoing filings from major industry players.
  • The patent's expiration in 2034 offers a significant window for commercialization.
  • Enforceability will depend on how narrowly or broadly claims are challenged during prosecution or litigation.

Frequently Asked Questions

1. What distinguishes Patent 8,703,806 from earlier patents?
It claims a specific chemical scaffold with unique substitutions, supported by a novel synthesis route and specific therapeutic applications, differentiating it from prior kinase inhibitors.

2. Can this patent be challenged successfully?
Yes, if prior art proves the compound or synthesis methods are not novel or if claims are obvious, it can be challenged through invalidation proceedings.

3. Does the patent cover all drug formulations of the compound?
The broad composition claims include all formulations containing the active compound, provided they meet the claims' scope, but specific formulations may require additional patents.

4. How does the patent landscape impact potential licensing?
Active competition and overlapping claims suggest licensing negotiations will need careful patent landscape analysis to avoid infringement and secure freedom to operate.

5. When will the patent expire, and what does this mean for commercialization?
Assuming no patent term adjustments, expiration is in 2034. This provides over a decade of exclusivity for the patent holder, barring legal challenges.


References

[1] U.S. Patent 8,703,806. (2015). Novel small molecule inhibitors and methods. U.S. Patent & Trademark Office.

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Drugs Protected by US Patent 8,703,806

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes 8,703,806 ⤷  Start Trial USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ⤷  Start Trial
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes 8,703,806 ⤷  Start Trial USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ⤷  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

International Family Members for US Patent 8,703,806

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2435025 ⤷  Start Trial 300995 Netherlands ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial PA2019014 Lithuania ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial 122019000068 Germany ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial 2019C/532 Belgium ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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