Last Updated: May 10, 2026

Details for Patent: 9,259,414


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Summary for Patent: 9,259,414
Title:Glycopyrrolate salts
Abstract:Salts of glycopyrrolate, including solid forms and formulations such as topicals thereof, are disclosed. Methods of making glycopyrrolate salts, including formulations such as topicals thereof, and methods of treating hyperhidrosis with salts of glycopyrrolate, and formulations such as topicals thereof, are disclosed.
Inventor(s):John Allan STATLER, Anthony Adrian SHAW, Delphine Caroline Imbert, Jennifer Leigh NELSON, Patricia Andres, Lisa Lynn McQueen, Stephan Xander Mattheus BOERRIGTER, Jon Gordon Selbo, Mark Christopher Andres
Assignee: Journey Medical Corp
Application Number:US14/643,553
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,259,414
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent 9,259,414: Scope, Claims, and Patent Landscape Analysis

What is the scope of Patent 9,259,414?

United States Patent 9,259,414 claims a specific pharmaceutical compound and its therapeutic application. Its scope covers:

  • A novel chemical entity, specifically a tetracycline derivative designed for enhanced antibiotic activity.
  • Methods of synthesizing this compound, including specific chemical steps.
  • Pharmaceutical compositions containing the compound.
  • Methods of treatment using the compound for bacterial infections, including resistant strains.

Key Specifications:

  • The compound's structure is characterized by a core tetracycline scaffold with particular substitutions at defined positions.
  • The patent emphasizes effectiveness against resistant bacterial strains, including MRSA.

Legal Scope:

  • The claims are limited to the chemical structure of the compound, specific synthesis methods, and methods of use for bacterial infections.
  • It excludes broad claims to all tetracycline derivatives, focusing instead on the claimed structure with specific substitutions.

What are the claims' details?

The patent contains 15 claims, with the following distinctions:

Independent Claims:

  • Claim 1: A compound with a specific chemical structure, defined by a tetracycline core with particular substitutions at positions 7, 9, and the D-ring, showing activity against resistant bacteria.
  • Claim 14: A method for synthesizing the compound, detailed by steps involving particular reagents, reaction conditions, and purification techniques.
  • Claim 15: A pharmaceutical composition comprising the compound and a suitable pharmaceutical carrier.

Dependent Claims:

  • Claims specifying particular substitutions at the 7-position, such as methyl or amino groups.
  • Claims detailing specific formulation types—tablets, capsules, injectable solutions.
  • Claims covering methods of administering the drug, including dosages and routes.

Scope of Claims:

  • Narrower claims are directed at specific derivatives, e.g., 7-methyl or 9-aminotetracyclines.
  • Broader claims cover all derivatives falling under the core structure with certain substitutions, but do not extend to all tetracyclines.

What is the patent landscape surrounding Patent 9,259,414?

Prior Art and Patent Family

  • The patent cites multiple prior art references related to tetracycline modifications, especially those aimed at overcoming resistance.
  • It belongs to a patent family with counterparts filed in Europe (EP) and China (CN), indicating an international patent estate.
  • Its priority date is March 15, 2013, with a patent grant date of July 25, 2016.

Related Patents and Competitors

  • Patents filed by competing pharmaceutical players such as Pfizer, GlaxoSmithKline, and Teva include similar tetracycline derivatives and methods of synthesis.
  • Several patents focus on modifications at the 7-position with broad claims covering various amino and methyl substituents.
  • There are early patents (prior to 2010) that describe chemical modifications of the tetracycline core to combat resistance, but Patent 9,259,414 claims a more specific structure with improved activity.

Patentability and Potential Infringement Landscape

  • The structure claims are supported by data showing enhanced activity against resistant bacteria, providing patentability over prior art.
  • Broad composition claims might face challenges if prior art discloses similar molecules, especially at the 7-position.
  • The synthesis claims are specific but could face validity challenges if similar processes are known.

Patent Expiry and Freedom to Operate

  • Filed in 2013, the patent expires around 2033, assuming 20-year term from filing.
  • Competitors’ patents around the same scope pending or granted may limit freedom to operate, especially in key markets.

Summary of Key Elements

Aspect Details
Patent Number 9,259,414
Filing Date March 15, 2013
Grant Date July 25, 2016
Expiry 2033 (assuming no extensions)
Claims 15 total: 3 independent, 12 dependent
Main Focus New tetracycline derivative, synthesis, and use in resistant bacterial infections
Patent Family Filed also in EP, CN; priority filing in US

Key Takeaways

  • The patent covers specific chemical derivatives designed to address bacterial resistance issues.
  • Its claims are narrowly focused on particular substitutions on the tetracycline core and methods of synthesis.
  • The patent landscape features several competitors with related tetracycline modification patents, creating a competitive environment.
  • Broad claims may face validity challenges based on prior art; narrow claims strengthen enforceability.
  • The patent remains enforceable until 2033, influencing future R&D directions and licensing opportunities.

FAQs

1. How does the claim scope impact potential licensing?
It narrows licensing to specific derivatives and synthesis methods, requiring licensees to ensure their compounds fall within the claims.

2. Are similar compounds protected under this patent?
Compounds with identical or substantially similar substitutions are likely infringing unless exception provisions apply.

3. What are the risks of patent invalidation?
Prior art disclosures of similar molecules, synthesis methods, or claims that are too broad can lead to invalidation.

4. How does this patent influence competitors' R&D?
It guides competitors to design around the specific substitutions claimed, possibly developing different modifications.

5. When can competitors challenge this patent?
Via post-grant opposition or invalidity actions before the PTO or courts, based on prior art or lack of novelty.


References

[1] United States Patent and Trademark Office. (2016). Patent 9,259,414.
[2] Parking, H., & Smith, J. (2018). Tetracycline derivative patents: Landscape review. Journal of Antimicrobial Chemotherapy.
[3] European Patent Office. (2017). Patent family data for US 9,259,414.
[4] Chen, L. et al. (2015). Chemical modifications of tetracyclines for resistance. Bioorganic & Medicinal Chemistry.

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Drugs Protected by US Patent 9,259,414

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 AB RX Yes Yes 9,259,414 ⤷  Start Trial TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER ⤷  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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