United States Patent 9,399,014: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,399,014, titled "Pharmaceutical Topical Compositions," is a significant patent in the field of pharmaceuticals, particularly focusing on topical formulations containing des-fluoroquinolone compounds. This patent, assigned to Ferrer Internacional, S.A., was granted on July 26, 2016. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Cristina Tarragó, Benjamin Santos, Manuel Raga, and Antonio Guglietta, all associated with Ferrer Internacional, S.A., a pharmaceutical company based in Barcelona, Spain[4][5].
Patent Scope
The patent covers pharmaceutical stable semisolid topical compositions that include between 0.2 to 5% of a des-fluoroquinolone compound. Des-fluoroquinolones are a class of antimicrobial agents, and the specific compound mentioned is ozenoxacin, a derivative of fluoroquinolones without the fluorine atom[4].
Key Components
- Des-fluoroquinolone Compound: The primary active ingredient, which is ozenoxacin.
- Semisolid Topical Compositions: These include creams, gels, and emulsions.
- Stabilizers and Excipients: Ingredients such as propylene glycol, emulsifying agents, preservatives, and surface-active agents are included to enhance stability and efficacy[4].
Claims
The patent includes multiple claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the pharmaceutical topical composition comprising ozenoxacin and specific excipients.
- Claim 2 specifies the concentration range of ozenoxacin (0.2 to 5%).
- Claim 3 details the types of semisolid formulations (creams, gels, emulsions)[4].
Dependent Claims
These claims further elaborate on the specific components and their roles, such as the use of propylene glycol, emulsifying agents, and preservatives[4].
Patent Landscape
Related Patents
- US 9,180,200 B2: Another patent by the same inventors, also covering pharmaceutical topical compositions, but with different claim specifics[2].
- US 6,335,447 B1: An earlier patent related to quinolonecarboxylic acid derivatives, which has since expired[2].
Patent Expiration
The patent US 9,399,014 B2 is set to expire in December 2029. This expiration date is crucial for understanding when generic versions of the drug can be launched[2].
Maintenance Fees
The patent owners have been paying maintenance fees to keep the patent active. The most recent payment was made in January 2024[2].
Technological Significance
Antimicrobial Therapy
The invention is significant in the field of antimicrobial therapy, providing stable and effective topical formulations for treating skin infections. Ozenoxacin, the des-fluoroquinolone compound, has shown efficacy in treating conditions like impetigo[1].
Formulation Stability
The patent emphasizes the stability of the semisolid formulations, which is critical for maintaining the potency of the active ingredient over time. This stability is achieved through the careful selection of excipients and stabilizers[4].
Market Impact
Competitive Advantage
The patent provides Ferrer Internacional, S.A. with a competitive advantage in the market for topical antimicrobial treatments until its expiration in 2029. This period allows the company to recoup its investment in research and development[2].
Generic Launch
After the patent expires, generic versions of the drug can be launched, potentially increasing market competition and reducing prices. This could expand access to the treatment but may also impact the revenue of the original patent holder[2].
Regulatory Aspects
Classification
The patent is classified under various CPC (Cooperative Patent Classification) categories, including A61K9/06, A61K47/06, and others, reflecting its relevance to pharmaceutical and medical fields[5].
International Filings
The patent has international filings, including priority data from European and other foreign applications, indicating a global strategy for protecting the invention[5].
Conclusion and Future Implications
The United States Patent 9,399,014 is a comprehensive patent that covers the formulation, composition, and application of des-fluoroquinolone compounds in topical treatments. The patent's scope and claims are well-defined, ensuring the protection of the invention until its expiration in 2029.
Key Takeaways
- The patent covers stable semisolid topical compositions containing ozenoxacin.
- It includes specific claims about the concentration of ozenoxacin and the types of formulations.
- The patent is set to expire in December 2029.
- The invention is significant in antimicrobial therapy and formulation stability.
- The patent provides a competitive advantage to Ferrer Internacional, S.A. until its expiration.
Frequently Asked Questions (FAQs)
1. What is the main active ingredient in the pharmaceutical topical compositions described in US 9,399,014?
The main active ingredient is ozenoxacin, a des-fluoroquinolone compound.
2. When is the patent set to expire?
The patent is set to expire in December 2029.
3. Who are the inventors of this patent?
The inventors are Cristina Tarragó, Benjamin Santos, Manuel Raga, and Antonio Guglietta.
4. What types of formulations are covered by this patent?
The patent covers semisolid formulations such as creams, gels, and emulsions.
5. Why is the stability of the formulations important?
The stability of the formulations is crucial for maintaining the potency of the active ingredient, ozenoxacin, over time.
Cited Sources:
- Tarragó C, Santos B, Raga M, Guglietta A, Inventor; FERRER INTERNATIONAL, S.A., Assignee. PHARMACEUTICAL TOPICAL COMPOSITIONS. United States patent US 9,180,200 B2. 2015 Nov 10.
- Pharsight - GreyB. Xepi patent expiration. Retrieved from https://pharsight.greyb.com/drug/xepi-patent-expiration
- SSRN. Patent Claims and Patent Scope. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents. US9399014B2 - Pharmaceutical topical compositions. Retrieved from https://patents.google.com/patent/US9399014B2/en
- Google APIs. United States Patent. Retrieved from https://patentimages.storage.googleapis.com/86/1c/5a/9e7255e1836278/US9399014.pdf
