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Last Updated: December 22, 2024

Details for Patent: 10,220,049


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Summary for Patent: 10,220,049
Title:Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Abstract: An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.
Inventor(s): Chang; Yunik (Clermont, FL), Dow; Gordon J. (Santa Rosa, CA)
Assignee: Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:15/425,844
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,220,049

Introduction

United States Patent 10,220,049 is a significant patent in the pharmaceutical sector, particularly for the treatment of acne vulgaris. This patent, owned by Bausch Health US LLC, involves the use of a combination of adapalene and benzoyl peroxide. Here, we will delve into the details of the patent, its claims, and the broader patent landscape.

Patent Overview

  • Patent Number: US 10,220,049
  • Title: Pharmaceutical Composition Comprising Adapalene and Benzoyl Peroxide
  • Owner: Bausch Health US LLC
  • Use: Treatment of acne vulgaris in patients 12 years of age and older[1].

Patent Claims

The claims of a patent are crucial as they define the scope of the invention and what is protected by the patent.

Independent Claims

Independent claims are those that stand alone and do not depend on other claims. For US Patent 10,220,049, the independent claims typically include the composition of the pharmaceutical product, its method of preparation, and its use in treating acne.

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These might include specific concentrations of adapalene and benzoyl peroxide, the form of the composition (e.g., gel, cream), and any specific methods of application.

Patent Scope

The scope of a patent is a critical aspect that determines its breadth and the extent of protection it offers.

Metrics for Measuring Patent Scope

Research has identified simple metrics to measure patent scope, such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Patent Maintenance and Scope

The maintenance of a patent, including payment of maintenance fees, is also indicative of its scope and the owner's commitment to its protection. For US Patent 10,220,049, the payment of maintenance fees, such as the 4th year large entity fee, ensures the patent remains in force[1].

Examination Process

The examination process for a patent involves a thorough review by the patent office to ensure the invention meets the criteria for patentability.

Publication and Grant

The patent was granted after a rigorous examination process. The recordation of the patent grant and the patent issue date used in the Patent Term Adjustment (PTA) calculation are critical milestones in this process[1].

Patent Landscape

Understanding the broader patent landscape is essential for navigating the intellectual property environment.

Related Patents and Applications

Using tools like the USPTO's Patent Public Search or the Global Dossier, one can identify related patents and applications, including those from other IP offices. This helps in understanding the patent family and any potential overlaps or conflicts[4].

Citation Data

The Common Citation Document (CCD) application provides a single point of access to citation data, helping to visualize the prior art cited by multiple offices for the same invention. This is particularly useful in assessing the novelty and non-obviousness of the invention[4].

Economic and Legal Implications

The economic and legal implications of a patent are significant and can impact innovation and competition.

Patent Quality and Innovation

The quality of patents, including their scope and clarity, can influence innovation. Overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation[3].

Small Claims Patent Court

There have been discussions and studies on the feasibility of a small claims patent court to address issues related to patent litigation costs. This could potentially impact how patents like US 10,220,049 are enforced and litigated[5].

Practical Applications and Impact

The practical applications of US Patent 10,220,049 are centered around its use in treating acne vulgaris.

Clinical Significance

The combination of adapalene and benzoyl peroxide has been clinically proven to be effective in treating acne. This patent ensures that Bausch Health US LLC has exclusive rights to this formulation, which can impact market competition and patient access to the treatment[1].

Market Competition

The patent landscape in the pharmaceutical industry is highly competitive. Patents like US 10,220,049 play a crucial role in protecting intellectual property and maintaining market share.

Conclusion

Understanding the scope and claims of US Patent 10,220,049 is vital for anyone involved in the pharmaceutical industry, particularly those dealing with acne treatments. The patent's protection of a specific formulation of adapalene and benzoyl peroxide ensures Bausch Health US LLC's exclusive rights, impacting both innovation and market competition.

Key Takeaways

  • Patent Overview: US Patent 10,220,049 is owned by Bausch Health US LLC and is used for treating acne vulgaris.
  • Claims: The patent includes independent and dependent claims defining the composition and use of the pharmaceutical product.
  • Patent Scope: Metrics like independent claim length and count help measure the patent's breadth and clarity.
  • Examination Process: The patent was granted after a thorough examination process.
  • Patent Landscape: Tools like the USPTO's Patent Public Search and Global Dossier help navigate related patents and applications.
  • Economic and Legal Implications: The patent's quality and scope can impact innovation and litigation costs.
  • Practical Applications: The patent ensures exclusive rights to a clinically effective acne treatment formulation.

FAQs

Q: What is the primary use of US Patent 10,220,049? A: The primary use of US Patent 10,220,049 is for the treatment of acne vulgaris in patients 12 years of age and older.

Q: Who owns US Patent 10,220,049? A: US Patent 10,220,049 is owned by Bausch Health US LLC.

Q: What are the key components of the pharmaceutical composition protected by this patent? A: The key components are adapalene and benzoyl peroxide.

Q: How can one measure the scope of a patent like US 10,220,049? A: Metrics such as independent claim length and independent claim count can be used to measure the patent's scope.

Q: What is the significance of the Common Citation Document (CCD) in patent searching? A: The CCD provides a single point of access to citation data, helping to visualize the prior art cited by multiple offices for the same invention.

Sources

  1. Pharsight: Cabtreo patent expiration.
  2. USPTO: Patent Claims Research Dataset.
  3. SSRN: Patent Claims and Patent Scope.
  4. USPTO: Search for patents.
  5. ACUS: U.S. Patent Small Claims Court.

More… ↓

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Drugs Protected by US Patent 10,220,049

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER ⤷  Subscribe
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Subscribe
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER ⤷  Subscribe
>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 10,220,049

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009255679 ⤷  Subscribe
Brazil PI0913326 ⤷  Subscribe
Canada 2723029 ⤷  Subscribe
China 102056481 ⤷  Subscribe
European Patent Office 2299810 ⤷  Subscribe
Spain 2773931 ⤷  Subscribe
Croatia P20200450 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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