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Last Updated: December 22, 2024

Details for Patent: 8,936,800


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Summary for Patent: 8,936,800
Title:Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Abstract: Dermatological/cosmetic compositions suited for preventing or treating cell differentiation and/or proliferation and/or keratinization disorders, including preventing or treating common acne, comprise, in a physiologically acceptable medium, (i) at least one dispersed retinoid, (ii) dispersed benzoyl peroxide, in free or encapsulated form, and (iii) at least one pH-independent gelling agent, selected from the group consisting of (a) polyacrylamide gelling agents, (b) gelling agents which are acrylic polymers coupled to hydrophobic chains, (c) modified starch gelling agents, and mixture thereof, said composition maintaining good chemical stability of (i) and (ii) without their degradation over time at a temperature of between 4.degree. C. and 40.degree. C.
Inventor(s): Orsoni; Sandrine (Mandelieu, FR), Willcox; Nathalie (Le Rouret, FR)
Assignee: Galderma Research & Development (Biot, FR)
Application Number:13/660,831
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,936,800

Introduction

Patent 8,936,800, titled "Pharmaceutical Composition Comprising Adapalene and Benzoyl Peroxide," is a significant patent in the pharmaceutical industry, particularly for the treatment of acne. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

  • Patent Number: 8,936,800
  • Grant Date: December 23, 2014
  • Expiration Date: December 23, 2022[1][4].

Patent Scope

The scope of a patent is defined by its claims, which outline the specific aspects of the invention that are protected. For Patent 8,936,800, the scope includes a pharmaceutical composition comprising adapalene and benzoyl peroxide, which is used for the treatment of acne.

Independent Claims

Independent claims are crucial as they define the broadest scope of protection for the invention. For this patent, the independent claims typically include the composition itself, its method of preparation, and its use in treating acne. Here is an example of what an independent claim might look like:

"A pharmaceutical composition comprising adapalene and benzoyl peroxide, wherein the composition is in a gel form and is used for the treatment of acne."

Dependent Claims

Dependent claims build upon the independent claims and provide additional specificity. These claims can include variations in the composition, such as different concentrations of adapalene and benzoyl peroxide, or specific methods of application.

"The pharmaceutical composition of claim 1, wherein the adapalene is present in a concentration of about 0.3% and the benzoyl peroxide is present in a concentration of about 2.5%."

Claim Management and Strategy

Effective claim management is vital for maximizing the value of a patent. Here are some strategies relevant to Patent 8,936,800:

Consolidation of Claims

During the patent prosecution phase, claims may be amended to align with the USPTO's requirements. Consolidating multiple dependent claims into fewer, broader independent claims can facilitate approval and enhance the patent's breadth and flexibility[5].

Utilizing Full Quota of Claims

The initial patent application filing fee covers up to 3 independent claims and a total of 20 claims. Ensuring that the patent utilizes its full complement of claims can secure more robust protection and enhance its value in licensing discussions or infringement disputes[5].

Patent Landscape

The patent landscape surrounding Patent 8,936,800 includes several other patents related to the same or similar pharmaceutical compositions.

Related Patents

Several patents related to adapalene and benzoyl peroxide compositions have been granted, each with its own set of claims and expiration dates. For example:

  • U.S. Patent 8,445,543: Expired on December 23, 2022[1].
  • U.S. Patent 8,703,820: Expired on March 12, 2023[1].
  • U.S. Patent 8,809,305: Expired on December 23, 2022[1].

These patents, along with Patent 8,936,800, form a complex web of intellectual property rights that need to be navigated by companies seeking to develop generic versions of the drug.

Exclusivities and Generic Launch

The FDA has granted exclusivities to the original drug, which can delay the launch of generic versions even after the patents have expired. For instance, the exclusivities granted to Epiduo, a drug containing adapalene and benzoyl peroxide, play a crucial role in delaying generic competition[4].

Litigation and Validity

Patent validity and potential litigation are critical aspects of the patent landscape. Companies seeking to launch generic versions often challenge the validity of the patents through paragraph IV certifications, as seen in the case of Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5%[1].

Metrics for Measuring Patent Scope

Researchers have developed metrics to measure patent scope, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims, which are important for assessing patent quality and potential for innovation[3].

Practical Implications

For businesses and inventors, understanding the scope and claims of Patent 8,936,800 is essential for navigating the intellectual property landscape. Here are some practical implications:

Licensing and Infringement

The robust protection offered by the patent can be a significant asset in licensing discussions or infringement disputes. Ensuring that all claims are strategically managed can enhance the patent's defensive capabilities and its commercial value[5].

Generic Competition

Companies planning to launch generic versions of the drug need to carefully consider the patent landscape, including the expiration dates of related patents and any exclusivities that may be in place[4].

Conclusion

Patent 8,936,800 is a critical piece of intellectual property in the pharmaceutical industry, particularly for the treatment of acne. Understanding its scope, claims, and the broader patent landscape is essential for both innovators and generic drug manufacturers.

Key Takeaways

  • Patent Scope: Defined by its claims, including the composition, method of preparation, and use in treating acne.
  • Claim Management: Strategic consolidation and utilization of the full quota of claims can enhance the patent's value and protection.
  • Patent Landscape: Includes multiple related patents with different expiration dates and exclusivities that can delay generic competition.
  • Metrics for Patent Scope: Independent claim length and count can provide insights into patent quality and breadth.
  • Practical Implications: Important for licensing, infringement disputes, and navigating generic competition.

FAQs

What is the primary use of the pharmaceutical composition described in Patent 8,936,800?

The primary use is for the treatment of acne.

What are the key components of the pharmaceutical composition in Patent 8,936,800?

The key components are adapalene and benzoyl peroxide.

When did Patent 8,936,800 expire?

It expired on December 23, 2022.

How do exclusivities affect the launch of generic versions of the drug?

Exclusivities granted by the FDA can delay the launch of generic versions even after the patents have expired.

What is the significance of claim management in patent applications?

Effective claim management can enhance the patent's breadth, flexibility, and commercial value by ensuring the full utilization of the allotted claims.

More… ↓

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Drugs Protected by US Patent 8,936,800

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

Foreign Priority and PCT Information for Patent: 8,936,800

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
France01 16747Dec 21, 2001

International Family Members for US Patent 8,936,800

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1458369 ⤷  Subscribe CA 2008 00029 Denmark ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe 08C0024 France ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe SPC/GB10/005 United Kingdom ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe C01458369/01 Switzerland ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe 380 Finland ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe SZ 31/2008 Austria ⤷  Subscribe
European Patent Office 1458369 ⤷  Subscribe 122008000041 Germany ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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