Details for Patent: 8,470,788

Which drugs does patent 8,470,788 protect, and when does it expire?

Patent 8,470,788 protects SOOLANTRA and is included in one NDA.

This patent has thirty-two patent family members in twenty-three countries.

Summary for Patent: 8,470,788

Title:	Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Abstract:	Dermatological conditions/afflictions such as rosacea, common acne, seborrheic dermatitis, perioral dermatitis, acneform rashes, transient acantholytic dermatosis, and acne necrotica miliaris, most notably rosacea, are treated by topically applying onto the affected skin area of an individual in need of such treatment, a topical pharmaceutical composition which comprises a thus effective amount of ivermectin.
Inventor(s):	Manetta; Vincent (Bordentown, NJ), Watkins; Gary R. (Piscataway, NJ)
Assignee:	Galderma S.A. (Cham, CH)
Application Number:	13/529,971
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,470,788
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 8,470,788: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,470,788, titled "Topical application of ivermectin for the treatment of dermatological conditions," is a significant patent in the field of dermatology. This patent, granted on June 25, 2013, covers the use of ivermectin in topical formulations for treating various dermatological conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Invention

The patent builds upon earlier research and applications related to the use of ivermectin, a well-known antiparasitic drug. Previous patents, such as U.S. Pat. No. 6,133,310, discussed the potential use of ivermectin in topical formulations but did not provide detailed compositions suitable for industrial pharmaceutical products[4].

Summary of the Invention

The invention described in U.S. Patent 8,470,788 involves the development of topical formulations of ivermectin for treating dermatological conditions such as rosacea, common acne, seborrheic dermatitis, perioral dermatitis, and acneform rashes. The patent outlines specific pharmaceutical compositions that have good cosmetic properties and a shelf-life of at least two years, addressing the limitations of earlier experimental preparations[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Here are some key claims:

• Claim 1: A topical composition for treating dermatological conditions, comprising ivermectin and a pharmaceutically acceptable excipient.
• Claim 2: The composition of claim 1, where the ivermectin is present in a concentration of about 0.5% to about 2% by weight.
• Claim 3: The composition of claim 1, where the excipient is selected from the group consisting of propylene glycol, sodium lauryl sulfate, and mixtures thereof[4].

These claims are crucial as they specify the exact components and their concentrations, which are essential for the efficacy and stability of the topical formulation.

Patent Family and Continuations

U.S. Patent 8,470,788 is part of a larger patent family, including several continuations and related applications. For example:

• It is a continuation of U.S. patent application Ser. No. 13/310,633, which is itself a continuation of earlier applications dating back to 2003[4].

This complex family structure indicates a thorough and iterative development process, ensuring that the final patent covers a broad and well-defined scope.

Prior Art and Related Patents

The patent landscape surrounding U.S. Patent 8,470,788 includes several related patents and prior art. For instance:

• U.S. Pat. No. 6,133,310, which discussed early experimental preparations of ivermectin in topical forms.
• Other patents within the same family, such as U.S. Pat. No. 8,080,530, which also pertain to the use of ivermectin in dermatological treatments[4].

Understanding this prior art is essential to appreciate the innovations and improvements introduced by U.S. Patent 8,470,788.

International Patent Landscape

The use of ivermectin in dermatological treatments is not limited to the United States. International patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can be searched to identify similar patents and applications globally[1].

Search and Analysis Tools

To conduct a comprehensive analysis of the patent landscape, various tools and resources are available:

• The USPTO's Patent Public Search tool and Global Dossier service can provide detailed information on related applications and prior art[1].
• The Patent Claims Research Dataset by the USPTO can offer insights into claim-level statistics and document-level statistics, helping to understand the scope and breadth of patent claims[3].

Economic and Market Impact

The economic impact of U.S. Patent 8,470,788 can be significant, given the prevalence of dermatological conditions and the need for effective treatments. The patent's scope and claims can influence market dynamics by:

• Protecting the intellectual property of the inventors and assignees.
• Influencing the development of similar products by competitors.
• Affecting the pricing and availability of ivermectin-based treatments in the market.

Litigation and Enforcement

Patents like U.S. Patent 8,470,788 can be subject to litigation to enforce their claims and protect against infringement. For example, instructions and labeling that result in direct infringement of the patent's claims can lead to legal actions[5].

Future Developments and Modifications

The patent's scope allows for various modifications and substitutions without departing from the spirit of the invention. This flexibility is crucial for ongoing research and development in dermatological treatments, enabling the creation of new formulations and applications based on the patented technology[4].

Key Takeaways

• Scope and Claims: U.S. Patent 8,470,788 covers specific topical formulations of ivermectin for treating dermatological conditions, with detailed claims defining the composition and concentration of ivermectin.
• Patent Family: The patent is part of a complex family of continuations and related applications, indicating a thorough development process.
• Prior Art: The patent builds upon earlier research and experimental preparations, introducing significant improvements.
• International Landscape: Similar patents and applications exist globally, accessible through international patent databases.
• Economic Impact: The patent can significantly influence the market for dermatological treatments, protecting intellectual property and affecting product development and pricing.

Frequently Asked Questions (FAQs)

Q: What is the primary focus of U.S. Patent 8,470,788?

A: The primary focus is on the development of topical formulations of ivermectin for treating various dermatological conditions.

Q: What are the key claims of the patent?

A: The key claims include the composition of ivermectin and pharmaceutically acceptable excipients, with specific concentrations of ivermectin.

Q: How does this patent relate to earlier research on ivermectin?

A: It builds upon earlier experimental preparations, addressing limitations such as cosmetic properties and shelf-life.

Q: What tools can be used to analyze the patent landscape?

A: Tools like the USPTO's Patent Public Search, Global Dossier, and Patent Claims Research Dataset can be used.

Q: How might this patent impact the market for dermatological treatments?

A: It can protect intellectual property, influence product development, and affect pricing and availability of ivermectin-based treatments.

Sources Cited

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. Unified Patents Portal - HU-S1500048-I1: https://portal.unifiedpatents.com/patents/patent/HU-S1500048-I1
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Justia - U.S. Patent 8,470,788: https://patents.justia.com/patent/8470788
5. Insight.RPXcorp - Litigation Documents: https://insight.rpxcorp.com/litigation_documents/12700987

Drugs Protected by US Patent 8,470,788

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes			Y			TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Foreign Priority and PCT Information for Patent: 8,470,788

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	03 05048	Apr 24, 2003

International Family Members for US Patent 8,470,788

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1620113		C300756	Netherlands
European Patent Office	1620113		CA 2015 00045	Denmark
European Patent Office	1620113		PA2015033	Lithuania
European Patent Office	1620113		122015000079	Germany