Details for Patent: 8,227,507

Which drugs does patent 8,227,507 protect, and when does it expire?

Patent 8,227,507 protects AKLIEF and is included in one NDA.

This patent has twenty-seven patent family members in twenty-three countries.

Summary for Patent: 8,227,507

Title:	Ligands that modulate RAR receptors
Abstract:	Novel ligand compounds having the general formula (I): ##STR00001## and pharmaceutical/cosmetic compositions comprised thereof are useful in human and veterinary medicine or, alternatively, in cosmetics.
Inventor(s):	Biadatti; Thibaud (Opio, FR), Dumais; Laurence (La Rouret, FR), Soulet; Catherine (Antibes, FR), Talano; Sandrine (Vence, FR), Daver; Sebastien (Antibes, FR)
Assignee:	Galderma Research & Development (Biot, FR)
Application Number:	12/842,347
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analyzing the Scope and Claims of United States Patent 8,227,507

Introduction

United States Patent 8,227,507, assigned to Galderma Research & Development, is a significant patent in the field of pharmaceuticals, particularly for the treatment of acne vulgaris. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Patent Number and Title

• The patent number is 8,227,507, and it pertains to the composition and use of trifarotene, a retinoid compound, for the topical treatment of acne vulgaris.

Assignee

• The patent is assigned to Galderma Research & Development, a company known for its innovations in dermatological treatments[4][5].

Claims Analysis

Independent and Dependent Claims

• The patent includes a set of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific limitations or features[3].

Claim Language and Scope

• The claims in this patent focus on the composition of trifarotene, its formulation, and its use in treating acne vulgaris. For instance, the independent claims might cover the chemical structure of trifarotene, its concentration in a topical formulation, and the method of application. Dependent claims could specify particular concentrations, formulations (e.g., creams, gels), or treatment regimens[4].

Patent Scope Metrics

Independent Claim Length and Count

• Research suggests that the scope of a patent can be measured using metrics such as the length and count of independent claims. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process compared to those with broader claims. This indicates that the claims in patent 8,227,507 are likely well-defined and specific to ensure clarity and validity[3].

Patent Landscape

Related Patents and Patent Family

• The patent 8,227,507 is part of a larger patent family that includes other related patents such as U.S. Patent Nos. 7,807,708 and 8,470,871. These patents collectively cover various aspects of trifarotene, including its synthesis, formulation, and therapeutic uses. Using tools like the Global Dossier, one can access the file histories and related applications from participating IP Offices, providing a comprehensive view of the patent family[1].

Citation Data and Prior Art

• The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool helps in understanding the prior art landscape and how the claims of patent 8,227,507 differentiate from existing inventions[1].

Regulatory and Legal Aspects

Patent Term Restoration

• The patent term for 8,227,507, along with other related patents, has been subject to restoration applications due to regulatory delays. The FDA's determination of the regulatory review period is crucial for calculating the patent term extension. For AKLIEF (trifarotene), the FDA verified the regulatory review period, which included both the testing and approval phases, to support the patent term extension applications[4][5].

Public Access and Search Tools

USPTO Resources

• The USPTO provides several resources for searching and analyzing patents, including the Patent Public Search tool, which replaced legacy tools like PubEast and PubWest. This tool offers enhanced access to prior art and can be used to search for patents like 8,227,507. Additionally, the Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer further assistance[1].

Industry Impact

Market and Therapeutic Significance

• The approval of AKLIEF (trifarotene) marked a significant advancement in the treatment of acne vulgaris, particularly for patients aged 9 and older. This patent and its related family members are crucial for Galderma Research & Development's market position in dermatological treatments. The patent's scope and claims ensure that the company maintains intellectual property protection over this innovative therapeutic approach[4][5].

Key Takeaways

• Patent Scope and Claims: The patent 8,227,507 has well-defined claims focusing on the composition and use of trifarotene for treating acne vulgaris.
• Patent Landscape: It is part of a larger patent family, and tools like Global Dossier and CCD provide insights into related applications and prior art.
• Regulatory Aspects: The patent term has been subject to restoration due to regulatory delays, with FDA determinations playing a critical role.
• Public Access: USPTO resources like Patent Public Search and PTRCs facilitate comprehensive patent searches.

FAQs

Q: What is the primary subject matter of U.S. Patent 8,227,507?

• The primary subject matter is the composition and use of trifarotene, a retinoid compound, for the topical treatment of acne vulgaris.

Q: How can one access the file histories and related applications for this patent?

• Using the Global Dossier service provided by the USPTO, which consolidates file histories and related applications from participating IP Offices[1].

Q: What is the significance of the FDA's regulatory review period for this patent?

• The FDA's determination of the regulatory review period is crucial for calculating the patent term extension due to delays in the regulatory approval process[4][5].

Q: How can the scope of a patent like 8,227,507 be measured?

• The scope can be measured using metrics such as the length and count of independent claims, which have been shown to correlate with patent quality and examination outcomes[3].

Q: Where can one find additional resources for searching and analyzing patents like 8,227,507?

• The USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online tools like Patent Public Search provide comprehensive resources for patent searches[1].

Sources

1. USPTO - How to Conduct a Preliminary U.S. Patent Search
2. U.S. Patent and Trademark Office (USPTO) | USAGov
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)
5. FDA U.S. FOOD & DRUG Re: AKLIEF Patent Nos. - Regulations.gov

Drugs Protected by US Patent 8,227,507

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	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	8,227,507					TOPICAL TREATMENT OF ACNE VULGARIS

Foreign Priority and PCT Information for Patent: 8,227,507

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	04 13848	Dec 23, 2004

International Family Members for US Patent 8,227,507

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1831149		301042	Netherlands
European Patent Office	1831149		CA 2020 00027	Denmark
European Patent Office	1831149		122020000029	Germany
European Patent Office	1831149		LUC00162	Luxembourg
European Patent Office	1831149		2020C/525	Belgium
European Patent Office	1831149		132020000000088	Italy
European Patent Office	1831149		2090021-3	Sweden