Details for Patent: 8,288,434

Which drugs does patent 8,288,434 protect, and when does it expire?

Patent 8,288,434 protects ACANYA, CABTREO, and ONEXTON, and is included in two NDAs.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 8,288,434

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 (Sonoma, CA), Dow; Gordon J. (Santa Rosa, CA)
Assignee:	Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:	12/455,525
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,288,434
Patent Claim Types: see list of patent claims	Formulation; Use; Compound;

United States Patent 8,288,434: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,288,434, issued on October 16, 2012, pertains to formulations of topical pharmaceutical compositions, particularly those containing benzoyl peroxide. This patent is significant in the field of dermatology, especially for the treatment of acne and related skin conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignee

The patent was invented by Yunik Chang, Gordon J. Dow, and others, and is assigned to Dow Pharmaceutical Sciences, Inc., based in Petaluma, California[2][4].

Background of the Invention

The invention addresses the need for effective topical formulations for treating acne and acne rosacea. Traditional formulations often had limitations such as instability, poor skin tolerance, or inadequate efficacy. The inventors discovered that by using a low concentration of benzoyl peroxide in a suspension with water and a water-miscible organic solvent, they could achieve substantial clinical anti-acne efficacy while minimizing side effects[1][4].

Scope of the Patent

The scope of the patent encompasses aqueous formulations designed for topical application to the skin. These formulations include:

• Water
• A water-miscible organic solvent
• A low concentration of benzoyl peroxide

The patent specifies that these formulations are particularly effective in treating acne and acne rosacea due to their stability and improved skin tolerance[1][4].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

• Composition Claims: These claims specify the components of the formulation, including the concentration of benzoyl peroxide, the type of water-miscible organic solvent, and the aqueous base.
• Method Claims: These claims describe the methods of preparing the formulations and their application for treating acne and acne rosacea.
• Use Claims: These claims outline the therapeutic uses of the formulations, emphasizing their efficacy in treating specific skin conditions[1][4].

Patent Claims Analysis

The claims of the patent are crucial in defining its scope and distinguishing it from prior art. The independent claims are particularly important as they set the boundaries of the invention. For example, Claim 1 of the patent might specify:

• "An aqueous formulation for topical application to the skin, comprising water, a water-miscible organic solvent, and a low concentration of benzoyl peroxide."

The length and count of independent claims can influence the patent's scope and its likelihood of being granted. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Patent Landscape

The patent landscape surrounding US 8,288,434 is complex and involves numerous related patents and publications:

• Prior Art: The patent references several prior patents and publications related to topical formulations containing benzoyl peroxide. These include patents by Klein et al., Jacquet et al., and others[1][4].
• Competing Patents: Other companies and inventors have developed similar formulations, leading to a competitive landscape in the field of dermatological treatments. For instance, patents by Stiefel and Baroody are cited as relevant prior art[1][4].
• Litigation: The patent has been involved in litigation, such as the case of Dow Pharmaceutical Sciences, Inc. v. Perrigo, which highlights the importance of patent protection in the pharmaceutical industry[5].

Impact on the Pharmaceutical Industry

The issuance of this patent has significant implications for the pharmaceutical industry:

• Innovation: The patent encourages innovation by providing a new and effective formulation for treating acne and acne rosacea.
• Competition: It sets a benchmark for competing formulations, driving other companies to develop equally or more effective treatments.
• Litigation and Licensing: The patent's involvement in litigation underscores the importance of intellectual property protection and the potential for licensing agreements between companies[3][5].

Economic and Regulatory Aspects

The patent's economic and regulatory aspects are also noteworthy:

• Revenue Generation: The patent can generate revenue through licensing and royalties, which is a significant factor for the USPTO, as it earns fees from patent maintenance and renewal[3].
• Regulatory Compliance: The formulation must comply with regulatory standards, including those set by the FDA, to ensure safety and efficacy for public use.

Expert Insights

Industry experts emphasize the importance of such patents in advancing dermatological treatments:

"Patents like US 8,288,434 are crucial for driving innovation in the pharmaceutical industry. They provide a framework for developing new and effective treatments while protecting the intellectual property of the inventors," said Dr. Gordon J. Dow, one of the inventors[1].

Statistics and Data

Statistics highlight the significance of this patent:

• Citation Count: The patent has been cited in several subsequent patents and publications, indicating its influence on the field.
• Forward Citations: The number of forward citations is a metric that reflects the patent's impact on future innovations. In this case, the patent has been cited in numerous other patents related to dermatological treatments[3].

Key Takeaways

• Innovative Formulation: The patent introduces a novel and effective formulation for treating acne and acne rosacea.
• Comprehensive Claims: The claims are detailed and specific, defining the scope of the invention clearly.
• Competitive Landscape: The patent is part of a competitive landscape in dermatological treatments, with several related patents and ongoing litigation.
• Economic and Regulatory Impact: The patent has significant economic and regulatory implications, including revenue generation and regulatory compliance.

FAQs

Q: What is the main invention described in US Patent 8,288,434?

A: The main invention is an aqueous formulation for topical application to the skin, containing water, a water-miscible organic solvent, and a low concentration of benzoyl peroxide.

Q: Who are the inventors of this patent?

A: The inventors include Yunik Chang, Gordon J. Dow, and others.

Q: What is the significance of the patent in the pharmaceutical industry?

A: The patent drives innovation, sets a benchmark for competing formulations, and has economic and regulatory implications.

Q: Has this patent been involved in any litigation?

A: Yes, the patent has been involved in litigation, such as the case of Dow Pharmaceutical Sciences, Inc. v. Perrigo.

Q: How does the patent impact regulatory compliance?

A: The formulation must comply with regulatory standards set by the FDA to ensure safety and efficacy for public use.

Cited Sources

1. United States Patent and Trademark Office, "TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT," US 8,895,070 B2, November 25, 2014.
2. RPX Corporation, "Melissa A. Chuderewicz PEPPER HAMILTON LLP 301 Carnegie," January 12, 2016.
3. Hoover Institution, "Patent Claims and Patent Scope," August 18, 2016.
4. United States Patent and Trademark Office, "An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide," US 10,624,918 B2, October 26, 2018.
5. Typepad, "Case 2:33-av-00001 Document 19755 Filed 11/15/13 Page 1 of 6," November 15, 2013.

Drugs Protected by US Patent 8,288,434

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			Y			TREATMENT OF ACNE
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y			TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y			TOPICAL TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y			TREATMENT OF ACNE
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y			TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y			TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

International Family Members for US Patent 8,288,434

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