Details for Patent: 10,137,142

Which drugs does patent 10,137,142 protect, and when does it expire?

Patent 10,137,142 protects ONEXTON and is included in one NDA.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 10,137,142

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), Pillai; Radhakrishnan (Santa Rosa, CA)
Assignee:	Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:	15/332,933
Patent Claim Types: see list of patent claims	Use; Formulation;

United States Patent 10,137,142: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,137,142, titled "Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent," is a significant patent in the field of dermatology and pharmaceutical formulations. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Purpose

Benzoyl peroxide is a widely used active ingredient in topical formulations for treating acne and other skin conditions. The patent in question addresses the formulation of benzoyl peroxide in a way that enhances its stability and efficacy.

Scope of the Patent

The patent covers a specific type of aqueous formulation designed for topical application to the skin. Here are the key components of the scope:

Formulation Composition

• The formulation includes water, a water-miscible organic solvent, and benzoyl peroxide in suspension[1].
• The use of a water-miscible organic solvent, such as propylene glycol, is crucial for maintaining the stability of benzoyl peroxide.

Disease Targets

• The formulation is intended for the treatment of acne, including acne vulgaris, and other skin conditions like rosacea[1].

Stability and Efficacy

• The patent emphasizes the importance of maintaining the stability of benzoyl peroxide, which is known to degrade over time. The formulation ensures that the active ingredient remains effective for a longer period.

Claims of the Patent

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

Independent Claims

• The independent claims outline the essential features of the formulation, including the concentration of benzoyl peroxide, the type of solvents used, and the method of preparation[1].

Dependent Claims

• Dependent claims further specify the details of the formulation, such as the ratio of water to organic solvent and the presence of additional ingredients like gelling agents[1].

Patent Claims Analysis

Claim Length and Count

• Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Claim Specificity

• The claims in this patent are specific and detailed, which helps in clarifying the scope of the invention and reducing the likelihood of disputes over patent infringement.

Patent Landscape

Industry Context

• The patent landscape for topical pharmaceutical formulations is highly competitive, with numerous patents covering various aspects of skin treatment products.

Litigation Trends

• Patent infringement lawsuits in the pharmaceutical sector have been on the rise. The U.S. Patent and Trademark Office (USPTO) has been working to improve patent quality to reduce litigation costs and enhance innovation[4].

Regulatory Environment

• The Leahy-Smith America Invents Act (AIA) of 2011 introduced significant changes to the U.S. patent system, affecting how patents are granted and litigated. This act has influenced the strategy behind filing and defending patents in the pharmaceutical industry[4].

Inventorship and Ownership

Determining Inventorship

• Correctly identifying the true and only inventors is crucial for the validity of a patent. Errors in inventorship, especially those made with deceptive intent, can render a patent unenforceable[5].

Assignment and Licensing

• The patent can be assigned or licensed to other entities, which is common in the pharmaceutical industry where companies often collaborate or acquire intellectual property rights.

Impact on Innovation

Encouraging Innovation

• Patents like US 10,137,142 encourage innovation by providing a protective environment for inventors to develop and commercialize their inventions.

Challenges and Opportunities

• The patent landscape presents both challenges and opportunities. While it protects the inventor's rights, it also requires careful navigation to avoid infringement and ensure compliance with regulatory requirements.

Statistics and Industry Insights

• According to the USPTO, the number of patent applications in the pharmaceutical sector has been increasing, reflecting the ongoing innovation in this field[2].

"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity." - Source: SSRN[3]

Key Takeaways

• The patent US 10,137,142 is specific to a formulation of benzoyl peroxide for topical application.
• The scope includes a detailed composition and method of preparation.
• The claims are narrow and specific, which is beneficial for patent grant and enforcement.
• The patent landscape is influenced by regulatory changes and litigation trends.
• Correct inventorship and compliance with regulatory requirements are crucial.

Frequently Asked Questions (FAQs)

What is the main purpose of the US 10,137,142 patent?

The main purpose is to provide a stable and effective topical formulation of benzoyl peroxide for treating acne and other skin conditions.

What are the key components of the formulation?

The key components include water, a water-miscible organic solvent, and benzoyl peroxide in suspension.

Why is the stability of benzoyl peroxide important?

The stability of benzoyl peroxide is crucial because it is prone to degradation, which can reduce its efficacy.

How does the patent landscape affect this invention?

The patent landscape, influenced by regulatory changes and litigation trends, requires careful navigation to ensure compliance and avoid infringement.

What are the implications of incorrect inventorship?

Incorrect inventorship, especially with deceptive intent, can render the patent unenforceable and invalid.

Sources:

1. US10137142B2 - Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent - Google Patents
2. U.S. Patent and Trademark Office (USPTO) | USAGov
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. Assessing Factors That Affect Patent Infringement Litigation ... - GAO
5. Determining Inventorship for US Patent Applications

Drugs Protected by US Patent 10,137,142

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	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 10,137,142

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