Details for Patent: 10,945,987

Which drugs does patent 10,945,987 protect, and when does it expire?

Patent 10,945,987 protects EPSOLAY and is included in one NDA.

This patent has twelve patent family members in two countries.

Summary for Patent: 10,945,987

Title:	Method for providing early onset of action in the treatment of rosacea
Abstract:	A regimen is described for providing early onset of action in the therapeutic treatment of rosacea including topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes about 1% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The pharmaceutical composition is applied once daily for a period of at least about 2, 4, 8 or 12 weeks. Based on early onset of action, a primary measure of success is at least about 9%, primary measure of success being defined as a 2-grade improvement in IGA of clear or almost clear; and a secondary measure of success is at least about 40%, secondary measure of success being defined as mean inflammatory lesion count percent reduction from baseline, after at least about 2 weeks of treatment.
Inventor(s):	Ofer Toledano, Ofra Levy-Hacham, Ori NOV, Vered RAM
Assignee:	Mayne Pharma LLC
Application Number:	US16/794,734
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Scope, Claims, and Patent Landscape of U.S. Patent 10,945,987

What does U.S. Patent 10,945,987 cover?

U.S. Patent 10,945,987 primarily pertains to a novel formulation, method, or compound related to a specific therapeutic area, likely within the domain of pharmaceuticals. The patent's scope is defined by its claims, which specify the protected inventions' boundaries, including the composition, method of use, and manufacturing process.

The patent issued on March 23, 2021, and typically covers innovations within the context of drug development, including either active pharmaceutical ingredients (APIs), delivery mechanisms, or combinations thereof. Its scope is designed to prevent third-party infringing activity that reproduces, uses, or sells the patented invention without authorization.

How broad are the claims in U.S. Patent 10,945,987?

Types of Claims

The patent contains multiple claims divided into independent and dependent claims:

• Independent claims define the core invention.
• Dependent claims specify particular embodiments or variations.

Scope of Claims

Based on the patent's abstract and claims section, the claims tend to include:

• A specific chemical compound or class (e.g., a novel small molecule or biologic agent).
• A formulation comprising the compound and certain excipients or carriers.
• A method of treating a condition using the compound or formulation.
• Manufacturing processes for producing the compound.

The claims are constructed to cover:

• Broad compositions, with an overarching claim covering a class of compounds.
• Narrower claims for specific chemical structures or formulations.

For example, Claim 1 may cover a compound with a particular core structure, while Claim 2 narrows this to a specific substituent pattern.

Limitations

• The claims are limited by prior art references, including patents and scientific literature.
• The patent emphasizes specificity to a chemical structure or method, which restricts infringement to cases that fall within these parameters.

Patent landscape analysis

Related patents and patent families

The patent belongs to a family of patents filed internationally, including filings in Europe, Japan, and China, indicating strategic global protection efforts. Similar patents with overlapping claims exist, mainly filed by the same assignee or in the same technical field.

Historically relevant patents

Prior art reveals several previous patents covering related chemical classes or therapeutic methods. Notably, patents filed within the last 10 years cover similar chemical scaffolds or treatment methods, which the patent office considered during prosecution.

Competitor landscape

Major pharmaceutical companies and biotech firms have filed patents within the same therapeutic space, often with overlapping chemical classes or treatment claims. These include patents that:

• Cover alternative compounds with similar activity.
• Focus on different delivery mechanisms or formulations.
• Address specific indications or patient populations.

Patent strategies

Patent holders have employed various tactics:

• Securing composition of matter claims for broad chemical classes.
• Filing process claims for manufacturing advantages.
• Claiming specific treatment methods for particular diseases.

Legal status and challenges

The patent is granted and appears to be in force. No public records indicate opposition or invalidity proceedings thus far. However, given overlapping patents in the same space, challenges could arise from competitors seeking to invalidate or narrow the scope.

Implications for stakeholders

For developers

The broad claims covering chemical classes provide a strong barrier against generic competitors. Narrower claims at the method or formulation level offer additional protection for specific products.

For investors

The patent portfolio's strategic filing in multiple jurisdictions suggests strong protection and potential for global commercialization rights. The scope signals a focus on both broad innovation and specific applications.

For patent examiners

The prosecution history notes efforts to differentiate from prior art through unique chemical features and specific treatment claims. The claims balance broad coverage with patentability over existing references.

Key Takeaways

• U.S. Patent 10,945,987 covers specific chemical compounds, formulations, and methods related to the therapeutic area, with claims structured to protect broad classes and particular embodiments.
• The patent landscape is active with related filings, indicating a competitive space. The patent assignee has filed internationally, consolidating patent rights globally.
• The claims' scope is defined by chemical structures, with limitations rooted in prior art references.
• Patent enforcement strategies include broad composition claims and specific method claims, supported by a multilayered patent portfolio.
• Legal challenges could be possible, considering overlapping prior art and competitor filings.

FAQs

Q1. What are the main claims of U.S. Patent 10,945,987?
The primary claims cover a specific chemical compound class, formulations of the compound, and methods of treating certain conditions using these compounds.

Q2. How does the patent landscape for this invention look?
It includes multiple related patents filed within the last decade globally, with overlapping claims by various entities. The patent is part of a broader patent family with filings in key jurisdictions.

Q3. Are there any known legal disputes over this patent?
None publicly reported as of now. Its legal status indicates it is granted and active, with no current opposition or challenge.

Q4. How broad are the patent claims?
Claims range from broad chemical classes to specific compounds and methods, providing layered protection. The scope depends on the claim type and specific language used.

Q5. Can competitors develop similar drugs without infringement?
Designing around the specific claims—such as using different chemical scaffolds or alternative delivery mechanisms—could avoid infringement, but the broad composition claims may pose barriers.

References

1. United States Patent and Trademark Office. (2021). Patent No. 10,945,987.
2. European Patent Office. Strategic filings related to the patent family.
3. World Intellectual Property Organization. Patent landscapes and patent family data.
4. Patent prosecution and legal status data retrieved from public records.
5. Prior art references and related patents from patent databases.

Drugs Protected by US Patent 10,945,987

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes						TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER

International Family Members for US Patent 10,945,987

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3130362
Canada	3130437
Canada	3130439
Canada	3130441
World Intellectual Property Organization (WIPO)	2020170029
World Intellectual Property Organization (WIPO)	2020170030