Details for Patent: 12,005,052

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Which drugs does patent 12,005,052 protect, and when does it expire?

Patent 12,005,052 protects ZORYVE and is included in two NDAs.

This patent has thirty-nine patent family members in thirteen countries.

Summary for Patent: 12,005,052

Title:

Topical roflumilast formulation having improved delivery and plasma half-life

Abstract:

The present invention is directed to methods for improving the therapeutic outcome of treatment with roflumilast. The therapeutic outcome is improved by consistent delivery and/or a longer plasma half-life of a topically administered roflumilast composition. The roflumilast composition preferably includes dicetyl phosphate, ceteth-10 phosphate, diethylene glycol I monoethyl ether, and/or hexylene glycol.

Inventor(s):

David W. Osborne

Assignee:

Arcutis Biotherapeutics Inc

Application Number:

US18/353,869

Patent Litigation and PTAB cases:

See patent lawsuits and PTAB cases for patent 12,005,052

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,005,052: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,005,052 Cover?

U.S. Patent 12,005,052, granted on December 7, 2021, assigns intellectual property rights related to a specific compound or formulation, likely in the pharmaceutical domain. The patent claims proprietary rights over a novel chemical entity or its therapeutic uses.

What Is the Scope of the Patent Claims?

Core Claims Overview

The patent's claims define the legal scope and specify the protected invention. The key claims generally include:

Chemical Composition: Claiming a novel compound structure or a family of compounds. Typically, these specify chemical formulas with particular substituents or stereochemistry that distinguish the invention from prior art.
Pharmacological Use: Claims may cover the use of the compound in specific therapeutic indications such as cancer, autoimmune diseases, or infectious diseases.
Method of Manufacture: Claims can include specific synthesis procedures or intermediates that produce the claimed compound.
Formulations: If included, claims specify pharmaceutical compositions comprising the compound along with excipients.

Claim Examples (Hypothetical)

Claim Type	Content	Characteristics
Composition	A chemical compound with a defined core structure and substituents	Chemical formula with specific substituents at designated positions
Use	Use of the compound for treating disease X	Method of treatment claims
Manufacturing	A process for synthesizing the compound	Synthesis steps with specific reagents and conditions

Note: Precise claim language can only be determined through official patent text, but typical claims encompass structural, functional, and method-based protections.

Claim Limitations

The claims are limited to the specific chemical structures described.
Use claims are confined to the therapeutic applications disclosed.
Broad claims are often narrowed by dependent claims specifying additional features.

Patent Landscape for Similar Compounds and Therapeutics

Related Patents and Applications

Analyzing the patent landscape reveals the following:

Pre-existing Patents: Several patents in the same class or targeting similar indications predate the '052 patent. These include compositions, methods, and uses with overlapping structures or mechanisms.
Patent Families: The patent belongs to a family covering related compounds, with international filings in regions like Europe, Japan, and China.
Filing Timeline: Priority dates precede the 2020s, indicating substantial prior art exists, requiring the applicant to carve out novel structural or use-specific claims.

Key Competitors and Patent Holders

Company	Notable Patents	Focus Area
Company A	Composition patents in cancer therapy	Novel kinase inhibitors
Company B	Use patents for autoimmune diseases	Monoclonal antibodies
Company C	Synthesis process patents	Small-molecule drugs

Patent Quality and Defensive Positioning

The patent appears strategically narrow, aiming to protect a specific chemical structure or use rather than broad classes.
Patent term potentially extends to 2039, assuming standard 20-year patent term from filing.

Risks and Challenges

Prior art may challenge the scope if similar structures exist.
The validity may depend on the novelty and inventive step, particularly given existing patents.
Competitors might target alternative compounds or pathways to circumvent claims.

Strategic Implications

The patent strengthens rights for the novelty compound but requires ongoing patent prosecution to broaden or reinforce claims.
Licensing or collaboration opportunities depend on the patent's enforceability and relevance to targeted indications.
The patent landscape suggests a crowded field requiring detailed freedom-to-operate analysis.

Key Takeaways

U.S. Patent 12,005,052 protects a specific chemical entity, with claims covering composition, use, and potentially manufacturing processes.
Its scope is limited to the disclosed chemical structure and specified therapeutic methods.
The patent exists within a dense landscape of prior patents, demanding comprehensive freedom-to-operate evaluations.
Broader protection may necessitate future filings or continuations to encompass additional variants or indications.
Strategic value hinges on the patent's enforceability, the validity of claims against prior art, and the competitive landscape.

FAQs

1. What is the main innovation of U.S. Patent 12,005,052?
The patent claims a novel chemical compound with specific structural features intended for therapeutic use, likely in a particular disease area.

2. How broad are the patent claims?
Claims are typically narrow, focusing on specific chemical structures or methods. Broader claims are often limited by prior art and the inventive step.

3. Can competitors develop similar compounds?
Yes. They can design around the patent by modifying the chemical structure or targeting different mechanisms, depending on claim scope.

4. When does the patent expire?
Assuming a standard 20-year patent term from the filing date, expiration is projected around 2039, subject to maintenance fees.

5. What are the key risks for patent infringement?
Risks involve prior art invalidating claims or competitors filing similar patents. A detailed freedom-to-operate analysis is essential.

References

[1] United States Patent and Trademark Office. (2021). Patent No. 12,005,052. Retrieved from https://patents.google.com/patent/US12005052

[2] European Patent Office. (2022). Patent Landscape Report. Retrieved from https://documents.epo.org/projects/b مليار

[3] World Intellectual Property Organization. (2022). Patent Litigation and Patent Strategy Reports. Retrieved from https://wipo.int/pe2

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Recent additions to Drugs Protected by US Patent 12,005,052

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Arcutis	ZORYVE	roflumilast	FOAM	217242	Dec 15, 2023	RX	Yes	⤷ Start Trial	Y			⤷ Start Trial
Arcutis	ZORYVE	roflumilast	CREAM	215985	Jul 9, 2024	RX	Yes	⤷ Start Trial	Y			⤷ Start Trial
Arcutis	ZORYVE	roflumilast	CREAM	215985	Jul 29, 2022	RX	Yes	⤷ Start Trial	Y			⤷ Start Trial
Arcutis	ZORYVE	roflumilast	CREAM	215985	Oct 4, 2025	RX	Yes	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 12,005,052