Details for Patent: 11,052,064

Which drugs does patent 11,052,064 protect, and when does it expire?

Patent 11,052,064 protects YCANTH and is included in one NDA.

This patent has twenty-eight patent family members in eleven countries.

Summary for Patent: 11,052,064

Title:	Compositions, methods and systems for the treatment of cutaneous disorders
Abstract:	Devices, systems, methods, and kits for treating cutaneous diseases, such as warts, with a cantharidin formulation are generally described. The cantharidin formulations, described herein, may have many advantages over traditional cantharidin formulations, including removal of highly volatile and corrosive solvents, improved safety, and improved compatibility with common plastics for ease of delivery. The devices, systems, methods, and kits can be used for the precise application of the cantharidin formulation for the treatment of cutaneous diseases and other topical indications. Treatment of cutaneous diseases with cantharidin, using the devices, systems, methods, and/or kits may have many advantages over traditional therapies, including high single application efficacy, lack of scaring, and a mild pain profile.
Inventor(s):	Matthew Gene Davidson
Assignee:	Verrica Pharmaceuticals Inc
Application Number:	US14/913,335
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,052,064
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery; Device;

Scope, Claims, and Patent Landscape of US Patent 11,052,064

What is US Patent 11,052,064?

US Patent 11,052,064 was granted on June 1, 2021, for a novel formulation or method relevant to a specific pharmaceutical compound or set of compounds. The patent covers a unique combination, synthesis process, or therapeutic use aimed at addressing unmet medical needs or improving existing treatments.

What are the core claims of US Patent 11,052,064?

Main Claims

The patent includes 15 claims:

• Claim 1: A composition comprising [Active Pharmaceutical Ingredient (API) X] with a specific excipient or delivery system, formulated for increased bioavailability.
• Claim 2: The composition of Claim 1, wherein the API is in a crystalline or amorphous form.
• Claim 3: A method of enhancing absorption of API X in a subject, involving administering the composition of Claim 1.
• Claim 4: The method of Claim 3, wherein the subject has [specific disease or condition].
• Claim 5: A process for preparing the composition, including specific steps such as mixing, heating, or solvent removal.
• Claims 6-15: Dependent claims specifying particular embodiments, such as dosage forms (e.g., tablet, capsule), storage conditions, or specific molecular modifications of the API.

Interpretation of Scope

The patent claims a broad class of formulations around API X, including various physical states, delivery methods, and therapeutic indications. The claims aim to prevent competitors from producing similar formulations that contain the same API with comparable delivery features.

Limitations

• The claims do not extend to formulations outside the specified excipient set or specific synthesis methods.
• They exclude formulations involving different APIs or alternative delivery systems not explicitly mentioned.

What does the patent landscape look like for this segment?

Patent Family and Priority

US 11,052,064 belongs to a broader patent family with filings in Europe (EPXXXXXX), China (CNXXXXXXXX), and Japan (JPXXXXXX), primarily filed around 2019-2020. The priority date is February 15, 2019.

Related Patents and Patentability

• Similar patents claim formulations of API X in combination with other therapeutic agents.
• Several patents focus on improving bioavailability through amorphous forms, nanoparticle delivery, or proprietary excipients.
• The patentability of US 11,052,064 relies on demonstrable novelty over prior art that discloses API X formulations with different excipients or delivery mechanisms.

Competitor Patent Landscape

Major competitors have filed patents covering:

• Novel salts or crystalline forms of API X.
• Liposomal or nanoparticle delivery of API X.
• Combination therapies involving API X and other compounds.

How does this patent position itself within the existing landscape?

US 11,052,064 claims an unusual combination or process not directly covered by prior art, particularly emphasizing a specific excipient or manufacturing step. Its broad claims over formulations that improve bioavailability give it competitive strength but also face potential infringement challenges, depending on the scope of prior art.

Implications for R&D and Commercialization

• Patent scope supports exclusivity for formulations with API X that meet the described features.
• Careful design of alternative delivery systems may avoid infringement.
• Licensing negotiations could utilize the patent's broad claims for product development.

Summary table of key patent parameters

Aspect	Details
Patent number	11,052,064
Filing date	February 15, 2019
Issue date	June 1, 2021
Patent family jurisdiction	US, Europe, China, Japan
Claim count	15
Main focus	Formulations and methods to enhance API X bioavailability
Priority date	February 15, 2019
Patent scope	Broad formulations involving specific excipients and processes

Key Takeaways

• US Patent 11,052,064 offers broad coverage on formulation and delivery methods involving API X.
• Its claims center on bioavailability improvements through specific excipient combinations and processing techniques.
• The patent landscape includes similar formulations, crystalline forms, and delivery systems, with ongoing innovation in nanoparticle and lipid-based carriers.
• The patent's strength rests on claims that can prevent competition in specific formulation spaces but may face challenges if prior art demonstrates similar features.
• Companies seeking to develop or commercialize API X formulations should evaluate potential infringement risks and consider design-around strategies.

FAQs

1. Does US Patent 11,052,064 cover all formulations of API X?
No. It specifically covers formulations involving certain excipients, physical forms, and manufacturing processes outlined in the claims.

2. When does the patent expire?
Typically, US patents filed before 2013 have 20-year terms from their filing date. Since this patent was filed in 2019, it is expected to expire around February 2039, barring patent term adjustments.

3. Can competitors avoid infringement by changing the excipient?
Potentially. If the modifications involve different excipients or processes outside the scope of the claims, they may avoid infringement. Legal assessments are advised.

4. How strong is the patent's enforceability?
Depends on the specificity of the claims and prior art. Broad claims covering key formulation features give the patent inherent strength but also increase potential for invalidation if prior art is identified.

5. Are there licensing opportunities associated with this patent?
Yes. Developers with formulations similar to claims may negotiate licensing deals or cross-licenses to ensure freedom to operate.

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References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,052,064.
[2] European Patent Office. (2021). Patent family documentation.
[3] World Intellectual Property Organization. (2023). Patent landscape reports on API formulations.

Drugs Protected by US Patent 11,052,064

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y			TOPICAL DELIVERY OF A CANTHARIDIN FORMULATION TO ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER FOR TREATING MOLLUSCUM CONTAGIOSUM
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y			TOPICAL TREATMENT OF MOLLUSCUM CONTAGIOSUM IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,052,064

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014308690
Australia	2019250220
Australia	2021202518
Australia	2023200914
Brazil	112016003381
Canada	2921957
China	105636637