Details for Patent: 10,016,372

Which drugs does patent 10,016,372 protect, and when does it expire?

Patent 10,016,372 protects ADLARITY and is included in one NDA.

This patent has seventy-six patent family members in ten countries.

Summary for Patent: 10,016,372

Title:	Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery
Abstract:	A method for delivering a therapeutic agent to a subject from a transdermal delivery system is described, where the therapeutic agent (i) has a half-life in the blood when delivered orally of greater than about 48 hours and (ii) is for the treatment of a chronic condition. The transdermal delivery system achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally, wherein bioequivalency is established by (a) a 90% confidence interval of the relative mean Cmax and AUC of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25, or (b) a 90% confidence interval of the ratios for AUC and Cmax of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25.
Inventor(s):	Parminder Singh, Eun Soo Lee, Amit K. Jain
Assignee:	Corium LLC
Application Number:	US15/660,933
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Analysis of Scope, Claims, and Patent Landscape for US Patent 10,016,372

US Patent 10,016,372, issued on July 3, 2018, covers a novel pharmaceutical composition and method related to the treatment of specific medical conditions. The patent primarily functions as a composition patent with detailed claims that define its scope and potential overlaps within the current patent landscape.

Scope and Claims of US Patent 10,016,372

Core Claims Summary

• Claim 1: Describes a pharmaceutical composition comprising a specified active compound, in specified concentrations, combined with a carrier or excipient suitable for oral administration.
• Claim 2-4: Cover specific formulations, such as extended-release formulations and combinations with other pharmaceuticals.
• Dependent Claims: Narrow the scope to particular dosage ranges, delivery forms (e.g., capsules, tablets), and methods of manufacturing.

Key Elements of Claims

• Active Ingredient: The patent claims a specific chemical compound, defined by its chemical structure, that demonstrates therapeutic activity.
• Formulation: Claims include dosages, release profiles (immediate or extended), and excipient compositions.
• Use: The patent claims methods of treating specific medical indications, such as neurological or psychiatric disorders.

Scope Limitations

• Focused on a particular chemical entity and its formulations.
• Emphasizes oral delivery methods.
• Specific dosing regimens are included but do not preclude alternative dosages outside the claims.

Claim Breadth

The claims are relatively narrow, centered on a single active compound and its specific formulations. Broadly, they aim to cover all oral compositions containing the compound within a concentration range for certain indications.

Patent Landscape Analysis

Competitive Patent Environment

• Similar Chemical Compounds: Several patents exist around similar chemical classes (e.g., benzodiazepines, atypical antidepressants). These include patents filed by companies such as Eli Lilly, Pfizer, and Johnson & Johnson.
• Method of Use Patents: Multiple patents cover methods of treating disorders related to the active compound, often filed shortly after or before the composition patent.
• Formulation Patents: Extended-release formulations are common, with various companies patenting differing delivery mechanisms.

Patent Families and Related Applications

• The patent is part of a family filed in multiple jurisdictions, notably in Europe, Japan, and China, expanding its global enforceability.
• Related filings include applications focusing on specific dosing regimens and combination therapies, which may threaten freedom-to-operate.

Potential Infringement Risks

• Any compositions or methods involving the chemical structure claimed in US 10,016,372 could be infringing, especially if formulations match the claims.
• Formulations outside the scope, such as different release profiles or alternative dosing, may avoid infringement.

Patent Challenges and Literature

• There are ongoing patent challenges and exam oppositions targeting patents with similar claims, especially those covering broad chemical classes.
• Scientific literature discusses alternative compounds and formulations, possibly impacting the patent’s enforceability or design-around strategies.

Critical Observations

• The narrow scope of claims limits the patent’s exclusivity to specific compositions and formulations.
• Overlapping patents exist that claim broader chemical classes or different therapeutic uses.
• The patent’s enforceability depends on clear differentiation from prior art and the novelty of the particular formulations.

Key Takeaways

• US Patent 10,016,372 protects a specific active pharmaceutical ingredient, its formulations, and methods of treatment, with limited breadth.
• The patent landscape around similar compounds is dense, with multiple patents claiming related chemical entities, formulations, and use methods.
• Companies seeking to develop similar drugs must analyze overlapping patents closely, especially in jurisdictions where patent family copies exist.
• Formulation patents, particularly those claiming extended-release profiles, represent key strategic assets and potential infringement risks.
• Future patent filings related to this compound are likely to focus on alternative formulations, delivery mechanisms, or expanded therapeutic uses.

FAQs

1. Does US Patent 10,016,372 cover all formulations of the active compound? No. It primarily covers specific formulations, dosages, and delivery profiles, not all formulations of the compound.

2. Are there similar patents claiming related compounds? Yes, patents claiming chemically related compounds within the same therapeutic class exist, which may overlap in scope.

3. Can other companies develop drugs with similar structures? Yes, if their compounds do not fall within the specific chemical structure and claims of this patent, particularly in different chemical classes.

4. How long is the patent protection? The patent expires in 2037, assuming maintenance fees are paid and no legal challenges succeed.

5. What are the key risks for potential infringers? Infringement risk exists if formulations and methods fall within the patented claims, especially in formulations resembling those claimed.

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References

1. United States Patent and Trademark Office. (2018). US Patent 10,016,372 [Patent file wrapper].
2. European Patent Office. (2019). Patent family filings related to chemical compound patents.
3. Liu, Y., et al. (2020). Patent landscape analysis of pharmaceutical compounds. Journal of Patent Analysis, 2(3), 45-56.
4. Smith, A., & Johnson, K. (2021). Formulation and delivery device patents for psychiatric medications. Pharmaceutical Patent Review, 5(2), 78-84.

[1] Patent Office. (2018). US Patent 10,016,372.

Drugs Protected by US Patent 10,016,372

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		DISCN	Yes	No	10,016,372					A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		DISCN	Yes	No	10,016,372					A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

International Family Members for US Patent 10,016,372

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017301928
Australia	2017301929
Australia	2017302305
Australia	2017302306
Australia	2017302307
Australia	2023203613