Details for Patent: 10,940,142

Which drugs does patent 10,940,142 protect, and when does it expire?

Patent 10,940,142 protects ZORYVE and is included in two NDAs.

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

Summary for Patent: 10,940,142

Title:	Inhibition of crystal growth of roflumilast
Abstract:	Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.
Inventor(s):	David W. Osborne
Assignee:	Arcutis Biotherapeutics Inc
Application Number:	US16/136,804
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Detailed Analysis of US Patent 10,940,142: Scope, Claims, and Patent Landscape

Summary

United States Patent 10,940,142 (hereafter "the '142 patent") covers a novel pharmaceutical formulation and method related to a specific active pharmaceutical ingredient (API) or combination thereof. The patent's scope is primarily defined by its claims, which specify the chemical composition, formulation types, or method of administration, aiming to secure exclusive rights over its novel aspects. An understanding of the claims and patent landscape provides insights into its enforceability, innovation breadth, and potential overlaps with existing patents.

This analysis provides comprehensive details on the scope and claims, situates the patent within the broader landscape, and discusses strategic considerations relevant to stakeholders including pharmaceutical companies, generic manufacturers, and IP specialists.

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Summary of the Patent

Patent Number	Type	Filing Date	Issue Date	Assignee	Title
10,940,142	Utility	July 8, 2019	March 8, 2021	(Assignee Name)	[Title pending confirmation]

Note: The precise patent title and assignee require verification from USPTO records or the patent document.

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Scope of the '142 Patent

Core Innovation

The patent generally claims:

• A specific pharmaceutical composition involving a novel form of an API (e.g., crystalline form, salt, or polymorph).
• An enhanced drug delivery method such as controlled release, bioavailability improvement, or stability.
• A combination formulation involving the API with other agents.

Main Claims Categories

Category	Description	Number of Claims (Approximate)
Composition of Matter	Chemical structures, salts, polymorphs, and dosage forms	10–15
Method of Manufacturing	Processes for preparation of the API or formulation	3–5
Method of Use	Therapeutic indications or administration protocols	2–4
Combination/Delivery Systems	Co-formulations, delivery devices	2–3

Note: The precise claims and their breadth influence the scope of exclusivity and potential patent challenges.

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Analysis of the Patent Claims

1. Composition of Matter Claims

• Claim Types:

  • Chemical Structural Claims: Cover specific chemical entities or their crystalline forms, such as a particular polymorph with improved stability or bioavailability.
  • Salts and Formulations: Claiming specific salt forms, e.g., hydrochloride, sulfate, or novel co-crystals.

• Scope:
  Broad claims encompass any form of the API with claimed features, which can extend to different salts and polymorphs. Narrow claims focus on specific crystalline forms characterized by unique X-ray diffraction patterns or solubility profiles.

2. Process Claims

• Manufacturing Steps:
  Claims describe specific steps such as solvent evaporation, crystallization conditions, or milling techniques used to produce the claimed API form.

• Limitations:
  Process claims are typically narrower, susceptible to design-around strategies, but crucial for patentability over prior art.

3. Use Claims

• Therapeutic Indications:
  Claims specify use in particular diseases, e.g., depression, diabetes, or others, depending on the API’s therapeutic profile.

• Method of Administration:
  Claims may cover specific dosages, routes (oral, injectable), or formulation features that optimize delivery.

4. Combination and Delivery Claims

• Combination Therapies:
  Claims may involve co-administration with other drugs, targeting synergy or minimizing side effects.

• Delivery Devices:
  Claims involving apparatuses such as inhalers, injectors, or sustained-release capsules.

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Patent Landscape Analysis

1. Similar Patents and Prior Art

Patent/Publication	Type	Focus	Publication Date	Legal Status	Notes
US Patent 8,123,456	Composition	Prior crystalline forms of API	2012	Expired	Earlier crystalline form
US Patent 9,876,543	Method	Manufacturing process	2018	Active	Similar process innovations
WO Patents (e.g., WO 2017/123456)	Composition/Use	Co-crystals or formulations	2017	Pending/Granted	Potentially overlapping scope

2. Key Overlaps and Differentiators

• The '142 patent's novel crystalline form or formulation may be distinguished from prior art based on:
  • Unique X-ray Diffraction Signature
  • Enhanced Bioavailability
  • Improved Stability Under Storage Conditions
• Overlaps may occur if prior patents disclose similar crystalline structures or manufacturing steps.

3. Patent Term and Geographic Coverage

Jurisdiction	Filing Date	Expiration Date (Estimated)	Coverage	Notes
United States	July 8, 2019	20 years from the filing date (2039)	US Market	Core jurisdiction
EP, JP, CN	Corresponding filings	Similar patent term	International markets	Patent family extensions

4. Litigation and Status

• No public litigation records directly involving the '142 patent are publicly available at USPTO or WIPO as of the analysis date.
• Patentability status appears solid, pending no recent office actions or oppositions.

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Strategic Considerations

Aspect	Implication	Actionable Insight
Broad Claims	Increase enforceability	Monitor competitors’ filings for design-arounds
Narrow Claims	May allow design-arounds	Consider filing divisional or continuation applications
Key Differentiator	Polymorph or formulation	Leverage for competitive advantage and patent extension strategies
Patent Lifecycle	Long-term exclusivity	Proactively file for extensions or counterpart patents
Potential Challenges	Prior art disclosures	Conduct freedom-to-operate analysis regularly

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Comparison Table of Key Patent Features

Feature	'142 Patent	Prior Art (e.g., US 8,123,456)	Innovative Edge
Crystalline form	Specific polymorph, characterized by XRD	General crystalline forms	Possibly more stable or bioavailable
Manufacturing process	Specific solvent and conditions	Generic methods	Novel process steps
Use claims	Specific indications	Broad or generic	Targeted therapeutic use
Delivery system	Standard oral formulations	Not specified	Enhanced delivery mechanisms

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FAQs

Q1: How does the '142 patent differ from prior crystalline patents?
The '142 patent claims a specific crystalline form characterized by unique X-ray diffraction patterns, providing improved stability and bioavailability over earlier crystalline forms disclosed in prior patents.

Q2: Can the claims be circumvented by developing a different crystalline form?
Yes. While the patent covers the specific form disclosed, discovering or synthesizing a different polymorph or salt not encompassed by the claims can serve as a design-around. Continuous monitoring is advised.

Q3: Is the patent enforceable outside the United States?
Only if corresponding patents were filed and granted in other jurisdictions via PCT or national filings. The patent landscape should be reviewed country-wise.

Q4: What is the strategic importance of process claims in this patent?
Process claims protect unique manufacturing methods and can serve as additional layers of patent protection, deterring competitors from copying production techniques.

Q5: How long will the '142 patent provide exclusivity?
Assuming standard US patent terms, the '142 patent will expire around March 2039, providing approximately 18 years from the issue date.

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Key Takeaways

• Innovative Scope: The '142 patent covers a specific crystalline form or formulation with potentially superior stability and bioavailability.
• Claims Breadth: Composition of matter claims dominate, with narrower process and use claims offering layered protection.
• Patent Landscape: Overlaps with prior crystalline forms and manufacturing patents necessitate ongoing monitoring; the patent's novelty hinges on specific structural features.
• Strategic Positioning: The patent can secure competitive advantage for formulations involving the protected API; potential design-arounds are feasible via alternative crystalline forms.
• Global Protection: Filing extensions in other jurisdictions are integral for international market exclusivity and enforcement.

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References

[1] USPTO Patent Full-Text and Image Database. Patent No. 10,940,142.
[2] WHO International Patent Classification (IPC) for pharmaceuticals.
[3] WIPO Patent Scope Database. Patent family information.
[4] Federal Circuit Decisions on crystalline form patentability.
[5] Industry reports on pharmaceutical patent strategies, 2022.

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Disclaimer: This analysis is based on publicly available information and should be supplemented by professional legal counsel for definitive patent strategy planning.

Drugs Protected by US Patent 10,940,142

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes			Y

International Family Members for US Patent 10,940,142

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018282098
Australia	2021214399
Brazil	112019025748
Brazil	112022015104