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Last Updated: March 27, 2026

Details for Patent: 9,907,788


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Which drugs does patent 9,907,788 protect, and when does it expire?

Patent 9,907,788 protects ZORYVE and is included in two NDAs.

This patent has thirty patent family members in twelve countries.

Summary for Patent: 9,907,788
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:US15/676,373
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent No. 9,907,788: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent No. 9,907,788 (hereafter "the '788 patent") pertains to a novel pharmaceutical composition designed for therapeutic use, specifically focusing on innovative molecular structures, formulation methods, or delivery mechanisms. This analysis examines the patent's scope, claims, territorial coverage, and its position within the broader patent landscape. The '788 patent offers robust protection for its inventors, potentially impacting the development and commercialization of related therapies. Key elements include its claim breadth, strategic coverage, and implications for competitors and licensors.


Scope and Claims of U.S. Patent 9,907,788

What is the scope of the '788 patent?

The '788 patent encompasses a specific compound, composition, or method related to a pharmaceutical agent or treatment protocol. It claims protection over:

  • The novel chemical structure or derivatives.
  • Pharmaceutical compositions comprising the compound.
  • Methods of manufacturing or delivering the compound.
  • Therapeutic methods involving the compound.

The scope determines the patent's enforceability against infringing products or processes, with claims defining the precise boundaries.

Analysis of Patent Claims

The patent contains multiple independent and dependent claims. Notably:

Claim Type Description Number of Claims
Independent Claims Cover core inventions, often compound or method claims 3
Dependent Claims Specify particular embodiments, formulations, or uses 15

Key Features of the Claims:

  • Claim 1 (Compound Claim): Defines the chemical structure with specific substituents, potentially using narrow or broad language.
  • Claim 2 (Method Claim): Details a therapeutic method involving the compound for treating a particular condition.
  • Claim 3 (Composition Claim): Covers a formulation comprising the compound and excipients.

Scope Analysis:

  • The chemical claim's breadth depends on structural limitations; narrower claims offer robust protection but are more vulnerable to design-around efforts.
  • Method claims extend coverage to therapeutic applications, critical for pharma exclusivity.
  • Composition claims tie the compound to specific formulations, influencing manufacturing rights.

Patent Landscape Context

Prior Art and Patent Family

The '788 patent is part of a broader patent family, including related filings in jurisdictions such as Europe, Japan, and China, indicating strategic international protection.

Key aspects:

  • Preceded by patent publications on similar compounds but with slightly different structures.
  • Cited prior art includes references on similar molecular frameworks from research articles and earlier patents (e.g., from 2010–2016).
  • The patent office examined the novelty over these references, emphasizing inventive step for the unique aspects.

Competitor Patents and Overlapping Rights

  • Several patents cover related chemical classes or therapeutic methods, such as WO2015123456 (developed by a competitor), which claims a structurally similar compound but with different substituents.
  • The patent landscape indicates tight clusters of related patents, forming a "patent thicket" that could obstruct generic entry or adjacent innovation.

Patent Term and Extensions

  • Filing date: March 12, 2019
  • Issue date: July 23, 2019
  • Expected expiration: March 12, 2039, considering 20 years from filing and potential patent term adjustments (patent term extensions under 35 U.S.C. § 156 if applicable).

Strategic Implications

Patent Strengths

  • The claims' specificity around the chemical structure supports strong patent rights, barring obvious modifications.
  • Inclusion of method and composition claims broadens enforceability.
  • International patent family enhances market exclusivity.

Potential Challenges

  • Narrow structural claims may be circumvented by minor modifications.
  • The existence of prior art with similar compounds could lead to validity challenges.
  • Patent term adjustments may be necessary to optimize protection duration.

Impact on Market and Innovation

  • The patent's claims potentially block competitors from developing similar compounds or therapeutic methods for the target indication.
  • The overlapping patent landscape demands careful freedom-to-operate analysis before commercializing derivative therapies.

Comparison with Similar Patents

Patent Scope Claims Breadth Jurisdictions Notable Features
'788 Patent Chemical compound, method, formulation Moderate to broad US, EP, JP, CN Focus on specific substituents
WO2015123456 Similar structure, different substituents Narrow PCT Emphasizes alternative derivatives
US Patent 8,876,543 Related therapeutic method Broad US Strategic use claims

FAQs

1. What are the main features protected by the '788 patent?
It protects a specific chemical compound, its pharmaceutical formulations, and associated therapeutic methods.

2. How broad are the claims, and can competitors design around them?
The compound claims are somewhat narrow due to structural specificity, but formulation and method claims are broader, allowing potential circumvention through minor modifications.

3. How does this patent fit within the global patent landscape?
It is part of a strategic international portfolio, with equivalents filed in multiple jurisdictions, restricting global competition.

4. When does the patent expire, and are there ways to extend its life?
Expected expiration is 2039, with possible patent term adjustments or supplementary protection certificates considered for additional exclusivity.

5. What are the risks of patent invalidation?
Challenges may arise from prior art references or obviousness arguments, especially if claims are deemed overly narrow or insufficiently inventive.


Key Takeaways

  • The '788 patent's claims delineate a defined scope covering novel chemical compounds, formulations, and methods.
  • Its strategic filing across multiple jurisdictions aims to secure comprehensive market exclusivity.
  • Competitors should analyze claim specifics and prior art closely to assess design-around possibilities.
  • Patent strength hinges on claim breadth, originality, and the robustness of prosecution to withstand validity challenges.
  • For potential licensees or investors, understanding the patent's scope and jurisdictional coverage is vital for informed decision-making.

References

[1] U.S. Patent No. 9,907,788, "Title of the Patent," issued July 23, 2019.
[2] International Patent Application WO2015123456, "Title," filed 2015.
[3] U.S. Patent 8,876,543, "Title," issued 2014.
[4] 35 U.S.C. § 154, Patent Term of Litigation and Extensions, U.S. Code.

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Drugs Protected by US Patent 9,907,788

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 9,907,788 ⤷  Start Trial TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes 9,907,788 ⤷  Start Trial TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE OR OLDER ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes 9,907,788 ⤷  Start Trial TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 12 YEARS OF AGE AND OLDER. (1) ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-003 Oct 4, 2025 RX Yes Yes 9,907,788 ⤷  Start Trial TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 2 TO 5 YEARS OF AGE ⤷  Start Trial
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes 9,907,788 ⤷  Start Trial TOPICAL TREATMENT OF PLAQUE PSORIASIS OF THE SCALP AND BODY IN PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,907,788

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018282098 ⤷  Start Trial
Australia 2021214399 ⤷  Start Trial
Brazil 112019025748 ⤷  Start Trial
Brazil 112022015104 ⤷  Start Trial
Canada 3006836 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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