United States Patent 9,907,788: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,907,788, titled "Inhibition of Crystal Growth of Roflumilast," is a significant patent in the pharmaceutical industry, particularly in the context of roflumilast formulations. This patent, issued on March 6, 2018, is part of a broader portfolio of patents held by Arcutis Biotherapeutics, Inc.
Background of the Invention
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor used in the treatment of various conditions, including chronic obstructive pulmonary disease (COPD) and plaque psoriasis. However, one of the challenges associated with roflumilast is the tendency of its crystals to grow during storage, which can affect the stability and efficacy of the formulation[4][5].
Scope of the Patent
The patent 9,907,788 focuses on methods and compositions for inhibiting the crystal growth of roflumilast. The invention involves incorporating hexylene glycol into the roflumilast composition to prevent crystal growth. This approach ensures the stability of the formulation, maintaining its therapeutic efficacy over time.
Key Components
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Hexylene Glycol: The patent highlights the use of hexylene glycol as a critical component in inhibiting crystal growth. This solvent helps in maintaining the amorphous state of roflumilast, thereby preventing crystallization[4].
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Topical Formulations: The patent also covers topical formulations of roflumilast, which are designed for systemic or local treatment of various disorders. These formulations are particularly useful for conditions like plaque psoriasis, where topical application is preferred[1][5].
Claims of the Patent
The claims of the patent are detailed and specific, covering various aspects of the invention:
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Composition Claims: These claims describe the specific composition of roflumilast with hexylene glycol and other pharmaceutically acceptable carriers. The claims specify the proportions and methods of preparation to ensure the inhibition of crystal growth[4].
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Method Claims: These claims outline the methods of preparing the roflumilast formulations and the process of inhibiting crystal growth. The methods include steps for mixing the ingredients and ensuring the stability of the final product[4].
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Use Claims: The patent also includes claims related to the use of these formulations for treating various disorders, such as skin conditions and respiratory diseases. These claims emphasize the therapeutic applications of the stable roflumilast formulations[5].
Patent Landscape
The patent 9,907,788 is part of a larger patent landscape related to roflumilast formulations and PDE-4 inhibitors.
Related Patents
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U.S. Patent No. 9,884,050: This patent, also held by Arcutis, covers similar aspects of inhibiting crystal growth of roflumilast and is closely related to the '788 patent[5].
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U.S. Patent No. 10,940,142: This patent extends the scope to include improved delivery and plasma half-life of topical roflumilast formulations[5].
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U.S. Patent No. 11,129,818: This patent focuses on topical roflumilast formulations with improved delivery and plasma half-life, further expanding the therapeutic applications[5].
Patent Expiration Dates
The patent 9,907,788 is valid and enforceable until its expiration date. However, the exact expiration date is not specified in the provided sources, but it is likely to be around the mid-2030s, given the typical patent term of 20 years from the filing date[2].
Litigation and Enforcement
Arcutis Biotherapeutics, Inc. has been active in enforcing its patent rights. For instance, the company has filed a complaint against Padagis Israel Pharmaceuticals Ltd. and its affiliates for patent infringement related to the '050, '788, and other patents, including the one in question. This litigation underscores the importance of these patents in protecting Arcutis's intellectual property[5].
Impact on the Pharmaceutical Industry
The patent 9,907,788 has significant implications for the pharmaceutical industry:
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Stability and Efficacy: By preventing crystal growth, the patent ensures the stability and efficacy of roflumilast formulations, which is crucial for maintaining therapeutic effectiveness.
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Compliance and Regulation: The patent's inclusion in the FDA's Orange Book highlights its importance in regulatory compliance and the approval process for generic or biosimilar products[5].
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Innovation and Research: The patent encourages further innovation in the field of PDE-4 inhibitors and topical formulations, driving research and development in pharmaceuticals.
Conclusion
United States Patent 9,907,788 is a pivotal patent in the field of pharmaceuticals, particularly for roflumilast formulations. Its scope and claims provide a comprehensive framework for inhibiting crystal growth, ensuring the stability and efficacy of these formulations. The patent's position within the broader patent landscape and its enforcement underscore its significance in protecting intellectual property and driving innovation.
Key Takeaways
- The patent 9,907,788 focuses on inhibiting crystal growth of roflumilast using hexylene glycol.
- It covers composition, method, and use claims related to stable roflumilast formulations.
- The patent is part of a larger portfolio held by Arcutis Biotherapeutics, Inc.
- It has significant implications for the stability, efficacy, and regulatory compliance of roflumilast formulations.
- The patent is actively enforced through litigation to protect Arcutis's intellectual property.
Frequently Asked Questions (FAQs)
What is the main invention described in U.S. Patent 9,907,788?
The main invention is a method and composition for inhibiting the crystal growth of roflumilast using hexylene glycol.
Why is inhibiting crystal growth of roflumilast important?
Inhibiting crystal growth ensures the stability and efficacy of roflumilast formulations, which is crucial for maintaining therapeutic effectiveness.
Who is the assignee of U.S. Patent 9,907,788?
The assignee of U.S. Patent 9,907,788 is Arcutis Biotherapeutics, Inc.
What are the implications of this patent for the pharmaceutical industry?
The patent ensures the stability and efficacy of roflumilast formulations, impacts regulatory compliance, and drives innovation in the field of PDE-4 inhibitors.
Is U.S. Patent 9,907,788 currently in litigation?
Yes, Arcutis Biotherapeutics, Inc. has filed a complaint for patent infringement related to this and other patents.
Cited Sources:
- Justia Patents: Roflumilast formulations with an improved pharmacokinetic profile.
- Drugs.com: Generic Zoryve Availability.
- SLWIP: Patent Analytics.
- Google Patents: Inhibition of crystal growth of roflumilast.
- Insight.RPXCorp: United States District Court for the District of Delaware - Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharmaceuticals Ltd. et al.
