United States Patent 10,940,142: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,940,142, titled "Inhibition of Crystal Growth of Roflumilast," is a significant patent in the pharmaceutical industry, particularly for the drug roflumilast. This patent, issued on March 9, 2021, is held by Arcutis Biotherapeutics, Inc. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Roflumilast
Roflumilast is a drug used primarily to reduce the risk of COPD (Chronic Obstructive Pulmonary Disease) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations[1]. However, its application has expanded, and it is now also used in topical formulations for the treatment of plaque psoriasis.
Scope of the Patent
The patent 10,940,142 focuses on the inhibition of crystal growth of roflumilast, which is crucial for maintaining the bioavailability and efficacy of the drug. Roflumilast crystals can increase in size during storage, affecting the drug's performance. This patent describes methods and compositions to prevent or reduce this crystal growth, ensuring the drug remains effective over time[4].
Key Aspects of the Scope
- Pharmaceutical Compositions: The patent details specific pharmaceutical compositions that inhibit the growth of roflumilast crystals. These compositions often include ingredients like hexylene glycol and water, which play a role in stabilizing the drug[4].
- Storage Conditions: The patent also addresses the storage conditions that can affect the crystal growth of roflumilast, providing guidelines to maintain the drug's stability.
- Bioavailability and Efficacy: By inhibiting crystal growth, the patent ensures that the bioavailability and efficacy of roflumilast are maintained, which is critical for its therapeutic use.
Claims of the Patent
The claims of the patent are specific and detailed, outlining what is protected under the patent.
Independent Claims
- The patent includes independent claims that describe the pharmaceutical compositions and methods for inhibiting crystal growth. For example, Claim 1 might describe a pharmaceutical composition comprising roflumilast and a stabilizing agent to prevent crystal growth[4].
Dependent Claims
- Dependent claims further specify the conditions, ingredients, and methods covered by the independent claims. These could include specific concentrations of ingredients, storage conditions, and manufacturing processes.
Patent Landscape
The patent landscape surrounding 10,940,142 is complex and involves multiple related patents.
Related Patents
- U.S. Patent No. 9,884,050: Also titled "Inhibition of Crystal Growth of Roflumilast," this patent was issued on February 6, 2018, and covers similar aspects of stabilizing roflumilast[5].
- U.S. Patent No. 9,907,788: Issued on March 6, 2018, this patent also deals with the inhibition of crystal growth of roflumilast, highlighting the ongoing research and development in this area[5].
- U.S. Patent No. 11,129,818: Titled "Topical Roflumilast Formulation Having Improved Delivery and Plasma Half Life," this patent, issued on September 28, 2021, expands the application of roflumilast to topical formulations[5].
Patent Expiration Dates
The patents related to roflumilast have various expiration dates, which are crucial for understanding the market and competition landscape.
- Patent 10,940,142: This patent is set to expire on June 7, 2037[2].
- Other Related Patents: Patents like U.S. Patent No. 11,129,818 and others also have expiration dates ranging from June 7, 2037, to December 3, 2041[2].
Litigation and Enforcement
The patents, including 10,940,142, are actively enforced by Arcutis Biotherapeutics, Inc. against potential infringers.
Recent Litigation
- Arcutis has filed a complaint against Padagis Israel Pharmaceuticals Ltd. and its affiliates for patent infringement related to the ANDA (Abbreviated New Drug Application) submitted by Padagis for a generic version of ZORYVE® (roflumilast cream)[5].
Impact on the Pharmaceutical Industry
The patent 10,940,142 and its related patents have significant implications for the pharmaceutical industry.
Innovation and Competition
- These patents protect innovative methods and compositions, encouraging further research and development in stabilizing pharmaceuticals.
- They also create a competitive landscape where generic manufacturers must navigate patent protections to enter the market.
Market Domination
- By holding these patents, Arcutis maintains a strong market position for ZORYVE® and other roflumilast-based products, ensuring their exclusivity until the patents expire.
Conclusion
United States Patent 10,940,142 is a critical component of the intellectual property portfolio related to roflumilast. It ensures the stability and efficacy of the drug, which is vital for its therapeutic applications. The patent landscape is complex, with multiple related patents and ongoing litigation to protect these intellectual property rights.
Key Takeaways
- Patent Scope: The patent focuses on inhibiting crystal growth of roflumilast to maintain its bioavailability and efficacy.
- Claims: The patent includes specific claims regarding pharmaceutical compositions and methods.
- Related Patents: There are several related patents covering similar aspects of roflumilast stabilization and application.
- Patent Expiration Dates: The patents expire between 2037 and 2041.
- Litigation: Arcutis actively enforces these patents against potential infringers.
- Industry Impact: The patents influence innovation, competition, and market dynamics in the pharmaceutical industry.
FAQs
What is the primary focus of United States Patent 10,940,142?
The primary focus of this patent is the inhibition of crystal growth of roflumilast to maintain its bioavailability and efficacy.
Who holds the patent 10,940,142?
Arcutis Biotherapeutics, Inc. holds this patent.
What are the implications of this patent for generic manufacturers?
Generic manufacturers must navigate the patent protections held by Arcutis to avoid infringement, which can delay their entry into the market.
When does the patent 10,940,142 expire?
The patent 10,940,142 is set to expire on June 7, 2037.
How does this patent impact the pharmaceutical industry?
It encourages innovation, affects competition by protecting exclusive rights, and influences market dynamics by maintaining Arcutis's market position for roflumilast-based products.
Are there any ongoing litigations related to this patent?
Yes, Arcutis has filed a complaint against Padagis for patent infringement related to their ANDA submission for a generic version of ZORYVE®.
Sources
- DrugBank: Roflumilast: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Zoryve Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Inhibition of Crystal Growth of Roflumilast.
- United States District Court: Complaint for Patent Infringement.
