United States Patent 9,555,048: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,555,048, titled "Corticosteroids for the treatment of joint pain," is a significant patent in the pharmaceutical industry, particularly in the treatment of inflammatory diseases such as osteoarthritis. This patent, assigned to Pacira Pharmaceuticals Inc., is crucial for understanding the current landscape of corticosteroid treatments and the intellectual property protections surrounding them.
Patent Overview
Publication and Status
The patent was issued on January 31, 2017, and is currently active, with an expected expiration date in August 2031[2].
Inventors and Assignees
The patent was invented by a team including Neil Bodick, Robert C. Blanks, Anjali Kumar, Michael D. Clayman, and Mark Moran, and is assigned to Pacira Pharmaceuticals Inc.[2].
Scope of the Patent
General Description
The patent describes formulations of corticosteroids, specifically microparticle formulations, designed for the treatment of pain caused by inflammatory diseases. These formulations are engineered to provide controlled release of the corticosteroid, which can be administered via injection[1].
Specific Claims
The patent includes several key claims that define its scope:
- Microparticle Formulations: The patent claims involve the use of microparticles made from biodegradable polymers such as poly(lactic acid-co-glycolic acid) (PLGA). These microparticles encapsulate corticosteroids, allowing for a sustained release of the drug over time[1].
- Controlled Release: The formulations are designed to release the corticosteroid in a controlled manner, reducing the need for frequent injections and minimizing adverse effects[1].
- Inflammatory Diseases: The patent covers the treatment of various inflammatory diseases, including osteoarthritis, bursitis, tenosynovitis, and other conditions involving joint pain[1].
Key Components and Methods
Biodegradable Polymers
The use of PLGA and other biodegradable polymers is central to the patent. These polymers degrade over time, releasing the encapsulated corticosteroid in a sustained manner[1].
Injection Methods
The patent describes methods for injecting these microparticle formulations directly into the affected joint, providing localized treatment and reducing systemic side effects[1].
Dosage Forms
The patent covers various dosage forms, including injectable compositions, which are designed to be administered in a clinical setting[1].
Patent Claims and Their Implications
Claim Structure
The patent claims are structured to capture a broad range of formulations and methods while ensuring that the claims are commensurate with the disclosure provided in the patent application. This balance is crucial to avoid invalidation under Section 112(a) of the U.S. patent laws, which requires that the claims be supported by a written description that enables any person skilled in the art to make and use the invention[3].
Enablement and Written Description
The patent must satisfy the enablement and written description requirements, meaning that the specification must provide enough detail to enable a person skilled in the art to make and use the claimed invention. This includes describing the specific materials, methods, and results in sufficient detail[3].
Patent Landscape and Exclusivity
Current Status and Expiration
As of the current date, the patent remains active and is set to expire in August 2031. This period of exclusivity is critical for Pacira Pharmaceuticals Inc. to recoup their investment in developing and commercializing the drug[2].
Generic Availability
There is currently no therapeutically equivalent generic version of the drug covered by this patent available in the United States. This exclusivity period allows the patent holder to maintain a monopoly on the market for this specific formulation and method of treatment[5].
Legal Activities and Patent Maintenance
Recent Activities
The patent has undergone several recent legal activities, including changes in power of attorney, correspondence address changes, and the payment of maintenance fees. These activities are essential for maintaining the patent's validity and ensuring that it remains in force until its expiration date[2].
Impact on the Pharmaceutical Industry
Innovation and Investment
The patent landscape for pharmaceuticals, particularly for corticosteroids, is highly competitive and requires significant investment. Patents like US 9,555,048 are crucial for innovators to protect their intellectual property and recoup their investments in research and development[3].
Market Implications
The market for therapeutic corticosteroids is substantial, and patents like this one play a critical role in shaping the competitive landscape. The exclusivity provided by this patent allows Pacira Pharmaceuticals Inc. to dominate the market for this specific treatment, influencing pricing and availability[3].
Challenges and Considerations
Genus Claims and Patent Scope
The Federal Circuit's rigid position on genus claims can make it challenging to obtain and maintain broad patent protection in the pharmaceutical industry. This patent must navigate these challenges to ensure that its claims are valid and enforceable[3].
Designing Around Patents
Competitors may attempt to design around the claims of this patent by making minor modifications to the formulation or method of administration. The patent's scope and the specificity of its claims are critical in preventing such circumvention[3].
Key Takeaways
- Patent Scope: The patent covers microparticle formulations of corticosteroids for treating joint pain, with a focus on controlled release and localized administration.
- Exclusivity: The patent remains active until August 2031, with no generic equivalent currently available.
- Legal Activities: Recent legal activities include maintenance fee payments and changes in power of attorney.
- Industry Impact: The patent is crucial for protecting intellectual property and influencing the market for therapeutic corticosteroids.
- Challenges: The patent must comply with strict genus claim requirements and prevent competitors from designing around its claims.
FAQs
What is the main focus of United States Patent 9,555,048?
The main focus of this patent is on microparticle formulations of corticosteroids for the treatment of joint pain caused by inflammatory diseases.
Who is the assignee of this patent?
The patent is assigned to Pacira Pharmaceuticals Inc.
When is the patent set to expire?
The patent is set to expire in August 2031.
Is there a generic version of the drug covered by this patent available?
No, there is currently no therapeutically equivalent generic version of the drug available in the United States.
What are the key components of the microparticle formulations described in the patent?
The key components include biodegradable polymers such as PLGA and the encapsulated corticosteroid, designed for controlled release.
Sources
- US9555048B2 - Corticosteroids for the treatment of joint pain - Google Patents
- Zilretta patent expiration - Pharsight
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Method and Compounds for Treating Peripheral Neuropathy - Google Patents
- Generic Zilretta Availability - Drugs.com
