United States Patent 8,633,162: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,633,162, titled "Methods of providing therapeutic effects using cyclosporin components," is a significant patent in the pharmaceutical industry, particularly in the treatment of ophthalmic conditions. This article will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent, assigned to Allergan, Inc., pertains to the use of cyclosporin-A and its derivatives for therapeutic effects, specifically in treating ophthalmic conditions such as dry eye syndrome. Cyclosporin-A is an immunosuppressive agent that has been adapted for topical use in ophthalmic formulations[1].
Scope of the Patent
Therapeutic Applications
The patent focuses on methods for providing therapeutic effects using cyclosporin components. It encompasses various formulations, including emulsions, that are designed to treat ophthalmic conditions. The therapeutic applications include reducing inflammation and improving tear production, which are critical for managing dry eye syndrome[1].
Formulations and Composition
The patent describes detailed compositions and formulations of cyclosporin-A and its derivatives. These include emulsions, mixtures, and other topical formulations that ensure the effective delivery of the active ingredient to the eye. The compositions often involve a combination of cyclosporin-A with other substances such as emulsifying agents, preservatives, and tonicity agents to enhance stability and efficacy[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover specific formulations, methods of preparation, and the therapeutic uses of cyclosporin-A in ophthalmic treatments. For example, Claim 1 might describe a method for treating dry eye syndrome using a cyclosporin-A emulsion, while subsequent claims might detail specific concentrations of cyclosporin-A and other components in the formulation[5].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and limitations. These claims might specify particular ratios of ingredients, methods of application, or specific patient populations that can benefit from the treatment. Dependent claims help to narrow the scope of the invention and provide a clearer definition of what is protected under the patent[1].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 8,633,162 includes several related patents that also pertain to the use of cyclosporin-A in ophthalmic treatments. For instance, patents such as U.S. Patents 8,629,111, 8,642,556, 8,648,048, and 8,685,930 are part of the same family and cover various aspects of cyclosporin-A formulations and their therapeutic applications[5].
Litigation and Challenges
The patent has been involved in several legal challenges, particularly in the context of generic drug manufacturers seeking to produce equivalent formulations. The case of Allergan, Inc. v. Actavis, Inc. is a notable example, where the court addressed issues related to patent infringement and the jurisdiction over generic manufacturers filing Abbreviated New Drug Applications (ANDAs)[5].
Tribal Immunity and Patent Challenges
In a unique twist, the Saint Regis Mohawk Tribe acquired the patents from Allergan and argued for tribal immunity in inter partes review (IPR) proceedings. However, the Patent Trial and Appeal Board (PTAB) denied the tribe's motion to terminate the IPR proceedings, citing that tribal immunity does not apply in such administrative proceedings[2].
Economic and Market Impact
Market Dominance
The patent has contributed significantly to Allergan's market dominance in the ophthalmic treatment sector, particularly with the product Restasis. Restasis, an ophthalmic emulsion containing cyclosporin-A, has been a leading treatment for dry eye syndrome, and the patent protection has allowed Allergan to maintain a strong market position[5].
Financial Implications
The financial implications of this patent are substantial. Allergan has generated significant revenue from Restasis, and the patent has also led to licensing agreements and royalty payments. For example, Allergan paid the Saint Regis Mohawk Tribe $13.75 million upfront and agreed to quarterly payments of $3.75 million in exchange for the tribe's agreement to defend the patents[2].
Technical and Scientific Aspects
Formulation Challenges
The development of cyclosporin-A formulations for ophthalmic use involves several technical challenges. The patent addresses these challenges by detailing specific emulsifying agents, preservatives, and other components that enhance the stability and bioavailability of cyclosporin-A in the eye[1].
Clinical Efficacy
Clinical trials and studies have demonstrated the efficacy of cyclosporin-A in treating dry eye syndrome. The patent's focus on specific formulations and methods ensures that the therapeutic effects are optimized, providing relief to patients suffering from this condition.
Global Patent System Integration
International Patent Filings
The patent is part of a global patent family, with filings in multiple jurisdictions. This integration is facilitated by services such as the Global Dossier, which allows users to access file histories of related applications from participating IP Offices[4].
Harmonization of Patent Scope
The USPTO's Patent Claims Research Dataset and other initiatives aim to harmonize patent scope measurements and provide detailed information on claims from U.S. patents. This helps in understanding the global patent landscape and the scope of protection for patents like U.S. Patent 8,633,162[3].
Key Takeaways
- Therapeutic Applications: The patent covers methods for treating ophthalmic conditions using cyclosporin-A and its derivatives.
- Formulations and Composition: Detailed compositions and formulations are described to ensure effective delivery of cyclosporin-A.
- Litigation and Challenges: The patent has been involved in several legal challenges, including those related to generic drug manufacturers and tribal immunity.
- Market Impact: The patent has contributed to Allergan's market dominance in ophthalmic treatments and generated significant revenue.
- Technical and Scientific Aspects: The patent addresses technical challenges in formulating cyclosporin-A for ophthalmic use and ensures clinical efficacy.
FAQs
Q: What is the primary therapeutic application of U.S. Patent 8,633,162?
A: The primary therapeutic application is the treatment of ophthalmic conditions, particularly dry eye syndrome, using cyclosporin-A and its derivatives.
Q: What are the key components of the formulations described in the patent?
A: The formulations include cyclosporin-A, emulsifying agents, preservatives, and tonicity agents to enhance stability and efficacy.
Q: How has the patent been involved in litigation?
A: The patent has been involved in litigation related to generic drug manufacturers filing ANDAs and in challenges related to tribal immunity in IPR proceedings.
Q: What is the financial impact of this patent on Allergan?
A: The patent has generated significant revenue for Allergan through the sale of Restasis and through licensing agreements and royalty payments.
Q: How does the patent integrate into the global patent system?
A: The patent is part of a global patent family, and services like the Global Dossier facilitate access to related applications from participating IP Offices.
Sources
- US8633162B2 - Methods of providing therapeutic effects using cyclosporin components - Google Patents
- Trials@uspto.gov Paper No. 130 - United States Patent and Trademark Office
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - United States Patent and Trademark Office
- Allergan, Inc. v. Actavis, Inc. - Robins Kaplan LLP Law Firm
