United States Patent 8,642,556: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,642,556, titled "Methods of providing therapeutic effects using cyclosporin components," is a significant patent in the field of ophthalmic treatments. This patent, owned by Allergan, Inc., pertains to the use of cyclosporin-A and its derivatives for treating ophthalmic conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent in question focuses on methods for providing therapeutic effects using cyclosporin components, specifically for treating ophthalmic conditions such as dry eyes. Cyclosporin-A, an immunosuppressive agent, is formulated into an ophthalmic emulsion, which is the active ingredient in Allergan's product Restasis®[2][5].
Scope of the Patent
The scope of the patent encompasses the use of cyclosporin-A and its derivatives in topical ophthalmic formulations. Here are some key aspects:
- Therapeutic Use: The patent covers the therapeutic application of cyclosporin components in treating ophthalmic conditions, particularly dry eye syndrome.
- Formulation: The invention includes the formulation of cyclosporin-A into an ophthalmic emulsion, which enhances its delivery and efficacy.
- Dosage and Administration: The patent specifies the methods of administering the cyclosporin components, including the concentration and frequency of application.
Claims of the Patent
The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the method of treating an ophthalmic condition using a cyclosporin-A ophthalmic emulsion.
- Dependent Claims: These claims narrow down the scope by adding specific details to the independent claims. For instance, a dependent claim might specify the concentration of cyclosporin-A in the emulsion or the frequency of application[5].
Patent Landscape
The patent landscape surrounding U.S. Patent 8,642,556 is complex and involves several key players and legal challenges.
Related Patents
The patent is part of a family of patents related to the use of cyclosporin-A in ophthalmic treatments. Other patents in this family include U.S. Patent Nos. 8,629,111, 8,633,162, 8,648,048, and 8,685,930. These patents collectively cover various aspects of the formulation, use, and administration of cyclosporin-A for ophthalmic conditions[2][4].
Legal Challenges
The patent has been involved in several legal disputes, particularly with generic manufacturers seeking to market similar products.
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Allergan, Inc. v. Actavis, Inc.: In this case, Actavis filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Restasis. Allergan filed a declaratory judgment action, arguing that Actavis could not trigger patent infringement under 35 U.S.C. § 271(e)(2) because the FDA had not received the ANDA due to deficiencies. The court ruled in favor of Allergan, determining that the FDA had not received the ANDA and thus the infringement trigger had not occurred[2].
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Inter Partes Review (IPR) Challenges: The patent has also faced IPR challenges from Mylan Pharmaceuticals, Teva Pharmaceuticals, and Akorn Inc. These challenges were filed with the Patent Trial and Appeal Board (PTAB) but raised issues of tribal sovereign immunity, which the PTAB lacks the authority to decide[4].
Search and Analysis Tools
To understand the broader patent landscape and conduct thorough searches related to this patent, several tools and resources are available:
- Patent Public Search: This tool, provided by the USPTO, allows for advanced searches of prior art and related patents. It replaces legacy search tools like PubEast and PubWest[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping to identify patent families and related citations[1].
- Common Citation Document (CCD): This application consolidates citation data from multiple IP Offices, enabling a comprehensive view of prior art cited by different offices[1].
Economic and Statistical Insights
The USPTO's Patent Claims Research Dataset provides valuable insights into patent scope and claims. This dataset, which includes data from 1976 to 2014, can help analyze trends and measurements of patent scope, including those related to ophthalmic treatments[3].
Key Takeaways
- Therapeutic Use: The patent covers the use of cyclosporin-A and its derivatives for treating ophthalmic conditions.
- Formulation and Administration: The invention includes specific formulations and methods of administration.
- Legal Challenges: The patent has faced significant legal challenges, including ANDA filings and IPR challenges.
- Patent Landscape: The patent is part of a larger family of related patents and involves complex legal and regulatory issues.
FAQs
What is the main subject of U.S. Patent 8,642,556?
The main subject of U.S. Patent 8,642,556 is the use of cyclosporin-A and its derivatives in topical ophthalmic formulations for treating ophthalmic conditions.
What product is associated with this patent?
The product associated with this patent is Restasis®, an ophthalmic emulsion used to treat dry eyes.
What were the key issues in the Allergan, Inc. v. Actavis, Inc. case?
The key issues were whether the court could exercise jurisdiction over Actavis and whether a patent infringement suit could be initiated when the FDA had not received the ANDA application.
Why did the PTAB lack authority to decide on tribal sovereign immunity?
The PTAB lacks the authority to decide on tribal sovereign immunity because such determinations require intensive factual discovery and analysis, which are beyond the scope of PTAB proceedings.
What tools can be used to conduct a thorough search of related patents?
Tools such as Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to conduct thorough searches of related patents.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Robins Kaplan LLP - Allergan, Inc. v. Actavis, Inc.: https://www.robinskaplan.com/newsroom/insights/allergan-v-actavis
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- IPWatchdog - The PTAB lacks authority to decide the applicability of tribal sovereign immunity: https://ipwatchdog.com/2017/12/10/ptab-lacks-authority-decide-tribal-sovereign-immunity/id=90860/
- Google Patents - US8642556B2: https://patents.google.com/patent/US8642556B2/en
