Understanding the Scope and Claims of United States Patent 8,691,871
Introduction
United States Patent 8,691,871, titled "Methods of treating mixed dyslipidemia," is a significant patent in the field of pharmaceuticals, particularly in the treatment of cardiovascular diseases. This patent, issued to treat mixed dyslipidemia, involves the use of ethyl eicosapentaenoate (EPA), a derivative of eicosapentaenoic acid. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background
Mixed dyslipidemia is a condition characterized by abnormal levels of various lipids in the blood, including high triglycerides, low HDL cholesterol, and elevated LDL cholesterol. It is a major risk factor for cardiovascular diseases, which are among the leading causes of death globally[4].
Patent Overview
Publication Number and Authority
The patent, US8691871B2, was granted by the United States Patent and Trademark Office (USPTO) and is part of the US patent system[4].
Prior Art and Related Patents
The patent builds upon prior art related to the use of EPA and other fatty acids in treating cardiovascular diseases. It distinguishes itself by specifying the use of ultra-pure EPA, which is defined as comprising at least 96% by weight EPA, and optionally including other cardiovascular agents[4].
Claims
The patent includes several claims that define the scope of the invention.
Independent Claims
- The patent claims methods of treating mixed dyslipidemia using pharmaceutical compositions containing EPA, specifically ethyl eicosapentaenoate.
- These compositions are characterized by the absence or minimal presence of docosahexaenoic acid (DHA) or its derivatives[4].
Dependent Claims
- The dependent claims further specify the formulation and administration of the EPA compositions.
- For example, the EPA can be co-formulated with other cardiovascular agents or administered separately but in a coordinated manner[4].
Scope of the Patent
Pharmaceutical Composition
The patent scope includes pharmaceutical compositions that contain ultra-pure EPA, defined as having at least 96% by weight EPA. This high purity is crucial as it ensures the efficacy and safety of the treatment[4].
Treatment Methods
The methods claimed involve administering these compositions to subjects in need, either as a single dosage unit or multiple units for combination or concomitant administration. The treatment aims to reduce the risk of cardiovascular-related diseases such as high blood pressure, coronary heart disease, and stroke[4].
Derivatives and Conjugates
The patent also covers derivatives of EPA, such as 2-substituted derivatives, which slow down the rate of oxidation without altering the biological action of EPA. Additionally, EPA-fatty acid conjugates are included, where EPA is conjugated to another molecule of EPA or another fatty acid[4].
Patent Landscape
Global Context
The USPTO's Global Dossier service can provide insights into the global patent family related to this invention. This service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices (the USPTO, the European Patent Office, the Japan Patent Office, the Korean Intellectual Property Office, and the State Intellectual Property Office of China)[1].
Competing Patents
Other patents in the field of cardiovascular disease treatment may overlap or complement this invention. For instance, patents related to other omega-3 fatty acids or different formulations for treating dyslipidemia could be relevant. A thorough search using the USPTO's Public Search Facility or online databases like Google Patents can help identify these competing patents[1][4].
Inventorship and Ownership
Determining Inventorship
The correct identification of inventors is crucial for the validity of a patent. According to US patent law, the true and only inventors must be listed on the patent application. This involves identifying those who conceived the idea or subject matter of the patent claims, which is a critical step in ensuring the patent's enforceability[5].
Implications of Incorrect Inventorship
Incorrect or deceptive identification of inventors can lead to the patent being declared invalid or unenforceable. Therefore, it is essential to ensure that all true inventors are properly identified and listed on the patent application[5].
Examination Process and Patent Quality
Metrics for Patent Scope
Research has shown that the scope of patent claims can be measured using metrics such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims, which are crucial for patent quality and the likelihood of grant[3].
Narrowing of Claims
During the examination process, patent claims often undergo revisions to narrow their scope. This process can affect the patent's validity and the duration of the examination. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Key Takeaways
- Ultra-Pure EPA: The patent emphasizes the use of ultra-pure EPA (at least 96% by weight) for treating mixed dyslipidemia.
- Pharmaceutical Compositions: The compositions can include EPA alone or in combination with other cardiovascular agents.
- Derivatives and Conjugates: The patent covers various derivatives and conjugates of EPA.
- Global Patent Landscape: The Global Dossier service can help track related applications globally.
- Inventorship: Correct identification of inventors is crucial for the patent's validity.
- Patent Quality: Metrics like independent claim length and count can measure patent scope and quality.
FAQs
Q: What is the main subject matter of United States Patent 8,691,871?
A: The main subject matter is methods of treating mixed dyslipidemia using pharmaceutical compositions containing ethyl eicosapentaenoate (EPA).
Q: What is ultra-pure EPA as defined in the patent?
A: Ultra-pure EPA is defined as a composition comprising at least 96% by weight EPA.
Q: Can the EPA be administered in combination with other agents?
A: Yes, the EPA can be co-formulated with other cardiovascular agents or administered separately but in a coordinated manner.
Q: Why is correct inventorship important for a patent?
A: Correct inventorship is crucial for the patent's validity and enforceability. Incorrect or deceptive identification can lead to the patent being declared invalid.
Q: How can the scope of patent claims be measured?
A: The scope of patent claims can be measured using metrics such as independent claim length and independent claim count.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims and Patent Scope - Search eLibrary :: SSRN. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- US8691871B2 - Methods of treating mixed dyslipidemia - Google Patents. Retrieved from https://patents.google.com/patent/US8691871B2/en
- Determining Inventorship for US Patent Applications. Retrieved from https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf
