United States Patent 5,164,194: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,164,194, titled "Azelastine containing medicaments," is a significant patent in the pharmaceutical sector, particularly for the treatment of allergic and asthmatic conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent, issued to the assignee of the original applicant, pertains to the use of azelastine, a compound with anti-allergic and antihistamine properties. Azelastine is specifically used for the prophylactic treatment of asthma and other allergic diseases[4].
Scope of the Patent
The scope of a patent is defined by its claims, which outline the specific inventions or methods that are protected. For US Patent 5,164,194, the scope includes various formulations and methods of using azelastine.
Claim Structure
The patent claims are structured to cover different aspects of azelastine-containing medicaments. These include:
- Composition Claims: These claims cover the specific formulations of azelastine, including solutions, suspensions, and other forms of medicaments[4].
- Method Claims: These claims pertain to the methods of treating allergic diseases and asthma using azelastine[4].
Metrics for Measuring Patent Scope
Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Claims Analysis
Independent Claims
The independent claims in this patent are crucial as they define the broadest scope of the invention. For example, Claim 1 might describe a medicament comprising azelastine in a specific formulation, while subsequent claims might detail the methods of administration or the therapeutic effects[4].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific concentrations of azelastine, additional ingredients, or particular methods of preparation[4].
Patent Landscape
International Patent Family
The patent landscape for azelastine-containing medicaments extends beyond the U.S. patent. The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This helps in understanding the global protection and any variations in claims across different jurisdictions[1].
Prior Art and Citations
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is essential for understanding the prior art landscape and how the claims of US Patent 5,164,194 differentiate from existing inventions[1].
Competitors and Litigation
The patent has been involved in litigation, as seen in cases where the validity and infringement of the claims were challenged. For instance, the '194 Patent was subject to a dispute regarding its claims and their infringement by generic products[5].
Search and Examination Process
Preliminary Search
Conducting a preliminary patent search, as outlined by the USPTO, is crucial for understanding the existing patent landscape. Tools like the Patent Public Search and resources from international patent offices help in identifying prior art and similar inventions[1].
Examination Data
The Patent Examination Data System (PEDS) provides insights into the examination process of patent applications. For US Patent 5,164,194, analyzing the examination data can reveal how the claims were narrowed or broadened during the examination process, which is a common occurrence as shown in research on patent scope changes[1][3].
Impact on Innovation
Patent Quality and Scope
The debate over patent quality often revolves around the breadth and clarity of patent claims. Research indicates that narrower claims, such as those in US Patent 5,164,194, are associated with higher grant probabilities and shorter examination times, which can foster innovation by reducing licensing and litigation costs[3].
Market and Therapeutic Impact
Azelastine-containing medicaments have a significant impact on the treatment of allergic diseases and asthma. The patent's protection allows the innovator to recoup investment in research and development, thereby incentivizing further innovation in the pharmaceutical sector.
Key Takeaways
- Scope and Claims: The patent covers specific formulations and methods of using azelastine, with narrower claims associated with higher grant probabilities.
- Patent Landscape: The patent is part of a global family with related applications in various jurisdictions, and its validity and infringement have been subject to litigation.
- Search and Examination: Tools like the Patent Public Search and PEDS are essential for understanding the patent's examination history and prior art.
- Impact on Innovation: The patent's scope and claims structure contribute to the broader debate on patent quality and innovation incentives.
FAQs
What is the main subject of US Patent 5,164,194?
US Patent 5,164,194 pertains to azelastine-containing medicaments, specifically for the prophylactic treatment of asthma and other allergic diseases.
How can one search for similar patents?
One can use the Patent Public Search tool provided by the USPTO, along with resources from international patent offices like the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO)[1].
What metrics can be used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope. Narrower claims are often associated with higher grant probabilities and shorter examination times[3].
Is the patent still in force?
The patent has expired, as indicated by its legal status[4].
How does the patent impact innovation in the pharmaceutical sector?
The patent's protection allows the innovator to recoup investment in research and development, thereby incentivizing further innovation in the pharmaceutical sector.
Cited Sources:
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USPTO - PDF Document: https://www.uspto.gov/web/offices/com/sol/foia/comm/pte/5164194.pdf
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US5164194A: https://patents.google.com/patent/US5164194A/en
- Patent Docs - Meda v. Zydus: http://patentdocs.typepad.com/files/meda-v-zydus.pdf
