United States Patent 6,329,404: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,329,404, titled "Pharmaceutical composition," is a significant patent in the field of medical science, particularly in the treatment of diabetes. This patent, assigned to Takeda Pharmaceutical Company Limited, describes a pharmaceutical composition that enhances insulin sensitivity. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Priority Dates
The patent was published on December 11, 2001, with a priority date of May 14, 1999. This indicates that the invention was conceived and initially filed several years before its publication[4].
Inventors and Assignees
The patent is assigned to Takeda Pharmaceutical Company Limited, a well-known pharmaceutical company. The inventors are credited with developing a novel pharmaceutical composition that addresses insulin sensitivity.
Scope of the Patent
Technical Field
The patent falls under the category of medical or veterinary science, specifically within the realm of pharmaceutical preparations. It is classified under various International Patent Classification (IPC) categories, including A61K31/44, which pertains to non-condensed pyridines and their hydrogenated derivatives[4].
Pharmaceutical Composition
The patent describes a pharmaceutical composition that includes an insulin sensitivity enhancer in combination with one or more other antidiabetic agents. This composition is designed to improve insulin sensitivity, thereby aiding in the treatment of diabetes. The enhancer and antidiabetic agents work synergistically to enhance the body's response to insulin, making it a valuable treatment option for patients with diabetes[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. Independent claims outline the core elements of the pharmaceutical composition, while dependent claims provide additional details and variations.
- Independent Claim 1: This claim describes the pharmaceutical composition comprising an insulin sensitivity enhancer and at least one other antidiabetic agent.
- Dependent Claims: These claims specify various combinations of antidiabetic agents, dosages, and formulations that can be used in conjunction with the insulin sensitivity enhancer[4].
Claim Language and Scope
The claim language is crucial in defining the patent's scope. The use of specific terms like "insulin sensitivity enhancer" and "antidiabetic agents" helps to narrow down the scope and prevent overly broad interpretations. However, the clarity and breadth of these claims can be subject to scrutiny, as debates over patent quality often highlight issues with claim clarity and scope[3].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US 6,329,404 includes other patents and applications related to diabetes treatment and pharmaceutical compositions. For instance, the European Patent Office (EPO) and other international patent offices may have similar patents or applications that cover related inventions. The Global Dossier service provided by the USPTO allows users to view the patent family for this application, including related applications filed at participating IP Offices[1].
International Protection
The patent's protection extends beyond the United States. Takeda Pharmaceutical Company Limited would have filed corresponding patent applications in other countries to secure international protection. Databases such as the World Intellectual Property Organization's (WIPO) PATENTSCOPE and the European Patent Office's esp@cenet provide access to international patent applications and granted patents related to this invention[1].
Patent Term and Expiration
Patent Term Extension
The patent term for US 6,329,404 was subject to extension due to regulatory delays. The USPTO received a patent term restoration application for this patent, which is a common practice to compensate for time lost during the regulatory approval process[5].
Current Status
As of the current date, the patent has expired. The legal status listed indicates that the patent's lifetime has ended, and it is no longer enforceable[4].
Impact on Innovation
Debate on Patent Quality
The patent's scope and claims are part of a broader debate on patent quality. Critics argue that overly broad or unclear claims can impede innovation by increasing licensing and litigation costs. However, metrics such as independent claim length and count can help measure patent scope and clarity, providing a more objective assessment of patent quality[3].
Industry Impact
The pharmaceutical industry is highly competitive, and patents like US 6,329,404 play a crucial role in protecting innovations. The expiration of this patent opens up the market for generic versions of the pharmaceutical composition, which can increase competition and reduce costs for consumers.
Key Takeaways
- Pharmaceutical Composition: The patent describes a novel pharmaceutical composition that enhances insulin sensitivity.
- Claims and Scope: The patent includes specific claims that define the composition and its variations.
- International Protection: The invention is protected internationally through corresponding patent applications.
- Patent Term: The patent term was extended due to regulatory delays but has since expired.
- Impact on Innovation: The patent's scope and claims are part of ongoing debates on patent quality and their impact on innovation.
FAQs
What is the main invention described in US Patent 6,329,404?
The main invention is a pharmaceutical composition that includes an insulin sensitivity enhancer in combination with one or more other antidiabetic agents.
Who is the assignee of this patent?
The patent is assigned to Takeda Pharmaceutical Company Limited.
What is the current status of the patent?
The patent has expired.
How can one search for related patents internationally?
One can use databases such as WIPO's PATENTSCOPE and the European Patent Office's esp@cenet to search for related international patent applications and granted patents.
What are the implications of the patent's expiration?
The expiration of the patent allows for the development and marketing of generic versions of the pharmaceutical composition, increasing competition and potentially reducing costs for consumers.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Regulations.gov - Patent Term Extension Application for OSENI®: https://www.regulations.gov/docket/FDA-2014-E-0155
- Hoover Institution - Patent Claims and Patent Scope: https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- Google Patents - US6329404B1: https://patents.google.com/patent/US6329404B1/en
- Federal Register - Patent Term Restoration Application for OSENI: https://public-inspection.federalregister.gov/2015-11002.pdf?1430916380
