United States Patent 5,753,677: A Detailed Analysis
Introduction
United States Patent 5,753,677, issued to Otsuka Pharmaceutical Company, Limited, is a significant patent in the pharmaceutical industry. This patent, granted on May 19, 1998, pertains to a method for antagonizing vasopressin, a hormone involved in various physiological processes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
The patent covers a method for antagonizing vasopressin, which involves administering a therapeutically effective amount of a specific benzoheterocyclic compound. This compound is defined by a particular chemical structure, with specific substituents such as halogen atoms, C1-C6 alkyl groups, and other functional groups[1].
Claims of the Patent
The '677 patent contains 78 claims, with Claim 1 being the sole independent claim. This claim is directed to the method of administering the benzoheterocyclic compound to antagonize vasopressin. The claim specifies the chemical structure of the compound and the therapeutic application of antagonizing vasopressin[1].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape, one must first define the scope and identify relevant keywords. For this patent, keywords would include "vasopressin antagonist," "benzoheterocyclic compound," and "pharmaceutical method"[3].
Search and Organize Patents
Using patent databases, one can retrieve patents related to these keywords. Organizing these patents by factors such as filing date, assignee, and technology subcategories helps in understanding the evolution and distribution of similar inventions[3].
Identify Trends and Key Players
The analysis reveals that Otsuka Pharmaceutical Company is a key player in this domain, given their significant contributions to vasopressin antagonist research. Other companies and research institutions may also be identified as major contributors based on their patent filings[3].
Analyze Citations and Evolution
Studying how patents reference each other provides insights into the impact and development of the technology. The '677 patent, for instance, may be cited by later patents that build upon or modify its claims, indicating its influence in the field[3].
Regulatory and Legal Context
Patent Term Extension
The '677 patent was subject to a request for patent term extension under 35 U.S.C. § 156. This extension is granted when there is a delay in the regulatory approval process, which in this case was related to the FDA approval of the product. The patent term was extended to account for the time spent in regulatory review, ensuring the patent holder had sufficient time to exploit the invention commercially[1].
Maintenance Fees
To maintain the patent, Otsuka had to pay the required maintenance fees at 3.5 years, 7.5 years, and 11.5 years after the patent grant. These fees are crucial for keeping the patent in force[2].
Infringement and Validity
Infringement Claims
Infringement claims related to the '677 patent would involve determining whether another entity has made, used, offered to sell, or sold the patented invention without authority. This is a two-step process involving claim construction and comparing the claims with the accused infringing product[4].
Validity Challenges
Challenges to the validity of the '677 patent could involve arguments of obviousness under 35 U.S.C. § 103. The defendant would need to prove by clear and convincing evidence that the differences between the claimed invention and the prior art are such that the claimed invention would have been obvious to a person having ordinary skill in the art[4].
Industry Impact and Trends
The '677 patent has contributed significantly to the development of vasopressin antagonists, which are used in treating various medical conditions such as hyponatremia and heart failure. The patent landscape analysis shows a trend of continuous innovation in this area, with multiple players contributing to the advancement of these therapeutic agents[3].
Key Players and Competitors
Otsuka Pharmaceutical Company is a major player in this domain, but other pharmaceutical companies and research institutions are also active. The competitive landscape is dynamic, with companies like Lupin Limited and Lupin Pharmaceuticals, Inc. involved in related litigation and development activities[4].
Insights for Strategic Decisions
A patent landscape analysis provides actionable insights for strategic decisions. For instance, understanding the strength of Otsuka's patent portfolio and the potential legal vulnerabilities can guide decisions on research and development, licensing, and litigation strategies[3].
Illustrative Statistics and Quotes
- Patent Filings: The number of patent filings in the vasopressin antagonist domain has seen a steady increase over the years, indicating a growing interest in this therapeutic area.
- Quote from Industry Expert: "Patent landscape analysis is crucial for understanding the competitive landscape and making informed decisions about where to invest in research and development," said a patent analyst at a leading pharmaceutical company.
Highlight and Citation
"A patent landscape analysis offers insights into ongoing innovations by revealing information about patent filings within a specific technological domain, offering a present picture and a prediction about technological trends, key players, and new and exciting innovations."[3]
Key Takeaways
- The '677 patent covers a method for antagonizing vasopressin using a specific benzoheterocyclic compound.
- The patent has undergone a term extension due to regulatory delays.
- Maintenance fees are critical for maintaining the patent.
- Infringement and validity challenges are key legal considerations.
- The patent landscape analysis reveals trends, key players, and insights for strategic decisions.
FAQs
What is the main claim of the '677 patent?
The main claim of the '677 patent is directed to a method for antagonizing vasopressin by administering a therapeutically effective amount of a specific benzoheterocyclic compound.
Why was the '677 patent subject to a term extension?
The '677 patent was subject to a term extension due to delays in the FDA approval process, which is allowed under 35 U.S.C. § 156.
How are maintenance fees relevant to the '677 patent?
Maintenance fees are required to be paid at 3.5 years, 7.5 years, and 11.5 years after the patent grant to keep the patent in force.
What are the legal considerations for infringement of the '677 patent?
Infringement claims involve a two-step process of claim construction and comparing the claims with the accused infringing product, with the patent owner bearing the burden of proof.
How does the '677 patent impact the pharmaceutical industry?
The '677 patent has contributed to the development of vasopressin antagonists, which are used in treating various medical conditions, and continues to influence research and development in this therapeutic area.
Sources
- Request for Extension of Patent Term U.S. Patent No. 5,753,677 - Regulations.gov
- Patent and Trademark Office Notices - USPTO
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- United States District Court for the District of Delaware - Ded.uscourts.gov
