United States Patent 4,797,405: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,797,405, titled "Stabilized Pergolide Compositions," was granted to Eli Lilly and Company, a corporation based in the State of Indiana. This patent is significant in the pharmaceutical industry, particularly in the development of ergoline derivatives. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Pergolide, an ergoline derivative, is known for its therapeutic properties, particularly in treating conditions such as Parkinson's disease and hyperprolactinemia. The patent addresses the stabilization of pergolide compositions, which is crucial for maintaining the efficacy and shelf life of the drug[2].
Claims of the Patent
The patent includes 10 claims that define the scope of the invention. Here are some key aspects of these claims:
- Claim 1: This claim describes a stabilized pergolide composition that includes pergolide and a stabilizing agent, such as an antioxidant or a chelating agent.
- Subsequent Claims: These claims specify various formulations, including tablets, capsules, and injectable solutions, and the methods for preparing these compositions.
- Specific Ingredients: The claims also detail the specific ingredients and their proportions that are necessary for stabilizing pergolide[2].
Scope of the Patent
The scope of the patent is defined by the claims and the description provided in the patent document. Here are some key points:
- Stabilization: The primary focus is on the stabilization of pergolide to prevent degradation, which is essential for maintaining the drug's potency.
- Formulations: The patent covers various formulations, indicating a broad application in different therapeutic settings.
- Method of Preparation: The method of preparing these stabilized compositions is also within the scope, ensuring that the invention is not limited to just the final product but also the process of making it[2].
Patent Landscape: Ergoline Derivatives
The patent landscape for ergoline derivatives is complex and involves numerous patents and applications. Here are some key points:
- Competitors: Other pharmaceutical companies have also developed ergoline derivatives, leading to a competitive landscape in terms of patent filings and approvals.
- Prior Art: The patent search would involve looking at prior art related to ergoline derivatives, stabilization methods, and pharmaceutical formulations to ensure novelty and non-obviousness[4].
Global Patent Search
To understand the global patent landscape, one would need to search databases from various international intellectual property offices. Here are some resources:
- European Patent Office (EPO): Using databases like esp@cenet to search European patents.
- Japan Patent Office (JPO): Searching Japanese patents and utilizing machine translations.
- World Intellectual Property Organization (WIPO): Using PATENTSCOPE to search international patent applications[4].
Patent Scope Metrics
When evaluating the scope of a patent like 4,797,405, metrics such as independent claim length and independent claim count can be useful. Research has shown that these metrics can predict the breadth of the patent and its likelihood of being granted[3].
Examination Process
The examination process for patents tends to narrow the scope of claims. For 4,797,405, the claims were likely scrutinized to ensure they were specific, clear, and not overly broad. The examination process would have involved checking for prior art, novelty, and non-obviousness[3].
Obviousness-Type Double Patenting (ODP)
In the context of patent law, ODP is a critical issue. Patents like 4,797,405 must be analyzed to ensure they do not claim the same invention as another patent with a different patent term, especially if there are terminal disclaimers involved. This ensures that the patent system does not allow for the extension of patent terms unfairly[1].
Patent Maintenance and Licensing
The maintenance of a patent involves periodic payments to keep the patent in force. Broader patents with clearer claims tend to have higher maintenance costs but also greater licensing potential. For 4,797,405, the licensing agreements would be crucial for its commercial success[3].
Forward Citations and Patent Impact
Forward citations, which are citations to the patent by later patents, can indicate the impact and influence of the patent. A high number of forward citations suggests that the patent has contributed significantly to the field and is likely to be of high quality[3].
Equitable Concerns and Litigation
Patents can be subject to litigation, especially if there are disputes over obviousness, novelty, or infringement. The equitable concerns underlying patent law aim to prevent harassment by multiple assignees and ensure that the patent system promotes innovation rather than stifling it[1].
Key Takeaways
- Stabilization of Pergolide: The patent focuses on stabilizing pergolide compositions, which is crucial for maintaining the drug's efficacy.
- Broad Formulations: The patent covers various formulations, including tablets, capsules, and injectable solutions.
- Global Search: Understanding the global patent landscape involves searching international databases.
- Patent Scope Metrics: Metrics like independent claim length and count can predict the breadth and grant likelihood of a patent.
- ODP Analysis: Ensuring that the patent does not fall under ODP is essential to prevent unfair extension of patent terms.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 4,797,405?
A: The primary focus is on the stabilization of pergolide compositions to prevent degradation and maintain the drug's potency.
Q: How many claims are included in the patent?
A: The patent includes 10 claims that define the scope of the invention.
Q: What resources can be used to search for prior art related to ergoline derivatives?
A: Resources include the USPTO's Patent Public Search, European Patent Office's esp@cenet, Japan Patent Office's database, and WIPO's PATENTSCOPE.
Q: What metrics can be used to evaluate the scope of a patent?
A: Metrics such as independent claim length and independent claim count can be used to evaluate the scope and predict the grant likelihood of a patent.
Q: Why is ODP analysis important in patent law?
A: ODP analysis is important to prevent an inventor from securing a second, later-expiring patent for the same invention, ensuring fairness in the patent system.
Cited Sources:
- In re Cellect - United States Court of Appeals for the Federal Circuit.
- United States Patent 4,797,405 - Stabilized Pergolide Compositions.
- Patent Claims and Patent Scope - SSRN.
- USPTO Patent Search - United States Patent and Trademark Office.
