United States Patent 4,746,680: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,746,680, titled "Pharmaceutical Compositions Containing Sibutramine and Its Hydrochloride Monohydrate," is a significant patent in the pharmaceutical industry, particularly in the context of weight management drugs. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
- Patent Number: 4,746,680
- Title: Pharmaceutical Compositions Containing Sibutramine and Its Hydrochloride Monohydrate
Issuance and Expiration
- Issuance Date: The patent was issued on May 24, 1988.
- Expiration Date: The patent has expired, as it was granted for a term of 17 years from the date of issuance, which was the standard term at the time.
Inventors and Assignees
- Inventors: The inventors of the patent are not specified in the provided sources, but typically, such information can be found in the patent document itself.
- Assignees: The patent was assigned to a pharmaceutical company, which in this case is likely to be the original developer of sibutramine, such as Knoll Pharmaceuticals or its successors.
Scope of the Patent
Claims
The patent claims cover specific pharmaceutical compositions containing sibutramine and its hydrochloride monohydrate. Here are some key aspects of the claims:
- Active Ingredient: Sibutramine, a centrally acting stimulant chemically related to amphetamines, was the primary active ingredient.
- Pharmaceutical Compositions: The patent includes claims for various formulations such as tablets, capsules, and other dosage forms that contain sibutramine or its hydrochloride monohydrate.
- Therapeutic Use: The primary therapeutic use was for weight management, specifically as an appetite suppressant.
Description
The patent describes the synthesis, formulation, and therapeutic applications of sibutramine. It outlines the chemical structure of sibutramine and its hydrochloride monohydrate, as well as methods for preparing these compounds and incorporating them into pharmaceutical compositions.
Claims Analysis
Independent Claims
- Independent claims typically define the broadest scope of the invention. For this patent, these claims would cover the basic composition of sibutramine and its hydrochloride monohydrate in pharmaceutical formulations.
- Example Claim: "A pharmaceutical composition comprising sibutramine or its hydrochloride monohydrate and a pharmaceutically acceptable carrier."
Dependent Claims
- Dependent claims narrow down the scope of the independent claims by adding additional limitations. These might include specific dosage forms, concentrations of the active ingredient, or particular methods of administration.
- Example Dependent Claim: "The pharmaceutical composition of claim 1, wherein the sibutramine or its hydrochloride monohydrate is present in a tablet form."
Patent Landscape
Related Patents
The patent landscape around U.S. Patent 4,746,680 includes other patents related to sibutramine and its use in weight management. These might include:
- Process Patents: Patents covering the synthesis and manufacturing processes of sibutramine.
- Formulation Patents: Patents covering different formulations or dosage forms of sibutramine.
- Use Patents: Patents covering specific therapeutic uses or combinations of sibutramine with other drugs.
Market Impact
Sibutramine, marketed under the brand name Meridia, was a significant player in the weight management market until its withdrawal from the market in 2010 due to safety concerns related to cardiovascular risks[5].
Regulatory Environment
The regulatory environment played a crucial role in the lifecycle of this patent. The FDA approved sibutramine in 1997, but later required additional safety studies and eventually led to its market withdrawal.
Legal and Policy Considerations
Patent Litigation
Patent litigation around sibutramine and its formulations would have been a significant aspect of the patent landscape. Companies involved in the development and marketing of sibutramine would have had to navigate patent infringement lawsuits and defend their intellectual property rights.
Public Health Impact
The public health impact of this patent was substantial, given the widespread use of sibutramine for weight management. However, the eventual withdrawal of the drug highlights the importance of ongoing safety monitoring and regulatory oversight.
Conclusion
U.S. Patent 4,746,680 was a pivotal patent in the development and commercialization of sibutramine, a drug used for weight management. The patent's claims covered specific pharmaceutical compositions and formulations, and its impact was felt across the pharmaceutical industry. However, the drug's eventual withdrawal due to safety concerns underscores the dynamic nature of the patent landscape and the importance of continuous regulatory scrutiny.
Key Takeaways
- Patent Scope: The patent covered pharmaceutical compositions containing sibutramine and its hydrochloride monohydrate.
- Claims Analysis: Independent and dependent claims defined the scope of the invention, including specific formulations and dosage forms.
- Patent Landscape: The patent was part of a broader landscape including related patents on synthesis, formulations, and therapeutic uses.
- Market Impact: Sibutramine was a significant player in the weight management market until its withdrawal.
- Regulatory Environment: FDA approval and subsequent safety concerns led to the drug's market withdrawal.
FAQs
What was the primary use of the drug covered by U.S. Patent 4,746,680?
The primary use of the drug covered by U.S. Patent 4,746,680 was for weight management as an appetite suppressant.
Why was sibutramine withdrawn from the market?
Sibutramine was withdrawn from the market due to safety concerns related to cardiovascular risks.
What is the current status of U.S. Patent 4,746,680?
The patent has expired, as it was granted for a term of 17 years from the date of issuance.
How did the regulatory environment impact this patent?
The FDA's approval and subsequent safety monitoring led to the eventual withdrawal of the drug from the market, highlighting the critical role of regulatory oversight.
Are there any related patents to U.S. Patent 4,746,680?
Yes, there are related patents covering the synthesis, formulations, and specific therapeutic uses of sibutramine.
Sources
- USPTO Notice of Final Determination - U.S. Patent No. 4,746,680[5].
- USPTO Patent Search - General information on patent searching and resources[4].
- Patent Claims Research Dataset - Information on patent claims and scope measurements[3].
