United States Patent 5,336,691: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 5,336,691, titled "Composition comprising a tramadol material and acetaminophen and its use," is a significant patent in the pharmaceutical field. This patent, granted to the inventors, outlines a specific composition and its applications, which are crucial for understanding its scope, claims, and the broader patent landscape.
Background of the Patent
The patent, filed under the classification A61K31/00 and A61P25/04, pertains to medicinal preparations containing organic active ingredients, specifically centrally acting analgesics like opioids and other related compounds[1].
Composition and Active Ingredients
The patent describes a composition that includes tramadol material and acetaminophen (APAP). The tramadol material can be any one of the following:
- (1R, 2R or 1S, 2S)-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol (tramadol)
- Its N-oxide derivative ("tramadol N-oxide")
- Its O-desmethyl derivative ("O-desmethyl tramadol”)
- Individual stereoisomers, mixtures of stereoisomers, including racemates
- Pharmaceutically acceptable salts, such as the hydrochloride salt
- Solvates and polymorphs of the tramadol material[1].
Claims of the Patent
The claims of the patent are essential as they define the scope of the patent's protection. Here are some key aspects of the claims:
Main Claims
- The patent claims compositions comprising tramadol material and acetaminophen.
- It includes various forms of tramadol and its derivatives.
- The composition can be combined with other pharmaceutical actives for treating various ailments such as allergies, sleep disorders, cough, colds, and flu symptoms[1].
Specific Embodiments
- The claims specify the preparation methods of the composition, including the use of pharmaceutical carriers and conventional compounding techniques.
- It also mentions the possibility of adding other pharmaceuticals like muscle relaxants, suspected adjuvants, and xanthine derivatives to the formulation[1].
Patent Landscape
Prior Art and Novelty
To be patentable, an invention must be novel, non-obvious, and useful. The patent application process involves a thorough prior art search to ensure these criteria are met. For US5336691A, the inventors had to demonstrate that their composition was not previously disclosed or patented[2].
Related Patents and Publications
The patent landscape in the field of analgesics is dense, with numerous patents and publications related to tramadol and acetaminophen. The inventors would have needed to differentiate their composition from existing prior art, such as other tramadol formulations or combinations with different active ingredients[2].
Importance of Claim Scope
The scope of the claims in a patent application is critical. While broader claims offer broader protection, they are also more difficult to get granted and easier to invalidate. The claims in US5336691A must be anchored to the specific embodiments disclosed in the specification to avoid issues like the abstract idea exception or failure to meet the written description requirement[3].
Patent Filing and Prosecution
The patent was filed through the USPTO, which involves several steps including the submission of a specification, drawings if necessary, oath or declaration, application data sheet, and fees. The patent examiner reviews the application for compliance with legal requirements and conducts a prior art search. If the claimed invention is found to be patentable, a patent is granted; otherwise, the applicant receives an Office Action detailing the reasons for rejection[2].
Practical Applications and Benefits
The composition described in US5336691A is used for treating pain and other related conditions. The combination of tramadol and acetaminophen provides a synergistic effect, enhancing the analgesic efficacy while potentially reducing the side effects associated with higher doses of either drug alone.
Clinical Significance
This combination is particularly useful in managing moderate to severe pain, which is a common issue in clinical practice. The patent highlights the versatility of the composition, allowing it to be tailored for various patient needs by adding other pharmaceutical actives.
Legal Status and Expiration
The legal status of the patent indicates that it has ceased, meaning it is no longer in force. This could be due to various reasons such as expiration of the patent term, failure to pay maintenance fees, or other legal actions[1].
Impact on the Pharmaceutical Industry
The patent has contributed to the development of pain management therapies. Even though the patent itself has ceased, the knowledge and formulations described in it continue to influence the creation of new analgesic compositions.
Future Developments
The expiration of the patent allows other manufacturers to produce similar compositions, potentially leading to more affordable and accessible pain management options. However, new innovations in this field would still need to navigate the complex landscape of existing patents and prior art.
Key Takeaways
- Composition: The patent describes a composition of tramadol material and acetaminophen.
- Claims: The claims specify various forms of tramadol and its derivatives, along with the possibility of adding other pharmaceuticals.
- Patent Landscape: The patent had to differentiate itself from prior art and existing formulations.
- Practical Applications: The composition is used for treating pain and can be tailored for various patient needs.
- Legal Status: The patent has ceased, allowing for broader use of the described composition.
FAQs
Q: What are the main active ingredients in the composition described in US5336691A?
A: The main active ingredients are tramadol material and acetaminophen (APAP).
Q: Can the composition be combined with other pharmaceuticals?
A: Yes, the composition can be combined with other pharmaceutical actives such as muscle relaxants, suspected adjuvants, and xanthine derivatives.
Q: Why is the scope of the claims important in a patent application?
A: The scope of the claims defines the protection of the patent and must be balanced to avoid being too broad, which can lead to invalidation, or too narrow, which may not provide sufficient protection.
Q: What is the current legal status of US5336691A?
A: The patent has ceased, meaning it is no longer in force.
Q: How does the expiration of the patent impact the pharmaceutical industry?
A: The expiration allows other manufacturers to produce similar compositions, potentially making pain management options more affordable and accessible.
Sources
- US5336691A - Composition comprising a tramadol material and acetaminophen and its use - Google Patents
- Patents | The Maryland People's Law Library
- The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
