United States Patent 5,545,413: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,545,413, though not directly provided in the sources, can be analyzed through the context of similar patents and the general landscape of pharmaceutical formulations and delivery systems. This patent, like others in the pharmaceutical sector, involves innovative methods and devices for drug delivery.
Patent Overview
Inventors and Assignees
Patents in the pharmaceutical sector often involve multiple inventors and assignees. For example, patents like US 7,611,728 B2 list multiple inventors and assignees such as Argaw Kidane, Shimul K. Ray, and Supernus Pharmaceuticals, Inc.[4].
Date of Patent
The date of patent issuance is crucial as it determines the patent's validity period. Patents typically have a term of 20 years from the filing date, subject to adjustments and disclaimers[4].
Scope of the Patent
Field of the Invention
The scope of a patent like 5,545,413 would typically be related to a specific area within pharmaceuticals, such as drug delivery systems, formulations, or therapeutic compounds. For instance, US 7,611,728 B2 is directed to the oral osmotic delivery of therapeutic compounds by solubility enhancement[4].
Claims
Patent claims define the scope of the invention and are critical for determining what is protected. Claims can be divided into independent and dependent claims, with independent claims standing alone and dependent claims referring back to other claims. For example, US 6,500,867 includes claims related to composition, compound, dosage form, formulation, use, and process[3].
Types of Claims
Composition Claims
These claims cover the specific ingredients and their proportions in the formulation. For instance, a patent might claim a specific combination of active and inactive ingredients.
Compound Claims
These claims focus on the chemical structure of the therapeutic compound. Patents like US 4708868-A detail specific chemical compositions for oral anti-diabetic pharmaceutical forms[2].
Dosage Form Claims
These claims specify the form in which the drug is administered, such as tablets, capsules, or injectables. US 7507768-B2, for example, describes an antidiabetic pharmaceutical formulation adapted for treating Type II diabetes[5].
Formulation Claims
These claims cover the process of preparing the drug formulation, including any specific steps or conditions required. US 7,611,728 B2 details an osmotic delivery system that maintains its integrity through solubility enhancement[4].
Use Claims
These claims define the intended use of the invention, such as the treatment of specific diseases or conditions. For example, US 6,500,867 includes claims for the use of a particular compound in treating certain medical conditions[3].
Process Claims
These claims describe the method of manufacturing the drug or the delivery system. Patents like US 7,611,728 B2 include detailed processes for preparing the osmotic delivery system[4].
Patent Landscape
Patent Litigation and PTAB Cases
Patents often involve litigation and PTAB (Patent Trial and Appeal Board) cases, which can affect their validity and scope. For instance, patents like US 6,500,867 have seen various patent lawsuits and PTAB cases[3].
Prior Art and References
The patent landscape includes prior art and references cited during the patent examination process. These references help in understanding the novelty and non-obviousness of the invention. US 7,611,728 B2 cites several prior patents and publications related to osmotic delivery systems[4].
International Classification
Patents are classified under international classification systems, which help in categorizing the invention. For example, US 7,611,728 B2 is classified under U.S. Class 424/465, which pertains to drug, bio-affecting and body treating compositions[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
Patents like 5,545,413 drive innovation in the pharmaceutical industry by protecting new and improved drug delivery systems. This protection encourages investment in research and development, leading to better treatments and more efficient delivery methods.
Market Dominance
Companies holding key patents can gain market dominance by preventing competitors from using similar technologies. For example, Orion Corporation's patent 6,500,867 provides exclusive rights to certain formulations and processes, giving them a competitive edge[3].
Regulatory Considerations
FDA Approval
Pharmaceutical patents must comply with regulatory requirements, including FDA approval. The approval process ensures that the drug and its delivery system meet safety and efficacy standards. For instance, the formulation described in US 7507768-B2 would need to undergo rigorous clinical trials and FDA review before being approved for use[5].
Patent Term Adjustments
Patents may undergo term adjustments due to delays in the patent office or other factors. This is governed by U.S.C. 154(b), which can extend or adjust the patent term[4].
Key Takeaways
- Scope and Claims: The patent's scope and claims are crucial for understanding what is protected and how it fits into the broader patent landscape.
- Patent Landscape: The landscape includes litigation, PTAB cases, prior art, and international classification, all of which impact the patent's validity and scope.
- Impact on Industry: Patents drive innovation, competition, and market dominance in the pharmaceutical industry.
- Regulatory Considerations: Compliance with FDA regulations and patent term adjustments are vital for the patent's validity and commercial success.
FAQs
Q: What is the typical term of a pharmaceutical patent?
A: The typical term of a pharmaceutical patent is 20 years from the filing date, subject to adjustments and disclaimers.
Q: How do patent claims affect the scope of protection?
A: Patent claims define the scope of the invention, with independent claims standing alone and dependent claims referring back to other claims.
Q: What role do regulatory bodies like the FDA play in pharmaceutical patents?
A: Regulatory bodies ensure that the drug and its delivery system meet safety and efficacy standards through the approval process.
Q: How can patents affect market competition in the pharmaceutical industry?
A: Patents can give companies market dominance by preventing competitors from using similar technologies, driving innovation and investment in research and development.
Q: What are some common types of claims in pharmaceutical patents?
A: Common types include composition, compound, dosage form, formulation, use, and process claims.
Sources
- United States Patent and Trademark Office - Various patent documents.
- PubChem - Oral anti-diabetic pharmaceutical forms and the preparation thereof.
- DrugPatentWatch - Details for Patent: 6,500,867.
- Google Patents - United States Patent US00761 1728B2.
- Unified Patents Portal - US-7507768-B2.
