United States Patent 6,610,327: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 6,610,327, titled "Pharmaceutical moxifloxacin preparation," is a patent that outlines a specific formulation and preparation method for the antibiotic moxifloxacin. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Moxifloxacin
Moxifloxacin is a broad-spectrum antibiotic used to treat various bacterial infections. It belongs to the class of fluoroquinolone antibiotics and is known for its efficacy against a wide range of bacteria.
Patent Overview
The patent, filed as US09/830,770, was granted on August 27, 2002. Here is a brief overview of its key components:
Inventors and Assignees
The patent was assigned to Bayer Aktiengesellschaft, a German multinational pharmaceutical and life sciences company.
Publication and Legal Status
The patent has expired, as indicated by its legal status. This means that the exclusive rights to the invention are no longer in effect, and the technology is now in the public domain[1].
Scope of the Patent
Pharmaceutical Preparation
The patent describes a pharmaceutical preparation for oral administration that includes moxifloxacin, its salts, and/or hydrates, along with lactose as an excipient. This formulation is designed to enhance the bioavailability and stability of moxifloxacin[1].
Formulation Details
The preparation is preferably in the form of a tablet, which may be coated with customary coating formulations such as those based on hydroxypropylmethylcellulose (HPMC) and/or polyethylene glycol. The coating can also include pigments like titanium dioxide or red iron oxide[1].
Therapeutic Use
The pharmaceutical preparation is intended for the treatment or prevention of bacterial infections in humans and animals.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the pharmaceutical preparation comprising moxifloxacin, its salts, and/or hydrates, and lactose.
- Claim 2 specifies the preparation in the form of a tablet, optionally coated.
Dependent Claims
- These claims further detail the composition, including the percentages of moxifloxacin and lactose, and the coating materials used[1].
Classification and International Patent Classification
The patent is classified under various international patent classifications, including A61K31/00, A61K31/33, and A61K31/47, which pertain to medicinal preparations containing organic active ingredients, heterocyclic compounds, and quinolines, respectively[1].
Patent Landscape
Related Patents
The patent landscape for moxifloxacin preparations includes several other patents related to formulations, methods of manufacture, and therapeutic uses. These patents often overlap in their claims but may differ in specific details such as excipients, dosages, or administration routes.
Global Dossier and Patent Families
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This helps in understanding the global patent family for moxifloxacin preparations and how different jurisdictions have treated similar inventions[4].
Enablement Requirement
The patent must meet the enablement requirement under 35 U.S.C. §112(a), which means the specification must be clear and concise enough for a person skilled in the art to make and use the invention. The description provided in the patent includes detailed formulations and methods, ensuring that it meets this requirement[2].
Economic and Practical Impact
Market Significance
The expiration of the patent has significant market implications, as it allows generic manufacturers to produce moxifloxacin preparations, potentially reducing costs and increasing accessibility.
Research and Development
The public domain status of the technology can also spur further research and development, as other companies can build upon the existing formulation without the need for licensing or royalties.
Conclusion
United States Patent 6,610,327 provides a detailed description of a pharmaceutical moxifloxacin preparation, including its formulation, therapeutic use, and manufacturing process. The patent's scope and claims are well-defined, ensuring that the invention is clearly described and enabled for those skilled in the art. With the patent now in the public domain, its impact on the pharmaceutical market and future research is significant.
Key Takeaways
- Pharmaceutical Preparation: The patent describes a moxifloxacin preparation with lactose for oral administration.
- Formulation Details: The preparation is preferably in tablet form, optionally coated with HPMC or polyethylene glycol.
- Therapeutic Use: Intended for treating or preventing bacterial infections.
- Classification: Classified under A61K31/00, A61K31/33, and A61K31/47.
- Patent Landscape: Part of a broader landscape including related patents and global dossier information.
- Enablement Requirement: Meets the requirement under 35 U.S.C. §112(a) with clear and concise descriptions.
- Economic Impact: Expiration allows for generic production, reducing costs and increasing accessibility.
FAQs
Q: What is the main active ingredient in the pharmaceutical preparation described in US Patent 6,610,327?
A: The main active ingredient is moxifloxacin.
Q: What is the preferred form of the pharmaceutical preparation?
A: The preferred form is a tablet, which may be optionally coated.
Q: What are the common coating materials used in this preparation?
A: Common coating materials include hydroxypropylmethylcellulose (HPMC) and/or polyethylene glycol, along with pigments like titanium dioxide or red iron oxide.
Q: What is the therapeutic use of the pharmaceutical preparation?
A: It is used for the treatment or prevention of bacterial infections in humans and animals.
Q: Why is the enablement requirement important in patent law?
A: The enablement requirement ensures that the patent specification is clear and concise enough for a person skilled in the art to make and use the invention.
Sources
- US6610327B1 - Pharmaceutical moxifloxacin preparation - Google Patents
- 21-757 Amgen Inc. v. Sanofi - Supreme Court
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- U.S. Patent Small Claims Court - ACUS
