United States Patent 6,136,799: A Comprehensive Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,136,799, titled "Cosolvent Formulations," is a significant patent in the pharmaceutical industry, particularly in the development of stable and self-preserved formulations of therapeutic agents. This patent, assigned to Abbott Laboratories, addresses critical issues in pharmaceutical formulation and has been a subject of interest in various legal and technological contexts.
Background and Invention
The patent, issued on October 24, 2000, describes pharmaceutical compositions that include a therapeutic agent, a low molecular weight alcohol, and a glycol derivative. These cosolvent formulations are designed to enhance the solubility and stability of therapeutic agents that lack adequate solubility in aqueous systems[4].
Claims and Scope
The patent includes several claims that define the scope of the invention:
- Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of a therapeutic agent and an organic solvent selected from low molecular weight alcohols and glycol derivatives.
- Claim 2: The composition of claim 1, where the therapeutic agent is selected from biologically and/or pharmacologically active substances.
- Claim 3: The composition of claim 1, where the low molecular weight alcohol is ethanol and the glycol derivative is propylene glycol.
- Claim 4: The composition of claim 1, where the formulation provides a synergistic preservative effect[4].
The scope of these claims is broad, covering a wide range of therapeutic agents and solvents, but they are also specific enough to protect the unique formulation and its benefits.
Technical Details
The patent provides detailed technical information on the formulation process and the properties of the resulting compositions:
- Synergistic Preservative Effect: The formulations exhibit a preservative effect that is greater than the sum of the individual effects of the alcohol and glycol derivative, ensuring the stability and sterility of the therapeutic agent[4].
- Sterilization: The formulations can be terminally sterilized to achieve a high sterility assurance level (SAL), reducing the risk of patient exposure to potential infections[4].
- Filtering and Filling: The solutions can be filtered using a 0.45 micrometer membrane filter and filled into ampoules or vials, which can then be sealed and terminally sterilized[4].
Patent Landscape
The patent landscape surrounding US 6,136,799 is complex and involves several key players and legal disputes:
- IP5 Offices: This patent is part of a larger global patent family, with related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and SIPO). The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from these offices[1].
- Litigation: The patent has been involved in several high-profile litigation cases. For example, Abbott Laboratories and the Wisconsin Alumni Research Foundation (WARF) sued Sandoz Inc. and Teva Parenteral for infringement of this patent, among others, related to the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of Abbott’s Zemplar® injectable products[2][5].
Economic and Legal Impact
The economic and legal impact of this patent is significant:
- Market Exclusivity: The patent has contributed to Abbott’s market exclusivity for certain pharmaceutical products, protecting their investment in research and development.
- Infringement Cases: The litigation surrounding this patent highlights the importance of patent protection in the pharmaceutical industry. The cases against Sandoz and Teva demonstrate the lengths to which companies will go to protect their intellectual property and the potential financial consequences for infringers[2][5].
Research and Data
The USPTO provides various datasets and tools that can be used to analyze patents like US 6,136,799. For instance, the Patent Claims Research Dataset contains detailed information on claims from US patents, including those related to this patent. This dataset can help in understanding the scope and trends in patent claims over time[3].
Public Access and Search Tools
The public can access information about this patent through various USPTO resources:
- Public Search Facility: The USPTO Public Search Facility in Alexandria, VA, provides access to patent and trademark information, including this patent[1].
- Patent and Trademark Resource Centers (PTRCs): Local PTRCs offer training in patent search techniques and maintain local search resources[1].
- Electronic Official Gazette: Users can browse issued patents, including this one, through the Electronic Official Gazette[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by all participating IP Offices for the family members of a patent application. This tool is useful for visualizing the search results for the same invention produced by several offices on a single page, which can be relevant for patents like US 6,136,799 that are part of a global patent family[1].
Conclusion and Key Takeaways
- Innovative Formulation: US 6,136,799 introduces a novel cosolvent formulation that enhances the solubility and stability of therapeutic agents.
- Broad Claims: The patent includes broad yet specific claims that protect the unique formulation and its benefits.
- Litigation and Market Impact: The patent has been central in several litigation cases, protecting Abbott’s market exclusivity and highlighting the importance of patent protection in the pharmaceutical industry.
- Public Access: Various USPTO resources provide public access to information about this patent.
- Global Patent Family: The patent is part of a global patent family, with related applications filed at participating IP Offices.
FAQs
Q: What is the main invention described in US 6,136,799?
A: The main invention is a pharmaceutical composition comprising a therapeutic agent, a low molecular weight alcohol, and a glycol derivative, designed to enhance solubility and stability.
Q: Who are the assignees of US 6,136,799?
A: The assignees are Abbott Laboratories and the Wisconsin Alumni Research Foundation (WARF).
Q: What is the significance of the synergistic preservative effect in this patent?
A: The synergistic preservative effect ensures that the formulation provides a level of preservation that is greater than the sum of the individual effects of the alcohol and glycol derivative.
Q: How can users access information about this patent?
A: Users can access information through the USPTO Public Search Facility, PTRCs, and the Electronic Official Gazette.
Q: What is the legal status of US 6,136,799 as of the current date?
A: The patent has expired, with its expiration date being April 8, 2018[2].
Cited Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/2376363
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US6136799A - Cosolvent formulations - Google Patents: https://patents.google.com/patent/US6136799A/en
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/3925076
