United States Patent 4,767,628: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,767,628, titled "Continuous release pharmaceutical compositions," was granted on September 6, 1988. This patent is significant in the field of pharmaceuticals, particularly for its innovative approach to delivering pharmacologically active polypeptides over an extended period. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes pharmaceutical compositions comprising a polylactide and a pharmacologically active, acid-stable polypeptide. These compositions are designed to provide continuous release of the polypeptide when placed in an aqueous, physiological environment. The invention is particularly relevant for parenteral administration, such as sub-dermal injection or implantation, and can be formulated as solid bodies (e.g., pellets or films) or suspensions for injection[4].
Key Components
- Polylactide Composition: The patent highlights the importance of the polylactide composition, including the proportion of lactic acid to glycolic acid in copolymers and the control of molecular weight.
- Polypeptide: The invention focuses on acid-stable polypeptides, which are crucial for maintaining the pharmacological activity over the release period.
- Formulation Parameters: The scope includes varying parameters such as the proportion of polypeptide to polylactide, the geometry of solid formulations, and the particle size in formulations for injection[4].
Patent Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical in understanding what is protected under the patent.
- Claim 1: This claim describes a pharmaceutical composition comprising a polylactide and a pharmacologically active, acid-stable polypeptide, designed for continuous release in an aqueous environment[4].
- Subsequent Claims: These claims further specify the composition, including the types of polylactides, the molecular weight ranges, and the methods of formulation.
Dependent Claims
Dependent claims build upon the independent claims, providing additional specifics about the invention. For example, they may detail the specific ratios of lactic acid to glycolic acid, the preferred molecular weight ranges, and the methods of manufacturing the compositions[4].
Scope of the Patent
Patent Scope Metrics
Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. For US Patent 4,767,628, the scope is relatively narrow due to the specific nature of the claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Innovation and Novelty
The patent introduces a novel method for delivering polypeptides, which was a significant innovation at the time of its filing. The continuous release mechanism and the use of polylactide as a carrier material were key advancements in pharmaceutical technology[4].
Patent Landscape
Global Context
To understand the broader patent landscape, it is essential to look at similar patents and innovations globally. The European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) provide databases that can be searched for similar patents. For instance, the EPO's esp@cenet and WIPO's PATENTSCOPE® Search Service can help identify related international patent applications[1].
Related Patents and Applications
Searching through international databases can reveal related patents and applications that may have been filed in other jurisdictions. This can include variations of the same invention or competing technologies. For example, a search on PATENTSCOPE® might reveal similar pharmaceutical compositions patented in other countries[1].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources can help in identifying prior art, understanding the examination process, and analyzing the patent family of related applications[1].
International Resources
In addition to USPTO resources, international databases such as those provided by the EPO, JPO, and WIPO are crucial for a comprehensive search. These databases offer machine translations and full-text searches, which can be invaluable in identifying global prior art and related patents[1].
Legal Status and Expiration
Current Status
As of the current date, US Patent 4,767,628 has expired. The legal status of a patent is an important factor in determining its impact on current innovations and whether it can be used freely or if licensing is required[4].
Impact on Pharmaceutical Industry
Innovation and Advancements
The invention described in US Patent 4,767,628 has contributed significantly to the field of pharmaceuticals, particularly in the area of controlled release formulations. This technology has paved the way for further innovations in drug delivery systems.
Commercial Applications
The continuous release pharmaceutical compositions have been commercially successful, with applications in various therapeutic areas. The patent has likely influenced the development of similar products and has been a reference point for subsequent research and development in the industry.
Key Takeaways
- Innovation in Drug Delivery: US Patent 4,767,628 introduced a novel method for continuous release of pharmacologically active polypeptides.
- Narrow Patent Scope: The patent's scope is relatively narrow, which is associated with a higher probability of grant and shorter examination process.
- Global Patent Landscape: Understanding the global patent landscape involves searching international databases and analyzing related patents and applications.
- Expired Patent: The patent has expired, making the technology freely available for use and further innovation.
- Impact on Industry: The invention has had a significant impact on the pharmaceutical industry, contributing to advancements in controlled release formulations.
FAQs
What is the main innovation of US Patent 4,767,628?
The main innovation is the development of pharmaceutical compositions that provide continuous release of pharmacologically active, acid-stable polypeptides over an extended period.
How can one search for related patents globally?
One can use international databases such as the EPO's esp@cenet, JPO's database, and WIPO's PATENTSCOPE® Search Service to search for related patents globally.
What tools does the USPTO provide for patent searching?
The USPTO provides tools like the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS) for searching and analyzing patents.
What is the current legal status of US Patent 4,767,628?
US Patent 4,767,628 has expired, meaning the technology described is no longer under patent protection.
How has this patent impacted the pharmaceutical industry?
The patent has contributed significantly to the development of controlled release formulations, influencing subsequent research and commercial applications in the pharmaceutical industry.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- FDA - Zoladex 3.6 mg Depot Administrative Documents. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19726-S018_ZOLADEX%203.6%20MG%20DEPOT_admindocs.pdf
- SSRN - Patent Claims and Patent Scope. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US4767628A. Retrieved from https://patents.google.com/patent/US4767628A/en
- Google APIs - United States Patent (19). Retrieved from https://patentimages.storage.googleapis.com/93/69/9e/8c118d8d60613d/US4767628.pdf
