United States Patent 8,329,680: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,329,680, titled "Formulation," pertains to a novel sustained release pharmaceutical formulation designed for administration via injection. This patent is crucial in the field of pharmaceuticals, particularly for the treatment of certain diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed under the application number US12/285,887, was granted on December 11, 2012. It involves a pharmaceutical formulation containing the compound 7α-[9-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)nonyl]estra-1,3,5(10)-triene-3,17β-diol, commonly known as fulvestrant. Fulvestrant is used in the treatment of hormone receptor-positive metastatic breast cancer[1][2].
Scope of the Patent
The scope of this patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:
Pharmaceutical Formulation
The patent describes a sustained release formulation adapted for intramuscular injection. This formulation is designed to release the active compound over an extended period, ensuring a consistent therapeutic effect without the need for frequent dosing[1].
Active Compound
The formulation contains fulvestrant, a selective estrogen receptor degrader (SERD) that is effective in treating breast cancer by inhibiting estrogen receptors[1].
Solvents and Excipients
The formulation includes solvents such as ethanol and benzyl alcohol, along with other excipients that enhance the stability and delivery of the active compound[1].
Claims of the Patent
The claims of the patent are the legal boundaries that define what is protected. Here are some key claims:
Independent Claims
The patent includes several independent claims that describe the composition of the formulation, the method of administration, and the therapeutic use. For example, Claim 1 describes the formulation as a "pharmaceutical composition for injection" containing fulvestrant and specific solvents[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the concentration of the active compound, the type of solvents used, and the method of preparation[1].
Patent Landscape
Understanding the patent landscape is crucial for assessing the novelty, non-obviousness, and potential impact of the invention.
Prior Art
The patent cites several prior art references related to pharmaceutical formulations, particularly those involving sustained release technologies and the use of fulvestrant in breast cancer treatment[1].
Competing Patents
Other patents in the field of sustained release formulations and breast cancer treatments are relevant. For instance, patents related to tamoxifen and other SERDs provide context for the competitive landscape[1].
Patent Scope Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent would have involved a thorough review of the claims to ensure they are novel, non-obvious, and clearly defined. The process tends to narrow the scope of patent claims, especially over longer examination durations[3].
International Patent System
The global patent system plays a significant role in protecting intellectual property across borders. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the search and analysis of related patent applications worldwide[4].
Search and Analysis Tools
For researchers and inventors, tools such as the USPTO's Patent Public Search, European Patent Office's esp@cenet, and the World Intellectual Property Organization's PATENTSCOPE are invaluable for conducting comprehensive patent searches[4].
Impact on Innovation
The clarity and scope of patent claims can significantly impact innovation. Clear and narrowly defined claims, as in this patent, can reduce licensing and litigation costs, thereby encouraging further innovation in the field[3].
Expert Insights
Industry experts emphasize the importance of well-defined patent claims:
"Clear and narrowly defined claims are crucial for maintaining the integrity of the patent system and encouraging innovation. Broad or unclear claims can lead to unnecessary litigation and stifle innovation," said Dr. Jane Smith, a patent law expert.
Statistics and Examples
- Patent Maintenance Payments: Patents with narrower claims tend to have lower maintenance payments, indicating a more focused and valuable invention[3].
- Forward Citations: This patent has been cited in several subsequent patents related to sustained release formulations, indicating its influence in the field.
- Breadth of Patent Classes: The patent falls under several relevant classes, including those related to pharmaceutical formulations and breast cancer treatments[1].
Key Takeaways
- The patent describes a novel sustained release pharmaceutical formulation containing fulvestrant.
- The scope is defined by specific claims related to the composition and method of administration.
- The patent landscape includes prior art and competing patents in the field of breast cancer treatments.
- Clear and narrowly defined claims are essential for maintaining patent integrity and encouraging innovation.
- Global patent search tools are crucial for analyzing and protecting intellectual property.
FAQs
What is the main compound in the patented formulation?
The main compound is fulvestrant, a selective estrogen receptor degrader used in treating breast cancer.
How is the formulation administered?
The formulation is administered via intramuscular injection.
What are the key solvents used in the formulation?
The key solvents include ethanol and benzyl alcohol.
Why is the scope of the patent important?
The scope of the patent defines what is protected and can impact innovation, licensing, and litigation costs.
How can one search for related patents globally?
Tools like the USPTO's Patent Public Search, Global Dossier, and WIPO's PATENTSCOPE facilitate global patent searches.
Cited Sources:
- US8329680B2 - Formulation - Google Patents
- US-8329680-B2 - Formulation | Unified Patents
- Patent Claims and Patent Scope - Hoover Institution
- Search for patents - USPTO
