United States Patent 9,186,328: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,186,328, titled "Formulation of diclofenac," is a patent that covers methods for producing particles of diclofenac using dry milling processes, as well as compositions comprising diclofenac. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to treat pain, inflammatory disorders, and dysmenorrhea. The patent in question addresses the formulation of diclofenac, specifically focusing on the production of diclofenac particles through dry milling processes. This method is significant because it can improve the bioavailability and stability of the drug[4].
Scope of the Patent
The scope of the patent is defined by its claims, which are the legal boundaries of what the patent protects. Here are the key aspects:
Claims
The patent includes multiple claims that describe the invention in detail. These claims can be categorized into two main types:
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Method Claims: These claims describe the process of producing diclofenac particles using dry milling processes. For example, the claims might specify the type of milling equipment, the conditions under which the milling is performed, and any subsequent processing steps[4].
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Composition Claims: These claims describe the compositions that result from the milling process. This includes the physical and chemical characteristics of the diclofenac particles, such as their size, shape, and purity[4].
Novelty, Non-Obviousness, and Utility
For a patent to be granted, the invention must meet the criteria of novelty, non-obviousness, and utility. The invention described in US 9,186,328 must be new and not obvious to one skilled in the art, and it must have a practical application. The use of dry milling to produce diclofenac particles likely satisfies these criteria by offering a novel and non-obvious method that improves the drug's properties[2].
Patent Application Process
To understand the context of this patent, it is essential to look at the patent application process.
Filing and Examination
The patent application for US 9,186,328 would have been filed with the United States Patent and Trademark Office (USPTO). The application would have included a specification, drawings if necessary, an oath or declaration, an application data sheet, and fees. The USPTO would then conduct a search and examination to determine if the invention meets the statutory requirements for patentability[2].
Fees and Costs
The process of obtaining a patent involves various fees, including filing, search, and examination fees. These fees can be significant, and recent changes to the USPTO fee structure may impact future patent applications. For instance, the USPTO has introduced new fees and adjusted existing ones to ensure financial sustainability and improve the predictability and reliability of patent protection[1].
Patent Landscape
The patent landscape surrounding US 9,186,328 includes other related patents and applications.
Prior Art and Related Patents
The patent application would have included a prior art search to ensure that the invention was novel and non-obvious. Other patents related to diclofenac formulations and production methods would have been considered. For example, patents like US 8,999,387 and US 9,017,721, which are mentioned in related proceedings, might be relevant in understanding the broader patent landscape[5].
Inter Partes Review (IPR)
The patent landscape also includes potential challenges to the patent's validity. For instance, the patent could be subject to an Inter Partes Review (IPR) proceeding, where the validity of the patent claims could be challenged based on prior art or other grounds[5].
Economic and Strategic Implications
The patent has significant economic and strategic implications for the pharmaceutical industry.
Market Impact
The improved formulation of diclofenac could enhance its market position by offering better bioavailability and stability. This could lead to increased sales and market share for the patent holder.
Competitive Advantage
The patent provides a competitive advantage by excluding others from using the same method to produce diclofenac particles. This can be particularly valuable in a competitive pharmaceutical market where small differences in formulation can significantly impact product performance and patient outcomes.
Key Takeaways
- Scope and Claims: The patent protects specific methods for producing diclofenac particles using dry milling processes and the resulting compositions.
- Patent Application Process: The application would have involved detailed documentation, fees, and a thorough examination by the USPTO.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and potential challenges through IPR proceedings.
- Economic and Strategic Implications: The patent can provide a competitive advantage and impact the market position of the drug.
FAQs
What is the main subject of United States Patent 9,186,328?
The main subject of United States Patent 9,186,328 is the formulation of diclofenac using dry milling processes.
What are the key claims of the patent?
The key claims include method claims for producing diclofenac particles and composition claims describing the resulting diclofenac formulations.
Why is the dry milling process significant?
The dry milling process is significant because it can improve the bioavailability and stability of diclofenac.
How does the patent application process work for this type of invention?
The patent application process involves filing with the USPTO, including necessary documentation and fees, and undergoing a search and examination to determine patentability.
What are the economic implications of this patent?
The patent can provide a competitive advantage and enhance the market position of the drug by offering improved bioavailability and stability.
Sources
- Federal Register: "Federal Register/Vol. 89, No. 224/Wednesday, November 20, 2024" - https://www.govinfo.gov/content/pkg/FR-2024-11-20/pdf/2024-26821.pdf
- Maryland People's Law Library: "Patents" - https://www.peoples-law.org/patents
- USPTO: "Patent Claims Research Dataset" - https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents: "US9186328B2 - Formulation of diclofenac" - https://patents.google.com/patent/US9186328B2/en
- Exparte: "UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD" - https://ai-lab.exparte.com/documents/ptab/ptacts-uspto/1463374/iUf0ZJAXSP79llYgmKaphcKgjMMA4PQ62VPO2NUtNctfDhJf5vn1CeY/-13/IPR2016-00397_doc_5_exparte.pdf
