United States Patent 9,539,335: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,539,335, titled "Diclofenac topical formulation," is a significant patent in the pharmaceutical industry, particularly in the field of topical pain relief. This patent, granted to its inventors, outlines a novel gel formulation of diclofenac sodium with enhanced transdermal flux properties. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US9539335B2
- Authority: United States
- Prior Art Date: The patent application was filed on April 11, 2016, with a priority date of April 11, 2015[4][5].
Invention Description
The patent describes a gel formulation containing diclofenac sodium, which is known for its anti-inflammatory and analgesic properties. This formulation is designed to improve the transdermal delivery of diclofenac, making it more effective for topical pain relief. The gel includes various components such as hydroxyethyl cellulose, dimethyl sulfoxide, and polyvinylpyrrolidone, which enhance the penetration and stability of the active ingredient[4][5].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: A gel formulation comprising diclofenac sodium, a gelling agent, and a solvent, where the gelling agent is hydroxyethyl cellulose and the solvent is dimethyl sulfoxide.
- Claim 2: The formulation of claim 1, further comprising a penetration enhancer.
- Claim 3: The formulation of claim 1, where the diclofenac sodium is present in a concentration of about 1% to about 5% by weight[4][5].
These claims are crucial as they define the boundaries of what is considered novel and non-obvious in the context of this patent.
Claims Analysis
Independent Claims
Independent claims, such as Claim 1, define the broadest scope of the invention. In this case, Claim 1 specifies the essential components of the gel formulation, including diclofenac sodium, a gelling agent, and a solvent.
Dependent Claims
Dependent claims, such as Claims 2 and 3, further narrow down the scope by adding additional features or limitations. For example, Claim 2 introduces a penetration enhancer, which is an optional but beneficial component for enhancing the transdermal flux of diclofenac sodium.
Patent Landscape
Prior Art
The patent landscape for topical diclofenac formulations is extensive. Prior art includes various formulations and methods for delivering diclofenac through the skin. However, the specific combination and proportions of components in this patent are novel and distinguish it from existing prior art.
International Patent Family
To understand the global reach of this patent, it is essential to look at the international patent family. Using tools like the Global Dossier provided by the USPTO, one can see related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA)[1].
Competing Patents
Other patents in the same field may offer similar or competing formulations. For instance, patents related to other topical pain relief formulations using different active ingredients or delivery mechanisms could be considered competitors. Analyzing these patents using databases like PATENTSCOPE by WIPO or esp@cenet by the EPO can provide a comprehensive view of the competitive landscape[1].
Search and Analysis Tools
USPTO Resources
The USPTO offers several tools for searching and analyzing patents, including the Patent Public Search tool, which replaced legacy tools like PubEast and PubWest. This tool provides enhanced access to prior art and is crucial for conducting thorough patent searches[1].
Global Dossier
The Global Dossier service allows users to view the file histories of related applications from participating IP Offices. This is particularly useful for understanding the global patent family and any office actions or citations related to the patent[1].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from multiple IP Offices, making it easier to visualize the search results for the same invention across different offices. This tool is invaluable for assessing the novelty and non-obviousness of the invention[1].
Economic and Market Impact
Market Demand
The demand for effective topical pain relief formulations is high, driven by the need for non-invasive and convenient treatment options. This patent addresses a significant market need by providing a formulation with superior transdermal flux properties.
Competitive Advantage
The unique combination of components and the enhanced delivery mechanism give this formulation a competitive edge in the market. Companies holding this patent can leverage this advantage to capture a significant share of the topical pain relief market.
Legal Status and Enforcement
Legal Status
As of the last update, the patent is listed as active. However, it is important to note that legal status can change, and it is always advisable to conduct a thorough legal analysis or consult with a patent attorney to determine the current status and any potential challenges or expirations[4].
Enforcement
Patent enforcement involves ensuring that others do not infringe on the patented invention. This can be done through various means, including monitoring for infringement, sending cease and desist letters, and pursuing legal action if necessary.
Conclusion
United States Patent 9,539,335 represents a significant advancement in the field of topical pain relief formulations. The detailed analysis of its scope, claims, and the broader patent landscape highlights its novelty and competitive advantage. For businesses and inventors, understanding these aspects is crucial for navigating the complex world of intellectual property and leveraging this patent to achieve market dominance.
Key Takeaways
- Novel Formulation: The patent describes a unique gel formulation of diclofenac sodium with enhanced transdermal flux properties.
- Claims Analysis: The patent includes several claims that define the scope of the invention, with independent and dependent claims specifying the essential and optional components.
- Patent Landscape: The patent is part of a broader international patent family, and its novelty is distinguished from prior art.
- Market Impact: The formulation addresses a significant market need and provides a competitive advantage in the topical pain relief market.
- Legal Status: The patent is currently active, but its status should be regularly checked for any changes.
FAQs
Q: What is the main component of the gel formulation described in US Patent 9,539,335?
A: The main component is diclofenac sodium, an anti-inflammatory and analgesic agent.
Q: What tools can be used to search for related patents internationally?
A: Tools like the Global Dossier, Common Citation Document (CCD), and databases from international IP Offices such as the EPO and WIPO can be used.
Q: How does the USPTO's Patent Public Search tool help in patent searching?
A: The Patent Public Search tool provides enhanced access to prior art and replaces legacy search tools, making it easier to conduct thorough patent searches.
Q: What is the significance of the Global Dossier service?
A: The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, providing a comprehensive view of the global patent family.
Q: How can businesses enforce this patent to protect their intellectual property?
A: Businesses can enforce the patent by monitoring for infringement, sending cease and desist letters, and pursuing legal action if necessary.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9539335B2: https://patents.google.com/patent/US9539335B2/en
- Unified Patents Portal - US-20160045605-A1: https://portal.unifiedpatents.com/patents/patent/US-20160045605-A1
