Detailed Analysis of the Scope and Claims of United States Patent 9,351,984
Introduction
United States Patent 9,351,984, titled "COMPOSITIONS COMPRISING LECITHIN AND NSAIDs FOR PROTECTING THE GASTROINTESTINAL TRACT AND PROVIDING ENHANCED THERAPEUTIC ACTIVITY," was granted on May 31, 2016, to the Board of Regents of the University of Texas System. This patent is a significant development in the field of pharmaceuticals, particularly in the formulation of nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce gastrointestinal toxicity.
Background
The invention described in this patent addresses a long-standing issue with NSAIDs: their potential to cause gastrointestinal (GI) toxicity, including ulcers and other tissue disorders. The patent aims to mitigate these side effects by incorporating NSAIDs into formulations that include phospholipid-containing oils, such as lecithin.
Patent Scope
Independent Claims
The patent scope is defined by its independent claims, which are crucial for understanding the breadth and specificity of the invention. Here, the independent claims focus on the composition and method of preparing the NSAID-containing formulations.
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Claim 1: This claim describes a pharmaceutical composition comprising an NSAID and a phospholipid, such as lecithin, in a bio-compatible oil. The composition is designed to reduce GI toxicity and enhance therapeutic activity[4].
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Claim 2: This claim specifies the method of preparing the composition, including the steps of mixing the NSAID with the phospholipid and bio-compatible oil to form a non-aqueous solution, paste, suspension, or dispersion[4].
Dependent Claims
Dependent claims further narrow down the scope by adding specific details to the independent claims. These include:
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Claim 3: This claim specifies the type of NSAID used, such as ibuprofen or naproxen, and the concentration of the phospholipid[4].
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Claim 4: This claim details the method of administration, such as oral or topical application[4].
Classification and Categorization
The patent is classified under several categories of the Cooperative Patent Classification (CPC) system:
- A61K 31/616: This classification pertains to pharmaceutical compositions containing phospholipids.
- A61K 9/107: This classification is for pharmaceutical compositions containing NSAIDs.
- A61K 9/1075: This classification is for specific types of NSAIDs and their formulations[4].
Prior Art and References
The patent cites several prior art documents, including U.S. and foreign patent documents, as well as official actions from various patent offices. These references highlight the existing state of the art in NSAID formulations and the innovations introduced by this patent.
- U.S. Patent 4,309,420: This patent is cited for its relevance to phospholipid-containing compositions.
- European Patent Office Official Actions: These documents are referenced for the responses to official actions during the patent examination process[4].
Examination Process
The examination process for this patent involved multiple office actions and responses. The patent office scrutinized the claims for clarity, novelty, and non-obviousness.
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Office Actions: The United States Patent and Trademark Office (USPTO) issued several office actions, each addressing various aspects of the patent application, including claim language and prior art[4].
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Responses to Office Actions: The applicants responded to these actions, making amendments and arguments to support the patentability of the claims[4].
Impact and Significance
This patent is significant for several reasons:
- Reduced GI Toxicity: The formulation described in the patent reduces the gastrointestinal side effects associated with NSAIDs, making these drugs safer for patients.
- Enhanced Therapeutic Activity: The inclusion of phospholipids enhances the therapeutic efficacy of the NSAIDs, providing better treatment outcomes for conditions such as inflammation, pain, and fever[4].
Market and Commercial Implications
The commercial implications of this patent are substantial:
- Pharmaceutical Industry: The patent opens up new avenues for pharmaceutical companies to develop safer and more effective NSAID formulations.
- Patient Benefits: Patients can benefit from reduced side effects and improved therapeutic outcomes, enhancing their quality of life.
Legal and Policy Considerations
The patent landscape surrounding this invention involves several legal and policy considerations:
- Patent Litigation: The scope and claims of the patent could be subject to litigation if other companies attempt to develop similar formulations without proper licensing or infringement clearance.
- Regulatory Approvals: The formulation must comply with regulatory requirements from bodies such as the FDA before it can be marketed and sold[4].
Future Developments
Future developments in this area could include:
- Further Research: Continued research into the effects of phospholipids on NSAID formulations could lead to even safer and more effective treatments.
- Expansion of Claims: The patent holders may seek to expand their claims through continuation applications or new patent filings based on further innovations.
Key Takeaways
- Innovative Formulation: The patent introduces a novel formulation of NSAIDs with phospholipids to reduce GI toxicity and enhance therapeutic activity.
- Significant Impact: The invention has significant implications for patient safety and therapeutic efficacy.
- Commercial Potential: The patent opens new commercial avenues in the pharmaceutical industry.
- Legal Considerations: The patent scope and claims are subject to legal scrutiny and potential litigation.
FAQs
Q: What is the main innovation of United States Patent 9,351,984?
A: The main innovation is the formulation of NSAIDs with phospholipids, such as lecithin, to reduce gastrointestinal toxicity and enhance therapeutic activity.
Q: What are the key claims of the patent?
A: The key claims include the composition of the NSAID and phospholipid formulation and the method of preparing this composition.
Q: How does the patent classification system categorize this invention?
A: The patent is classified under CPC categories A61K 31/616, A61K 9/107, and A61K 9/1075.
Q: What were the challenges during the patent examination process?
A: The examination process involved multiple office actions and responses to address issues of claim clarity, novelty, and non-obviousness.
Q: What are the potential commercial implications of this patent?
A: The patent could lead to the development of safer and more effective NSAID formulations, benefiting both pharmaceutical companies and patients.
Sources
- United States Patent and Trademark Office. US 9,351,984 B2. Retrieved from https://patentimages.storage.googleapis.com/8c/2b/58/a9854eb7684d6d/US9351984.pdf
- Wikipedia. 1836 U.S. Patent Office fire. Retrieved from https://en.wikipedia.org/wiki/1836_U.S._Patent_Office_fire
- SSRN. Patent Claims and Patent Scope. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google APIs. US 9,351,984 B2. Retrieved from https://patentimages.storage.googleapis.com/8c/2b/58/a9854eb7684d6d/US9351984.pdf
- ACUS. U.S. Patent Small Claims Court. Retrieved from https://www.acus.gov/research-projects/us-patent-small-claims-court
