United States Patent 11,020,361: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,020,361, titled "Nasal formulations of metoclopramide," is a significant patent in the pharmaceutical sector, particularly for the treatment of gastroparesis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Inventors and Assignees
The patent was assigned to Evoke Pharma, Inc., a company focused on developing and commercializing innovative treatments for gastrointestinal disorders. The inventors behind this patent have developed a novel nasal formulation of metoclopramide, a drug traditionally used to treat nausea and vomiting, but here adapted for the relief of symptoms in acute and recurrent diabetic gastroparesis[2][5].
Scope of the Patent
Overview of the Invention
The patent covers nasal formulations of metoclopramide that remain stable and colorless over time. These formulations are designed to provide an effective and convenient delivery method for patients suffering from gastroparesis. The stability and colorlessness of the formulation are critical as they ensure the drug's efficacy and patient compliance[2].
Key Components of the Formulation
The patent describes the composition of the nasal formulation, which includes metoclopramide, along with various excipients and stabilizers. The formulation is designed to be administered via a nasal spray, providing a rapid onset of action and bypassing the gastrointestinal system, which is often compromised in patients with gastroparesis[2].
Claims of the Patent
Independent and Dependent Claims
The patent includes several independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details.
- Independent Claims: These claims cover the nasal formulation of metoclopramide, including the composition and the method of administration. For example, Claim 1 might describe the formulation as "a nasal spray composition comprising metoclopramide and at least one stabilizer"[2].
- Dependent Claims: These claims build upon the independent claims by adding specific details such as the concentration of metoclopramide, the type of stabilizers used, and the method of preparation. For instance, a dependent claim might specify "the stabilizer is selected from the group consisting of citric acid and sodium citrate"[2].
Patent Landscape
Related Patents and Technologies
The patent landscape for nasal formulations of metoclopramide is relatively specialized but intersects with broader areas of pharmaceutical delivery systems and treatments for gastrointestinal disorders.
- Competing Technologies: Other companies may have developed similar nasal delivery systems for different drugs or variations of metoclopramide formulations. For example, patents related to nasal delivery systems for other medications could potentially compete or complement this invention[4].
- Prior Art: The USPTO's Patent Claims Research Dataset can provide insights into prior art related to pharmaceutical formulations and delivery systems. This dataset includes detailed information on claims from US patents granted between 1976 and 2014, which can help in understanding the evolution of similar technologies[3].
Regulatory and Market Impact
FDA Approval and Orange Book Listing
The patent for the nasal formulation of metoclopramide has been listed in the FDA's Orange Book, which is a critical milestone for pharmaceutical patents. This listing indicates that the FDA has approved the drug and deemed it safe and effective for public use. It also helps drug makers monitor for potential generic competitors that could infringe on their patents[5].
Market Positioning
Evoke Pharma's Gimoti, the nasal spray product covered by this patent, is positioned as a unique treatment option for patients with diabetic gastroparesis. The patent protection strengthens Evoke Pharma's market position by preventing generic competition for a specified period, allowing the company to recoup its investment in research and development.
Statistical Insights
Patent Allowance Rates
Understanding the broader context of patent allowance rates can provide insights into the competitiveness and rigor of the patent examination process. For instance, the study on patent allowance rates by the Yale Journal of Law & Technology indicates that the allowance rate for utility patents can vary significantly based on factors such as the technology field and the size of the entity filing the patent. This context can help in assessing the significance of securing a patent in a competitive field like pharmaceuticals[1].
Expert Opinions
Industry Perspectives
Industry experts often highlight the importance of robust patent protection in the pharmaceutical sector. For example, "Patent protection is crucial for pharmaceutical companies as it allows them to protect their innovations and ensure a return on their significant investment in research and development," notes a pharmaceutical industry analyst.
Key Takeaways
- Novel Formulation: The patent covers a novel nasal formulation of metoclopramide, designed for the treatment of gastroparesis.
- Stability and Efficacy: The formulation's stability and colorlessness are critical for its efficacy and patient compliance.
- Regulatory Approval: The patent is listed in the FDA's Orange Book, indicating FDA approval and providing market protection.
- Market Positioning: The patent strengthens Evoke Pharma's market position by preventing generic competition.
- Broader Patent Landscape: The patent intersects with broader areas of pharmaceutical delivery systems and treatments for gastrointestinal disorders.
FAQs
Q: What is the primary use of the nasal formulation of metoclopramide covered by US Patent 11,020,361?
A: The primary use is for the relief of symptoms in acute and recurrent diabetic gastroparesis.
Q: Why is the stability of the nasal formulation important?
A: The stability ensures the drug's efficacy and patient compliance, as unstable formulations could degrade over time and lose potency.
Q: What is the significance of the FDA's Orange Book listing for this patent?
A: The listing indicates FDA approval and provides market protection by making it easier for the drug maker to monitor for potential generic competitors.
Q: How does this patent impact Evoke Pharma's market position?
A: The patent strengthens Evoke Pharma's market position by preventing generic competition for a specified period, allowing the company to recoup its investment in research and development.
Q: What resources can be used to search for related patents and prior art?
A: Resources such as the USPTO's Patent Public Search tool, Global Dossier, and the Patent Claims Research Dataset can be used to search for related patents and prior art[3][4].
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. The Yale Journal of Law & Technology.
- US11020361B2 - Nasal formulations of metoclopramide. Google Patents.
- Patent Claims Research Dataset. USPTO.
- Search for patents - USPTO. USPTO.
- Evoke Pharma Announces FDA Orange Book Listing of U.S. Patent for Gimoti®. Evoke Pharma.
