United States Patent 10,357,570: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,357,570, titled "Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron," is a significant patent in the pharmaceutical field, particularly in the treatment of nausea. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, assigned to Heron Therapeutics, pertains to methods and compositions for treating nausea using semi-solid delivery vehicles. These vehicles incorporate a polyorthoester and an excipient, providing a controlled release of the active ingredient, granisetron[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Claims Overview
The patent includes multiple claims that cover various aspects of the invention:
- Independent Claims: These claims define the core of the invention and are not dependent on other claims. For example, Claim 1 might describe the method of treating nausea using a semi-solid delivery vehicle composition.
- Dependent Claims: These claims build upon the independent claims and provide additional details or variations. For instance, a dependent claim might specify the type of polyorthoester used or the concentration of granisetron[4].
Claim Structure
The strategic management of claims is crucial for maximizing the patent's value. The patent includes a mix of independent and dependent claims to ensure comprehensive protection. For example, the practice of adding a new dependent claim for every claim that is canceled during the prosecution phase can enhance the patent’s breadth and flexibility without incurring additional costs[2].
Key Claims
Here are some of the key claims and their implications:
Claim 1
Claim 1 typically sets the foundation for the invention, such as:
- "A method of treating nausea in a patient, comprising administering a semi-solid delivery vehicle composition comprising a polyorthoester and granisetron."
Dependent Claims
Dependent claims might include:
- "The method of claim 1, wherein the polyorthoester is selected from the group consisting of poly(1,6-hexanediol diacrylate) and poly(1,6-hexanediol dimethacrylate)."
- "The method of claim 1, wherein the granisetron is present in an amount of about 1 mg to about 10 mg per dose."
These claims provide a detailed description of the invention, ensuring that various aspects are protected.
International Protection
In addition to the U.S. patent, Heron Therapeutics has secured international patents for this invention. These include patents in Europe, Japan, Korea, and other jurisdictions, ensuring global protection for the method and composition described[1].
Patent Landscape
The patent landscape surrounding this invention is complex and involves several related patents and applications.
Related Patents
- SUSTOL®: This product, also developed by Heron Therapeutics, is protected by a series of patents that may overlap or complement the claims in US 10,357,570. For example, US Patent Numbers such as US 8,252,304 and US 9,913,910 cover related aspects of semi-solid delivery vehicles[1].
- Other Heron Therapeutics Patents: Patents like those for CINVANTI® and ZYNRELEF® may also be relevant, as they involve similar technologies and compositions[1].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents play a crucial role in protecting innovations. Companies like Heron Therapeutics must navigate a complex web of existing patents to ensure their inventions are novel and non-obvious.
Strategic Claim Management
The management of claims in this patent is strategic and aimed at maximizing value. By ensuring that the patent utilizes its full entitlement of claims, Heron Therapeutics can secure a more robust and nuanced protection. This approach also demonstrates a meticulous and value-driven management of intellectual property, which is essential in licensing discussions or infringement disputes[2].
Economic and Legal Implications
The economic implications of this patent are significant. By protecting the method and composition for treating nausea, Heron Therapeutics can maintain market exclusivity and generate revenue through sales or licensing agreements. Legally, the patent provides a strong defensive position against potential infringers and ensures that the company’s investment in research and development is protected.
Data and Statistics
The USPTO's Patent Claims Research Dataset provides insights into the trends and statistics of patent claims. For instance, the dataset shows that the strategic composition and management of claims can significantly enhance a patent’s effectiveness and value. This dataset can be useful in understanding the broader context of patent claims and their impact on innovation and economic growth[3].
Expert Insights
Industry experts emphasize the importance of strategic claim management. As Neil Kardos notes, "Each claim in a patent application can be viewed as a unique tool for protecting different facets of the invention." This approach ensures that the final patent utilizes the full quota of claims, thus maximizing its breadth and flexibility[2].
Conclusion
The United States Patent 10,357,570 is a critical asset for Heron Therapeutics, providing comprehensive protection for their method of treating nausea using semi-solid delivery vehicle compositions. The strategic management of claims, international protection, and the complex patent landscape all contribute to the patent's value and the company's competitive edge.
Key Takeaways
- Comprehensive Protection: The patent includes a mix of independent and dependent claims to ensure robust protection.
- Strategic Claim Management: Ensuring the full utilization of claims enhances the patent’s breadth and flexibility.
- International Protection: Global patents secure protection in multiple jurisdictions.
- Competitive Landscape: The patent navigates a complex web of existing patents in the pharmaceutical industry.
- Economic and Legal Implications: The patent maintains market exclusivity and provides a strong defensive position.
Frequently Asked Questions (FAQs)
Q: What is the main invention protected by US Patent 10,357,570?
A: The main invention is a method of treating nausea using semi-solid delivery vehicle compositions comprising a polyorthoester and granisetron.
Q: How does the strategic management of claims impact the patent's value?
A: Strategic claim management ensures that the patent utilizes its full entitlement of claims, enhancing its breadth and flexibility, and thus maximizing its value.
Q: What is the significance of international patents for this invention?
A: International patents provide global protection, ensuring that the method and composition are protected in multiple jurisdictions.
Q: How does this patent fit into the broader patent landscape?
A: The patent is part of a complex landscape involving related patents and applications, particularly those related to Heron Therapeutics' other products like SUSTOL® and CINVANTI®.
Q: What are the economic implications of this patent?
A: The patent allows Heron Therapeutics to maintain market exclusivity and generate revenue through sales or licensing agreements, protecting their investment in research and development.
Cited Sources
- Heron Therapeutics - Patent Information: https://www.herontx.com/patents/
- Harrity LLP - Maximizing Patent Value: https://harrityllp.com/maximizing-patent-value-a-strategic-approach-to-claim-management/
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US10357570B2: https://patents.google.com/patent/US10357570B2/en
