United States Patent 9,271,975: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,271,975, titled "Compositions and methods for treating centrally mediated nausea and vomiting," is a significant patent in the pharmaceutical industry, particularly in the treatment of nausea and vomiting associated with chemotherapy, radiotherapy, or surgery. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Abstract
The patent, assigned to Helsinn Healthcare SA, focuses on compositions and methods for treating or preventing nausea and vomiting in patients undergoing various medical treatments. The abstract outlines the use of specific combinations of active ingredients to address centrally mediated nausea and vomiting[1].
Inventors and Assignee
The inventors listed are Fabio Trento, Sergio Cantoreggi, Giorgia Rossi, Roberta Cannella, and Daniele Bonadeo. The patent is assigned to Helsinn Healthcare SA, a company based in Lugano/Pazzallo, Switzerland[1].
Scope of the Patent
Therapeutic Use
The patent covers the use of a combination of netupitant and palonosetron hydrochloride, marketed under the tradename AKYNZEO, for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy, including highly emetogenic chemotherapy. This combination is used in conjunction with dexamethasone in adults[1].
Dosage Form
The dosage form specified is an oral capsule, indicating the method of administration for the therapeutic composition[1].
Claims of the Patent
Use Claims
The patent includes use claims that specify the therapeutic application of the composition. These claims are crucial as they define the scope of protection for the invention, ensuring that the combination of netupitant and palonosetron hydrochloride for the stated therapeutic use is protected[1].
Dosage Form Claims
The patent also includes claims related to the dosage form, which is an oral capsule. This ensures that the specific formulation and delivery method are protected under the patent[1].
Patent Family and International Protection
Global Coverage
The patent has a significant global footprint with sixty-eight patent family members in forty-one countries. This extensive international protection ensures that the invention is safeguarded across various jurisdictions, preventing unauthorized use and manufacture of the therapeutic composition[1].
Supplementary Protection Certificates (SPCs)
In addition to the basic patent protection, the patent may also be eligible for Supplementary Protection Certificates (SPCs) in certain countries, which can extend the protection period beyond the standard patent term[1].
Patent Litigation and PTAB Cases
Legal Challenges
The patent has been involved in patent litigation and PTAB (Patent Trial and Appeal Board) cases, which are indicative of the patent's significance and the potential disputes over its validity or infringement. These cases highlight the importance of robust legal protection for pharmaceutical patents[1].
Economic and Strategic Impact
Market Dominance
The protection afforded by this patent allows Helsinn Healthcare SA to maintain market dominance for AKYNZEO, a critical medication for patients undergoing chemotherapy. This exclusivity can influence pricing, market share, and the overall competitive landscape in the pharmaceutical industry[1].
Innovation Incentives
The patent system, by granting exclusive rights for a limited period, incentivizes innovation. In this case, the patent encourages further research and development in the area of antiemetic therapies, potentially leading to new and improved treatments[5].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[5].
Global Patent Landscape
International Intellectual Property Offices
The global patent landscape is complex, with various international intellectual property offices providing searchable databases for patents. Tools like the Patent Public Search, Global Dossier, and Common Citation Document (CCD) facilitate the search and analysis of patent families across different jurisdictions[4].
Harmonization Efforts
Efforts to harmonize the global patent system, such as the CCD application, aim to consolidate prior art cited by different offices, making it easier to visualize search results for the same invention on a single page. This harmonization is crucial for managing the global patent landscape efficiently[4].
Conclusion
United States Patent 9,271,975 is a pivotal patent in the pharmaceutical sector, offering comprehensive protection for a critical therapeutic composition. The scope of the patent, including its use and dosage form claims, ensures that Helsinn Healthcare SA maintains exclusivity over AKYNZEO. The extensive international protection and potential for supplementary protection certificates further solidify its position. Understanding the metrics for measuring patent scope and the broader global patent landscape is essential for navigating the complexities of intellectual property in the pharmaceutical industry.
Key Takeaways
- Therapeutic Use: The patent covers the treatment of centrally mediated nausea and vomiting associated with chemotherapy, radiotherapy, or surgery.
- Dosage Form: The protected dosage form is an oral capsule containing netupitant and palonosetron hydrochloride.
- Global Protection: The patent has sixty-eight family members in forty-one countries.
- Economic Impact: The patent grants Helsinn Healthcare SA market exclusivity, influencing pricing and market share.
- Innovation Incentives: The patent system incentivizes further research and development in antiemetic therapies.
- Metrics for Scope: Independent claim length and count are used to measure patent scope and clarity.
FAQs
Q: What is the primary therapeutic use of the composition protected by US Patent 9,271,975?
A: The primary therapeutic use is the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy.
Q: Who is the assignee of US Patent 9,271,975?
A: The assignee is Helsinn Healthcare SA, based in Lugano/Pazzallo, Switzerland.
Q: What is the dosage form specified in the patent?
A: The dosage form is an oral capsule.
Q: How many patent family members does US Patent 9,271,975 have globally?
A: It has sixty-eight patent family members in forty-one countries.
Q: What metrics are commonly used to measure the scope of a patent?
A: Independent claim length and independent claim count are commonly used metrics to measure patent scope and clarity.
Sources
- Drug Patent Watch: Summary for Patent: 9,271,975.
- Justia: City of Glendale v. Bradshaw.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- SSRN: Patent Claims and Patent Scope.
