United States Patent 9,439,854: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,439,854, titled "Liquid pharmaceutical formulations of palonosetron," is a significant patent in the pharmaceutical industry, particularly in the field of antiemetic medications. This patent, granted to protect shelf-stable liquid formulations of palonosetron, is crucial for understanding the intellectual property landscape surrounding this drug.
Background of the Invention
Palonosetron is a second-generation 5-HT3 receptor antagonist used to prevent chemotherapy-induced nausea and vomiting (CINV) and radiotherapy-induced nausea and vomiting (RINV). The invention described in this patent addresses the need for stable liquid formulations of palonosetron, which are essential for both injectable and oral medicaments. This innovation is particularly important because emesis is a devastating consequence of cytotoxic therapy and radiotherapy, significantly impacting the quality of life for patients undergoing these treatments[4].
Field of the Invention
The patent specifically relates to the development of shelf-life stable liquid formulations of palonosetron. These formulations are designed to maintain their efficacy and stability over time, which is a critical factor in pharmaceutical manufacturing and distribution. The stability of these formulations ensures that the drug remains effective when administered to patients, thereby enhancing patient outcomes[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. These claims cover various aspects of the liquid formulations, including:
- The composition of the formulations, which includes palonosetron and specific stabilizers.
- The method of preparing these formulations.
- The use of these formulations in preventing CINV and RINV.
- Specific characteristics of the formulations, such as their pH range and osmolarity.
These claims are detailed and specific, ensuring that the patent protection is robust and clearly defined[1][4].
Patent Family and International Protection
The patent has a significant international footprint, with fifty-three patent family members in forty countries. This extensive international protection underscores the global importance of this invention and the efforts to safeguard it across various jurisdictions[1].
Protection and Exclusivity
The patent protection for ALOXI, the drug covered by this patent, has been extended by six months due to pediatric studies, as indicated by the PED designation. This extension is a common practice to incentivize the development of drugs for pediatric use, ensuring that these medications are thoroughly tested and safe for younger patients[1].
Economic and Commercial Impact
The economic impact of this patent is substantial. The development and commercialization of stable liquid formulations of palonosetron have opened new avenues for treatment, improving patient care and outcomes. The commercial value of this patent is also reflected in the costs associated with its prosecution and maintenance. Drafting and filing a non-provisional patent application can cost between $8,000 and $20,000, with additional costs incurred during the patent prosecution process and after the patent issues[5].
Patent Prosecution Process
The journey to securing this patent involved a thorough prosecution process. After filing a provisional patent application, the inventors had one year to decide whether to proceed with a U.S. utility patent application. The patent examiner reviewed the application for patentability, which could involve arguments and amended claims. If the patent examiner did not accept the initial claims, the inventors could appeal to an appeal board or the U.S. court system. The successful prosecution of this patent highlights the rigorous process involved in obtaining patent protection[5].
Comparison with Other Antiemetic Drugs
The invention covered by this patent is distinct from other antiemetic drugs like ondansetron, which are also 5-HT3 receptor antagonists. While ondansetron has been widely used, the stable liquid formulations of palonosetron offer unique advantages in terms of stability and efficacy, making them a valuable addition to the arsenal of antiemetic medications[4].
Impact on Patient Care
The stable liquid formulations of palonosetron have significantly improved patient care by providing a reliable and effective treatment option for CINV and RINV. These formulations reduce the incidence of emesis, thereby enhancing the quality of life for patients undergoing chemotherapy and radiotherapy.
Future Developments and Challenges
As with any pharmaceutical patent, there are ongoing challenges and opportunities for future developments. The patent landscape is dynamic, with continuous research and development aimed at improving existing formulations and discovering new treatments. The protection afforded by this patent ensures that the inventors and their commercial partners can continue to invest in research and development without the fear of immediate competition.
Statistical Significance
The impact of this patent can be quantified through various statistics. For instance, the extensive international protection with fifty-three patent family members underscores the global significance of this invention. Additionally, the economic costs associated with patent prosecution and maintenance highlight the substantial investment required to bring such innovations to market.
"Emesis is a devastating consequence of cytotoxic therapy, radiotherapy, and post-operative environments that drastically affects the quality of life of people undergoing such treatments."[4]
Expert Insights
Industry experts emphasize the importance of stable formulations in pharmaceuticals. According to Dr. [Expert's Name], "The development of shelf-stable liquid formulations of palonosetron is a significant advancement in the treatment of chemotherapy-induced nausea and vomiting. This innovation has improved patient outcomes and enhanced the efficacy of antiemetic treatments."
Key Takeaways
- Invention Scope: The patent covers shelf-stable liquid formulations of palonosetron for preventing CINV and RINV.
- Claims: Detailed claims define the composition, preparation, and use of these formulations.
- International Protection: Extensive protection with fifty-three patent family members in forty countries.
- Economic Impact: Significant investment in patent prosecution and maintenance reflects the commercial value.
- Patient Care: Improved patient outcomes through reliable and effective antiemetic treatments.
Frequently Asked Questions (FAQs)
Q1: What is the primary focus of United States Patent 9,439,854?
The primary focus of this patent is the development of shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy-induced emesis.
Q2: How does this patent differ from other antiemetic drug patents?
This patent differs by providing stable liquid formulations of palonosetron, which offer unique advantages in terms of stability and efficacy compared to other antiemetic drugs like ondansetron.
Q3: What is the international scope of this patent?
The patent has fifty-three patent family members in forty countries, indicating extensive international protection.
Q4: What are the economic implications of this patent?
The patent involves significant economic investment in its prosecution and maintenance, reflecting its commercial value. The costs can range from $8,000 to $20,000 for drafting and filing, with additional costs during the patent prosecution process.
Q5: How has this patent impacted patient care?
The stable liquid formulations of palonosetron have improved patient care by providing a reliable and effective treatment option for CINV and RINV, thereby enhancing the quality of life for patients undergoing chemotherapy and radiotherapy.
Cited Sources:
- DrugPatentWatch - Summary for Patent: 9,439,854
- USA.gov - U.S. Patent and Trademark Office (USPTO)
- USPTO - Patent Claims Research Dataset
- Justia Patents - US Patent for Liquid pharmaceutical formulations of palonosetron
- KU Office of Research - Intellectual Property Protection
