United States Patent 8,153,632: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,153,632, issued on April 10, 2012, is a significant patent in the pharmaceutical sector, particularly in the area of anti-proliferative agents. This patent is associated with the drug VONJO (pacritinib citrate), developed by CTI Biopharma Corp. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignees
The patent was invented by a team including Stephanie Blanchard, Cheng Hsia Angeline Lee, Harish Kumar Mysore Nagaraj, Anders Poulsen, Eric T. Sun, Yee Ling Evelyn Tan, and Anthony Deodaunia William. The assignee of the patent is S*BIO Pte Ltd., although the rights are now associated with CTI Biopharma Corp.[5].
Scope of the Patent
Claims and Description
The patent pertains to oxygen-linked pyrimidine compounds, which are useful as anti-proliferative agents. These compounds are specifically designed for the treatment of proliferative disorders, including tumors and cancers, as well as other conditions related to or associated with kinases. The patent includes methods for the preparation of these compounds, pharmaceutical compositions containing them, and their uses in medical treatments[5].
Claim Language and Scope Metrics
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth and clarity of patent claims. For U.S. Patent 8,153,632, the independent claims are detailed and specific, indicating a narrower scope which is generally associated with higher patent quality and a shorter examination process[3].
Patent Claims and Examination Process
Narrowing of Claims
During the patent examination process, the scope of patent claims can be narrowed to ensure clarity and validity. For this patent, the examination process would have involved a thorough review to ensure that the claims are not overly broad and are supported by sufficient disclosure. This process helps in maintaining the quality of the patent and reducing potential litigation costs[3].
Regulatory Review and Approval
FDA Approval and Patent Term Extension
The drug associated with this patent, VONJO, underwent a lengthy regulatory review process. The FDA verified the dates for the investigational new drug application (IND) and the new drug application (NDA), which were February 6, 2008, and March 30, 2021, respectively. The drug was approved on February 28, 2022. The regulatory review period, which includes testing and approval phases, was 5,138 days, highlighting the extensive time and effort involved in bringing this drug to market[2].
Patent Term and Exclusivity
Patent Expiration and Generic Availability
The patent is set to expire on January 17, 2029. As of now, there is no generic version of VONJO available in the United States. The exclusive marketing rights granted by the FDA, combined with the patent protection, ensure that CTI Biopharma Corp. maintains a monopoly on the drug until the patent expires[5].
Economic and Social Impact
Investment and Public Access
The development of VONJO involved significant private investment. However, the patent landscape also includes provisions for public access, such as march-in rights reserved by federal agencies. These rights allow the government to ensure that taxpayer-funded inventions are accessible and affordable to the public, preventing nonuse or unreasonable use of such patents[4].
Technological Classification
Fields of Technology
The patent falls under the broader technology classification of "Drugs and Medicine." However, finer analyses might categorize it more specifically within the realm of anti-proliferative agents and kinase inhibitors. This classification helps in understanding the patent's position within the broader technological landscape[1].
Maintenance and Reinstatement
Patent Maintenance Fees
To keep the patent in force, the patent holder must pay maintenance fees at specified intervals. Failure to pay these fees can result in the patent expiring, although reinstatement is possible under certain conditions, such as unintentional or unavoidable delay[1].
Forward Citations and Patent Quality
Indicators of Patent Quality
The number of forward citations a patent receives can be an indicator of its quality and impact. Patents with more forward citations are generally considered more influential and of higher quality. However, the specific citation data for U.S. Patent 8,153,632 is not provided here, but it would be an important metric to evaluate its impact on subsequent innovations[3].
Conclusion
U.S. Patent 8,153,632 is a critical patent in the pharmaceutical industry, particularly for the treatment of proliferative disorders. The patent's scope is defined by its specific claims related to oxygen-linked pyrimidine compounds. The regulatory approval process and patent term extension highlight the complex and time-consuming nature of bringing new drugs to market. Understanding the patent landscape, including economic and social implications, is essential for both innovators and policymakers.
Key Takeaways
- Patent Scope: The patent is specific to oxygen-linked pyrimidine compounds for anti-proliferative uses.
- Regulatory Approval: The drug associated with this patent underwent extensive FDA review before approval.
- Patent Term: The patent is set to expire on January 17, 2029.
- Economic Impact: Significant private investment was involved, with provisions for public access through march-in rights.
- Technological Classification: Falls under "Drugs and Medicine" with finer classifications possible.
FAQs
1. What is the main subject of U.S. Patent 8,153,632?
The main subject of U.S. Patent 8,153,632 is oxygen-linked pyrimidine compounds used as anti-proliferative agents.
2. Who are the inventors and assignees of this patent?
The inventors include Stephanie Blanchard, Cheng Hsia Angeline Lee, and others, with the assignee being S*BIO Pte Ltd., now associated with CTI Biopharma Corp.
3. What is the regulatory review period for the drug associated with this patent?
The regulatory review period for VONJO was 5,138 days, including both testing and approval phases.
4. Is there a generic version of VONJO available?
No, there is currently no generic version of VONJO available in the United States.
5. What are the implications of march-in rights for this patent?
March-in rights allow federal agencies to ensure that taxpayer-funded inventions, like VONJO, are accessible and affordable to the public, preventing nonuse or unreasonable use of such patents.
Cited Sources:
[1] https://www.law.gmu.edu/pubs/faculty_working_paper_pdfs?fd=%251D%25EAtv%2560I%2598%2595AjxAM24ECSUb
[2] https://downloads.regulations.gov/FDA-2023-E-1467-0006/attachment_1.pdf
[3] https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
[4] https://www.ftc.gov/system/files/ftc_gov/pdf/2024.02.06March-InRightsComment.pdf
[5] https://www.drugs.com/availability/generic-vonjo.html
