Detailed Analysis of the Scope and Claims of United States Patent 8,324,225
Introduction
United States Patent 8,324,225, issued on December 4, 2012, is a crucial patent in the pharmaceutical industry, particularly for the treatment of cancer. This patent is owned by Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd. and is associated with the drug KISQALI®, which contains the active ingredient ribociclib succinate.
Patent Overview
Issuance and Inventors
The patent was issued to inventors Brain Christopher Thomas, Sung Moo Je, and Thoma Gebhard. It describes organic compounds, specifically pyrrolopyrimidine compounds and their derivatives, which are useful for the treatment, prevention, and/or amelioration of diseases, particularly proliferative diseases like cancer[5].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- Claim 1: This claim describes a compound of Formula I, which includes ribociclib or its pharmaceutically acceptable salt. The formula specifies the structure of the compound, including the presence of a double bond and specific substituents[1][2].
- Claims 2 and 9: These claims also read on the approved product, KISQALI®, and are integral to the patent's protection of the drug[1].
Method of Use and Manufacturing
The patent not only claims the compound itself but also methods of using and manufacturing the approved product. This includes the treatment of cancer by inhibiting protein kinases, which are enzymes involved in cell signaling pathways that can lead to cancer when dysregulated[2].
Regulatory Review and Patent Term Extension
Regulatory Approval
The patent is associated with the FDA-approved drug KISQALI®, which was approved on March 13, 2017, for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor[4].
Patent Term Extension
The applicants have sought a patent term extension under 35 U.S.C. § 156 due to the regulatory review period. The requested extension is for 879 days, which would extend the patent term until November 13, 2030. This extension is calculated based on the regulatory review period that began on August 26, 2010, and ended with the FDA approval on March 13, 2017[1][4].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 8,324,225 includes other related patents owned by Novartis and Astex Therapeutics. These include patents such as U.S. Patent 8,685,980, U.S. Patent 8,962,630, and U.S. Patent 9,416,136, which also claim pyrrolopyrimidine compounds and their uses in treating cancer[2].
Litigation
There have been legal actions related to the infringement of these patents. For example, Novartis and Astex Therapeutics have filed complaints against generic manufacturers, such as MSN Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd., alleging patent infringement related to the submission of Abbreviated New Drug Applications (ANDAs) for generic versions of KISQALI®[2].
Generic Availability
As of the current date, there is no therapeutically equivalent generic version of KISQALI® available in the United States. This is due in part to the ongoing patent protection and the lack of FDA approval for any generic versions[5].
Patent Scope and Quality
Metrics for Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of patent claims. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process[3].
Clarity and Validity
The clarity and validity of patent claims are critical for maintaining patent quality. The claims in U.S. Patent 8,324,225 are specific and detailed, ensuring that the invention is well-defined and distinguishable from prior art. This clarity is essential for avoiding disputes and ensuring that the patent provides meaningful protection for the inventors[3].
Key Takeaways
- Patent Claims: U.S. Patent 8,324,225 claims specific pyrrolopyrimidine compounds and their methods of use and manufacture.
- Regulatory Approval: The patent is associated with the FDA-approved drug KISQALI®, used in the treatment of breast cancer.
- Patent Term Extension: The patent term is set to be extended by 879 days due to the regulatory review period.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing litigation against generic manufacturers.
- Generic Availability: No generic version of KISQALI® is currently available in the United States.
FAQs
What is the main compound claimed in U.S. Patent 8,324,225?
The main compound claimed is ribociclib or its pharmaceutically acceptable salt, specifically described in Formula I.
What is the approved product associated with this patent?
The approved product is KISQALI®, which is used in the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
When was the FDA approval for KISQALI® received?
The FDA approval for KISQALI® was received on March 13, 2017.
Is there a generic version of KISQALI® available?
No, there is currently no therapeutically equivalent generic version of KISQALI® available in the United States.
What is the expected expiration date of U.S. Patent 8,324,225 after the requested extension?
The expected expiration date after the requested extension is November 13, 2030.
Sources
- Regulations.gov: Application for Patent Term Extension of U.S. Patent No. 8,324,225.
- Insight.rpxcorp.com: Complaint in the United States District Court for the District of Delaware.
- Hoover Institution: Patent Claims and Patent Scope.
- Federal Register: Notice of Patent Term Extension.
- Drugs.com: Generic Kisqali Availability.
