United States Patent 8,415,355: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,415,355, titled "Pyrrolopyrimidine compounds and their uses," is a significant patent in the pharmaceutical industry, particularly related to the drug KISQALI® (ribociclib succinate). This patent, issued on April 9, 2013, to inventors Christopher Thomas Brain, Moo Je Sung, and Bharat Lagu, is crucial for understanding the intellectual property landscape surrounding this important cancer treatment.
Patent Overview
Title and Abstract
The patent is titled "Pyrrolopyrimidine compounds and their uses" and pertains to compounds of a specific formula, including their pharmaceutically acceptable salts and uses, particularly in the treatment of cancer[5].
Inventors and Assignees
The patent was granted to inventors Christopher Thomas Brain, Moo Je Sung, and Bharat Lagu, with the rights owned by Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd.[2].
Claims
Claim Structure
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
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Claims 1-6: These claims specifically read on the approved product, ribociclib succinate. Claim 1 describes a compound of the formula 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide[1].
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Claim Scope: The claims are structured to cover the compound itself, its pharmaceutically acceptable salts, and methods of using or manufacturing the compound. This ensures broad protection for the invention, including its application in medical treatments.
Patent Scope and Metrics
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length (ICL) and independent claim count (ICC) to measure the breadth and clarity of patent claims. While specific data for U.S. Patent 8,415,355 is not provided in the sources, these metrics are generally used to assess patent quality and scope. Narrower claims, as indicated by shorter ICL and lower ICC, are often associated with higher probabilities of grant and shorter examination processes[3].
Patent Term and Extensions
Original Expiration Date
The original expiration date of U.S. Patent 8,415,355 is February 19, 2031, which includes adjustments for patent term adjustment (PTA) under 35 U.S.C. § 154(b)[1].
Patent Term Extension
An application for patent term extension was filed under 35 U.S.C. § 156, which allows for the extension of the patent term to compensate for the time spent in regulatory review. The extension is limited to a maximum of five years, and in this case, the earlier date between the calculated extension and the regulatory review period is March 13, 2031[1].
Regulatory Review and Approval
NDA Approval
The patent is associated with the New Drug Application (NDA) 209092 for KISQALI®. The NDA approval date is March 13, 2017, which is a critical date for determining the patent term extension[1][4].
Regulatory Review Period
The regulatory review period began on August 26, 2010, and the permission for commercial marketing or use was the first received under Section 505 of the Federal Food, Drug, and Cosmetic Act. This period is significant for calculating the patent term extension[4].
Patent Landscape
Related Patents
U.S. Patent 8,415,355 is part of a group of patents related to ribociclib succinate, including U.S. Patents 8,685,980, 8,962,630, and 9,416,136. These patents collectively protect various aspects of the compound and its uses[2].
Litigation and Enforcement
The owners of these patents, Novartis Pharmaceuticals Corporation and Astex Therapeutics Ltd., are actively engaged in protecting their intellectual property rights. This includes litigation to enforce the patents against potential infringers[2].
Maintenance and Corrections
Maintenance Fees
The first maintenance fee for U.S. Patent 8,415,355 was timely paid on September 22, 2016. No disclaimer or reexamination certificate was issued for this patent[1].
Certificate of Correction
A Certificate of Correction was issued on September 30, 2014, to correct minor errors in the patent specification[1].
Conclusion
U.S. Patent 8,415,355 is a critical component of the intellectual property portfolio for KISQALI®, a significant cancer treatment. The patent's claims are carefully structured to protect the compound, its uses, and manufacturing methods. The patent term extension and regulatory review process highlight the complex interplay between patent law and regulatory approvals. Understanding this patent's scope and claims is essential for navigating the patent landscape in the pharmaceutical industry.
Key Takeaways
- Patent Scope: The patent covers specific pyrrolopyrimidine compounds and their uses.
- Claims: Claims 1-6 read on the approved product, ribociclib succinate.
- Patent Term Extension: The patent term can be extended up to five years to compensate for regulatory review time.
- Regulatory Review: The regulatory review period began on August 26, 2010, and is crucial for determining the patent term extension.
- Related Patents: The patent is part of a group of patents protecting ribociclib succinate.
- Maintenance and Corrections: The patent has had maintenance fees paid and a Certificate of Correction issued.
FAQs
What is the main subject of U.S. Patent 8,415,355?
The main subject of U.S. Patent 8,415,355 is pyrrolopyrimidine compounds, specifically ribociclib succinate, and their uses in medical treatments.
Who are the inventors of U.S. Patent 8,415,355?
The inventors of U.S. Patent 8,415,355 are Christopher Thomas Brain, Moo Je Sung, and Bharat Lagu.
What is the original expiration date of U.S. Patent 8,415,355?
The original expiration date of U.S. Patent 8,415,355 is February 19, 2031.
Can the patent term of U.S. Patent 8,415,355 be extended?
Yes, the patent term can be extended under 35 U.S.C. § 156 to compensate for the time spent in regulatory review, up to a maximum of five years.
What is the significance of the regulatory review period for U.S. Patent 8,415,355?
The regulatory review period, which began on August 26, 2010, is significant for determining the length of the patent term extension.
Are there other related patents to U.S. Patent 8,415,355?
Yes, there are other related patents, including U.S. Patents 8,685,980, 8,962,630, and 9,416,136, which collectively protect various aspects of ribociclib succinate.
