United States Patent 7,230,098: A Comprehensive Analysis
Introduction
United States Patent 7,230,098, titled "Aminoheteroaryl compounds as protein kinase inhibitors," is a crucial patent in the pharmaceutical industry, particularly for the treatment of certain types of cancer. This patent is owned by Pfizer Inc. and protects the active ingredient of the drug Xalkori (crizotinib).
Inventors and Assignees
The patent was granted to a team of inventors including Jingrong Jean Cui, Dilip Bhumralkar, Iriny Botrous, Ji Yu Chu, Lee A. Funk, Cathleen Elizabeth Hanau, G. Davis Harris, Lei Jia, Joanne Johnson, Stephen A. Kolodziej, Pei-Pei Kung, Xiaoyuan (Sharon) Li, Jason (Qishen) Lin, Jerry Jialun Meng, Mitchell David Nambu, Christopher G. Nelson, Mason Alan Pairish, Hong Shen, Michelle Tran-Dube, Allison Walter, Ang-Jie Zhang, and Jennifer Zhang. The patent was assigned to Pfizer Inc. after being initially filed by Sugen Inc.[1][2][5].
Patent Claims
The patent claims a genus of chemical compounds, specifically aminoheteroaryl compounds, that act as protein kinase inhibitors. Here are the key aspects of the claims:
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Claim 1: This claim covers the genus of chemical compounds of a specific formula, including aminoheteroaryl compounds where Y is CR1R2, R1 is selected from C6-12 aryl, 5-12 membered heteroaryl, C3-12 cycloalkyl, or 3-12 membered heteroalicyclic, and each hydrogen in R1 is optionally substituted by one or more R3 groups. This claim specifically reads on the approved product crizotinib[1][4].
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Claim 2: This claim is similar to Claim 1 but with a restricted definition of A2, which can be C6-12 aryl substituted by three R3 groups that are each halogen[1].
Patent Expiration and Adjustments
The normal expiration date of U.S. Patent 7,230,098 is February 26, 2024, which is 20 years from the date the application was filed in the United States (February 26, 2004). However, the patent received a 369-day patent term adjustment (PTA) under 35 U.S.C. ยง 154(b), resulting in an extended expiration date of March 1, 2025. However, another source indicates the expiration date as August 26, 2025[1][2][5].
Patent Landscape and Related Patents
Xalkori, the drug protected by this patent, is also covered by several other patents that extend its market exclusivity. Here are some key patents related to Xalkori:
- US7858643: Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors, expiring on October 8, 2029[2][5].
- US7825137: Method of treating abnormal cell growth, expiring on May 12, 2027[2][5].
- US8785632: Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors, expiring on March 1, 2025[2][5].
- US8217057: Polymorphs of a c-MET/HGFR inhibitor, expiring on November 6, 2029[2][5].
These patents collectively protect the active ingredient, dosage forms, and methods of administration of Xalkori, ensuring that no generic versions can be marketed until the latest of these patents expires.
Exclusivities and Generic Launch
In addition to the patent protection, Xalkori has been granted several exclusivities by the FDA, which further delay the generic launch. The estimated generic launch date for Xalkori, based on the last expiry date of its patents and exclusivities, is November 6, 2029[2][5].
Legal Activities and Challenges
The patents protecting Xalkori have been subject to various legal activities, including maintenance fee payments and potential challenges. Tracking these activities is crucial for understanding the patent landscape and predicting any changes in the generic launch date. For instance, payments of maintenance fees and any amendments or term extensions can affect the patent's expiry date[2].
Global Patent Protection
Xalkori is protected by patents in multiple countries, not just the United States. Understanding the global patent landscape is essential for strategizing market entry, as it helps identify markets with weaker patent protection that could be ideal for generic entry[2].
Impact on Market Dominance
The robust patent protection and exclusivities surrounding Xalkori have allowed Pfizer to maintain market dominance for this drug. The extended exclusivity period ensures that Pfizer can continue to market Xalkori without generic competition until the patents expire, which is crucial for the company's revenue and market position.
Key Takeaways
- Patent Claims: U.S. Patent 7,230,098 claims aminoheteroaryl compounds as protein kinase inhibitors, specifically protecting the active ingredient of Xalkori.
- Expiration Date: The patent's expiration date is extended to August 26, 2025, or March 1, 2025, depending on the source.
- Related Patents: Xalkori is protected by multiple patents extending its market exclusivity until November 6, 2029.
- Exclusivities: FDA-granted exclusivities further delay the generic launch of Xalkori.
- Global Protection: Xalkori is protected by patents in multiple countries, influencing global market strategies.
- Market Impact: The patent and exclusivity landscape ensures Pfizer's market dominance for Xalkori until the patents expire.
FAQs
Q: What is the main subject of U.S. Patent 7,230,098?
A: The main subject is aminoheteroaryl compounds that act as protein kinase inhibitors, specifically protecting the active ingredient of the drug Xalkori.
Q: Who are the inventors and assignees of this patent?
A: The inventors include a team of researchers from Sugen Inc., and the patent is assigned to Pfizer Inc.
Q: What is the estimated generic launch date for Xalkori?
A: The estimated generic launch date for Xalkori is November 6, 2029, based on the last expiry date of its patents and exclusivities.
Q: How does the patent term adjustment affect the expiration date of U.S. Patent 7,230,098?
A: The patent term adjustment extends the expiration date from February 26, 2024, to either March 1, 2025, or August 26, 2025, depending on the source.
Q: What other patents protect Xalkori besides U.S. Patent 7,230,098?
A: Xalkori is also protected by patents such as US7858643, US7825137, US8785632, and US8217057, which cover various aspects of the drug.
Cited Sources
- Untitled - U.S. Patent No. 7,230,098, ISSUED: JUNE 12,2007[1].
- Xalkori patent expiration - Pharsight[2].
- Patent Dispute Report: 2023 in Review - Unified Patents[3].
- US7230098B2 - Aminoheteroaryl compounds as protein kinase inhibitors - Google Patents[4].
- Generic Xalkori Availability - Drugs.com[5].
