Detailed Analysis of the Scope and Claims of United States Patent 7,173,038
Introduction
United States Patent 7,173,038, granted to AstraZeneca AB, is a significant patent in the pharmaceutical sector, particularly in the area of cancer treatment. This patent covers quinazoline derivatives that act as VEGF (Vascular Endothelial Growth Factor) inhibitors, which are crucial in the treatment of various cancers.
Background and Inventors
The patent was granted on February 6, 2007, to inventors Andrew Peter Thomas, Elaine Sophie Elizabeth Stokes, and Laurent Francois Andre Hennequin. The patent is assigned to AstraZeneca AB, a company incorporated in Sweden[1].
Patent Claims
Claims to the Approved Product
The patent includes several claims that read on the approved product. Specifically, claims 1, 2, 3, 4, 5, 6, 7, 8, and 11 of U.S. Patent 7,173,038 encompass the approved product. These claims define the chemical structure of the quinazoline derivatives, including specific substituents and moieties[1].
Claim 1 Example
Claim 1 reads:
"A quinazoline derivative of the formula I:
wherein: m is an integer from 1 to 3; R1 represents halogeno or C1-3alkyl; X1 represents -O-; R2 is selected from one of the following three groups: 1) C1-5alkylR3, wherein R3 is piperidin-4-yl which may bear one or two substituents selected from hydroxy, halogeno, C1-4alkyl, C1-4hydroxyalkyl and C1-4alkoxy; 2) C2-5alkenyIR3, wherein R3 is as defined herein; 3) C2-5alkynyIR3, wherein R3 is as defined herein;"[1].
Claims to the Method of Manufacturing the Approved Product
The patent also includes claims related to the method of manufacturing the approved product. Specifically, claim 10 of U.S. Patent 7,173,038 encompasses a process for the preparation of the quinazoline derivative. This claim details the reaction steps involved in synthesizing the compound[1].
Claim 10 Example
Claim 10 reads:
"A process for the preparation of a quinazoline derivative of formula I, as defined in claim 1, or a salt thereof which comprises: (a) the reaction of a compound of the formula III: with a compound of the formula IV:"[1].
No Claims to the Method of Using the Approved Product
It is noteworthy that there are no claims in U.S. Patent 7,173,038 directed towards a method of using the approved product[1].
Patent Term Extension
AstraZeneca AB has sought an extension of the patent term for U.S. Patent 7,173,038 under the Drug Price Competition and Patent Term Restoration Act of 1984. This extension is based on the regulatory review period for the approved product. The application for extension highlights that the patent claims read on the approved product and demonstrates how these claims are relevant to the product's approval[2][4].
Regulatory Review Period
The regulatory review period for this patent is significant, as it affects the patent term extension. The applicant claims April 20, 2000, as the date of submission of the first regulatory submission, and the patent term extension is sought based on this period[2].
Patent Landscape
Related Patents
AstraZeneca AB has also filed for patent term extensions for related patents, such as U.S. Patent RE42,353, which is a reissue patent. These patents are often related to the same regulatory review period, and the company must elect which patent to extend under the relevant regulations[1][4].
Industry Impact
The quinazoline derivatives covered by U.S. Patent 7,173,038 are crucial in cancer treatment, particularly as VEGF inhibitors. These compounds inhibit angiogenesis, the process of new blood vessel formation, which is a key factor in tumor growth. The patent's scope and claims are therefore highly relevant to the development and marketing of cancer therapies[5].
Economic and Legal Implications
Patent Scope Measurements
The scope of a patent like U.S. Patent 7,173,038 can be measured using various metrics, such as the number of claims, the breadth of claims, and the dependency between claims. The USPTO's Patent Claims Research Dataset provides detailed information on such metrics, which can help in understanding the economic and legal implications of the patent[3].
Market Domination
Patents like U.S. Patent 7,173,038 can provide significant market exclusivity to the patent holder, allowing them to dominate the market for the approved product. This exclusivity can impact competition and innovation in the pharmaceutical sector.
Conclusion
United States Patent 7,173,038 is a critical patent in the field of cancer treatment, covering quinazoline derivatives that act as VEGF inhibitors. The patent's claims are detailed and specific, covering both the approved product and the method of manufacturing it. The patent term extension sought by AstraZeneca AB highlights the regulatory complexities and the importance of these patents in the pharmaceutical industry.
Key Takeaways
- Patent Coverage: U.S. Patent 7,173,038 covers quinazoline derivatives as VEGF inhibitors.
- Claims: The patent includes claims for the approved product and the method of manufacturing it.
- Patent Term Extension: The patent term extension is sought based on the regulatory review period.
- Regulatory Review: The regulatory review period is crucial for determining the patent term extension.
- Industry Impact: The patent is significant in cancer treatment and affects market competition.
FAQs
Q: What is the main subject of U.S. Patent 7,173,038?
A: The main subject of U.S. Patent 7,173,038 is quinazoline derivatives that act as VEGF inhibitors.
Q: Who are the inventors of U.S. Patent 7,173,038?
A: The inventors are Andrew Peter Thomas, Elaine Sophie Elizabeth Stokes, and Laurent Francois Andre Hennequin.
Q: What is the significance of the patent term extension for U.S. Patent 7,173,038?
A: The patent term extension is sought to extend the exclusivity period based on the regulatory review period, which is crucial for maintaining market exclusivity.
Q: Are there any related patents to U.S. Patent 7,173,038?
A: Yes, there are related patents such as U.S. Patent RE42,353, which is a reissue patent and is part of the same regulatory review period.
Q: How does U.S. Patent 7,173,038 impact the pharmaceutical industry?
A: The patent impacts the industry by providing market exclusivity for the approved product, affecting competition and innovation in cancer treatment.
Sources
- U.S. Patent and Trademark Office, "In re United States Patent No. 7,173,038" [PDF].
- Federal Register, "Patent Term Restoration Application for Vandetanib (U.S. Patent No. 7,173,038)".
- USPTO, "Patent Claims Research Dataset".
- U.S. Patent and Trademark Office, "PA"ENTd~NSION - Regulations.gov".
- Unified Patents, "US-20100215773-A1 | Unified Patents".
