Detailed Analysis of the Scope and Claims of United States Patent 7,459,561
Introduction
United States Patent 7,459,561, issued on December 2, 2008, is a significant patent in the pharmaceutical industry, particularly related to the drug Cresemba. This patent is owned by Basilea Pharmaceutica International Ltd. and covers N-Substituted Carbamoyloxyalkyl-azolium derivatives. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.
Patent Overview
Inventors and Assignee
The patent was invented by a team of researchers including Hiroshi Fukuda, Tadakatsu Hayase, Eisaku Mizuguchi, Nobuo Shimma, Jun Ohwada, Nobuhiro Oikawa, Masahiro Sakaitani, Masao Tsukazaki, and Isao Umeda. The assignee of the patent is Basilea Pharmaceutica International Ltd.[1][4].
Issue Date and Expiration
The patent was issued on December 2, 2008, and its original expiration date was October 31, 2020. However, the patent term has been extended due to regulatory review periods[1][4].
Scope of the Patent
Subject Matter
The patent covers N-Substituted Carbamoyloxyalkyl-azolium derivatives, which are compounds used in the development of pharmaceutical drugs. Specifically, it relates to the drug isavuconazole, marketed as Cresemba, used for treating fungal infections[2].
Claim Structure
The patent claims are structured to protect the specific chemical compounds and their uses. The claims include:
- Independent Claims: These define the broadest scope of the invention. For example, claims related to the specific chemical structure of the N-Substituted Carbamoyloxyalkyl-azolium derivatives.
- Dependent Claims: These narrow down the scope by adding additional limitations to the independent claims, such as specific uses or formulations of the compounds[1].
Patent Claims and Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can indicate the breadth and clarity of the patent. For U.S. Patent 7,459,561, the independent claim length and count would be critical in determining its scope. Generally, narrower claims with fewer words and fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].
Patent Term Extension
Regulatory Review Period
The patent term has been extended under 35 U.S.C. §156 due to the regulatory review period for the drug Cresemba. The extension was calculated based on the regulatory review period, which was reduced by specific days according to 37 C.F.R. §1.775(d)(1)(i) and (iii). The total available extension was determined to be 1264 days, extending the patent term from October 31, 2020, to April 17, 2024[1][4].
Calculation of Extension
The calculation involved reducing the 3528-day regulatory review period by 1242 days under 37 C.F.R. §1.775(d)(1)(i) and further reducing it by 1022 days under 37 C.F.R. §1.775(d)(1)(iii), resulting in the 1264-day extension[1][4].
Patent Landscape
Generic Entry and Competition
The extension of the patent term delays the entry of generic versions of the drug, allowing Basilea Pharmaceutica to maintain market exclusivity for a longer period. This is crucial in the pharmaceutical industry where patent protection is a significant factor in the profitability of drugs[2].
Litigation and Patent Quality
The patent has been subject to detailed scrutiny due to its impact on the market. The clarity and breadth of the claims are important factors in patent quality debates. Broader or unclear claims can lead to increased litigation costs and may impede innovation[3].
Significant Activities During Regulatory Review
The marketing applicant, Basilea Pharmaceutica, undertook several significant activities during the regulatory review period, including clinical trials and regulatory submissions. These activities are detailed in the patent term extension application and are crucial for demonstrating the eligibility for the patent term extension[4].
Conclusion on Patent Eligibility
The patent satisfies all the requirements for a patent term extension under 35 U.S.C. §156(a), including the regulatory review period and the approval of the drug product. The applicant has provided detailed calculations and justifications for the extension, ensuring compliance with all regulatory requirements[1][4].
Key Takeaways
- Patent Scope: U.S. Patent 7,459,561 covers N-Substituted Carbamoyloxyalkyl-azolium derivatives, specifically related to the drug isavuconazole (Cresemba).
- Claim Structure: The patent includes independent and dependent claims defining the chemical compounds and their uses.
- Patent Term Extension: The patent term has been extended by 1264 days due to regulatory review periods.
- Regulatory Review: The extension was calculated based on specific reductions of the regulatory review period.
- Patent Landscape: The extension delays generic entry and maintains market exclusivity, while the clarity and breadth of claims are critical in patent quality debates.
FAQs
What is the subject matter of U.S. Patent 7,459,561?
U.S. Patent 7,459,561 covers N-Substituted Carbamoyloxyalkyl-azolium derivatives, specifically related to the drug isavuconazole (Cresemba).
Who are the inventors and assignee of the patent?
The inventors include Hiroshi Fukuda, Tadakatsu Hayase, Eisaku Mizuguchi, Nobuo Shimma, Jun Ohwada, Nobuhiro Oikawa, Masahiro Sakaitani, Masao Tsukazaki, and Isao Umeda. The assignee is Basilea Pharmaceutica International Ltd.
What is the significance of the patent term extension for U.S. Patent 7,459,561?
The patent term extension delays the entry of generic versions of the drug, allowing Basilea Pharmaceutica to maintain market exclusivity for a longer period.
How was the patent term extension calculated?
The extension was calculated by reducing the 3528-day regulatory review period by 1242 days under 37 C.F.R. §1.775(d)(1)(i) and further reducing it by 1022 days under 37 C.F.R. §1.775(d)(1)(iii), resulting in a 1264-day extension.
What are the implications of the patent claims on patent quality debates?
The clarity and breadth of the claims are critical in patent quality debates, as broader or unclear claims can lead to increased litigation costs and may impede innovation.
Sources
- Regulations.gov: DEC 80 2015 - Regulations.gov
- DrugPatentWatch: Pharmaceutical drugs covered by patent 7,459,561.
- Hoover Institution: Patent Claims and Patent Scope
- Regulations.gov: Mary C. Till - Regulations.gov
- Regulations.gov: FEB t 4 2017 - Regulations.gov
