United States Patent 10,456,399: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,456,399, titled "Method for treating cancer patients with severe renal impairment," is a significant patent in the pharmaceutical industry, particularly in the treatment of cancer. This patent, issued to Taiho Pharmaceutical Co., Ltd., protects a specific method of treating cancer patients with severe renal impairment. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventor and Assignee
The patent was invented by Yoshida Kenichiro and assigned to Taiho Pharmaceutical Co., Ltd.[2][4].
Issue Date and Expiration
The patent was issued on October 29, 2019, and is set to expire on February 3, 2037[2][4].
Scope of the Patent
Method of Treatment
The patent describes a method for treating cancer in patients with severe renal impairment, specifically those with a creatinine clearance of 15 mL/min or more and less than 30 mL/min. The method involves administering a combination drug containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5. The drug is administered in a dose of 30 to 50 mg/m²/day as FTD-equivalent, divided into two to four times a day, and taken orally[2][4].
Claims of the Patent
Specific Claims
The patent claims are specific to the method of treating cancer patients with severe renal impairment. It does not claim methods of treating patients who do not have severe renal impairment. The claims are narrowly focused on the dosing regimen and the specific patient population with severe renal impairment[5].
Patent Use Code
The patent has a use code (U-2642) that specifies the method of treating cancer by detecting a patient's creatinine clearance and administering the specified drug regimen. This use code is crucial for determining the scope of protection and any potential barriers to generic drug approval[1][2].
Patent Landscape
Related Patents
There are other related patents held by Taiho Pharmaceutical Co., Ltd., such as Patent 10,457,666, which covers a stable crystal form of tipiracil hydrochloride and its crystallization method. Another related patent is 10,960,004, which also pertains to the method of treating cancer patients with severe renal impairment, although it was issued later and has a different focus[2].
Generic Drug Approval
The patent landscape affects the approval of generic drugs. For a generic version of the drug to be approved, the ANDA (Abbreviated New Drug Application) applicant must address the patents listed in the Orange Book. This includes submitting either a paragraph III certification (delaying approval until the patent expires), a paragraph IV certification (challenging the patent's validity or non-infringement), or a statement that the patent does not claim a use for which the ANDA is seeking approval[1].
Impact on Generic Drug Market
Exclusivity and Patent Protection
The patent provides exclusivity to Taiho Pharmaceutical Co., Ltd. until its expiration in 2037. This exclusivity period, combined with any FDA-granted exclusivity, can significantly delay the entry of generic versions of the drug into the market. Generic drug manufacturers must navigate these patent protections carefully to avoid infringement and ensure their products are approved by the FDA[2][3].
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. Narrower claims are generally associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims to ensure clarity and validity[3].
Clarity and Validity
The clarity and validity of patent claims are crucial. Broad or unclear claims can lead to increased licensing and litigation costs, potentially diminishing innovation incentives. The patent in question has specific and clear claims, which helps in maintaining its validity and scope[3].
Regulatory Considerations
FDA Requirements
The FDA requires NDA applicants to submit patent information, which is then published in the Orange Book. For method-of-use patents, the FDA evaluates whether the differences in labeling between the RLD (Reference Listed Drug) and the ANDA product affect safety and efficacy for non-protected conditions of use. If the differences do not render the ANDA product less safe or effective, the method-of-use patent will not serve as a barrier to ANDA approval[1].
Conclusion
United States Patent 10,456,399 is a critical patent in the treatment of cancer patients with severe renal impairment. Its specific claims and narrow scope protect a unique method of treatment, ensuring exclusivity for Taiho Pharmaceutical Co., Ltd. until its expiration in 2037. The patent landscape, including related patents and regulatory requirements, plays a significant role in the approval of generic drugs and the overall market dynamics.
Key Takeaways
- Specific Method of Treatment: The patent protects a method for treating cancer patients with severe renal impairment using a specific drug regimen.
- Exclusivity: The patent provides exclusivity to Taiho Pharmaceutical Co., Ltd. until its expiration in 2037.
- Generic Drug Approval: Generic drug manufacturers must address the patent protections through paragraph III or IV certifications or statements.
- Patent Scope and Quality: The patent has clear and specific claims, which are important for maintaining its validity and scope.
- Regulatory Considerations: The FDA's requirements for patent information and labeling differences are crucial for ANDA approval.
FAQs
What is the main claim of United States Patent 10,456,399?
The main claim is a method for treating cancer patients with severe renal impairment using a specific combination drug regimen.
Who is the assignee of this patent?
The assignee is Taiho Pharmaceutical Co., Ltd.
When does the patent expire?
The patent expires on February 3, 2037.
How does this patent affect generic drug approval?
Generic drug manufacturers must submit either a paragraph III or IV certification or a statement addressing the patent to avoid infringement and ensure FDA approval.
What is the significance of the use code (U-2642) in this patent?
The use code specifies the method of treating cancer by detecting a patient's creatinine clearance and administering the specified drug regimen, which is crucial for determining the scope of protection.
Cited Sources
- Docket No. FDA-2022-P-0155 - Regulations.gov
- Generic Lonsurf Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Method for treating cancer patients with severe renal impairment - Google Patents
- HYMAN, PHELPS & MCNAMARA, P.C. - Regulations.gov
