United States Patent RE46284: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent RE46284, titled "Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor," is a reissue patent that plays a crucial role in the treatment of various types of cancer. This patent is associated with the drug TAS-102, which is marketed under the brand name Lonsurf. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Reissue Application
The patent RE46284 is a reissue application of U.S. Pat. No. 7,799,783, which was issued from application Ser. No. 11/042,059 filed on January 26, 2005. This reissue indicates that the original patent has been re-examined and potentially modified to clarify or broaden its claims[4].
Scope of the Patent
Therapeutic Use
The patent covers a method for treating cancer using a composition containing α, α, α-trifluorothymidine (FTD) and a thymidine phosphorylase inhibitor (TPI). FTD is a nucleoside analogue that has been shown to have significant therapeutic effects against various cancers. The inclusion of TPI prevents the degradation of FTD, allowing for its oral administration and maintaining its blood concentration[4].
Types of Cancer Treated
The method outlined in the patent is intended for treating a wide range of cancers, including but not limited to:
- Esophageal
- Gastric
- Liver
- Gallbladder-bile duct
- Pancreatic
- Colorectal
- Head and neck
- Lung
- Breast
- Cervical
- Ovarian
- Bladder
- Prostate cancers
- Cancer of the testicles
- Soft tissue and bone sarcomas
- Skin cancer
- Malignant lymphoma
- Leukemia
- Brain tumors
The patent particularly emphasizes its application in malignant solid cancers such as gastric, pancreatic, breast, colorectal, head and neck, gallbladder-bile duct, and lung cancers[4].
Claims of the Patent
Key Components
The patent claims revolve around the administration of a composition containing FTD and TPI. Here are the key components:
- α, α, α-Trifluorothymidine (FTD): A nucleoside analogue with a trifluoromethyl group substitution at the 5-position of thymidine.
- Thymidine Phosphorylase Inhibitor (TPI): Specifically, 5-chloro-6-(1-(2-iminopyrrolidinyl)methyl)uracil hydrochloride, which prevents the degradation of FTD and allows for its oral administration[4].
Administration Method
The method involves orally administering the composition in a specific molar ratio of FTD to TPI, typically 1:0.5. This ratio is crucial for maintaining the therapeutic efficacy of FTD by preventing its premature degradation[4].
Patent Landscape
Related Patents
The patent RE46284 is part of a broader portfolio of patents related to Lonsurf, which includes multiple patents covering various aspects such as:
- Methods for treating cancer patients with severe renal impairment[1].
- Stable crystal forms of tipiracil hydrochloride and their crystallization methods[1].
These patents collectively protect the intellectual property surrounding the drug TAS-102, ensuring its exclusivity in the market for treating specific types of cancer.
Competitor Landscape
The patent landscape in the oncology sector is highly competitive, with multiple pharmaceutical companies and research institutions actively involved in drug discovery and development. The use of patent landscaping tools and knowledge graphs, as described in other studies, helps in identifying trends and applications in patents for various diseases, including cancer[3].
Regulatory and Legal Aspects
The patent is subject to regulatory oversight, particularly by the FDA. The listing of patents in the Orange Book and disputes over patent claims and use codes are common in the pharmaceutical industry. The Hatch-Waxman Act and accompanying FDA regulations govern these disputes, ensuring that there are clear procedures for resolving issues related to the scope and validity of listed patents[2].
Clinical and Market Impact
Approval and Use
TAS-102, the drug associated with this patent, has been approved for the treatment of metastatic colorectal cancer and metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have been previously treated with certain types of chemotherapy. The approval is based on clinical trials that demonstrated the efficacy and safety of the drug in these patient populations[1].
Market Dominance
The exclusive rights granted by this patent and related patents ensure that Lonsurf remains a dominant player in the market for treating these specific types of cancer. This exclusivity is crucial for the drug's commercial success and for the company's ability to recoup its investment in research and development.
Key Takeaways
- Therapeutic Use: The patent covers a method for treating various types of cancer using a composition containing FTD and TPI.
- Scope: The method is applicable to a wide range of cancers, with a focus on malignant solid cancers.
- Claims: The patent claims center around the administration of FTD and TPI in a specific molar ratio.
- Patent Landscape: The patent is part of a broader portfolio protecting the drug TAS-102, with multiple related patents and a competitive landscape in the oncology sector.
- Regulatory and Legal Aspects: The patent is subject to FDA regulations and the Hatch-Waxman Act, with clear procedures for resolving disputes over patent claims.
FAQs
What is the primary use of the drug associated with United States Patent RE46284?
The primary use of the drug associated with this patent is the treatment of various types of cancer, including metastatic colorectal cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.
What are the key components of the composition described in the patent?
The key components are α, α, α-trifluorothymidine (FTD) and a thymidine phosphorylase inhibitor (TPI), specifically 5-chloro-6-(1-(2-iminopyrrolidinyl)methyl)uracil hydrochloride.
How is the composition administered?
The composition is administered orally in a specific molar ratio of FTD to TPI, typically 1:0.5.
What is the significance of the thymidine phosphorylase inhibitor in the composition?
The thymidine phosphorylase inhibitor prevents the degradation of FTD, allowing for its oral administration and maintaining its therapeutic efficacy.
How does this patent fit into the broader patent landscape for cancer treatments?
This patent is part of a broader portfolio of patents related to Lonsurf, protecting the intellectual property surrounding the drug TAS-102 and ensuring its exclusivity in the market for treating specific types of cancer.
What regulatory frameworks govern disputes related to this patent?
The patent is subject to FDA regulations and the Hatch-Waxman Act, which provide clear procedures for resolving disputes over patent claims and use codes.
Sources
- Drug Patent Watch - Lonsurf Drug Patent Profile
- United States District Court - In the United States District Court - District of Delaware
- BioRxiv - A novel approach to understand patents from the drug discovery perspective
- Google Patents - Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor
