Transient Protection of Normal Cells During Chemotherapy: A Detailed Analysis of US Patent 11,040,042
Introduction
The protection of healthy cells during chemotherapy is a critical area of research, given the debilitating side effects of traditional chemotherapeutic agents. US Patent 11,040,042, assigned to G1 Therapeutics, Inc., addresses this issue by introducing improved compounds, compositions, and methods for transiently protecting normal cells, particularly hematopoietic stem and progenitor cells (HSPC) and renal cells.
Background
Chemotherapy, while effective against cancer cells, often damages healthy cells, leading to severe side effects such as myelosuppression and renal toxicity. The need for selective protection of normal cells has driven the development of innovative therapeutic strategies.
Patent Overview
Inventors and Assignee
US Patent 11,040,042 was invented by Jay Copeland Strum, John Emerson Bisi, Patrick Joseph Roberts, and Francis Xavier Tavares, and is assigned to G1 Therapeutics, Inc.[2].
Publication and Expiration Dates
The patent was issued on August 10, 2021, and is set to expire on March 14, 2034[2].
Key Claims and Innovations
CDK 4/6 Inhibitors
The patent discloses the use of highly selective and short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors. These compounds are designed to protect healthy cells from damage caused by DNA-damaging chemotherapeutic agents. The transient nature of these inhibitors ensures that they do not interfere with the long-term efficacy of chemotherapy[2].
Protection of HSPC and Renal Cells
The invention specifically targets the protection of hematopoietic stem and progenitor cells (HSPC) and renal cells. These cell types are particularly vulnerable to the adverse effects of chemotherapy, and their protection is crucial for maintaining patient health and reducing the risk of long-term complications[2].
Pharmaceutical Compositions
The patent includes pharmaceutical compositions that incorporate the disclosed CDK 4/6 inhibitors. These compositions are formulated to ensure optimal delivery and efficacy of the protective compounds during chemotherapy regimens[2].
Mechanism of Action
Selective Inhibition
The CDK 4/6 inhibitors work by selectively inhibiting the cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle. By transiently inhibiting these kinases, the compounds prevent the entry of healthy cells into the cell cycle, thereby protecting them from the cytotoxic effects of chemotherapy[2].
Transient Effect
The transient nature of these inhibitors is crucial. They are designed to be active only during the period when chemotherapy is administered, ensuring that the protective effect is limited to the duration of chemotherapy exposure. This approach minimizes the risk of interfering with the therapeutic efficacy of chemotherapy or causing long-term side effects[2].
Patent Landscape
Related Patents
Several related patents have been issued to G1 Therapeutics, Inc., including patents 10,085,992, 10,189,849, 10,189,850, and 10,927,120. These patents also relate to CDK 4/6 inhibitors and their use in protecting healthy cells during chemotherapy. The patent landscape indicates a strong focus on developing and refining these protective strategies[2].
Patent Expiration Dates
The expiration dates of these related patents vary, with some expiring as early as October 25, 2031, and others as late as July 23, 2039. This staggered expiration timeline suggests a strategic approach to maintaining intellectual property protection over an extended period[2].
Intellectual Property and Exclusivity
Drug Patents and Exclusivity
The patent assigns exclusive legal rights to G1 Therapeutics, Inc., allowing the company to protect its proprietary chemical formulations. The patent term, typically 20 years from the date of filing, can be influenced by various factors, including the development of new formulations and patent infringement litigation[2].
Impact on Innovation
The granting of these patents can have a dual impact on innovation. On one hand, they provide a financial incentive for companies to invest in research and development. On the other hand, overly broad patents can potentially stifle innovation by increasing licensing and litigation costs[3].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Clinical and Market Implications
Clinical Benefits
The transient protection of normal cells during chemotherapy can significantly reduce the side effects associated with traditional chemotherapy, improving patient outcomes and quality of life. This approach also has the potential to enable higher doses or more frequent administration of chemotherapy, enhancing its efficacy[2].
Market Potential
Given the significant clinical benefits, these protective compounds have substantial market potential. They could become a standard adjunct therapy in chemotherapy regimens, providing a competitive edge to companies like G1 Therapeutics, Inc. that hold the intellectual property rights[2].
Conclusion
US Patent 11,040,042 represents a significant advancement in the protection of healthy cells during chemotherapy. The use of transient CDK 4/6 inhibitors offers a promising strategy for reducing the adverse effects of chemotherapy, enhancing patient care, and potentially improving treatment outcomes.
Key Takeaways
- Selective Protection: The patent discloses compounds that selectively protect healthy cells, particularly HSPC and renal cells, from chemotherapy-induced damage.
- Transient Action: The CDK 4/6 inhibitors are designed to be transiently active, ensuring they do not interfere with long-term chemotherapy efficacy.
- Pharmaceutical Compositions: The patent includes formulations for optimal delivery of these protective compounds.
- Patent Landscape: The patent is part of a broader portfolio of related patents held by G1 Therapeutics, Inc.
- Clinical and Market Implications: The technology has significant potential to improve patient outcomes and market competitiveness.
FAQs
What is the primary focus of US Patent 11,040,042?
The primary focus is on the transient protection of healthy cells, particularly hematopoietic stem and progenitor cells (HSPC) and renal cells, during chemotherapy using CDK 4/6 inhibitors.
Who are the inventors of this patent?
The inventors are Jay Copeland Strum, John Emerson Bisi, Patrick Joseph Roberts, and Francis Xavier Tavares.
What is the expiration date of this patent?
The patent is set to expire on March 14, 2034.
How do the CDK 4/6 inhibitors work?
These inhibitors selectively inhibit cyclin-dependent kinases 4 and 6, preventing healthy cells from entering the cell cycle and thus protecting them from chemotherapy-induced damage.
What are the potential clinical benefits of this technology?
The technology can reduce the side effects of chemotherapy, improve patient outcomes, and potentially enable higher doses or more frequent administration of chemotherapy.
