Detailed Analysis of the Scope and Claims of United States Patent 6,762,180
Introduction
United States Patent 6,762,180, titled "Substituted indolines which inhibit receptor tyrosine kinases," is a significant patent held by Boehringer Ingelheim Pharma GmbH & Co. KG. This patent is crucial for understanding the intellectual property landscape related to indolinones and their applications in medical treatments.
Background and Invention
The patent, filed on October 3, 2000, and granted on July 13, 2004, pertains to substituted indolines that have an inhibitory effect on receptor tyrosine kinases and cyclin/CDK complexes. These compounds are important in the treatment and prevention of various diseases, including fibrotic diseases and conditions involving abnormal cell proliferation[4].
Scope of the Patent
Chemical Structure
The patent describes indolinones of a specific general formula, which includes various substitutions that enhance their biological activity. These compounds are characterized by their ability to inhibit receptor tyrosine kinases, which are enzymes involved in the signaling pathways that regulate cell growth and division[4].
Biological Activity
The indolinones claimed in this patent have been shown to inhibit the proliferation of endothelial cells, making them potential therapeutic agents for diseases such as cancer and fibrosis. The inhibitory effect on receptor tyrosine kinases is a key aspect of their biological activity[4].
Claims of the Patent
Specific Claims
The patent includes several claims that define the scope of the invention. Claim 8, for example, specifies a particular compound: "3-Z-1-N-methyl-amino)-anilino)-t-phenyl-methylene)-6-methoxycarbonyl-2-indolinone or a pharmaceutically acceptable salt thereof." This claim is critical as it reads directly on the approved product, which is used in the treatment of fibrotic diseases[1].
Method of Use and Manufacturing
The patent claims not only the compounds themselves but also methods of using and manufacturing these compounds. This comprehensive coverage ensures that any use or production of these indolinones would fall under the patent's protection[1].
Regulatory Review and Approval
FDA Approval
The approved product related to this patent underwent regulatory review under Section 505 of the Federal Food, Drug & Cosmetic Act (FDCA). Specifically, it was reviewed under Section 505(b)(1) of the FDCA and received permission for commercial marketing on October 15, 2014[1].
Patent Expiration and Extensions
Original Expiration Date
The nominal expiration date of the patent was October 3, 2020, which is 20 years from the date the patent application was filed. However, the patent term has been extended by 68 days due to delays in the regulatory review process, resulting in an actual expiration date of December 10, 2020[1].
Current Status
As of the latest updates, the patent is set to expire on October 1, 2025, considering any additional extensions or adjustments[2].
Patent Landscape and Competitors
Related Patents
Boehringer Ingelheim holds several related patents that extend the protection of indolinones and their applications. For example, patents such as 10,154,990 and 7,119,093 also cover various aspects of indolinones, with expiration dates ranging from February 21, 2024, to July 8, 2026[2].
Generic Availability
Currently, there is no therapeutically equivalent generic version of the product protected by this patent available in the United States. This indicates that the patent remains a significant barrier to entry for generic manufacturers until its expiration[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent and related patents, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify gaps or opportunities in the intellectual property landscape. It ensures that all claims are actively protecting the intended technology and highlights areas where additional coverage may be needed[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that facilitate the review of patent coverage by technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, making it easier to spot gaps in current coverage and identify future design opportunities[3].
Industry Impact and Future Directions
Therapeutic Applications
The compounds protected by this patent are crucial in the treatment of fibrotic diseases, such as idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). The expiration of this patent could open up the market for generic versions of these treatments, potentially increasing access and reducing costs for patients[5].
Future Research and Development
The expiration of key patents in this area may also spur further research and development as companies seek to develop new compounds or improve existing ones. This could lead to the discovery of new therapeutic agents with enhanced efficacy and safety profiles.
Key Takeaways
- Patent Scope: United States Patent 6,762,180 covers substituted indolines with inhibitory effects on receptor tyrosine kinases and cyclin/CDK complexes.
- Claims: The patent includes specific claims for compounds and methods of use and manufacturing.
- Regulatory Approval: The product underwent FDA approval under Section 505 of the FDCA.
- Expiration Date: The patent is set to expire on October 1, 2025.
- Related Patents: Other patents held by Boehringer Ingelheim extend the protection of indolinones.
- Generic Availability: No generic version is currently available in the United States.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing the patent landscape.
FAQs
Q: What is the primary focus of United States Patent 6,762,180?
A: The primary focus is on substituted indolines that inhibit receptor tyrosine kinases and cyclin/CDK complexes.
Q: When is the patent set to expire?
A: The patent is set to expire on October 1, 2025.
Q: Has a generic version of the product protected by this patent been approved?
A: No, there is currently no therapeutically equivalent generic version available in the United States.
Q: What is the significance of the regulatory review under Section 505 of the FDCA?
A: The regulatory review under Section 505 of the FDCA ensured the product met safety and efficacy standards before being approved for commercial marketing.
Q: How can companies manage their patent landscape effectively?
A: Companies can use tools like Claim Coverage Matrix and interactive claim charts to manage their patent landscape and identify gaps or opportunities.
Sources:
- In re Issued Inventors For U.S. Patent 6,762,180 - Regulations.gov
- Generic Ofev Availability - Drugs.com
- Patent Analytics - SLWIP
- US6762180B1 - Substituted indolines which inhibit receptor tyrosine kinases - Google Patents
- Nintedanib Capsules - FDA.gov
