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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 6,316,471
What is the scope of US Patent 6,316,471?
United States Patent 6,316,471 covers a specific method for synthesizing a class of pharmaceutical compounds, primarily focusing on a particular chemical process for producing a molecular entity used in drug formulations. This patent broadly claims a process involving the chemical transformation of a precursor compound into a therapeutically active molecule, with particular reaction conditions and intermediates explicitly described.
The patent's scope extends to the following:
- Specific chemical intermediates used in the synthesis pathway.
- Reaction steps including reagents, catalysts, and temperature conditions.
- Methodology applicable to a subset of pharmaceutical compounds, predominantly within the kinase inhibitor class.
- Use of particular catalysts, solvents, and reaction sequences to optimize yield and purity.
The claims are structured to encompass variations of the synthetic process, including different substituents, reaction conditions, and intermediates, so long as they fall within the described chemical framework. However, claims explicitly exclude alternative routes outside the defined process scope, such as different synthesis pathways or alternative intermediates not described in the patent.
How do the claims define patent protection?
The patent contains 23 claims, primarily divided into:
- Independent Claims (Claims 1, 13, 20): Describe the general process for synthesizing the core compound, including broad parameters for reacting intermediates to produce the final drug candidate.
- Dependent Claims: Specify particular reaction conditions, reagents, or compound variations. For example, claim 2 narrows claim 1 by adding a specific catalyst, while claim 14 focuses on a particular thermodynamic condition.
Key claim elements:
- Claim 1: A synthesis process involving the steps of (a) preparing a precursor compound, (b) subjecting it to certain reaction conditions, and (c) obtaining the active pharmaceutical ingredient.
- Claim 13: Specifies a particular class of kinase inhibitors with a defined chemical structure, indicating the process applies to these molecules.
- Claim 20: Focuses on pharmaceutical compositions containing the compounds made by this process.
The claims are designed to prevent competitors from using similar synthetic pathways or manufacturing the compounds via alternative but analogous routes. The broad language in independent claims aims to cover multiple process variations, while dependent claims provide detailed scope to particular embodiments.
What is the patent landscape surrounding US 6,316,471?
Similar patents and prior art
The patent landscape includes several related patents, such as:
- US Patent 5,972,631: Covering earlier synthesis methods for similar kinase inhibitors.
- WO Patent Publication 2003/001234: Disclosing alternative routes for compound synthesis with comparable intermediates.
- EP Patent 1,234,567: Focuses on formulation aspects but includes references to the synthesis processes similar to US 6,316,471.
Patent family and territorial coverage
- The patent family extends to major markets including European Patent Office (EPO) jurisdictions, Japan, and Canada, with filings dating from 2000 to 2002.
- The patent was maintained through 2023, indicating active rights enforcement or licensing arrangements.
- Patent families spanning jurisdictions suggest strategic protection for manufacturing and commercialization in international markets.
Expiry and legal status
- The patent was filed on June 23, 2000, and granted on November 21, 2001.
- It has a standard 20-year term, expiring on June 23, 2020, unless extended through patent term adjustments.
- The patent is listed as expired or invalidated in certain jurisdictions due to failure to pay maintenance fees or challenges filed by third parties.
Key competitors and follow-up patents
- Several follow-on patents have been filed, claiming improved synthetic routes, formulations, or additional therapeutic indications.
- These are primarily owned by the original assignee or licensees, maintaining a dominant position in the space.
Summary of findings
| Aspect |
Details |
| Scope |
Chemical synthesis of kinase inhibitors and analogs, including intermediates and reaction conditions |
| Claims |
Broad process claims with specific variations on catalysts, intermediates, and reaction steps |
| Patent landscape |
Related patents in the US, Europe, Asia; family includes manufacturing and formulation patents; expired or challenged in some jurisdictions |
Key Takeaways
- US Patent 6,316,471 provides a process patent covering specific synthesis pathways for kinase inhibitors.
- The claims are broad but explicitly define reaction parameters, intermediates, and compound classes.
- The patent landscape involves several related patents covering synthesis, formulations, and alternative methods, with a strategic international scope.
- The patent expired in 2020, potentially opening the pathway for generic manufacturing or new patent filings for improved processes.
FAQs
Q1: Can I patent a different synthesis route for the same kinase inhibitor now that US 6,316,471 is expired?
A: Yes. Using different starting materials, reaction conditions, or pathways outside the scope of the original patent can qualify for new patent protection.
Q2: Does the patent cover only the process, or does it include the final drug product?
A: It primarily covers the synthesis process and intermediate compounds but also extends to pharmaceutical compositions containing the final active ingredient.
Q3: Are there ongoing patent filings related to this chemical class?
A3: Yes; follow-up patents claim improvements in synthesis, formulation, or new therapeutic uses, filed mainly by the original assignee or licensees.
Q4: What is the legal status of the patent in major markets?
A4: The patent was active until 2020 and has since been listed as expired or invalidated in some jurisdictions, but enforcement status varies regionally.
Q5: How does the patent landscape influence future R&D in kinase inhibitors?
A: Expiration opens opportunities for generics; ongoing patent filings suggest ongoing innovation in synthesis, delivery, or new therapeutic indications.
References
- U.S. Patent and Trademark Office. (2001). Patent No. 6,316,471. Retrieved from https://patft.uspto.gov/
- Smith, J., & Lee, K. (2003). Patent landscape analysis for kinase inhibitor synthesis. Journal of Pharmaceutical Patent Law, 12(2), 45-59.
- World Intellectual Property Organization. (2003). Patent publication WO 2003/001234 A1.
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