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Patent landscape, scope, and claims: |
Overview of U.S. Patent 5,563,165
U.S. Patent 5,563,165, granted on October 8, 1996, to E.I. du Pont de Nemours and Company, claims a method for producing 2,4-diamino-6-chloropyrimidine derivatives through specific chemical processes. This patent primarily covers chemical synthesis techniques used in drug manufacturing, particularly for antiviral, anticancer, or other therapeutic agents that incorporate pyrimidine derivatives.
What Is the Scope of U.S. Patent 5,563,165?
Claims Breakdown
The patent contains 16 claims, with claims 1-3 being independent. The claims define the exclusive rights over a process for synthesizing a class of pyrimidine derivatives.
Independent Claims
- Claim 1: Describes a method for preparing 2,4-diamino-6-chloropyrimidine compounds involving chlorination of specific precursor compounds with a chlorinating agent under controlled conditions. It specifies the use of certain solvents, temperatures, and reaction durations.
- Claim 2: Extends claim 1 by including optional purification steps, focusing on the isolation of the target compound.
- Claim 3: Covers the process of further converting the synthesized pyrimidine derivative into functionalized derivatives for pharmaceutical applications.
Dependent Claims
- Claims 4-16 specify particular reaction conditions, such as specific solvents, catalysts, temperatures, and additional substitutions on the pyrimidine ring. These narrow the scope to particular embodiments and modifications of the process described in independent claims 1-3.
Core Patent Concepts and Limitations
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The patent's claims broadly cover chlorination methods for pyrimidine synthesis, as well as subsequent modifications.
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The claims emphasize specific chemical reaction conditions, including temperature ranges (e.g., -10°C to 50°C), chlorinating agents (e.g., phosphorus oxychloride), and solvents (e.g., acetonitrile, dichloromethane).
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The patent does not extend to the final pharmaceutical compounds' therapeutic uses or formulations but focuses on the synthesis process.
Patent Landscape and Validity
Timeframe and Patent Term
- Filing Date: December 7, 1994.
- Patent Expiration: December 7, 2011, assuming maintenance fees were paid timely.
Citations and Related Patents
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The patent is widely cited by subsequent patents focusing on pyrimidine derivatives and chemical synthesis methods, indicating its influence on the field and potential foundational status.
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It shares priority with other patents assigned to DuPont or pharmaceutical companies involved in pyrimidine chemistry, such as U.S. Patent 5,585,259 and patents filed around the same timeframe.
Legal Status
- As of 2023, the patent has expired, opening the landscape for commercialization of processes described within. Prior to expiration, it provided enforceable rights preventing third-party manufacturing or use of the claimed methods in the United States.
Legal Challenges and Litigation
- No records suggest significant legal disputes or patent litigations specifically targeting U.S. Patent 5,563,165. Its expired status reduces the likelihood of current enforceability issues.
Implications for Drug Development and R&D
Scope for Generics and Follow-on Innovations
Post-expiration, generic manufacturers can now utilize the disclosed processes without infringing on the patent rights. Furthermore, existing patents citing U.S. Patent 5,563,165 indicate potential areas of improvement or alternative synthesis routes.
Researchers and Patent Holders
- Companies focusing on pyrimidine derivatives for antiviral or anticancer drugs could have initially relied on this patent for synthesis methods.
- Innovators aiming to develop novel derivatives or more efficient synthesis routes may explore patent alternatives or design around the core methods claimed.
Summary of Key Points
| Aspect |
Details |
| Patent Number |
5,563,165 |
| Grant Date |
October 8, 1996 |
| Expiration Date |
December 7, 2011 |
| Patent Category |
Chemical synthesis of pyrimidine derivatives |
| Claims |
16 claims: 3 independent, 13 dependent |
| Core Claims |
Chemical process for chlorinating precursors to produce pyrimidines |
| Patent Landscape |
Widely cited in pyrimidine synthesis patents; foundational in chemical methods development |
| Legal Status |
Expired; open for use post-2011 |
Key Takeaways
- U.S. Patent 5,563,165 covers a specific chemical process for producing pyrimidine derivatives utilized in pharmaceutical manufacturing.
- Its scope is confined to synthetic methods, not to drug formulation or therapeutic use.
- The patent's expiration allows unrestricted use of the claimed methods.
- The patent landscape features significant citations, indicating its influence in medicinal chemistry.
- Companies developing pyrimidine-based drugs can leverage this process freely now but must review newer patents for subsequent innovations.
FAQs
Q1: What is the main chemical process patented in U.S. Patent 5,563,165?
A1: It covers a chlorination method for preparing 2,4-diamino-6-chloropyrimidine derivatives, including specific reaction conditions and purification steps.
Q2: Does the patent claim the therapeutic application of the pyrimidine derivatives?
A2: No, it focuses on the chemical synthesis process, not on medical uses.
Q3: Is this patent applicable to current drug manufacturing?
A3: The patent expired in 2011, so its claims are in the public domain and can be freely used.
Q4: Are there related patents that extend or improve upon this method?
A4: Yes, there are subsequent patents citing this one, exploring alternative synthesis routes or derivative modifications.
Q5: How does this patent influence the landscape for pyrimidine drugs?
A5: It laid foundational synthesis techniques widely utilized and built upon in pharmaceutical chemistry, especially for antiviral and anticancer agents.
Citations
- U.S. Patent 5,563,165. (1996).
- Related patents citing this patent include U.S. Patent 5,585,259 and other filings around 1993-1998.
- Patent legal status information obtained from USPTO records.
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