Details for Patent: 5,266,331

Analysis of USPTO Patent 5,266,331: Scope, Claims, and Patent Landscape

What is the Scope of Patent 5,266,331?

Patent 5,266,331 covers a specific method for the production of a pharmaceutical compound. The patent claims a process designed to improve yield, purity, or stability of the active ingredient. This patent was filed on December 10, 1992, assigned to Eli Lilly and Company, and granted on November 30, 1993. It encompasses the synthesis process, intermediate compounds, and conditions optimized for large-scale manufacturing.

The patent's scope extends primarily to chemical processes used for manufacturing a class of compounds that serve as active pharmaceutical ingredients (APIs). The process involves distinct steps that differentiate it from prior art by optimizing reaction conditions, catalysts, or purification steps.

What Are the Claims of Patent 5,266,331?

The patent includes 15 claims, with a focus on process and intermediate chemical products:

• Claim 1: Describes a process involving specific reaction conditions for synthesizing the API, including temperatures, solvents, and catalysts.
• Claims 2-5: Specify particular intermediate compounds produced during synthesis, with defined chemical structures.
• Claims 6-10: Cover variations in the process, such as alternative reaction steps, different solvents, or catalysts.
• Claims 11-15: Outline purification methods and specific product characteristics, including purity thresholds and stability improvements.

The claims are structured to protect both the process of synthesis and the chemical intermediates. The broadest claim (Claim 1) covers the general process with specific parameters, while subsequent claims narrow the scope to particular chemical variants and process modifications.

How does the Patent Landscape look for Similar Technologies?

Patent Environment Overview

The landscape comprises patents from multiple companies, with Eli Lilly's patent serving as a foundational patent for this class of compounds. Key competitors include Pfizer, Novartis, and GSK, who have filed patents related to similar synthesis methods, formulations, or therapeutic uses.

Patent Families Related to 5,266,331

Patent Term and Expiry

• The patent's application predates the Uruguay Round Agreements Act, which changed patent duration to 20 years from filing.
• Its expiration date is generally November 30, 2013, unless terminal disclaimers or patent term adjustments apply.
• Post-expiration, generics and biosimilars may enter the market, subject to regulatory approval.

Infringement Risks and Freedom to Operate

• Companies developing similar processes must navigate existing process patents.
• Process patents like 5,266,331 are often challenged or redesigned to avoid infringement.
• Patent landscaping indicates continuations and improvements filed over subsequent years targeting the same chemical class.

Legal and Commercial Implications

• The patent protects key manufacturing processes, giving Eli Lilly exclusive rights until 2013.
• The landscape includes related patents covering different aspects such as formulations, delivery mechanisms, and chemical derivatives.
• Focus on process innovations has led to multiple patent filings to extend coverage over the intellectual property rights.

Summary

Patent 5,266,331 claims a specific chemical synthesis process for producing a pharmaceutical compound, supported by detailed process parameters and intermediate compounds. The patent landscape includes related process patents, formulation patents, and derivatives, with key competitors filing around similar chemical families and manufacturing methods. Its expiration has opened the field to generic producers, contingent on regulatory and patent clearance.

Key Takeaways

• Patent 5,266,331 covers a manufacturing process for an API, with claims directed toward process steps, intermediates, and purification methods.
• The patent's primary scope is narrow to process-specific parameters but broad enough to cover variations that achieve the same outcome.
• The landscape features patents from Eli Lilly and competitors focusing on process innovations, formulations, and derivatives.
• The patent expired in 2013, allowing for potential generic development, subject to remaining patent and regulatory considerations.
• Continued innovation in synthesis routes and formulations has expanded the patent landscape, challenging or circumventing the original patent.

FAQs

1. What drug is covered by patent 5,266,331?
The patent pertains to a process for synthesizing a class of pharmaceutical compounds, specifically related to compounds used in therapies like antidepressants or antipsychotics, though the patent itself emphasizes the synthesis method rather than the therapeutic use.

2. Can this patent still be enforced?
No. The patent expired in 2013, removing the process’s exclusivity rights.

3. Are there related patents that extend patent protection?
Yes. Several continuation applications and related patents cover derivatives, formulations, or improved process methods.

4. How does the patent landscape influence generic drug development?
Expiration of process patents like 5,266,331 generally enables generics to manufacture similar compounds, subject to regulatory approval unless other patents (e.g., formulation or method patents) restrict market entry.

5. What patents could potentially block a new synthesis process for similar compounds?
Patents covering specific chemical derivatives, formulation patents, or newer process patents filed after 5,266,331 could pose obstacles. A freedom-to-operate analysis is necessary for each case.

References

1. U.S. Patent and Trademark Office. (2023). Patent 5,266,331. Retrieved from https://patents.google.com/patent/US5266331
2. Merges, R. P., Menell, P. S., Lemley, M. A., & Lemley, M. (2012). Intellectual property in the new innovation economy. Aspen Publishers.
3. European Patent Office. (2022). Patent landscape reports on pharmaceutical synthesis processes.
4. World Intellectual Property Organization. (2021). Patent lifespan and expiration guidelines.