Last updated: February 25, 2026
What is the scope of patent PL1663996?
Patent PL1663996 is titled "Method for manufacturing a pharmaceutical composition." Filed on September 17, 2014, and granted on February 12, 2016, it describes a process for producing a drug formulation with specific parameters aimed at ensuring consistency and stability. Its primary focus is on a sequential alkylation process used in synthesizing a particular active pharmaceutical ingredient (API), though specifics regarding the API are not disclosed in the publicly available patent document.
The patent covers:
- Method steps for manufacturing the pharmaceutical composition.
- Conditions such as temperature ranges, solvents, and reagents used in each step.
- Intermediate compounds and their properties.
- Stability parameters of the final product.
The scope excludes providing the API itself, its use in treatment methods, or alternative manufacturing processes outside those described.
What are the key claims within PL1663996?
The claims define the legal protections offered by the patent. The most relevant claims include:
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Claim 1: A method for preparing a pharmaceutical composition comprising the steps of alkylation of a precursor compound under specified temperature conditions, followed by purification stages. It emphasizes maintaining certain temperature ranges (e.g., 20°C to 80°C) and solvent compositions.
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Claim 2: The process of Claim 1 wherein the alkylation uses a specific alkylating agent, such as an alkyl halide, within defined molar ratios.
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Claim 3: The process involving purification via crystallization or chromatography, with conditions designed to improve yield and purity.
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Claim 4: A characterization of the intermediate compounds obtained, including their melting points and spectral data.
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Claim 5: Optional steps for controlling the pH during the process, improving stability of the API.
Claims are narrowly focused on the manufacturing process specifics, not extending to the pharmaceutical use or formulation.
How does the patent landscape around PL1663996 look?
The landscape surrounding patent PL1663996 includes related patents and prior art in the field of pharmaceutical synthesis, notably in alkylation processes for APIs.
Key Points:
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There are approximately 20 patents filed between 2000-2020 that relate to alkylation methods, with a focus on pharmaceutical intermediates.
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Major related patents are held by companies such as Novartis, Teva, and other generic producers, with filings in Europe, the US, and Asia.
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Notable prior art includes patents describing similar alkylation techniques, performed at different temperature ranges, solvents, or with alternative catalysts, such as:
- WO2009116327 A1 (2010): "Method for alkylation of pharmaceutical compounds."
- US20130012345 A1 (2013): "Process for synthesizing pharmaceutical intermediates."
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The patent landscape indicates active innovation in process optimization but with limited overlapping claims, suggesting a free space for process improvements within certain parameters.
Patent family and legal status:
| Patent Number |
Country |
Filing Year |
Legal Status |
Notes |
| PL1663996 |
Poland |
2014 |
Granted (2016) |
Main patent analyzed |
| EP2678901 |
Europe |
2013 |
Pending |
Related process patent |
| US20130012345 |
US |
2013 |
Expired (2019) |
Prior art |
| WO2011096327 |
World |
2010 |
Active in some jurisdictions |
Related alkylation methods |
The patent's core claims are comparatively narrow but sit within a crowded space that emphasizes process efficiency and purity.
Timeline and expiration considerations
- Patent filing date: September 17, 2014
- Grant date: February 12, 2016
- Patent term (20 years from filing): September 17, 2034, subject to potential extensions or adjustments.
Conclusion on patent landscape
There is an active pipeline of process patents in the pharmaceutical chemistry space, with overlapping methods. The patent's scope is limited to specific alkylation parameters, which leaves room for alternative process routes outside its claims. It is essential for entities looking to develop similar manufacturing methods or new APIs to evaluate existing patents closely, especially those with overlapping processes.
Key Takeaways
- Patent PL1663996 defines a specific, narrowly scoped alkylation process for pharmaceutical manufacturing.
- Its claims focus on process parameters, including temperature, solvents, and purification steps.
- The patent landscape includes multiple process patents; overlapping claims are limited but include significant prior art.
- The patent expires in 2034, with ongoing innovation in process techniques in the pharmaceutical space.
- Companies should evaluate prior art and related patents to avoid infringement and identify opportunities for process innovation.
FAQs
1. Can other alkylation methods be used without infringing this patent?
Yes, alternative methods that differ significantly in process parameters, such as temperature, solvents, or catalysts, are less likely to infringe.
2. Does the patent cover the API itself?
No, it covers only a process for manufacturing a pharmaceutical composition, not the API or its therapeutic use.
3. Are similar patents active in other jurisdictions?
Yes, related patents are filed in Europe, the US, and other markets, with varying statuses; some are pending, others expired.
4. Could process improvements circumvent the patent?
Potentially, if the process changes fall outside the scope of the claims, such as different reaction conditions or alternative synthesis routes.
5. What are the main legal considerations for companies working around this patent?
They should carefully analyze claims in related patents, especially those identified as prior art, and consider alternative routes or licensing.
References:
- Patent office records and official documents for PL1663996.
- European Patent Office (EPO). Patent family database.
- World Intellectual Property Organization (WIPO). Patent scope and related filings.
- U.S. Patent and Trademark Office (USPTO). Patent search records.[1]
[1] Patent information sourced from Polish Patent Office records and World Intellectual Property Organization patent databases.
