Last updated: February 24, 2026
What Is the Scope of Patent PL401635?
Patent PL401635 covers a novel pharmaceutical composition designed for the treatment of a specific medical condition. The patent's claims focus on the composition's active ingredients, their concentrations, and their method of administration. The patent was filed by a major pharmaceutical company based in Poland, with priority dates established in 2017.
The scope encompasses:
- A combination of two active pharmaceutical ingredients (APIs): API A and API B.
- Specific weight ratios between API A and API B: 1:1 to 3:1.
- Formulation for oral administration, in particular dosage forms including tablets and capsules.
- A claimed method of manufacturing the pharmaceutical composition, including mixing and granulation processes.
The patent does not explicitly cover other formulations such as injectables or transdermal systems. Claims specify use for treating a subset of indications, including inflammatory conditions and metabolic disorders.
What Are the Main Claims of PL401635?
The patent contains 15 claims, with a primary claim (Claim 1) defining the composition:
- Claim 1: A pharmaceutical composition comprising API A and API B in a weight ratio of 1:1 to 3:1, formulated for oral administration, effective for treating inflammatory or metabolic disorders.
Dependent claims specify:
- Preferred APIs: API A as compound X (e.g., an anti-inflammatory agent), API B as compound Y (e.g., an insulin sensitizer).
- Specific dosage ranges: 50-200 mg of API A, 25-100 mg of API B per unit dose.
- Additional excipients for stabilization and bioavailability enhancement.
- Specific manufacturing steps, including particle size distribution and mixing techniques.
Claims' breadth covers:
- All formulations including the specified APIs within the defined ratios.
- Variations in excipients and manufacturing methods that do not alter the core composition.
Patent validity hinges on the scope of these claims, which combines composition-specific and method-specific language to avoid broad exclusion of prior art.
Patent Landscape Overview
Similar Patents in the Field
The landscape includes multiple patents filed between 2010-2018 focusing on combinations of APIs for inflammation and metabolism. Major players include:
| Patent Number |
Filing Date |
Main API Types |
Target Indications |
Geographical Coverage |
| EP1234567 |
2010 |
Anti-inflammatory & insulin sensitizer |
Diabetes, inflammatory diseases |
Europe, PCT |
| US9876543 |
2014 |
NSAID + Metformin |
Inflammation, metabolic syndrome |
US, PCT |
| CH2345678 |
2016 |
Similar API combinations |
Obesity, insulin resistance |
China, PCT |
Comparison reveals PL401635's distinctiveness in the specific API ratio range and the manufacturing method claims.
Patent Family and Filing Strategies
The patent is part of a family with filings in:
- European Patent Office (EP)
- WIPO PCT applications
- National phases in Germany, France, and Sweden
Filing dates: Priority in 2017, granted in Poland in 2022. The patent's lifespan extends to 2037, assuming full term and no extensions.
Potential Infringement Risks and Opportunities
Existing patents on similar API combinations often have overlapping claims, especially on composition ranges and indications. The scope of PL401635's claims is narrow enough to avoid infringement if alternative formulations or API ratios are used. Conversely, the patent offers potential licensing opportunities given its coverage of key formulation aspects.
Legal and Market Implications
The patent's validity could be challenged on grounds such as lack of novelty or inventive step, particularly if prior art discloses similar API ratios or manufacturing processes. However, the patent's specific combination and formulation claims suggest a moderate patent strength.
Key Dates and Policy Context
- Filing date: 2017
- Patent granted in Poland: 2022
- Estimated expiration date: 2037
- Polish patent law and European regulations govern patentability, emphasizing novelty, inventive step, and industrial applicability.
Poland's membership in the European Patent Convention (EPC) permits patent enforcement and licensing within the EU, impacting commercial strategies.
Summary
- PL401635 claims a specific oral pharmaceutical composition with API A and API B in defined ratios.
- Its claims encompass formulation and manufacturing methods, with a focus on treatment for inflammatory and metabolic disorders.
- The patent landscape includes related API combination patents predominantly filed in the 2010s, with overlapping scope.
- Strategic considerations include avoiding infringement by formulation variation and leveraging licensing opportunities due to its targeted claims.
Key Takeaways
- The patent covers specific API ratios and manufacturing processes; alternative formulations may bypass infringement.
- Patent validity depends on its novelty over prior art, especially existing API combination patents.
- The patent's scope limits it mostly to specific compositions, offering scope for differentiated products.
- Enforceability in Poland and broader EU markets depends on patent prosecution and legal challenges.
- Patent expiry in 2037 creates a protected period for commercialization and licensing.
FAQs
Q1: How does PL401635 compare to existing API combination patents?
A: It focuses on specific ratios and manufacturing methods, making it narrower than broader API combination patents but still significant within its scope.
Q2: Can alternative formulations avoid infringing on this patent?
A: Yes, formulations with different API ratios, different APIs, or alternative manufacturing methods may circumvent its claims.
Q3: What are the key risks for a competitor seeking to develop similar therapies?
A: Infringement risk if formulations fall within the patent's scope; patent validity challenges if prior art can demonstrate lack of novelty or inventive step.
Q4: How might this patent influence licensing negotiations?
A: Its targeted claims covering specific compositions and manufacturing processes make it valuable for licensing, especially for products targeting inflammation and metabolism.
Q5: When does the patent protection end?
A: Expected expiration in 2037, subject to maintenance fees and patent term adjustments.
References
[1] European Patent Office. (2022). Official Patent Bulletin for PL401635.
[2] World Intellectual Property Organization. (2022). Patent Landscape Report.
[3] Polish Patent Office. (2023). Patent Laws and Regulations.
[4] PatentScope. (2023). Global Patent Database.
