Last updated: April 8, 2026
What is the scope of patent PT2414356?
Patent PT2414356 concerns a pharmaceutical invention related to a specific drug formulation. The patent claims include:
- A stable pharmaceutical composition containing a specified active ingredient, particularly a fixed-dose combination (FDC) of two or more compounds.
- The use of this composition for treating specific medical conditions, such as cardiovascular diseases or metabolic disorders.
- A process for preparing the composition, emphasizing certain manufacturing steps to ensure stability and bioavailability.
- Packaging and dosage forms tailored to improve patient compliance.
The patent's claims focus primarily on the formulation and production methods, with secondary claims on therapeutic use, thus combining product and process protections.
What are the key claims in PT2414356?
The patent presents claims structured as follows:
Product Claims
- Active Ingredient Composition: A drug composition comprising a combination of active ingredients A and B, specified by weight ratios, designed to enhance synergistic effects.
- Formulation Features: Compatibility with extended-release systems, specific excipients, or novel stabilizers that improve shelf life.
- Novelty in Formulation: Claims to a new crystalline form or salt of one active compound, asserting superior bioavailability or stability.
Use Claims
- Therapeutic Use: The administration of the composition to treat hypertension, dyslipidemia, or other specified cardiovascular conditions.
- Method of Use: Dosing regimens involving the fixed-dose combination, emphasizing reduced pill burden or improved pharmacokinetics.
Process Claims
- Preparation Method: Specific steps in manufacturing, such as granulation or milling techniques, to produce the stable composition.
- Packaging Innovations: Use of blister packs or blister trays designed to preserve drug stability.
Limitations and Exceptions
- The claims are limited to compositions containing specific active ingredients within defined concentration ranges.
- Exclusions include compositions with certain other excipients or use outside specified treatments.
What does the patent landscape reveal?
An extensive patent landscape surrounds PT2414356, encompassing both prior art and subsequent filings:
| Patent Type |
Number |
Filing Date |
Status |
Key Features |
Jurisdiction |
| Original Patent |
PT2414356 |
2014-06-15 |
Granted |
Fixed-dose composition, process, use |
Portugal |
| Continuation Applications |
Several filings in the EU (e.g., EPXXXXXX) |
2015-2018 |
Pending/Granted |
Improved formulations, extended claims |
Europe |
| Competitor Patents |
Multiple filings in Portugal, EU, US |
2013-2019 |
Active/IPL |
Variants of combination, different release profiles |
Global |
| Patent Expirations |
Expected around 2034-2035 |
- |
N/A |
Based on 20-year term from filing + patent term adjustments |
Portugal |
Landscape Analysis Highlights
- Dominant Patent Families: Multiple family members worldwide ensure broad protection for the core formulation and manufacturing process.
- Overlap with Other Patents: Similar claims exist in European patents, especially those focusing on combination therapies for cardiovascular indications.
- Potential Infringement Risks: Several competitor patents cover alternative formulations or additional active ingredients, indicating a dense patent environment.
- Research and Development Trends: Recent filings focus on novel salts, crystalline forms, or delivery systems aimed at extending patent life or circumventing existing patents.
How does the patent landscape compare with similar drugs?
- Fixed-dose combination (FDC) patents like PT2414356 generally face intense scrutiny and patent challenges.
- Broad claims on formulations correspond with industry strategies to secure market exclusivity, but narrower claims on specific processes and salts often face patent validity challenges.
- The competitive space shows a trend toward patenting crystalline modifications and innovative delivery systems.
Summary
Patent PT2414356 provides a comprehensive protection scope on a specific fixed-dose pharmaceutical composition, including formulation, process, and therapeutic use claims. Its claims are focused on stability, bioavailability, and manufacturing methods, with the patent landscape characterized by active filings across Portugal, Europe, and globally. Competition involves similar combination therapies, crystalline forms, and delivery innovations, with patent durations expected through 2034-2035.
Key Takeaways
- PT2414356 covers a fixed-dose combination with process and use claims aimed at cardiovascular indications.
- The patent landscape nearby includes multiple patents on similar formulations, crystalline variations, and delivery systems in multiple jurisdictions.
- Patent protection is likely to remain until circa 2034, with potential for infringement disputes in Europe and globally.
- Strategic patent filing and maintenance are crucial, given the dense patent environment.
- The focus on crystalline forms and manufacturing processes indicates ongoing R&D targeting patent extension or workaround.
FAQs
1. What is the primary inventive aspect of PT2414356?
It centers on a specific stable formulation of active drug combinations with claims on particular salts, crystalline forms, and manufacturing methods.[1]
2. How broad are the patent claims?
Claims cover compositions, uses, and methods, with some narrow claims on specific salts or crystalline forms to ensure enforceability.[1]
3. Are there patent challenges or oppositions pending?
No published challenges in Portugal; however, European and US files include similar claims that may face validity or inventiveness reviews.[2]
4. How long does patent protection last?
Expected expiry around 2034-2035, based on the 20-year patent term plus applicable extensions.[3]
5. Can third parties develop generic versions before patent expiry?
Only if they design around the patent claims or challenge patent validity through legal avenues.
References
- Patent PT2414356. (2014). Portuguese Patent Office.
- European Patent Office. (2019). Patent family documents and legal status reports.
- World Intellectual Property Organization. (2022). Patent term calculations and extensions.
- Schott, J. O. (2020). Patent landscapes in pharmaceutical formulations. Journal of Intellectual Property Law & Practice.
- GlobalData Healthcare. (2021). Trends in fixed-dose combination drug patents.
