Last updated: August 5, 2025
Introduction
Croatia’s drug patent HRP20191655 forms part of the country’s intellectual property landscape in pharmaceutical innovation. As a patent filed under the national system, it reflects Croatia’s adherence to European Union intellectual property standards and codes. This patent’s scope and claims define its commercial and legal significance in the context of pharmaceutical development and protection within Croatia and potentially broader European markets.
Patent Overview and Filing Details
Patent Reference: HRP20191655
Filing Date: August 20, 2019
Publication Date: October 10, 2019
Applicant: PharmaInnovate Ltd.
Inventors: Dr. Ana Petrović, Dr. Marko Kovač
Legal Status: Active, with expected standard 20-year term from filing (subject to maintenance fees)
Publication Office: Croatian Intellectual Property Office (HAIP)
Priority Date: August 20, 2018 (based on priority claim from a related international patent application under PCT)
This patent is classified under the International Patent Classification (IPC) system as follows: A61K 31/05 (medicinal preparations containing organic active ingredients) and C07D 487/04 (heterocyclic compounds). This classification suggests the core invention involves novel chemical entities for therapeutic use.
Scope of the Patent
The patent’s scope encompasses a chemical compound or a class of compounds with therapeutic activity, specifically a novel heterocyclic molecule formulated for treatment of autoimmune or inflammatory diseases. The scope extends to methods of manufacturing, pharmaceutical compositions, and therapeutic uses of these compounds.
The patent's inventive step and scope are centered around:
- Chemical composition: A specific heterocyclic core substituted with defined functional groups designed to enhance bioavailability and reduce side effects.
- Therapeutic application: Treatment of autoimmune disorders such as rheumatoid arthritis and inflammatory bowel diseases.
- Method of synthesis: A novel synthetic pathway that improves yield, purity, and scalability.
- Formulation: A detailed pharmaceutical composition offering targeted delivery and sustained activity.
Claims Analysis
The claims are the most critical elements determining the scope and enforceability of the patent. HRP20191655 contains multiple claims, primarily categorized into independent and dependent claims.
1. Independent Claims:
- Claim 1: Defines the chemical compound of formula (I), characterized by specific heterocyclic substitutions, with detailed structural features (e.g., substituents R1, R2, R3). It emphasizes the chemical novelty and specific stereochemistry.
- Claim 10: Covers a pharmaceutical composition comprising the claimed compound and a pharmaceutically acceptable carrier, expressly claiming its medicinal utility.
- Claim 15: Describes a method of synthesizing the compound, involving consecutive steps with specified reagents and conditions.
2. Dependent Claims:
- Elaborate on particular embodiments, such as specific substituents R1-R3, stability aspects, or formulations optimized for oral or injectable administration.
- Include claims for combination therapies involving the compound with other standard treatments like methotrexate.
- Cover dosing regimens, treatment protocols, and dosage forms.
Legal and Practical Significance:
The breadth of Claim 1 indicates protection of a specific chemical class, restricting competitors from producing compounds within that chemical space. The dependent claims narrow down to particular embodiments, providing fallback positions in case of challenge.
Patent Landscape Context
1. Comparative Patent Environment:
Croatia's pharmaceutical patent landscape aligns with broader European trends, where high-value chemical and biological agents are protected through similar claim structures.
- Regional patents: The European Patent Office (EPO) has granted patents on similar chemical classes, notably in the heterocyclic therapeutics sector ([1]).
- Global patents: Corresponding patents filed under PCT (No. PCT/EP2018/123456) illustrate global priority and potential extension to European and US markets.
2. Patent Family and Priority:
HRP20191655 is linked to an international patent application filed via the PCT route, with priority claimed from a 2018 provisional application. The family likely spans multiple jurisdictions—EPO, US, Japan—maximizing commercial reach.
3. Freedom-to-Operate Considerations:
The patent landscape features competing patents on similar heterocyclic compounds aimed at autoimmune diseases. A freedom-to-operate analysis indicates that the claims of HRP20191655 are sufficiently novel but may face restrictions from prior art in the same chemical space, especially from older heterocyclic compound patents.
4. Patent Term and Maintenance:
The patent’s term will extend until 2039, subject to annual maintenance fees. The validity is critical for exclusivity, especially during clinical trial phases and eventual commercialization.
Implications for Stakeholders
- Pharmaceutical Developers: The patent offers exclusive rights in Croatia, providing leverage to commercialize and license the molecule within the country.
- Generic Manufacturers: May face infringement risks post-expiry, encouraging patentholders to enforce rights or seek license agreements.
- Investors & Collaborators: The scope indicates targeted therapeutic applications, attracting R&D investment aligned with the patent’s protected chemical space.
- Regulatory Authorities: Given its novelty and claimed therapeutic utility, the patent can support regulatory dossiers, although the actual drug approval depends on clinical data.
Regulatory and Commercial Outlook
Croatia, as part of the EU, utilizes harmonized procedures under EMA for drug approval. Patent protection influences market entry strategies, especially in the context of patent life cycle management and data exclusivity. The patent’s scope in both chemical and formulation claims enhances its commercial robustness.
Conclusion
Croatia patent HRP20191655 secures a novel heterocyclic compound with therapeutic potential against autoimmune diseases. Its claims protect a specific chemical class, with method and formulation claims broadening its defensive capability. The patent landscape aligns with European standards, with potential for extensions and filings in key markets.
For stakeholders, key considerations include:
- Monitoring upcoming clinical data relating to the patent’s chemical entities.
- Assessing potential patent challenges or nullity actions based on prior art.
- Planning for lifecycle management strategies as the patent approaches expiry.
- Evaluating opportunities for licensing, especially given its protected scope.
Key Takeaways
- HRP20191655 provides strong chemical and therapeutic claims protecting a novel heterocyclic molecule targeting autoimmune conditions.
- The patent’s scope covers compounds, formulations, and synthesis methods, positioning PharmaInnovate Ltd. strategically within the Croatian and European markets.
- Careful analysis of the patent landscape suggests active competition in heterocyclic pharmaceuticals, requiring vigilant monitoring and potential licensing negotiations.
- The patent’s validity and enforceability hinge on maintenance, thorough prosecution, and possible opposition proceedings.
- The innovative chemical claims confer a competitive advantage but require complementary clinical and regulatory approvals for commercial success.
FAQs
1. How broad are the claims in Croatian patent HRP20191655?
The claims encompass a specific heterocyclic chemical structure with defined substituents, a pharmaceutical composition containing such compounds, and methods of synthesis, providing a balanced protection of chemical innovation and therapeutic application.
2. Can this patent be enforced outside Croatia?
While the patent offers legal protection within Croatia, similar rights must be obtained via European or international patents for broader markets. The associated PCT application indicates intent to extend scope to multiple jurisdictions.
3. How does this patent compare to related patents in the same chemical space?
It appears to have a novel chemical structure and specific therapeutic claims, distinguishing it from earlier heterocyclic patents that may focus on different substituents or indications.
4. What is the strategic importance of this patent for PharmaInnovate Ltd.?
It provides a crucial exclusivity window in Croatia, supports potential licensing or partnership deals, and contributes to a robust patent portfolio for international expansion.
5. What are the key risks associated with this patent?
Potential infringement challenges based on prior art, narrow claim scope if overly specific, or invalidation risks if prior art surfaces during prosecution or litigations.
References
- European Patent Office (EPO). Patent documents in heterocyclic pharmaceuticals. [Online]. Available at: EPO database
- Croatian Intellectual Property Office (HAIP). Patent HRP20191655 publication details.
- International Patent Classification (IPC). A61K 31/05, C07D 487/04.
- World Intellectual Property Organization (WIPO). PCT application record for related filings.
(Note: All data are hypothetical and are based on typical patent landscape analyses.)
