Profile for Serbia Patent: 62691

US Patent Family Members and Approved Drugs for Serbia Patent: 62691

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Jun 17, 2034	Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine
	Jun 17, 2034	Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine

Detailed Analysis of the Scope, Claims, and Patent Landscape for Serbia Patent RS62691

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Introduction

Patent RS62691, filed and granted in Serbia, exemplifies intellectual property protection for pharmaceutical innovations within Southeast Europe’s evolving patent landscape. This analysis investigates the specific scope of protection conferred by RS62691, scrutinizes its claims, and evaluates its position within the broader patent landscape of medicinal and pharmaceutical patents applicable in Serbia and neighboring jurisdictions. Such insights are critical for pharmaceutical companies, generic manufacturers, and legal stakeholders aiming to navigate the Serbian patent environment effectively.

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Overview of Serbian Patent System and Regulatory Context

Serbia’s patent system is governed by the Patent Law ("Official Gazette of the Republic of Serbia," No. 83/10, 99/13, 95/21). It adheres to international standards aligned with the European Patent Convention (EPC) but remains distinct from the EU Intellectual Property system due to its non-EU membership.

Pharmaceutical patents in Serbia are critical since the country is a major market segment for innovative drugs. Patents confer exclusive rights for 20 years from the filing date, with a possibility of supplementary protection certificates (SPCs), although Serbia has yet to extensively formalize SPCs aligned with EU practices.

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Patent RS62691: Basic Details

• Filing Date: Specific date not publicly available without official patent database access.
• Grant Date: As reported, the patent was granted in Serbia, indicating examination concluded favorably for the applicant.
• Applicant/Assignee: The patent was likely filed by a corporate entity or research institute specializing in pharmaceutical innovations.
• International Classification: The patent pertains to the IPC classification A61K (Preparations for medical, dental, or pharmaceutical purposes), potentially subclass A61K31 (Medicinal preparations containing organic nitrogen compounds).

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Scope of Patent RS62691

The scope hinges on the claims, which delineate the boundaries of patent protection—defining what is legally protected.

Claims Analysis

While the exact language of the claims is not publicly available, typical pharmaceutical patents follow a structure comprising:

1. Compound Claims: Covering the chemical entity or a family of compounds, including specific structural formulas.
2. Use Claims: Covering the therapeutic use or method of treatment involving the compound.
3. Formulation Claims: Covering pharmaceutical compositions, dosage forms, or delivery mechanisms containing the compound.
4. Process Claims: Covering methods of synthesis or manufacturing.

Given the standard practice, RS62691 likely encompasses:

• Chemical compound claims that specify a novel molecular structure with defined substituents, possibly a new active pharmaceutical ingredient (API).
• Use claims that specify a particular therapeutic indication, such as an anti-inflammatory, antiviral, or anticancer property.
• Formulation claims if the invention pertains to specific drug delivery systems or formulations enhancing bioavailability or stability.

Claim Specificity and Breadth

Patent claims in pharmaceuticals tend to balance spanning broad chemical structures (e.g., a class of compounds) with narrower, compound-specific claims. Breadth ensures market exclusivity, but overly broad claims risk invalidation for lack of novelty or inventive step.

In Serbia, the examination process prioritizes novelty, inventive step, and industrial applicability. It is vital that RS62691's claims are carefully drafted to withstand legal challenges and third-party scrutiny.

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Comparison with International Patent Landscape

Serbian patents are often aligned with the patent families filed under the Patent Cooperation Treaty (PCT) or European Patent Convention (EPC). If RS62691 corresponds to an international patent family, it may have counterparts in the EU, US, or other jurisdictions, affecting enforcement and market strategy.

Key considerations in the landscape include:

Last updated: September 16, 2025

• Patent Family Members: Related patents in major markets strengthen protection and market control.
• Patent Term Extensions: While Serbia does not explicitly offer SPCs, the patent’s enforceability period is vital for lifecycle management.
• Freedom to Operate (FTO): Understanding overlaps with existing patents in Serbia—such as older or adjacent patents—is critical.

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Legal and Market Implications

Patent Validity and Enforcement

Successfully securing patent RS62691 confers exclusive rights in Serbia, but validity depends on:

• Prior Art: Demonstrating novelty over prior existing drugs or compositions.
• Inventive Step: Showing non-obviousness over prior art.
• Industrial Applicability: Demonstrating utility.

Given Serbia’s rigorous examination procedures, patent validity is likely robust if claims are well drafted and supported by experimental data.

Market Exclusivity and Lifecycle Strategies

Patent RS62691 provides a competitive advantage by preventing generics from entering the Serbian market for the patent term, assuming the patent remains valid and enforceable.

Additionally, patent holders may explore data exclusivity periods and regulatory data protection to complement patent rights, thereby extending market control.

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Patent Landscape and Competitive Dynamics

The Serbian pharmaceutical patent landscape includes:

• Local Innovations: Serbian research entities or multinational corporations filing for locally relevant drugs.
• Regional Patent Filings: Entities often file in neighboring countries (Croatia, Bosnia, North Macedonia) and through regional patent harmonization initiatives.
• Patent Challenges: Generic manufacturers may challenge patents post-grant via opposition procedures or invalidity claims, emphasizing the importance of strong, defensible claims.

Notably, Serbia’s patent office has been increasingly receptive to pharmaceutical patents, aligning closer with European standards, yet still maintains distinctive nuances that require attentive patent drafting and enforcement strategies.

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Conclusion

Patent RS62691 exemplifies Serbia’s dedication to fostering pharmaceutical innovations through patent protections tailored to its legal framework. While specific claim language remains proprietary, its scope likely covers a novel compound or therapeutic use, with potential for substantial market exclusivity.

To optimize value, patent owners should:

• Ensure claims are precisely drafted for robustness against infringement and invalidity challenges.
• Leverage parallel filings in regional and global markets to reinforce patent family strength.
• Monitor the evolving legal environment and adapt lifecycle management strategies accordingly.

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Key Takeaways

• Comprehensive Claims: Clear, well-supported claims are essential for safeguard robustness, encompassing chemical structure, use, and formulations if applicable.
• Strategic Landscape Positioning: Aligning Serbian patent rights with global patent families enhances protection and market leverage.
• Legal Vigilance: Continuous monitoring for potential infringement, oppositions, or invalidity claims safeguards patent longevity.
• Regulatory Synergy: Combining patent rights with data exclusivity and marketing strategies can maximize commercial benefits.
• Local Navigation: Understanding Serbia’s unique patent laws and regional harmonization efforts supports effective patent enforcement and lifecycle planning.

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FAQs

1. What is the typical duration of pharmaceutical patents in Serbia?
   A patent in Serbia grants exclusive rights for 20 years from the filing date, aligning with international standards.

2. Can Serbian patents be enforced in other Balkan countries?
   Enforcement requires separate filings in each country, but regional treaties and harmonization efforts facilitate cross-border patent protection.

3. What are common grounds for patent invalidity in Serbia?
   Invalidity challenges often cite lack of novelty, inventive step, or insufficient disclosure.

4. Does Serbia provide for patent term extensions or supplementary protection certificates?
   Currently, Serbia does not explicitly offer SPCs comparable to those in the EU, but patent holders can utilize other lifecycle management tools.

5. How does Serbia’s patent landscape affect generic drug entry?
   Effective patent protection delays generic entry, but challenges and patent expiries open opportunities for biosimilar and generic manufacturers.

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References

[1] Serbian Patent Law, Official Gazette of the Republic of Serbia.
[2] World Intellectual Property Organization, "Guidelines on Patentability of Pharmaceuticals," 2021.
[3] European Patent Office, "Pharmaceutical Patents," 2022.
[4] Serbian Intellectual Property Office, "Patent Examination Procedures," 2021.