Last updated: July 29, 2025
Introduction
Lithuania, as a member of the European Patent Organisation, aligns its patent system closely with European standards. The Lithuanian Patent Office (Tulko Office), responsible for examining patent applications, operates under the European Patent Convention (EPC) and national law, shaping distinct considerations for biopharmaceutical inventions. Given the sector’s complexity, access to nuanced legal frameworks on patentability, enforceability, and claim scope is vital for innovators aiming to secure robust patent protections in Lithuania. This overview distills key insights pertinent to biopharmaceutical patent strategy within Lithuania, emphasizing current standards, potential limitations, and opportunities for applicants navigating the Lithuanian patent landscape.
1. Patentability of Biopharmaceutical Inventions in Lithuania
1.1. General Patentability Criteria
Biopharmaceutical inventions can qualify for patent protection in Lithuania if they meet three core criteria:
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Novelty: The invention must be new, meaning no identical claims have been disclosed publicly before the filing date. Disclosure includes academic publications, prior patent filings, or public use in Lithuania or abroad[1].
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Inventive Step (Non-Obviousness): The invention must involve an inventive step, i.e., it would not be obvious to a skilled person based on prior art. The Lithuanian Patent Office assesses whether the invention differs sufficiently from existing solutions[2].
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Industrial Applicability: The invention must be capable of practical application. For biopharmaceuticals, this includes enabling manufacturing, therapeutic use, or process application[3].
1.2. Specific Considerations for Biopharmaceuticals
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Patentability of Natural Substances and Biomolecules: Under Lithuanian and European practice, naturally occurring substances are not patentable if isolated without a technical modification. Nonetheless, biotechnological processes that produce novel, purified, or modified biomolecules are patentable[4].
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Patentability of Methods: Medical methods, including surgical and therapeutic procedures, are generally excluded from patentability under Lithuanian law per the EPC's provisions (Art. 53(c)). However, product claims related to the substances used in such methods are patentable[5].
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Gene and DNA Patents: Isolated DNA sequences with specific utility can be patentable if they meet novelty, inventive step, and industrial applicability. The Lithuanian Patent Office follows European standards, requiring detailed descriptions demonstrating the biological functions and applications[6].
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Second-Use or ‘Swiss-Type’ Claims: Allowed in Lithuania, these claims cover new therapeutic applications of known substances, provided sufficient evidence of novelty and inventive contribution exists[7].
2. Enforceability of Biopharmaceutical Patents in Lithuania
2.1. Patent Enforcement Framework
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Enforcement in Lithuania occurs via civil litigation before courts. The Lithuanian Civil Procedure Code facilitates patent holders to initiate infringement proceedings, seek injunctive relief, damages, or criminal sanctions for counterfeiting[8].
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Patents are valid for 20 years from the filing date, with annual renewal fees payable to maintain enforceability[9].
2.2. Challenges in Enforcement
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Biologics and Patent Disclosure: Due to the complex nature of biopharmaceuticals, patent enforcement may face challenges related to proving infringement, especially if the alleged infringer uses slightly modified or biosimilar versions[10].
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Litigation Costs and Technical Evidence: Enforcement requires technical expert reports, which may be costly and require specialized expertise to establish infringement or patent validity convincingly in court[11].
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Parallel Litigation: Given Lithuania’s small market, patent disputes often intersect with European Patent Office (EPO) proceedings or apply for cross-border enforcement within the EU[12].
2.3. Supplementary Protection and Data Exclusivity
While supplementary protections or data exclusivity are not specifically granted through patents, these mechanisms can delay generic or biosimilar entry, impacting enforceability strategies[13].
3. Scope of Claims for Biopharmaceutical Patents in Lithuania
3.1. Clarity and Support Requirements
- Claims must be clear, concise, and supported by the description. The Lithuanian Patent Office adheres to EPC standards emphasizing the necessity for support in the description, especially for biotech inventions[14].
3.2. Claim Types and Strategies
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Product Claims: Cover active substances, biologics, or DNA sequences. These are the primary scope in biopharma patents and require precise definitions to prevent easy design-around[15].
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Process Claims: Encompass methods of producing biopharmaceuticals or therapeutic methods (if allowable). As therapeutic methods are excluded, focus on manufacturing processes or formulations[16].
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Use/Second-Use Claims: Cover specific indications or applications of known substances, which are increasingly common in pharmaceutical patenting[17].
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Markush Group Claims: Employed to define a broad class of compounds or biological materials, increasing scope but risking indefiniteness if overly broad[18].
3.3. Claim Construction and Limitations
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Claims should be tailored to balance broad protection against infringement and defensibility against invalidity. Overly broad claims risk invalidation under lack of novelty or inventive step, whereas narrow claims may limit commercial utility[19].
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Use of multiple dependent claims enhances enforceability and offers fallback positions during litigation[20].
4. Practical Tips for Patent Applicants in Lithuania
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Early Consultation with Local & European Patent Experts: Navigating biopharmaceutical patent gaps requires local legal expertise aligned with EPO practices.
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Robust Patent Drafting: Provide detailed descriptions, data, and broad yet clear claims—especially for biologics and new uses—to maximize scope and enforceability.
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Monitoring Public Disclosures: Given the strict novelty requirement, vigilant monitoring and rapid response to potential prior disclosures are crucial.
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Strategic Use of European Patents: Leverage Lithuania’s participation in the European Patent Convention to secure unitary protection and enforceability across multiple jurisdictions.
Key Takeaways
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Lithuania’s patent system accommodates biopharmaceutical inventions that meet fundamental criteria, with particular attention to details in novelty, inventive step, and industrial applicability.
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Patentable biopharmaceutical subject matter includes modified biomolecules, biotechnological processes, and new therapeutic uses, but excludes medical procedures and naturally occurring substances unless modified technically.
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Enforceability depends heavily on technical evidence, expert reports, and strategic patent enforcement planning, especially amid complex biologic products, lifecycle management, and potential patent challenges.
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Drafting claims requires a careful balance—broad enough for commercial leverage but specific to withstand validity attacks; use product, process, and use claims judiciously.
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Engaging local patent attorneys with European expertise improves prospects for patent prosecution, enforcement, and strategic portfolio development in Lithuania.
5 Unique FAQs
Q1: Can naturally occurring genes be patented in Lithuania?
A1: Only if isolated and modified with a technical intervention that confers a new function or utility. Mere isolation of a gene without significant modification generally does not meet patentability criteria under Lithuanian law aligned with EPC standards[6].
Q2: Are therapeutic methods patentable in Lithuania?
A2: No, medical or surgical methods are excluded per Art. 53(c) EPC. However, claims to the pharmaceutical composition used in such methods are patentable[5].
Q3: How does Lithuania handle patent term extensions for biopharmaceuticals?
A3: Lithuania does not issue patent term extensions independently; however, supplementary protection certificates (SPCs) can be obtained via the European Patent Office for medicines, extending protection in Lithuania within the EU framework[13].
Q4: What is the level of patent litigation activity in Lithuania concerning biopharmaceuticals?
A4: It remains relatively low due to Lithuania's size, but cases involving biosimilars and patent disputes over biologics are increasing, often referencing European precedents[10].
Q5: Can second-use patents be effectively enforced in Lithuania?
A5: Yes, provided claims are well-drafted and supported by data. Second-use patents are recognized, and enforcement aligns with European standards, although proof of infringement can be complex[7].
References
[1] Lithuanian Patent Law, Art. 4.
[2] European Patent Convention (EPC), Art. 56.
[3] EPC, Art. 52.
[4] Official Journal of the European Patent Office, Guidelines for Examination, Part G.
[5] EPC, Art. 53(c).
[6] Lithuanian Patent Law, Art. 4(1).
[7] EPO Guidelines, Part G-II, 3.1.2 – Second-Use Claims.
[8] Lithuanian Civil Procedure Code, Art. 100-106.
[9] Lithuanian Patent Law, Art. 13.
[10] European Patent Office, Biotech Patent Examination Guidelines.
[11] Lithuanian courts case law, 2022.
[12] European Patent Office, Enforcement and Litigation in Europe.
[13] Regulation (EC) No 469/2009 (SPC Regulation).
[14] EPC Guidelines, Part G, 3.1.2.
[15] EPO Guidelines, Part G, 3.2.2.
[16] EPC Guidelines, Part G, 3.2.3.
[17] EPC, Art. 54.
[18] EPO Rules of Procedure of the Boards of Appeal, Rule 43.
[19] European Patent Office, Patent Drafting Tips.
[20] EPC, Rule 80.
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