Patentable Subject Matter
In South Korea, the scope of patentable subject matter is broader compared to some other jurisdictions. Here are the key points:
- Biological Materials: Isolated genes, proteins, small molecules, and herbal extracts are all patentable in Korea, unlike in the United States where such materials may not be patentable due to decisions like Myriad and Alice[1].
- Cells and Higher Life Forms: Cells, including stem cells, and higher life forms such as plants and animals are also eligible for patent protection. Stem cells can be patented by defining them through their origins, expression markers, morphological features, functions, and preparation methods[1].
- Plant Varieties: Plant varieties can be protected separately under the Seed Industry Law, which aligns with the UPOV Convention[1].
Ethical and Public Order Considerations
- Morality and Public Order: Inventions that contravene public order or morality cannot be patented. This provision particularly affects stem cells and higher life forms due to ethical considerations[1].
Medical Treatment Methods
- Human vs. Animal Treatments: Methods of medical treatment for humans are not patentable in Korea, primarily due to concerns about the misuse of privately owned patent rights against public health. However, methods of medical treatment for animals, explicitly excluding humans, can be patented[1].
- Second Medical Use Claims: Medical use of a pharmaceutical composition must be claimed as a type of second medical use claim, such as "A pharmaceutical composition comprising X for the treatment of Y"[1].
Dosage Regimens
- Patentability of Dosage Regimens: The Supreme Court of Korea has ruled that dosage regimens can be patentable technical features, providing clarity on what was previously a grey area[1].
Prodrugs and Pharmaceutical Compounds
- Scope of Pharmaceutical Compound Patents: The Korean courts have established that the scope of a pharmaceutical compound patent can include prodrug forms of the compound, both during the regular term of the patent and during a Patent Term Extension (PTE)[3].
- Examples and Case Law: In the case involving AstraZeneca's patent on dapagliflozin, the courts ruled that prodrugs of the compound were within the scope of the original patent, even during the PTE period[3].
Research and Testing Exemptions
- Article 96 of the Korean Patent Act: This article allows for the practice of patented inventions for research and testing to obtain product approval. However, the court has emphasized the need for a higher burden of proof and sufficient evidence to claim this exemption. Stockpiling products before patent expiration is not allowed under this exemption[2].
Enforceability of Patents
- Injunctions and Patent Infringement: Korean courts have issued injunctions against biosimilar companies engaging in infringing activities, emphasizing the protection of patentees' rights. The necessity of preservation to protect the patentee's interest is a key factor in these decisions[2].
- Burden of Proof: The court requires a higher burden of proof for potential infringers relying on the research and testing exemption, ensuring that sufficient and objective evidence is produced to support their claims[2].
Patent-Approval Linkage System
- Data Exclusivity and Generic Challenges: Korea's patent-approval linkage system acts as a de facto data exclusivity period, where generics can only apply for approval after the relevant PMS period expires. This system has led to earlier filings of KIPO actions against drug patents, often to preserve generic exclusivity rights[5].
Recent Amendments to the Korean Patent Act
- Extended Response Time: The deadline to respond to final rejection has been extended from 30 days to 3 months, enhancing convenience for applicants[4].
- Guidelines for Patent Examination: New guidelines have been introduced to improve the quality and predictability of examination standards, particularly for applications related to autonomous vehicles and other complex technologies[4].
Key Takeaways
- Broad Scope of Patentable Subject Matter: South Korea allows for the patenting of a wide range of biological materials and life forms.
- Ethical Considerations: Inventions must comply with public order and morality.
- Distinct Treatment for Human and Animal Medical Methods: Human medical treatment methods are not patentable, while those for animals are.
- Inclusive Scope for Pharmaceutical Compounds: Prodrugs are included within the scope of the original patent.
- Stringent Research and Testing Exemptions: High burden of proof and evidence required for claiming research and testing exemptions.
- Strong Enforcement of Patents: Courts issue injunctions to protect patentees' rights.
- Complex Patent-Approval Linkage System: Early filings of KIPO actions to preserve generic exclusivity rights.
FAQs
Q: Are isolated genes patentable in South Korea?
A: Yes, isolated genes and other biological materials such as proteins and small molecules are patentable in South Korea[1].
Q: Can methods of medical treatment for humans be patented in Korea?
A: No, methods of medical treatment for humans cannot be patented in Korea, but methods for animals can be patented if they explicitly exclude humans[1].
Q: Are prodrugs included within the scope of a pharmaceutical compound patent in Korea?
A: Yes, prodrugs are included within the scope of the original patent, both during the regular term and during a Patent Term Extension (PTE)[3].
Q: What is the significance of Article 96 of the Korean Patent Act?
A: Article 96 allows for the practice of patented inventions for research and testing to obtain product approval, but with a high burden of proof and evidence required to claim this exemption[2].
Q: How does the patent-approval linkage system in Korea affect generic drug approvals?
A: The system acts as a de facto data exclusivity period, delaying generic approvals until the relevant PMS period expires, and has led to earlier filings of KIPO actions to preserve generic exclusivity rights[5].
Cited Sources
- Managing IP: "South Korea: Patentable subject matter – what's new?" - February 24, 2016.
- Kim & Chang: "Korean Court Rejects Biosimilar Company's Defense to Patent Infringement" - July 19, 2024.
- Kim & Chang: "Korean Courts Confirm that Scope of a Pharmaceutical Compound Patent Can Include Prodrug Forms" - February 2, 2023.
- Kim & Chang: "Korean Supreme Court Loosens Criteria for Patentability of Inventions" - April 20, 2022.
- Kim & Chang: "Korean Patent-Approval Linkage System" - Fall/Winter 2015 Newsletter.
