Key Features in Korea

This document outlines the major intellectual property (IP) systems in South Korea, focusing on patent protection in biotechnology, microorganism deposit requirements, patent term extension for pharmaceuticals and agrochemicals, and international collaborations such as the Patent Prosecution Highway (PPH) and Collaborative Search and Examination (CSP).

Biotechnology and Patents

Biotechnology has rapidly expanded and diversified since the first genetically engineered insulin received FDA approval in 1982. This field now encompasses biopharmaceuticals, bioelectronics, biochemistry, bio-food, bio-agriculture, and bio-environment. South Korea recognizes the crucial role of IP rights in this burgeoning industry.

Patentable Subject Matter in Biotechnology

Since 1988, South Korea has established patent examination guidelines for biotechnology, aligning with international trends. These guidelines clarify the patentable subject matter, including:

• Gene (DNA Sequence): Patentable if utility is identified.
• Protein (Amino Acid Sequence): Patentable.
• Single-celled Organisms (Virus, Bacteria): Patentable, requiring deposit of related microorganisms.
• Animals: Patentable except for inventions contrary to public order and morality.
• Parts of the Human Body: Not patentable due to concerns about human dignity.
• Surgery, Treatment Methods: Not patentable for humans, patentable for animals.
• Gene Therapy: Not patentable for humans, patentable for animals.
• Diagnostic Methods: Not patentable for humans, patentable for animals.

Electronic Filing of Sequence Listings

To streamline the disclosure and expedite the examination of patent applications containing nucleotide or amino acid sequences, South Korea introduced an electronic filing system for sequence listings.

• Effective July 1, 2022: All domestic and international applications (excluding certain types) must submit sequence listings in XML format, following WIPO Standard ST.26.
• Prior to July 1, 2022: Sequence listings were included in the specification, with optional electronic files if compliant with WIPO Standard ST.25.

Failure to comply with these requirements may result in a notice for correction from the Korean Intellectual Property Office (KIPO).

Deposit of Microorganisms

Due to the complexity of describing microorganisms in written patent applications, South Korea uses a microorganism deposit system to complement disclosures and ensure reproducibility.

Purpose and Scope

Patent applicants can deposit microorganisms (e.g., bacteria, viruses, fungi, yeast, algae, animal cells, plant cells, fertilized eggs, seeds) at authorized depository institutions, ensuring availability for third parties to reproduce the invention after patent grant.

Legal Framework

• Patent Act and Related Regulations: Outline deposit requirements for microorganism-related inventions.
• Budapest Treaty: South Korea's membership simplifies the deposit process for international patent applications.

Designated Depository Institutions

Four institutions are authorized to accept microorganism deposits for patent purposes in South Korea:

1. Korean Collection for Type Cultures (KCTC)
2. Korean Culture Center of Microorganisms (KCCM)
3. Korean Cell Line Research Foundation (KCLRF)
4. National Institute of Agricultural Sciences, Rural Development Administration (KACC)

Patent Term Extension for Pharmaceuticals and Agrochemicals

South Korea offers a patent term extension system to account for the significant time and resources required for regulatory approvals.

Eligibility

Patent term extension of up to five years is available for patents related to:

• Pharmaceuticals (human and veterinary)
• Agrochemicals (active ingredients)

Requirements

• The patent must cover the active ingredient with its first marketing approval.
• The patent must be in force in Korea.
• The patent applicant must be the marketing authorization holder or have a valid license.

Calculation of Extension Period

The extension period is based on the time spent on regulatory review and clinical trials, excluding delays attributable to the patent holder.

International Cooperation

South Korea actively engages in international collaborations to streamline the patent examination process and promote global innovation.

Patent Prosecution Highway (PPH)

PPH enables expedited patent prosecution by leveraging favorable examination results from one country's patent office when applying for corresponding patents in other participating countries.

• Participating Offices: South Korea has PPH agreements with 36 countries/regions and IP5.
• Benefits: Reduced examination time and resources, leading to faster patent grants.

Collaborative Search and Examination (CSP)

CSP facilitates collaboration between patent offices during the examination process, particularly in sharing prior art information.

• Pilot Programs: South Korea has ongoing CSP programs with the United States, Saudi Arabia.
• Benefits: Enhanced examination quality, increased consistency, and faster processing times.

Other Notable IP Provisions

Grace Period for Public Disclosures

Korea offers a 12-month grace period allowing inventors to disclose their inventions publicly without losing patent eligibility, provided that a patent application is filed within the grace period.

1. Public Disclosure by the Right Holder:
   • The invention must be filed within 12 months of the disclosure.
   • The application must indicate reliance on the grace period provision.
   • Evidence supporting the disclosure date and content must be submitted within 30 days of filing.
   • For international applications, evidence must be submitted within 30 days after the national phase entry.
2. Disclosure Against the Right Holder's Will:
   • There are no restrictions on the method of disclosure.
   • The invention must be filed within 12 months of the unauthorized disclosure.
   • The application does not need to indicate reliance on the grace period provision.
3. Procedural Flexibility:
   • If the applicant pays a supplementary fee, the required documents indicating reliance on the grace period or proving the disclosure date can be submitted within specific periods:
     • During the correction period as defined in Patent Act Article 47(1).
     • Within 3 months from the date of receiving a copy of the patent decision or the decision to cancel the rejection under Articles 66 or 176(1) respectively, but not later than the date of registration as per Article 79.

Patent Recognition Program (PRP)

The PRP streamlines patent protection for Korean businesses in countries with less developed IP infrastructures, using a granted Korean patent as a basis for obtaining patent protection in partner countries like Brunei, Cambodia, and Laos.

• Eligibility: Requires the same earliest priority date and a granted Korean patent.
• Country-Specific Requirements: Each partner country has detailed requirements regarding application filing dates, claim amendments, documentation, and processing times.

Priority Examination

Priority examination allows for expedited processing of patent applications under specific criteria, such as public implementation, national importance, international agreements, and other significant circumstances.

• Eligibility Criteria: Includes inventions related to national defense, export promotion, green technologies, and those crucial for disaster response or the 4th Industrial Revolution.
• Application Process: Requires a request with justification, supporting documents, and fees, leading to faster examination.

Conclusion

South Korea has established a comprehensive IP system promoting innovation and protecting intellectual property rights. The country's patent laws and regulations evolve continually to keep pace with technological advancements and global trends in intellectual property protection.