Introduction to Taiwan's Patent System
Taiwan has a robust patent system designed to protect intellectual property, particularly in the biopharmaceutical sector. Here are the key insights into patentability, enforceability, and the scope of claims for biopharmaceutical patents in Taiwan.
Patent Subject Matter Eligibility
Animals, Plants, and Biological Processes
According to Article 24 of the Taiwan Patent Act, animals, plants, and essential biological processes for the production of animals or plants are not eligible for patent protection. However, this exclusion does not apply to processes for producing microorganisms or methods involving genetic engineering that do not rely on entire genome recombination and natural mixing of genes[5].
Natural Forms and Isolated Substances
Matters in their natural forms, such as wild plants or natural crystals, are not patentable. However, substances obtained by separation from nature, which have different structures, forms, or physical chemistry properties from those known and can be clearly defined, are eligible for patent protection. For example, a gene or microorganism isolated from nature through a special procedure can meet the definition of an invention[5].
Diagnostic, Therapeutic, and Surgical Methods
Diagnostic, therapeutic, and surgical methods for the treatment of humans or animals are excluded from patent protection under Article 24 of the Taiwan Patent Act. The Patent Examination Guidelines provide specific criteria for determining what constitutes a diagnostic method, which must fulfill certain conditions to be considered patent ineligible[5].
Patent Linkage System
Overview
The patent linkage system in Taiwan, introduced in January 2018, aims to resolve disputes on patent invalidity and infringement between brand drug companies and generic drug companies more efficiently. This system is part of the amended Pharmaceutical Affairs Act[1][2].
Requirements for Brand Drug Companies
Brand drug companies must submit a list of patents associated with a new drug to the Taiwan FDA within 45 days of receiving approval. This information is published in the Orange Book for public inspection[1][2].
Declarations by Generic Drug Companies
Generic drug companies must make one of four declarations when filing an application for a generic drug:
- The new drug has not been patented.
- The patent for the new drug has already expired.
- Drug approval for the generic drug will not be issued until the patent for the new drug has expired.
- The patent for the new drug is not infringed or is invalid.
If a generic drug company declares that the patent is not infringed or is invalid, they must notify the patentee and provide grounds and evidence within 20 days of receiving notice from the Taiwan FDA[1][2].
Enforceability of Biopharmaceutical Patents
Litigation Process
If a generic drug company declares that the patent is not infringed or is invalid, the patentee or exclusive licensee can file a lawsuit within 45 days. The Taiwan FDA will stay the approval of the generic drug for up to 12 months if a lawsuit is filed. If the court renders a final judgment in favor of the patentee within this period, the generic drug company will receive approval only after the patent expires. Otherwise, the generic drug company will receive approval and a 12-month market exclusivity if it is the first to complete the application[1][2].
Data Exclusivity
Taiwan provides data exclusivity for new chemical entities and biologics, with a 5-year exclusivity period. For new indications with international data, there is a 3-year data exclusivity period, which can be extended to 5 years for those with domestic clinical trials[2].
Scope of Claims
Extended Patent Rights
The Taiwan Patent Act allows for the extension of patent rights for pharmaceuticals and agrochemicals. The scope of an extended patent right is limited to the active pharmaceutical ingredients (API) and the indications specified on the new drug approvals. This ensures that the extended patent right does not cover broader or unrelated aspects[3].
Specificity and Limitations
The Intellectual Property and Commercial Court in Taiwan has clarified that the scope of extended patent rights must be strictly interpreted according to Article 56 of the Patent Act. This means that any claims beyond the specified API and indications are not protected during the extended period[3].
Comparison with International Standards
Eligibility Requirements
Taiwan's eligibility requirements for biotech and pharma patents differ significantly from those in other countries, such as the United States. In Taiwan, specific gene sequences and microorganisms are more likely to be considered patentable, whereas in the U.S., they are often deemed natural products and may be rejected under 35 U.S.C. §101[5].
Key Takeaways
- Patent Subject Matter Eligibility: Taiwan excludes essential biological processes and natural forms but allows patents for genetically engineered organisms and isolated substances.
- Patent Linkage System: This system requires brand drug companies to list associated patents and generic drug companies to make specific declarations, facilitating faster resolution of patent disputes.
- Enforceability: The system allows for litigation within 45 days, with a stay on generic drug approval for up to 12 months, and provides market exclusivity for the first successful generic challenger.
- Scope of Claims: Extended patent rights are limited to specified API and indications, ensuring narrow and specific protection.
- Data Exclusivity: Taiwan offers data exclusivity periods ranging from 3 to 5 years, depending on the type of new drug or indication.
FAQs
What is the patent linkage system in Taiwan?
The patent linkage system in Taiwan is a mechanism established to resolve disputes on patent invalidity and infringement between brand drug companies and generic drug companies more efficiently. It involves the submission of patent information by brand drug companies and specific declarations by generic drug companies.
How long can the Taiwan FDA stay the approval of a generic drug if a lawsuit is filed?
The Taiwan FDA can stay the approval of a generic drug for up to 12 months if a lawsuit is filed by the patentee or exclusive licensee within 45 days of receiving notification from the generic drug company.
What is the scope of extended patent rights in Taiwan?
The scope of extended patent rights in Taiwan is limited to the active pharmaceutical ingredients (API) and the indications specified on the new drug approvals.
How does Taiwan's patent eligibility differ from the U.S.?
Taiwan allows patents for specific gene sequences and microorganisms, whereas in the U.S., these are often deemed natural products and may be rejected under 35 U.S.C. §101.
What is the data exclusivity period in Taiwan for new chemical entities and biologics?
Taiwan provides a 5-year data exclusivity period for new chemical entities and biologics, with additional provisions for new indications.
Sources
- Saint Island International Patent & Law Offices, "The Patent Linkage System in Taiwan," January 2018.
- Ministry of Health and Welfare, Taiwan, "Pharmaceutical Intellectual Property Protections in Taiwan," February 23, 2018.
- Saint Island International Patent & Law Offices, "Protection Scope during the Extended Period of Patent Rights in Taiwan," Q1 2024.
- Wisdom Law, "In-depth Guide of Eligibility Requirements for Biotech and Pharma Patents in the United States, Taiwan, Japan and China," December 24, 2021.
