Biotech and Medical Inventions: Moving the Goal Posts  

he Amendment to the Taiwan Patent Act is expected to come into effect in January 2013. As the government endeavours to stimulate the growth of the biotech and pharmaceutical industries in Taiwan, many new rules will be implemented.

Biological materials deposit

Taiwan is not a signatory to the Budapest Treaty, and the current and the new Patent Act both require a patent applicant for biological materials to make a deposit in Taiwan regardless of whether the biological materials have been deposited in a foreign depository already. There are instances, however, that would allow a patentee to avoid making a domestic deposit. As well as circumstances in which a person of ordinary skill in the art can easily obtain the materials, a domestic deposit can be exempted if the applicant has already deposited biological materials in a country, which has reciprocal recognition with Taiwan. At the moment there is no foreign depository that recognises the effect of deposits in Taiwan, but the inclusion of this rule may implicate any possible bilateral recognition in the future.

The general rule under the current Patent Act is to make a deposit prior to the filing date of a patent application. If the applicant has made a deposit in an International Depositary Authority (IDA) recognised under the Budapest Treaty prior to filing a patent application in Taiwan, a three-month grace period will be granted for making a domestic deposit and submitting a certificate to the Taiwan Intellectual Property Office (TIPO). Pursuant to the new Patent Act, a lenient time period of four months from the application date or 16 months from the earliest priority date will be granted to the applicants.

Patent term extension

The current patent term extension is applicable for an invention patent involving pharmaceuticals and agrichemicals, or their preparation processes, and that is subject to regulatory approval under other laws, if this approval takes more than two years from the publication of a patent. The two-year threshold requirement is removed from the new Patent Act so that, as long as regulatory approval is obtained after the publication of a patent, the patentee may be able to obtain an extension of the patent term for a period of not more than five years. It is noted that regulatory approval may only provide a one-time basis for an extension of the patent term, and the subject of the extended patent term shall be limited to effective ingredients and usage identified in the regulatory approval. 

Patent exemption for generic drug testing

Generic drug testing will no longer be an issue for patent infringement. The new Patent Act exempts the testing of generic drugs from the exclusive right of a patent, if the purpose of the testing is obtaining regulatory approval. The scope of patent exemption includes research, trials and necessary acts performed for the purpose of obtaining regulatory approvals for new products, or obtaining marketing permits for foreign products. Therefore, for the purpose of obtaining pharmaceutical approval or permits, the new Patent Act will exempt the direct or indirect implementation of invention patents such as testing drugs and medical devices during both pre-clinical and clinical trials, as well as offers for sale, sales and imports.

Compulsory licence for pharmaceuticals

Following the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health, the new Patent Act stipulates compulsory licence provisions for pharmaceuticals. To facilitate access to pharmaceuticals for HIV/AIDS, tuberculosis, malaria or other epidemics afflicting populations in many developing and underdeveloped countries, the TIPO may grant an applicant a compulsory licence to practice a patent in order to supply an amount of pharmaceuticals needed by a particular country. However, negotiations with patentees involving reasonable conditions and time frames are a prerequisite for the grant of a compulsory licence, unless the patented pharmaceutical is already a subject of a compulsory licence in the recipient country. A compulsory licensee shall pay reasonable compensation to a patentee.