The Korea Food and Drug Administration (KFDA) set the generic permission procedure suspension during patent disputes of domestic pharmaceutical firms at 12 months in the partly amended pharmacy law, one year before the adoption of the Korea-America FTA licensing-patent linkage system.

The KFDA explained, “During the period wherein a patent suit proceeds between original and generic, sales permission is suspended for 12 months, but safety and effectiveness examinations will continue, so the actual damage due to permission delay is less than 12 months.”

Another change is the ‘one year exclusive right to sell’ given to a generic which takes over from the patent of the original. The KFDA decided to introduce a ‘preferential sale item permission system’, whereby if a pharmaceutical firm that won a patent lawsuit against another patentee applies first for item permission they can restrict another firm to sell the same drug for one year at the longest. The “exclusive right to sell” in America is 6 months.

Nevertheless, the current situation is that once multinational pharmaceutical firms have obtained the first generic position after breaking the patent of the original in this country, the domestic firms have to also yield the generic market to multinational pharmaceutical firms.

Therefore, domestic pharmaceutical companies are unfolding a strategy to receive generic permission in advance before the licensing-patent linkage system is applied.

2. KIPO will also do package examination for trademarks and designs from April

KIPO announced that the package examination system would extend to trademarks and designs from April 1 and the regulation for application requirements would be improved as well. The package examination system, which was launched last year for patents and utility models, is a customized one-stop examination support service, whereby many intellectual property rights are examined in a desired period by one application for a package examination. Up to now, an application for preferential examination was required for a package examination of all applications, but it has been improved such that an application for examination need only be filed for the primary case.

3. Government to invest in small and medium business fund

The Financial Services Commission Growth Ladder Fund Secretariat will raise a Konex fund of 440 billion won for acquisitions and mergers, as well as intellectual property within the year. Jointly with the company that takes over, the government will take on risk that could occur in M & A investment through joint investment with a mid-sized company that takes over a blue-chip company. The intellectual property (IP) fund will be operated in such a way that the intellectual property rights owned by small and medium companies are purchased directly or the stakes held by the companies holding the intellectual property rights are invested in. The fund is expected to not only support financing small and medium businesses owning excellent intellectual property rights but also play a role of facilitating the utilization of intellectual property rights such as obtaining patent rights and fluidizing intellectual property rights.

4. KIPO launches a patent strategy support group to improve competitiveness of intellectual property rights of small and medium businesses

The support group, to which over 110 examiners holding both intellectual property rights and technical professionalism joined voluntarily, will give support for improving intellectual property right competitiveness of small and medium businesses. Further, they will visit small and medium businesses, universities, public research institutions, and the like to perform consulting roles with regard to creation, protection and utilization of patents.

KIPO expects through the activity of the group that companies can secure core patents and formulate utilization strategies together with the best experts, and the examiners can have an opportunity for better understanding the policy demand of industrial sites and the latest trends of various techniques and fields.