The Ministry of Trade, Industry and Energy is expected to convene a biotechnology expert committee next month to review whether to maintain or lift the designation of botulinum toxin as a national core technology. The industry views it as a watershed that could reshape the regulatory landscape for the K-toxin sector.
According to the industry on the 22nd, the Korea Industrial Technology Protection Association recently collected opinion letters from individual corporations on whether to lift the national core technology designation for botulinum toxin. The Ministry of Trade and Industry (MOTI) plans to prepare an agenda submission document based on this and begin procedures to convene the expert committee.
This reconsideration is a process to reexamine the appropriateness of the 2010 notice that designated the botulinum toxin production process as a national core technology and the 2016 revision that expanded protection to include the strain itself.
Those in favor of lifting say the national core technology designation acts as a constraint on industry growth. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) estimates that the opportunity cost losses from the designation reach the 100 billion won range annually. They note there are not a few cases in which contracts are delayed or canceled during overseas technology transfer, strategic investment attraction, and global co-development negotiations, as the question of whether it falls under national core technology becomes a due diligence risk.
Some corporations argue they missed first-mover opportunities as export approvals take an average of four to six months, and as long as nearly a year. One company also cites a case in which, due to administrative delays, it supplied at prices up to 45% lower than a competitor's.
Proponents of lifting also question the scarcity of the technology. They say botulinum toxin production technology was developed in the 1940s and that major patents from the 1980s have expired. They argue it is difficult to recognize technological exclusivity for the strain as well, as it was secured from overseas.
Opponents of lifting counter that this is a "simplification of technological realities." They say the core lies in the process technology after securing the strain. Botulinum bacteria must be cultured in an anaerobic environment, and the toxin protein is vulnerable to heat, light, and vibration. They explain that commercial strains are the result of maximizing toxin productivity through hundreds of passages and are distinct from research strains.
Opponents also stress that the national core technology designation is not a system that blocks exports per se. They argue it is a safeguard that controls indiscriminate leakage in technology transfer and in overseas mergers and acquisitions. In particular, the possibility of foreign capital acquiring domestic toxin corporations is cited as a concern.
Ultimately, the decision rests with the Ministry of Trade and Industry (MOTI) expert committee. Depending on what balance the government chooses between easing regulations and protecting technology, it is expected to have a significant impact on investment and overseas strategy in the domestic toxin industry.