Lee International

Under the current Patent Act, the pharmaceutical patents eligible for Patent Term Extension (PTE) are limited to an invention for medicines that have been approved under the Pharmaceutical Affairs Act and narcotic drugs that have been approved under the Narcotics Control Act.  In September 2020, the Advanced Regenerative Bio Act was newly enacted and separately implemented from the Pharmaceutical Affairs Act.  With this, advanced biopharmaceuticals including cellular therapy products, gene therapy products and tissue engineering products, which are approved under the Advanced Regenerative Bio Act, not under the Pharmaceutical Affairs Act, are no longer eligible for PTE under the current Patent Act.  This appears to be a simple legislative mistake, considering that biopharmaceuticals, which had been approved under the Pharmaceutical Affairs Act before the enforcement of the Advanced Regenerative Bio Act, were eligible for PTE. 

Against this backdrop, the Korean Intellectual Property Office is currently reviewing revisions to the Patent Act to add advanced biopharmaceuticals approved under the Advanced Regenerative Bio Act to the subject matter eligible for PTE.  Since the pharmaceutical industry including original and generic pharmaceutical companies are in favor of such revisions, it is likely that the Patent Act will be soon revised. 

Until now, a total of 18 products, including Kymriah, were approved as advanced biopharmaceuticals.  Given the continued developments of advanced biopharmaceuticals and approvals thereof, it is expected that the Patent Act will be soon revised to resolve confusion caused by legislative shortcomings.