The Ministry of Food and Drug Safety said it was pushing to amend the limited exclusive sales rights approval system, introduced in 2015, to help raise local drugmakers’ research and development capabilities.
The ministry is reviewing the revision plan by collecting opinions from the pharmaceutical industry and referencing annual reports on the impact of the “patent approval linkage system.” It is to come up with a final plan as early as April.
The government's move aims to enhance the initial purpose of the limited exclusive sales rights system, which is to reinforce local pharmaceutical firms’ global competitiveness when they try to nullify the patents of original drugs.
The nation introduced the limited exclusive sales rights system as part of the patent approval linkage system, following the Korea-U.S. Free Trade Agreement.
Under the limited exclusive sales rights system, the authorities allow a generic drugmaker to exclusively sell the generic copy for nine months if the company wins a patent lawsuit against an original drug manufacturer. During the nine months, any other generic medicine cannot enter the market.
Seventy-three domestic pharmaceutical firms won the limited exclusive sales rights for 263 products (33 ingredients in total) from March 15, 2015, to Feb. 15, 2019. Forty-four companies still have sales deadlines left for 130 drugs (13 ingredients).
Initially, the government adopted the system to help raise domestic firms’ R&D and global capabilities when they aim to nullify the original drugmakers’ patents. However, the program has become ineffective to meet its original goal, critics have said.
Many local generic makers have taken advantage of the system to obtain exclusive sales rights through consigned or joint bioequivalence tests. The method allows drugmakers incapable of developing generic copies to consign generics to another company to sell them.
For example, as many as 45 local companies obtained the limited exclusive sales rights for generic drugs containing amlodipine, a hypertension treatment, even though only one company put much effort to nullify the original drug’s patent. Being aware of the problem, the pharmaceutical industry urged the government to amend the system.
The authorities give generic drugmakers 14 days for filing a patent lawsuit, after the first one, to provide them with the limited exclusive sales rights. If a pharmaceutical firm initially files a patent suit and dozens of other firms follow suit with the same patent litigation, and they win the lawsuit together, all of the generic drugmakers will receive the exclusive sales rights to the involved drug. This creates excessive patent lawsuits, critics have said.
One of the opinions from the pharmaceutical industry collected by the ministry was that the 14-day limit made it difficult for companies to focus on R&D because they had to file a patent lawsuit to get the exclusive sales rights.
The ministry said it would reflect industry opinions on the revision plan, but it would make sure to balance out widely different opinions from patent holders and generic developers.