기업의 내부통제 활성화 방안

다국어 초록 (Multilingual Abstract)

To implement the Korea-U.S. Free Trade Agreement, the Patent-Regulatory Approval Linkage System will be enforced from March 2015. This has driven a growing concern about the side effects of evergreening, such as the inflation of drug prices and the delayed release of generics. The active evergreening approaches of multinational pharmaceutical companies over major essential drugs have recently sparked controversy over patenting and the right to health. Article 31 of the TRIPs Agreement allows the use of the compulsory license; thus, its member countries can regulate their patents. However, it also stipulates that the original purpose of a patent should not be overlooked when restricting the patent and that the interest of a patentee and a third party should be reasonably controlled. The international discussion on the compulsory license system can be considered as a process of establishing the balance point between a patentee’s own interest and public interests, such as public health considerations.
On April 1, 2013, India’s Supreme Court gave its ruling on Glivec, which was considered as a confrontation between a patent and the right to health with regard to guaranteeing accessibility to essential drugs. The government’s policy on the compulsory license for pharmaceutical patents has to invest a particularly considerable effort to establish a balance between the human right to health, on the one hand, and patents, on the other hand. The South Korea’s government has promoted the policy enhancing patent applications. Thus, it appears to have some concerns about potential side effects that can occur with the compulsory license system regulating patents.
As the compulsory license for pharmaceutical patent has never been exercised in South Korea, the requisite to public interests tends to be strictly interpreted. On the other hand, there are more than 100 cases that accepted the compulsory license for the sake of monopoly regulation as they put emphasis on the right to health. With regard to the implementation of the compulsory license for pharmaceutical patents, an objective and reasonable standard needs to be set in detail for the protection of the right to health.
It is expected that a policy will be able to be enacted in South Korea, which puts more emphasis on the right to health than the pharmaceutical patents regarding the compulsory license that is guaranteed by both international and domestic laws.

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