한국형 의약품 허가-특허 연계제도 - 한⋅미 FTA 및 개정 약사법상 제도 -

The United States had introduced the world’s first drug approval-patent linkage system by establishing Hatch-Waxman Act and revised the above system since then through Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which restrict the exercise of rights of drug developers because the excessive exclusivity period of new drug inventorsbecame a problem. In contrast, Canada, Australia and Republic of Korea (ROK) has introduced the same system by treaty with external (US) in the background. Canada began to consolidate the position of patentee in order to reflect the contents of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the NAFTA (North American Free Trade Agreement) and the WTO (World Trade Organization). In this situation, Canadian drug approval-patent linkage system has been introduced as one content of the NAFTA in 1993. On the other hand, Australia introduced the same system by the FTA with US in 2004. ROK partially enforced drug approval-patent linkage system in March 2012 at the same time that KORUS FTA took effect. ROK implemented the prohibition of sale and the generic exclusivity in March 2015 after the 3 years’ grace period. Korean drug approval-patent linkage system is considering the indicated issues while operating the same system in the US and Canada, and including provisions to prevent abuse of the patent, while also reflecting the Korean characteristic judicial process, such as the Intellectual Property Trial and Appeal Board system. Contrary to the case of Canada and Australia, ROK introduced the similar system as the generic exclusivity of the United States and it reflects Korean dual patent dispute solution process such as lawsuits and administrative appeals. In other words, the authorization for the first sale of medicine (Korean generic exclusivity) can resolve the patent disputes in advance by requesting administrative appeals (patent nullity trial or confirmation trial for the scope of patent right) prior to applying the license to sell the drug, it is expected to provide a motive to accelerate the market entry of second-tier medicine. Over the last 20 years, it is true the number of new drug approvals has been steadily reduced. This continuous reduction of innovation justifies that Korean Food & Drug Administration can grant the market exclusive rights to ensure high profits for the drug developers. The new biopharmaceuticals suggest the highest-tech methods to the most difficult disease to treat in our times. However, these treatments may be no good if they are too expensive for the general public to access. In order to implement KORUS FTA Article §18.9(5), the newly created drug approval-patent linkage system of Korean Pharmaceutical Affairs Act includes the registration for the patent list, the notice of applying the license to sell the drug, the prohibition of sale and the generic exclusivity. In particular, the authorization for the first sale of medicine (Korean generic exclusivity) is not the item required by KORUS FTA where there is no part for the compensation for the drug developers, but it is introduced to indemnify pharmaceutical companies which challenge the patent at the expense of bearing the burden of the risks and costs for the legal disputes. In the United States, the US drug approval-patent linkage system came in contemplating not only the protection of patent but also the purpose of ANDA (Abbreviated New Drug Application) aimed at promoting second-tier pharmaceutical market. In the case of the United States, BPCIA (The Biologics Price Competition and Innovation Act of 2009) was enacted in October 2010, which stipulates ABLA (Abbreviated Biologic License Application) known as biosimilar process. Similar to the existing Hatch-Waxman Act, BPCIA is seeking the balance between two conflicting interests of innovation and accessibility, as the main objective. In like manner, the drug approval-patent linkage system of the revised Korean Pharmaceutical Affairs Act has to be operated carefully and prudently to accomplish the equilibrium point between two conflicting objectives of the innovation for new drugs and the accessibility of general public.

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