제약산업분야에서의 역지불 합의에 관한 연구

Abstract

On March 15, 2012, the Free Trade Agreement between the Republic of Korea and the United States of America (KORUS FTA) went into effect. One of the outcomes of the KORUS FTA is the introduction of the patent-drug approval linkage system. Currently, the system is being enforced only partly, and its full implementation will take place three years after the effective date of the KORUS FTA, i.e., March 15, 2015. Under the patent-drug approval linkage system envisaged in the KORUS FTA, if a patentee files a lawsuit within a designated period of time after receiving notice of an application for a generic drug approval such filing acts as an automatic stay of the parallel FDA approval process.

The introduction of the patent-drug approval linkage system is likely to have a dramatic impact on the Korean pharmaceutical industry and the domestic consumers. The triggering of the automatic stay of the FDA approval process for the generic drugs is likely to result in according favorable treatment to the branded manufacturers by potentially extending the patent protection period. On the other hand, the introduction of the new system is likely to hurt the generic manufacturers and the consumers because it will delay the approval and sale of generic drugs. In order to ensure that no unwarranted inequities created in this area, the administration, when enacting the relevant laws and regulations governing the patent-drug approval linkage system, should carefully consider the competing interests amongst the brand drug manufacturers, the lower-priced generic drug manufacturers and the consumers.

One of the critical elements of the patent-drug approval linkage system is its impact on the outcome of patent litigation involving introduction of new generic drugs. In the U.S. where the patent-drug approval linkage system has been in place since 1984, many patent litigations involving the introduction of new generic drugs are resolved by way of reverse payment agreements entered into between the patentees (branded drug manufacturers) and the generic drug manufacturers. And these agreements have spurred debate regarding whether they should be construed as a fair use of the underlying patent or deemed as anti-competitive arrangements entered into between the original brand drug manufacturer and the first generic manufacturer. The introduction of the patent-drug approval linkage system in Korea is likely to bring on the same debate thus a forethought regarding the legality of reverse payment agreements is not only relevant, but necessary.

Most U.S. courts that have considered this issue have ruled that reverse payment agreements are not anti-competitive, provided that the contents of the agreements fall within the scope of the underlying patent. Additionally, the Hatch-Waxman Act was revised in 2003 to remedy its shortcomings revealed by various reverse payment agreement cases, and, as a result, the number of anti-competitive types of reverse payment agreements in the U.S. is expected to decrease.

In this article, I explore the developments that have taken place in this area in the U.S. and also suggest a legislative proposal to deal with the potential and inherent conflict between the fair use of patent and the prevention of anti-competitive arrangements in the area of the patent-drug approval linkage system in Korea.