Jun-Seok Park, Scope of Protection for Term-Extended Patent Rights: Interpreting the New “Substantial Identity” Standard in the Solifenacin Decision (Supreme Court, Jan 17, 2019, 2017Da245798), Journal of Industrial Property, Vol. 62 (2020), pp. 1-72.
<Abstract>
In 2019, Our Supreme Court's decision in the Solifenacin case proposed a new standard of “substantial identity” in determining the scope of protection that the term-extended patent covers. This new standard is valuable because it overcomes the problem that all the previous discussions, which were approached from the point of view of the Korean Pharmaceutical Affair Act, were wrong approach and leading to too rigid standards in interpreting Article 95 of Korean Patent Act concerning the scope of protection for the term-extended patent. However, there could be some possibility that the new standard set by the Solifenacin decision is mistakenly understood as the same standard as that of the equivalent theory or misunderstood as a another rigid standard similar to the previous ones if someone misinterprets the two below criteria given in the Solifenacin decision: the first criterion is whether or not a person having ordinary skill in the art (PHOSITA) could easily modify a salt of a drug even though the specific type of salts in the compared drugs are different, then the second criterion is whether the considered factors such as active ingredient, therapeutic effect, use and etc. are substantially identical. By avoiding the above dangerous possibility and developing a wise and harmonious interpretation, some flaws residing in the Solifenacin decision should be cured. This article try to elucidate the proper direction of such interpretation. To get such interpretation, this article does emphasize some points as follows: The very scope of protection for the substantial identity theory in Solifenacin decision is clearly narrower than that for the equivalent theory. For proper application of the substantial identity standard set by Solifenacin decision, the concept of ‘active ingredient, therapeutic effect and use’, which are the considered factors presented in the Solifenacin decision, should be interpreted as broadly as possible while the other factors must be also considered in addition to the above factors. In addition, even if the specific jargon (‘substantial identity’) for the new standard of Solifenacin decision is exactly same as that of the Japanese Intellectual Property High Court decisions, it is never allowable to deadly follow the related interpretation of Japanese court. Because the specific legislations for patent term extension in Korea, Japan, US, and the European Union are quite different in many ways, such Japanese interpretation and its related trend is no more than a reference, not a binding.
<Keywords>
Solifenacin Decision VESIcare Case Salt-modified Drug Term-extended Patent Right Patent Term Extension System Equivalent Theory
Jun-Seok Park, Scope of Protection for Term-Extended Patent Rights: Interpreting the New “Substantial Identity” Standard in the Solifenacin Decision (Supreme Court, Jan 17, 2019, 2017Da245798), Journal of Industrial Property, Vol. 62 (2020), pp. 1-72.
<Abstract>
In 2019, Our Supreme Court's decision in the Solifenacin case proposed a new standard of “substantial identity” in determining the scope of protection that the term-extended patent covers. This new standard is valuable because it overcomes the problem that all the previous discussions, which were approached from the point of view of the Korean Pharmaceutical Affair Act, were wrong approach and leading to too rigid standards in interpreting Article 95 of Korean Patent Act concerning the scope of protection for the term-extended patent. However, there could be some possibility that the new standard set by the Solifenacin decision is mistakenly understood as the same standard as that of the equivalent theory or misunderstood as a another rigid standard similar to the previous ones if someone misinterprets the two below criteria given in the Solifenacin decision: the first criterion is whether or not a person having ordinary skill in the art (PHOSITA) could easily modify a salt of a drug even though the specific type of salts in the compared drugs are different, then the second criterion is whether the considered factors such as active ingredient, therapeutic effect, use and etc. are substantially identical. By avoiding the above dangerous possibility and developing a wise and harmonious interpretation, some flaws residing in the Solifenacin decision should be cured. This article try to elucidate the proper direction of such interpretation. To get such interpretation, this article does emphasize some points as follows: The very scope of protection for the substantial identity theory in Solifenacin decision is clearly narrower than that for the equivalent theory. For proper application of the substantial identity standard set by Solifenacin decision, the concept of ‘active ingredient, therapeutic effect and use’, which are the considered factors presented in the Solifenacin decision, should be interpreted as broadly as possible while the other factors must be also considered in addition to the above factors. In addition, even if the specific jargon (‘substantial identity’) for the new standard of Solifenacin decision is exactly same as that of the Japanese Intellectual Property High Court decisions, it is never allowable to deadly follow the related interpretation of Japanese court. Because the specific legislations for patent term extension in Korea, Japan, US, and the European Union are quite different in many ways, such Japanese interpretation and its related trend is no more than a reference, not a binding.
<Keywords>
Solifenacin Decision VESIcare Case Salt-modified Drug Term-extended Patent Right Patent Term Extension System Equivalent Theory