IP Newsletter | Spring/Summer 2019
	PATENT
	Korean Patent Court Clarifies that Product Approvals Under the Narcotics Control Act Also Are a Valid Basis for Patent Term Extension
	Patent term extensions ("PTEs") for regulatory approval delays were introduced into Korea in 1987, but there are a number of areas of uncertainty that remain unresolved in the PTE legal system to this day. The Patent Court recently rendered a decision clarifying one of these areas, by overturning the final rejection by the Korean Intellectual Property Office (KIPO) of a PTE application that was filed on the basis of a psychotropic drug for treatment of obesity that was approved under the Narcotics Control Act, as opposed to the Pharmaceutical Affairs Act which governs most drug approvals in Korea.
	Legal Provisions Relating to Eligibility for PTE
	The Korean Patent Act ("KPA") provides that the specific types of inventions and approvals that can qualify for PTE are to be defined by its implementing regulations (the Enforcement Decree of the KPA), which KIPO is responsible for creating and administering. At present, the Enforcement Decree states that a patented invention covering a pharmaceutical product approved under the Pharmaceutical Affairs Act or an agrochemical product registered under the Pesticide Control Act is eligible for PTE. However, while the Pharmaceutical Affairs Act covers pharmaceutical product approvals in Korea in general, it provides that drugs that are potentially addictive or subject to abuse are to be regulated and approved under a separate law, the Narcotics Control Act.
	KIPO's Rejection
	In the case at issue, the applicant had filed for PTE based on the approval of a drug under the Narcotics Control Act, rather than the Pharmaceutical Affairs Act. KIPO issued a final rejection of the PTE application on the ground that because the Narcotics Control Act was not expressly identified as a valid basis for PTE in the Enforcement Decree, no PTE could be granted for the patent at issue. This reasoning was confirmed at the first instance by the Intellectual Property Trial and Appeal Board (IPTAB).
	Patent Court's Determination
	The Patent Court reversed the IPTAB's decision and concluded that the PTE at issue was erroneously rejected, holding that the Enforcement Decree of the KPA failed to properly implement the full scope of the KPA concerning PTE eligibility, and therefore was an improper basis for the rejection in this case.
	The Patent Court first determined that an approval under the Narcotics Control Act is substantially the same as an approval under the Pharmaceutical Affairs Act, given that the agency reviewing the approval, the entity obtaining the approval, the items to be reviewed for the approval, and the process and examination period for the approval are basically the same. The Patent Court then noted that although the KPA delegates to the Enforcement Decree the specific identification of inventions eligible for PTE, the KPA broadly defines such inventions as those involving approvals under other laws that require lengthy periods to conduct safety, validity, or other testing before the approval can be issued. Further, as pointed out by the applicant's counsel, there had been no discussion at all regarding the Narcotics Control Act in connection with PTE requirements when the Enforcement Decree was drafted or amended.
	Therefore, the Patent Court concluded that the KPA did not delegate to KIPO the authority to arbitrarily select only some "other laws" or types of approvals as eligible for PTE while excluding others that would also involve lengthy approval-related testing, and that as a result, the Enforcement Decree was defective and an improper basis for KIPO's rejection in this case. The Patent Court also stated that treating approvals under the Narcotics Control Act and the Pharmaceutical Affairs Act differently in this case would be a violation of the principle of equality under the Constitution.
	Significance of the Patent Court's Decision
	This is a rare instance where the Patent Court determined that an Enforcement Decree provision was overly narrow in implementing its governing statute, despite arguably being literally within the scope of the statute, and overturned a KIPO rejection as a result. The decision was particularly surprising in this case because the IPTAB had already previously rejected another PTE based on an approval under the Narcotics Control Act for the same reasons as in this case, which had not been appealed. The Patent Court took the unusual step in this case of construing in detail the intent of the relevant KPA provisions in this case, and then determined that the Enforcement Decree was inconsistent with and improperly added limitations to the intended scope of the KPA provisions concerning PTE.
	This decision indicates that the Patent Court may be taking a more serious look at whether the Korean PTE system adequately protects patentees' rights as currently implemented, with an eye to greater harmonization with other major PTE jurisdictions. It is difficult to say whether in the near term KIPO will act to comprehensively clarify the proper basis for PTE beyond including the Narcotics Control Act in the Enforcement Decree, but at a minimum the Patent Court decision suggests that PTE may become more broadly available for delays in regulatory approval whether or not specifically listed in the Enforcement Decree.
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