IP Newsletter | Spring/Summer 2017
	PATENT
	Korean Patent Court Dismisses Generics' Challenges to PTE Terms
	In a recent decision announced on March 16, 2017 that could have led to the severe shortening or elimination of nearly all existing patent term extensions ("PTEs") for pharmaceutical patents in Korea, the Patent Court emphatically rejected the challenges raised by generics against the existing PTE system, and potentially affirmed the validity of the full term of extended patent rights of numerous innovator pharmaceutical companies.
	Background
	Article 89 of the Korean Patent Act provides that a PTE should be equivalent to the length of time a patented invention cannot be worked after grant due to regulatory approvals or registrations under other statutes required to practice the invention. Article 89 also states that any periods of delay that are attributable to the patentee should not be included as part of the PTE term.
	Pursuant to Article 89, the Korean Intellectual Property Office ("KIPO") has been using the following general formula to calculate PTEs in Korea:
	PTE period = domestic clinical trial period (from first patient in to last patient out) + Ministry of Food and Drug Safety ("MFDS") review period – any delay attributable to Patentee during the MFDS review period
	KIPO has also further defined "delay attributable to Patentee during the MFDS review period" to mean specifically only periods of time where there is a supplementation request pending in all MFDS departmental examinations (standard and testing method; safety and efficacy test; good manufacturing practice; and drug master file) at the same time. In other words, even if there is even a single departmental examination that is proceeding without any supplementation needed, this time period cannot be attributable to the Patentee.
	Numerous PTE invalidation actions were filed in Korea by generic companies challenging KIPO's PTE practice in the last two years (partly because the new patent-approval linkage system has incentivized such filings as one basis to obtain generic marketing exclusivity). In view of the potential impact of this challenge on KIPO's practice, the Patent Court arranged special panels of judges (including the President of the Patent Court) to hear two cases involving the most commonly-asserted PTE invalidity arguments.
	Generics had primarily challenged the validity of PTEs on two grounds: that the PTE was invalid on the procedural ground that the marketing approval holder for the drug on which the PTE was granted was not registered as a patent licensee before the PTE application was filed, and that various periods of time included within the PTE should not have been included under the relevant statutes.
	The Patent Court's ruling regarding PTE periods
	The Patent Court emphasized the following two points as fundamental principles when it verbally announced its decisions in court:
	1) "Time period during which the patented invention could not have been worked" (referred to as "Total Delay") begins on the day when the test for safety and efficacy is initiated or the day when the patent is registered (whichever is later) and ends on the date when the regulatory approval is "delivered" to the applicant (rather than "issued"), which presumably includes the period from the close of clinical trials to the drug approval application date.
	2) "Time period of delay attributable to the patentee" (referred to as "Patentee Delay" as above) should be construed to mean periods which is the responsibility of the patentee and which can reasonably be said to have caused delay in the regulatory approval.
	According to the above principles, the Patent Court rejected all alternative PTE term calculation methods proposed by the generics and found the granted PTE periods to be proper.
	While the Court appears to recognize the propriety of the granted PTE periods according to KIPO's current methods, it appears that the Court suggests different standards for the PTE period (= Total Delay – Patentee Delay), rather than KIPO's current method where the PTE period = clinical trial period + MFDS review period – Patentee Delay.
	Implications regarding the Patent Court's decisions
	Based on the Court's rulings, if a patentee proves that certain supplementations of documents are not attributable to the patentee or that there is no delay in the regulatory approval that can be reasonably found to be caused by such supplementations, the periods of these supplementations should also be eligible to be included in PTE.
	Further, since the Court did not limit the test for drug approval to domestic clinical trials, it is possible other test periods (e.g., clinical trials conducted in foreign countries after the patent registration and reviewed by the MFDS for the drug approval) may be requested as part of the PTE term. Also, the time period spent to prepare the drug approval application (i.e., from the closing date of domestic clinical trials to the application date of the drug approval) may also be requested as part of a PTE application, with supporting evidence.
	However, KIPO has tended to be very conservative about granting PTE terms, and the Patent Court's decisions do not state explicitly that clinical trials conducted in foreign countries or time spent to prepare the drug approval application are also eligible for PTE term. Thus, it is possible KIPO may continue to exclude such periods from PTEs regardless of whether the Patent Court's decisions can reasonably be read to allow them. It is likely that further guidance will be needed from the Patent Court to resolve future cases involving these specific issues.
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	Duck-Soon CHANG ducksoon.chang@kimchang.com Tae Min KIM tmkim@kimchang.com Inchan Andrew KWON ickwon@kimchang.com
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