IP Newsletter | Winter 2016/17
	PATENT
	IPTAB Upholds Inventiveness of Quantitatively Superior Selection Invention for the First Time
	In March 2015, the new pharmaceutical patent-regulatory approval linkage system (similar to the Hatch-Waxman system in the US) was fully implemented in Korea. Subsequently, massive numbers of Intellectual Property Trial and Appeal Board (IPTAB) actions (i.e., patent invalidation and scope confirmation actions) were initiated by generic companies to take advantage of the 9-month exclusivity period provided to generic companies who successfully challenge listed pharmaceutical patents. Most of the actions filed by generic companies have been directed towards secondary patents or patents directed to species-type inventions (often referred to in Korea as selection inventions).
	In Korea, selection inventions (i.e., a species-type invention claimed over genus-type prior art) have very strict patentability requirements. In particular, a selection invention must provide either qualitatively different or quantitatively superior effects over the prior art genus. Moreover, such effects must be described in the specification. Due to these strict patentability requirements, almost all selection invention patents that have been challenged in Korea have been invalidated.
	However, one selection invention patent recently withstood a validity challenge. Shire-NPS obtained a patent for a drug controlling parathyroid hormone levels for the treatment of secondary hyperparathyroidism. The patent was licensed to Kyowa Hakko Kirin, and the patented drug Regpara® (API: cinacalcet) has been sold in Korea since 2011. Four local generic pharmaceutical companies sought to invalidate the Regpara® product substance patent in March 2015, but the IPTAB recently affirmed the validity of the patent valid despite these challenges.1
	Shire-NPS's patent is directed to a single chemical compound, cinacalcet. The cited prior art reference disclosed a general chemical formula genus concept that encompassed cinacalcet, along with an enormously large number of compounds (but did not expressly disclose cinacalcet). A second reference disclosed another general chemical formula within the genus concept of the first reference, but which did not encompass cinacalcet. Since both references described similar effects (e.g., treatment of secondary hyperparathyroidism by regulating the activity of calcium receptors in parathyroid cells), patentability was determined based on whether the effect of the claimed invention was quantitatively superior.
	Prior to the Shire-NPS patent, only a couple of cases had upheld the patentability of selection inventions, and these were based on qualitatively different rather than quantitatively superior effects. Moreover, there was no clear standard on how to evaluate quantitatively superior effects. The Shire-NPS patent is the first patent to be found inventive by the IPTAB based specifically on quantitatively superior effects.
	The specification of the Shire-NPS patent described cinacalcet as having about 1.9 times higher activity at low concentrations over the most promising compound described in the genus prior art at the time of filing. The generics tried to counter that another species prior art compound within the same genus (but not expressly described in the prior art reference) had similar effects as the compound from the Shire-NPS patent. However, the IPTAB held that the other species compound (although falling within the same genus) could not be used as a point of comparison for the superior effects of the selection invention, because only compounds specifically identified in the genus reference can be so used. Thus, the IPTAB held that because the cinacalcet compound was superior to any compound disclosed in the genus prior art reference, this warranted a finding of patentability. The IPTAB decision is notable as (1) it found that 1.9 times higher activity was a remarkably superior effect and (2) the compared compound was limited to compounds that were specifically disclosed in the genus prior art reference. This case is a first step towards set standards for objectively evaluating the inventiveness of selection inventions based on quantitatively superior effects.
	Due to the favorable IPTAB result, the generic companies voluntarily withdrew their pricing applications. Without their voluntary withdrawal, the original drug price would have been significantly reduced (e.g., by as much as 30%, regardless of whether the generics actually entered the market on the designated entry date in their pricing applications). This case was the first case in Korea under the new patent-regulatory approval linkage system where the original company successfully prevented reduction of the original drug price even after generic companies filed generic pricing applications. However, it still remains uncertain whether the original price would be reduced if a generic company fails to withdraw a pricing application despite losing a related infringement or positive scope confirmation action.
	1 Kim & Chang represented both Shire-NPS and Kyowa Hakko Kirin and achieved positive results in both invalidation and scope confirmation actions against the patent.
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	Sang-Young LEE sylee4@kimchang.com John J. KIM jjhkim@kimchang.com Yunki LEE yklee2@kimchang.com
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