IP Newsletter | Summer/Fall 2016
	PATENT
	IPTAB Rules that Extended Patent Term Covers All Drugs With the Same Approved Active Ingredient and Use
	In Korea, the term for a patent covering an approved drug product can be extended to compensate for delays attributable to the drug approval process. However, under Article 95 of the Korean Patent Act, during the extended term, the patent can only be enforced against drugs that are used in the same way as the approved products.
	However, it has been unclear whether an extended patent term granted for an approved product containing a single active ingredient also covers a combination product comprising the active ingredient of the approved product and one or more other active ingredients. Recently, an Intellectual Property Trial and Appeal Board ("IPTAB") decision in April 2016 resolving several scope-confirmation action cases filed by Korean generic manufacturers against the same Korean pharmaceutical patent has now answered that question in the affirmative.
	Background
	The patent in question is owned by an innovator pharmaceutical company, and claims a group of compounds sharing a general chemical formula as well as several medicinal uses for the compounds. The patent was granted a patent term extension ("PTE") based on a related approval for a single-active ingredient drug used to treat hypercholesterolemia, containing one of the claimed compounds as the active ingredient ("A").
	The petitioners in the above-mentioned scope-confirmation actions are Korean generic manufacturers who obtained approvals for generic drugs which were combination products containing both A and another active ingredient. The combination product was also to be used for treating hypercholesterolemia. The generic manufacturers sought a ruling that their generic products were outside the scope of the subject patent during the extended patent term on the basis that the extended term was limited to the approved drug product containing a single active ingredient, and thus, could not cover combination products.
	The decision
	The petitioners argued that product approval would need to be separately obtained for a combination drug product containing A and another active ingredient. In particular, the generics argued that their combination product should be considered to be a different product from the respondent's approved single-active ingredient product. Thus, the generics argued that under Article 95 of the Patent Act, during the extended term, the patent should not cover the combination product.
	The IPTAB first clarified that the drug approval at issue approved the use of A (as the active ingredient) for the treatment of hypercholesterolemia. Therefore, the enforceable scope of the subject patent during the extended term covered the use of A for the treatment of hypercholesterolemia.
	The IPTAB then referenced a previous patent infringement case which held that since extended patent terms would be useless if the scope of protection of a patent during the extended term was limited to exactly the same product as the approved product (including all ingredients in the approved product besides the active ingredient), the scope of protection during the extended term should cover all products with the same active ingredient, function, and effect as the approved product, regardless of different dosages, amounts, preparation methods, etc. (Seoul Central District Court, Preliminary Injunction Order, Case No. 2009 Kahap 235 rendered on March 19, 2009).
	In view of the above, the IPTAB concluded that because the combination product contained the same active ingredient A as the approved product, and had the same use (for treating hypercholesterolemia), the combination product was covered by the subject patent even during the extended patent term.
	Implications
	This is the first decision in Korea where a patent covering a single-active ingredient drug approval was used against combination drug products containing the same active ingredient during the extended term of the patent. While IPTAB judgments are not binding legal authority, the decision seems to be in line with the majority opinion in the Korean patent community regarding the proper standard for determining infringement of patents during their extended terms (whether the accused product has the same active ingredient and the same use as the approved product).
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