As of March 15, 2015, the new Pharmaceutical Act was implemented for the Korean version of HWA of patent drug market approval (MA) linkage. The key features are summarized below.
1. Listing Drug patents in Green List – the Korean version of Orange Book
When an drug application has obtained a drug market approval (MA) from KFDA, the NDA holder must list patent information in the patent list (“Green List”) of KFDA. The Green List is similar to the Orange Book in the U.S., but is not the same. The deadline to list is 30 days from the receipt date of MA.
Unlike the Orange Book in the U.S., a NDA holder must list patents with the claim-by-claim basis in the Green List. Therefore, an applicant must specify every claim that covers the approved drug product and further an applicant must submit detailed explanation between each claim and the approved drug to KFDA.
2. Submitting a Certification of ANDA Applicant regarding Listed Patents
Like the HWA, an applicant of a generic drug application (ANDA) must submit a certification regarding listed patents of Green List to KFDA. The patent certification is similar to those of HWA. For example, an ANDA applicant must file a Para. IV certification if he wants to launch a generic drug before the expiry date of listed patents. In such a certification, the generic drug applicant must provide a detailed statement demonstrating that the listed patent is invalid or that the generic drug does not infringe the listed patent.
3. Notice to an NDA holder and a Patentee
Like the HWA, an ANDA applicant with Para. IV certification must notify the fact that an application for generic drug approval has been filed and the filing date of the application to the product approval holder and patent owner within 20 days of the application filing date. The obligation to notice will apply to an ANDA applicant who will launch their product before the expiry date of term of the listed patent. Otherwise, this provision does not apply to generic applicants who intend to launch their drug after the expiration of the listed patent.
4. 9-Months Stay on Generic Drug Entry
Within 45 days from the receipt date of the notice, the patentee may file: a patent infringement action or a scope confirmation trial before the Korea Intellectual Property Tribunal (KIPT) against the generic drug. Further, the patentee/NDA holder may request KFDA to take an action stay generic drug entry for 9 months from the receipt date of the notice from an ANDA applicant. Such stay shall apply only once to each generic applicant.
5. First Generic's 9-Month Marketing Exclusivity
The first applicant may obtain first generic marketing exclusivity for 9 months over other generics. The first applicant for this marketing exclusivity means : (a) to be the first filer of ANDA application or skinny (paper) NDA applications that are similar to 505(b)(2) applications in USA; (b) to be the first filer of patent invalidity petition or non-infringement declaration action before the IPT, and (c) to be successful in obtaining an IPT decision or a court decision from challenging actions against listed patents including a scope confirmation trial or invalidation action. The actions must be filed before filing a generic approval application.
6. Forfeiture of 9-Month Marketing Exclusivity
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 9 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
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