It has been more
than 2 years to implement the Korean version of HWA of patent drug market
approval (MA) linkage. The key features are as bellows:
1. Listing Drug patents in Green List –
the Korean version of Orange Book
When a 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.
