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.
Showing posts with label Green List. Show all posts
Showing posts with label Green List. Show all posts
BMS sued Korean pharmaceutical companies alleging patent infringement of entecavir compound patent and low dose formulation patent
Baraclude tablets are a blockbuster drug of BMS that has
been sold for the treatment of chronic hepatitis B virus infection in Korea.
BMS listed 2 patents in Green List of KFDA that is a local version of the
Orange Book of US FDA. Entecavir compound is the active ingredient of
Baraclude.
Korean generic companies obtained MA for generic
versions to Baraclude and are ready to launch their generic products to the local
market. BMS filed patent infringement lawsuits against Korean pharmaceutical
companies recently.
Before BMS patent infringement lawsuits,
local companies filed invalidity trials to challenge the validity of the
corresponding Korean entecavir compound patent. Also, they filed trials to
confirm the scope of patent right about the corresponding Korean low dose
formulation patent. The invalidity case of the compound patent is pending in
the IPT of KIPO. But the IPT decided that generic products do not infringe the
scope of the low dose formulation patent. In appeal, the Patent Court upheld the
IPT decision that low dose entecavir formulations of 0.5mg or 1.0 mg should be
regarded being obvious over the prior art and that generic drug do not infringe
the subject patent.
Korea has the bifurcated system that allocates
decision power to separate authorities. Patent infringement issue and patent invalidity
issue must be decided by two separate and independent courts. Patent infringement
and invalidity challenge may occur simultaneously but two proceedings are
correlated.
In the patent infringement lawsuits,
defendants Korean companies will raise an affirmative defense about invalidity of
entecavir compound patent. Such invalidity defense is allowed and the court may
stay the infringement lawsuit proceeding on its discretion until the IPT of
KIPO decides validity issue.
On the other hand, defendants are quite
safe from patent infringement liability of low dose formulation patent because
they had prior decisions from the IPT and the Patent Court that their products
are out of the scope of the patent claims in issue.
Patent Marketing Approval Linkage
The FTA between Korea and USA includes provisions regarding the patent drug market approval (MA) linkage. Pursuant to the KORUS FTA, Korea has to fully implement patent drug market approval linkage from March 15, 2015. The key changes are summarized below.
When a company of a new drug application (NDA) 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.
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.
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 7 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.
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 12 months from the receipt date of the notice from an ANDA applicant. Such stay shall y apply only once to each generic applicant.
The first applicant may obtain first generic marketing exclusivity for 12 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; and (b) 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.
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 12 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
The patent MA linkage system in Korea may share basic principle with the HWA system of the U.S. Upon reviewing the Bill to the Drug Act and the draft of KFDA regulations, however, we can find that many details will be quite different from those of HWA. In order to grasp practical implications, it is better to compare two systems in detail after the Korean version has been fixed. The FTA of Korea and U.S. set the deadline to implement a full system of patent MA linkage in Korea: March 15, 2015. Therefore, we will certainly have final versions of law provisions and regulations within this year. We will provide you with them when they are available.
1. Green List – the Korean version of Orange Book
When a company of a new drug application (NDA) 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. ANDA Applicant’s Certification 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 7 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. 12-Month 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 12 months from the receipt date of the notice from an ANDA applicant. Such stay shall y apply only once to each generic applicant.
5. First Generic's 12-Month Marketing Exclusivity
The first applicant may obtain first generic marketing exclusivity for 12 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; and (b) 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 12-Month Marketing Exclusivity
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 12 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
7. Substantial Differences from the HWA system of USA
The patent MA linkage system in Korea may share basic principle with the HWA system of the U.S. Upon reviewing the Bill to the Drug Act and the draft of KFDA regulations, however, we can find that many details will be quite different from those of HWA. In order to grasp practical implications, it is better to compare two systems in detail after the Korean version has been fixed. The FTA of Korea and U.S. set the deadline to implement a full system of patent MA linkage in Korea: March 15, 2015. Therefore, we will certainly have final versions of law provisions and regulations within this year. We will provide you with them when they are available.