Under the Korean Patent Act, if a pharmaceutical or
agrochemical patent (claimed in the form of a compound, a
composition/formulation, or a process for preparation thereof)
cannot be practised after registration to acquire marketing
approval, according to the relevant acts, the patent term can
be extended for a time period of up to five years, the time
taken to obtain marketing approval after patent registration.
An application for patent term extension must be filed by the
patentee within three months of the date of the marketing
approval but no later than six months before the expiration
date of the patent.
According to the revised Enforcement Decree of the Korean
Patent Act, implemented on April 3 2013, patent term extension
is possible only based on initial marketing approval for a new
substance whose active moiety, showing a pharmacological
effect, has a novel chemical structure. Under the current law,
it is clear that a patent for a second medical use of a known
drug is not eligible for patent term extension. However, no
guidelines or explanation have been provided as to what
constitutes a new substance.
The trustee of the bankrupt entrepreneur appointed a meeting
of creditors on November 29 2017 where the controversial trade
mark was going to be sold. The starting price was $50. As a
result of the auction the mark was finally sold for $500 to
Kantemirovskaya Ltd. An assignment for that mark was signed but
as the situation stands on February 20 2018 the assignment is
yet to be recorded. As a result, the trade mark is still
formally in the name of the bankrupt owner. According to
judicial practice (even though it is scant), the period of
non-use is not interrupted because of change of ownership.
Hence the option of non-use action is still open for Heineken.
The new owner may invoke force majeure. Is it worth initiating
a non-use case in such circumstances? The answer to this
question remains unanswered as yet.
Tretinoin, also known as all-trans retinoic acid, had been
marketed for the treatment of acne, fine wrinkles, or dark
spots by topical application (e.g. in the form of a cream or
ointment), and for the treatment of acute promyelocytic
leukemia by oral administration (e.g. in the form of a
capsule). In 2013, Alitretinoin, also known as 9-cis retinoic
acid, was newly approved by the Ministry of Food and Drug
Safety (MFDS) for treating chronic hand eczema, refractory to
treatment with strong topical steroids for at least four weeks.
Glaxo Group Limited filed applications for patent term
extension with regard to patents directed to a medicament for
the treatment of eczema comprising 9-cis retinoic acid, a
process for the preparation of 9-cis retinoic acid and a new
formulation comprising a retinoid such as 9-cis retinoic acid,
based on the marketing approval for Alitretinoin.
The examiner rejected all of the applications for patent
term extension on the grounds that Alitretinoin, a geometric
isomer of Tretinoin previously approved by the MFDS, is not
recognised as a new substance, and thus, the marketing approval
cannot be used for patent term extension.
On appeal, the Trial Board upheld the final rejection by the
examiner, indicating that since Alitretinoin and Tretinoin are
geometric isomers converting into each other and have a common
property of binding to retinoic acid receptors (RARs),
Alitretinoin is not acknowledged as a new substance in which
the active moiety exerting a pharmacological effect has a novel
chemical structure, and thus the patents relating to
Alitretinoin are not eligible for patent term extension.
Reversing the Trial Board decision, however, the Patent
Court ruled that Alitretinoin is considered as a new substance
on the grounds that:
Geometric isomers have different
stereochemical structures and thus may show significant
differences in physicochemical properties or biological
- Tretinoin binds and activates RARs, but
not retinoid X receptors (RXRs), whereas Alitretinoin binds
and activates RXRs in addition to RARs.
- Alitretinoin has an additional medical use
in the treatment of chronic hand eczema, which cannot be
cured by Tretinoin.
- In view of general properties of geometric
isomers, and the action and effect of each active ingredient,
Alitretinoin has a different medical use, and the chemical
structure of its moiety exerting a therapeutic effect is
novel in comparison with the previously approved
This Patent Court decision suggests that it is possible to
obtain patent term extension for patents relating to
stereoisomers which have a different mechanism of action and a
different therapeutic effect from other stereoisomers, owing to
their unique chemical configuration. Therefore, development of
new stereoisomers would be a promising approach to secure
second generation patents with the possible benefit of patent
term extension in Korea.
Meanwhile, the Korean Intellectual Property Office (KIPO)
recently announced the following statistics on patent term
As pharmaceuticals or agrochemicals are required to obtain
regulatory approval to be marketed in Korea, the patent term
extension system should be kept in mind to compensate for time
spent in acquiring such approval after patent registration.
(all-trans retinoic acid)
HANOL Intellectual Property & Law
6th Floor, Daemyung Tower, 135, Beobwon-ro, Songpa-gu
Republic of Korea
Tel: +82 2 942 1100
Fax: +82 2 942 2600