Patent Term Extension (PTE) Disputes on Period and the Scope of Protection in Korea

Many generic drug companies challenged the validity of PTEs on period and the protection scope of extended patent rights.

The first issue for PTE disputes in Korea is whether the extended period is valid or not because certain periods of time included within the PTE should not have been included under the relevant statutes. The second issue is on the scope of the patent right protection for an extended term after the expiry of an original term.

1. Recent Decisions of IPTAB and Patent Court on Period Issue  

In principle, the "time period during which the patented invention could not have been worked" of the Patent Act starts on the date on which the test for safety and efficacy is initiated or the date on which the patent is registered (whichever is later) and ends on the date on which the regulatory approval is reached to the MA applicant. It is not the date of MA issuance.

Under the Patent Act, the "time period of delay attributable to the patentee" must be deducted from the total delay period. The period is periods for which the patentee is responsible for delay in the regulatory approval.

The IPTAB of KIPO and the Patent Court affirmed the above principle. In practice, The IPTAB and The Patent Court appear to recognise and confirm the present status of the granted PTE periods according to KIPO's practice.

Because many cases are still pending, the issue has not been settled yet. The Supreme Court shall decide the issue in not too distant future.

2. Recent Decisions of IPTAB and Patent Court on the Scope of an Extended Patent Right

 The Korean Patent Act Article 95 (Effects of Patent Right with its Term Extended by Permit, etc) “The effects of a patent right, the term of which has been extended pursuant to Article 90 (4), shall not extend to any other acts except the working of the patented invention with respect to such products for which approval, etc. was the basis for registering the extension (or where approval, etc. was obtained for any specific use of the product, with respect to the product adapted for such specific use).”

What is the effective scope of an extended patent right through PTE registration? Article 95 of the Korean Patent Act specifically limits the scope of the extended patent right to be effective within working of the patented invention with respect to the 'approved product.'

Accordingly, there has been disputes over how the terms "product" and "usage" in the above clause should be interpreted. However, there are as yet no definitive criteria or court decisions issued as to the interpretation of this issue.

Before the IPTAB of KIPO and the Patent Court rendered their decisions, the IP Courts of Japan issued their decisions. Because the corresponding provisions on PTE of the Japanese Patent Act are really similar to those of the Korean Patent Act, the interpretations of IP courts of Japan were closely watched by Korean patent practitioners.

For information, Article 68bis (68-2) of the Japanese Patent Law is described as follows: “a patent right the term of which is extended via PTE registration "shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition designated by Regulation in Article 67, paragraph 2 of the Patent Law that constituted the reason for the PTE registration (when the specific usage of the product is prescribed in the disposition, the product used specifically for that usage)".

The Tokyo IP High Court stated in their opinion that "in light of the purpose of the PTE registration system and that of a patent infringement action, it is reasonable to understand that in the case of a patented invention relating to an ingredient of a medicine, a patent right whose duration was extended and by 'effectiveness/efficacy'and 'dosage/regimen' as the 'usage'." For example, the scope of an extended patent right based on a specific salt of API shall cover other salts of API.

Unlike the IP court’s decisions of Japan, the IPTAB of KIPO and the Patent Court of Korea held that the scope of an extended patent right based on a specific salt of API shall NOT cover other salts of API. Thus it was totally different interpretation. Namely, the scope of an extended patent right based on a specific salt of API only covers the approved Drug Product itself.

At present, the IPTAB of KIPO and the Patent Court maintain really strict interpretations on the scope of an extended patent right. Again, several cases are pending before the Supreme Court, this issue has not been settled yet. The Supreme Court shall decide the issue relating to the effective scope of a patent right extended via PTE registration in not too distant future, too.