South Korea allows data exclusivity for pediatric drugs approved through foreign clinical trials

From May 5, 2021, a four-year re-examination period for post-marketing surveillance (PMS) for pediatric drugs may be granted by the Ministry of Food and Drug Safety (MFDS) upon regulatory approval with ‘foreign’ clinical trials. Previously, only pediatric drugs approved on the basis of ‘domestic’ clinical trials were re-examined.

In South Korea, the re-examination period (PMS period) acts as the de facto data exclusivity period for new drugs and certain prescription drugs. With patent protection, this de facto data exclusivity plays an important role in protecting originator companies.

Protection through actual data exclusivity

As evidenced by the de facto, there is no data exclusivity per se in South Korea; however, the re-examination system provides much the same protection as data exclusivity in other jurisdictions.

Under this system, the re-examination period running from the time of marketing approval may vary depending on the criteria below (see table), and successive companies (i.e. generic companies) seeking marketing approval for the same medicine, should discuss their own safety. and efficacy data equal to or greater than the data of the original approval holder, except in the following cases:

When permission to use the data has been obtained from the original approval holder; or

When an application is submitted under the condition that the medicine is approved after the re-evaluation period.

In other words, generic companies should not rely on the data of the original approval holder during the PMS period to obtain regulatory approval for their generic product. Since it is difficult for generic companies to meet such data submission requirements, re-examination works just like data exclusivity.

After the re-examination period has expired, the submission of safety and efficacy data is exempted for marketing approval of the same product.

This significantly reduces the burden on the successor farms and allows marketing authorization to be granted after submission of the bioequivalence data. The re-examination system applies to both chemical drugs and biological drugs.

Eligible Drugs, Re-examination Period and Exemption

The following table provides an overview of eligible drugs and the re-examination period.

criteria

Period of time

1-i.

new medicines – Drugs with a new chemical entity

6 years

1-ii.

New combination – Prescription drugs differ from already approved drugs in terms of active ingredient(s) or combination ratio

1-iii.

New route of administration – Prescription drugs that differ from already approved drugs in terms of route of administration, while containing the same active substance(s)

2-i.

New indication – Prescription drugs identical to already approved drugs in terms of active ingredient(s) and route(s) of administration, but with clearly different indication(s) added

4 years

2-ii.

Other drugs determined under consideration of the MFDS

3-i.

Orphan drugs for use in a disease for which adequate treatment and drugs have not been developed

10 years

3-ii.

Orphan drugs from 3-i where a pediatric indication has been added

11 years

While the above drugs are eligible for re-examination, the MFDS may, in its sole discretion, waive the re-evaluation of the drugs for those who meet any of the following:

Pesticides, etc. which are not applied directly to a human body;

orphan drugs;

Drugs for which re-examination by the MFDS is deemed unnecessary due to lack of novelty;

Medicines whose safety and efficacy are considered to be sufficiently guaranteed by the MFDS; and

Medicines for which the number of patients to be examined is too small to meet the re-examination requirements.

As a result, of course, there is no actual data exclusivity if the re-examination is exempt.

What strategies are available?

From the perspective of branded companies, a de facto data exclusivity period of six years can be granted, which is relatively long compared to other jurisdictions, for so-called ‘incrementally modified medicines’.

Step-modified drugs are drugs with some improvements to existing drugs, such as new combinations and new routes of administration. The practicality of the system becomes apparent when the improvement of the drug is not so remarkable that patent protection is possible. The patent may not protect the drug, but data exclusivity does, at least for six years.

As for new medicines, as in many other countries, the patent term extension (PTE) may also be available if there is an initial marketing approval for the new substance, up to five years, for the period that the patented inventions could not have been put into practice.

As for generic companies, those who want to enjoy the first generic exclusivity should fine-tune the timing of filing an invalidation investigation. Under the Korean drug patent linkage system, the first nine-month generic exclusivity can be granted to the successful generic challenger(s) that meet the “first trial condition”. To earn the position of first-trial challenger, it is better to start the annulment procedure as early as possible. However, because the patent must be validly stated when the generic company applies for the marketing authorization, those seeking the first exclusivity must ensure that the patent is not invalidated prematurely before applying for the marketing authorization to request.

Min Son, PhD

Managing partner, Hanol IP & Law

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