Welcoming preemptive measures to protect generic exclusivity

Protection of rights by restricting deletion of patent list after acquisition of the generic for exclusivity

Protection measures are needed even in the process of patent challenge

#Most of the pharmaceutical industry is welcoming the plan to improve the generic for exclusivity items contained in the amendment to the Pharmaceutical Affairs Act on the 20th.

 

It is a "preemptive measure" for the method of restricting the patentee's deletion of patents from the patent list after the generic has received generic exclusivity.

 

However, other than the industry, some argue that it is an 'excessive measure' to block cases where patent invalidation is confirmed and it is removed from the patent list.

 

On the 20th, the MFDS announced a legislative amendment to the Pharmaceutical Affairs Act to operate the drug patent linkage system more reasonably.

 

Particularly noteworthy in the amendment is the method to prevent the deletion of a patent from the patent list after the generic exclusivity was acquired.

 

The patent right registered in the patent list can be deleted if the registered person requests it, but if there are drugs that have been granted the generic exclusivity by challenging the relevant patent, they are limited to maintain the effect of the generic exclusivity.

 

In response, the MFDS said, "According to the current laws and regulations, it is difficult to prohibit the sale of the same drug (with the same active ingredient as the registered drug) to maintain the effect if there is no registered drug for generic exclusivity." If a patent for a listed drug is deleted from the patent list, the drug can enter the market even though the generic exclusivity is granted.

 

This is in accordance with Article 50-9, Paragraph 1 of the Pharmaceutical Affairs Act.

 

However, there have been no such cases since the enforcement of the generic exclusivity system.

 

Instead, the MFDS explained that there are cases that are likely to be problematic.

 

An official from the MFDS said this plan was prepared to preemptively respond to the protection of the generic exclusivity drugs.

 

Officials in the pharmaceutical industry also generally positively answered that domestic pharmaceutical companies welcome this preemptive plan.

 

An official from a pharmaceutical company said that they welcomed the company's rights to generic exclusivity in the generic market through a patent challenge.

 

However, the pharmaceutical industry was concerned about the case where the patentee arbitrarily deleted the list of patent rights.

 

Other officials in the industry pointed out that if a patentee deletes a patent from the patent list in a situation where a patent is challenged to obtain the right copyright, generic companies' efforts will be in vain.

 

The pharmaceutical industry explains that there are many cases of deletion of patent lists, and the pharmaceutical industry explains that it needs to be supplemented..

 

There are rather different opinions outside the pharmaceutical industry.

 

It is whether it is necessary to maintain even the patent deleted from the patent list due to the determination of the invalidity of the patent.

 

In the event that the patent is invalidated, even if there is a generic exclusivity drug, other generics should freely obtain the approval and put it on the market.

 

A person in the legal profession said, “The Ministry of Food and Drug Safety had shown a position that it was inevitable until ex officio deletion due to the confirmation of patent invalidation.

 

It seems that the opinions of the pharmaceutical industry were more accepted.”