5 years after the drug patent linkage system

It should be used to push into the US market

Utilization of system, raises the need for benchmarking generic overseas success stories

The MFDS, identify improvement points and collect opinions, next year legislative proceeds

At the Four Points Hotel Seoul Guro, the 2019 Drug Forum was held under the direction of Jae-Hyun Lee, School of Pharmacy, Sungkyunkwan University (fourth from left).

"There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system.

 

But Korean pharmaceutical companies haven't even tried it.

 

It's time to think about why they are not using the system".

 

More than five years have passed since the introduction of Korean licensed patent linkage system based on the US Hatch Waxman Act with the Korea-US FTA in March 2015.

 

The licensed patent linkage system protects the original drug patents listed in the MFDS and grants generic monopoly rights to companies that have neutralized the patents.

 

Although there was a lot of concern that generic drugs would enter the market in the early stages of implementation, the impact on the market is less than expected.

 

Director General, Myung-jin Chung

Myung-jin Chung , head of the Korea Health Industry Development Institute, who conducted an impact assessment during the 2018 year at the Policy Forum held at the Four Points Hotel Seoul Guro, said, “Contrary to concerns over the introduction of the system, domestic pharmaceutical companies sales increased YoY due to the lack of many original companies’ ban on sales and the activation of exclusivity for generic product.

 

The KHID's impact assessment showed that sales of generics increased up to ₩6.5 billion in 2018, and the market entry period was also shortened from 1.3 months to 4.6 months.

 

However, there are a lot of comment that the drug patent linkage system lacks effectiveness.

 

In the policy forum discussions, Sung-min Park, lawyer at HnL Law Office, pointed out that there were no cases of entry into the United States using the drug patent linkage system.

 

“Even if a generic market monopoly is given through exclusivity for generic product, lower profits will be lowered if the market entry rate or market share of the latter is low during that period.

 

In the US, the market share of late-release drugs is high in the monopoly period of 180 days, but in Korea, this is not the case, so we need to discuss how to increase the speed and market share” emphasized the lawyer.

 

Hye-eun Shin, professor of law at Chungbuk National University, made a similar point.

 

Professor Shin said, "There are no successful cases of entry into foreign countries by using the law, we should identify the cause and give direction".

 

The professor added, "We need benchmarking on success cases such as Teva and Ranbak".

 

Yoon-ho Kim, the chairman of the Korea Pharmaceutical Patent Research Society (Hanmi, Patent Team) said, “Maybe the goal was to minimize the impact when it was introduced in Korea.

 

Now, I think that we will be a better system if we become more substantial and develop it as an opportunity for R & D development and globalize it”.

 

In addition, the company is likely to raise the profits of items sold in exclusivity for generic product., and the MFDS, which is a related ministry, is concerned about entering the global market.

 

Hyo-jeong Kim, Director of the Drug Management and Patent Licensing Division, said, "The way to increase the market entry rate and market share of exclusivity for generic product is deeply related to the reliability of generic drugs." "Currently, the MFDS is the most important part, and there is a part to improve awareness Kim said, "I believe that a patent case and product development technology have been accumulated through the introduction of the drug patent linkage system, so a real case study position is necessary for entering the US market." Some also suggested that the market entry period was shorter than the impact assessment results with the drug patent linkage system.

 

Kyung-Joon Lee, head of Boryeong Pharmaceuticals, said, “If we take into consideration the fact that patents are incapacitated due to the challenges of pharmaceutical companies, we will have a much more positive number than the results of impact assessments.” “We are still unable to lag behind our competitors.

 

There are many cases of requesting unconditional judgment without consideration, and I hope that the related laws will be revised in such a way that the positive aspects of the introduction of the drug patent linkage system can be highlighted through the impact assessment”.

 

It was pointed out that if the patent invalidation is confirmed, exclusivity for generic product efforts will be lost.

 

Therefore, even if it is determined to be invalid, it is necessary to improve the system so that it can be used as a right target.

 

However, Hyo-jeong Kim explained, "There are some parts that are difficult to consider as a result of the review so far, but if you get exclusivity for generic product, you can be protected even if the patent is invalid In addition, it also defeats exclusivity for generic product challenge by intentionally deleting the patent list.

 

Kim said, "There is a reasonable part, and we will revise and revise it".

 

Kim said, “We will go through the process of collecting opinions by the end of this year, and we will start the legislative process for improvement plan, and we made some practical improvements and gathered opinions”.