‘1+3 will also impact Korea’s patent linkage system'

Expected to improve the practicality of the first generic exclusivity system

Myung-Hee Lee, senior researcher at KIIP states so at the Medical Intellectual Property Policy Forum…” is analyzing the impact of the 1+3 system”

“Simultaneous filing of patent challenges will decrease…will strengthen practicality in protecting the exclusivity of first generics”

“Amendment to the patent term extension system will be helpful to generic companies” The key is in whether the bill can pass the National Assembly

The so-called ‘1+3 restriction on bioequivalence testing’ system is expected to impact the Drug Approval-Patent Linkage System as well.

 

If applied, the 1+3 system is expected to eradicate the practice of multiple generic companies jointly filing patent challenges and improve the practicality of the first generic exclusivity right (first generic exclusivity).

 

Also, the ‘Bill for the Amendment to the Drug Patent Term Extension System’ that is pending at the National Assembly is expected to have a positive effect on generic companies that challenge the original drug’s patent.

 

However, there is also a possibility that this bill will not be passed due to the nearing end of the 21st National Assembly session.

 

​ "1+3 restriction will improve the effect of first generic exclusivity system… but be disadvantageous for generic companies" Myung Hee Lee, Senior Researcher at the Korea Institute of Intellectual Property presented the prospects mentioned above at the ‘2023 Medical Intellectual Property Policy Forum’ that was held at the Korea Intellectual Property Service Center on the 16th.

 

During her presentation, Lee pointed to 2 changes that will significantly affect the patent linkage system in the future.

 

One is the Bioequivalence Testing 1+3 Restriction System, and the other is the Drug Patent Term Extension System.’ The 1+3 system limits the participating generic makers to 3 consignees per consignor when conducting joint biological equivalence tests or clinical tests.

 

This means that the number of times the clinical data owned by the pharmaceutical company that directly conducted the trial can be shared is limited to 3.

 

Regarding this, Lee predicted that there would be a change in the existing practice of multiple pharmaceutical companies challenging one patent at the same time.

 

At the same time, it was predicted that the effectiveness of the generic exclusivity system would improve.

 

Lee added, “We are currently analyzing the impact of the implementation of the systems.

 

Because the system was not applied to existing applications at the time, the impact of the new system will begin to be felt in earnest from 2022.” “In the past, many companies challenged patents at the same time.

 

In this process, the criticism was that the original purpose of the first generic exclusivity system had faded somewhat.

 

With more than 20 pharmaceutical companies receiving exclusivity at the same time, the significance of the ‘exclusivity’ offered by the system had faded somewhat.” Lee added, “Simultaneous filing of patent challenges will also decrease.

 

We are also observing situations where consignees who have not been granted data from the consignor companies that have directly conducted the bioequivalence tests are unable to join in the early release of generics.

 

This will lead to many small pharmaceutical companies giving up development of generic drugs.” In the discussion session that followed the presentation, In-Bum Kim, an expert consultant at Kimg & Chang added, “From the generic companies’ part, it is now time to seriously consider selecting and focusing on a specific subject.

 

If the companies had all challenged a single patent together, it is now the time for them to each select and pursue a field they can do well at.” "Patent term extension system is beneficial for generic companies…but will it be able to pass NA remains a question" On the other hand, the amendment to the drug patent term extension system was expected to have a positive effect on generic companies.

 

The amendment, which is currently pending at the National Assembly, was presented to limit cases of excessive patent term extensions by original companies.

 

The drug patent term extension system extends the patent term of original companies by the time the company spent on clinical trials or approval, by up to 5 years.

 

However, criticism arose that the system rather works in favor of the original companies in Korea than in the US and Europe.

 

The amendment limits the 'effective patent term’ to 14 years from the time of application for term extension to its expiration, and allows the company to only apply for term extension of one patent among the many that are registered for a single drug.

 

Lee said, “The amendment will be detrimental to original companies and beneficial to generic companies.

 

It is expected to serve in favor of generic companies on the other side of the 1+3 system.” However, whether it will pass the National Assembly review remains in question.

 

To be enacted, the bill must be passed within this year’s session ahead of the general election in April next year.

 

The panels who participated in the discussion predicted that the possibility of passing the amendment in the 21st National Assembly was low.

 

Professor Cha-ho Jung from Sungkyunkwan University Law School who chaired the panel discussions, said, “If it was a bill with no objections, it might have passed; but due to strong opposition from original companies, it will not be easy for the bill to pass NA.

 

I believe the chances are low."