KIPO opposes to objections to new drug patent extended cap

KRPIA states that "Introducing a cap would worsen individual access to new drugs"

The Korean Intellectual Property Office (KIPO)

The Korea Research-based Pharma Industry Association (KRPIA) and others have submitted an opinion disagreeing with the proposed legislation that would introduce a maximum cap for terms of patent protection for new drugs.

 

The proposed legislation is intended to facilitate an earlier market launch for Korea-made new drugs.

 

The Korean Intellectual Property Office (KIPO) stated its opposition to this issue at the 21st National Assembly.

 

At that time, KIPO stressed that the original draft instead of a revised Patent Law that would limit the number of patents to a single (1 patent).

 

A similar proposed legislation has been submitted to the 22nd National Assembly.

 

Therefore, it is highly likely that KIPO would state an opinion agreeining with the original draft.

 

On November 26, the Trade, Industry and Energy Small and Medium Venture Business Committee is scheduled to hold a small committee for legislative review.

 

Rep.

 

Koh Dong-jin, a member of the People Power Party, will review the draft of the revision to the Patent Law.

 

Rep.

 

Koh Dong-jin's proposal contains key messages, including ▲legislating a 14-year maximum (cap) on the effective duration of patent rights and ▲ limiting the number of patents eligible for extension to a single patent per drug.

 

The proposed legislation is based on concerns that the current patent term extension system under Korean patent law differs from those in advanced countries such as the United States and Europe, potentially reverse discriminiate the domestic pharmaceutical industry.

 

KRPIA "It worsens individual access to medications…disagreeing with the legislation" In Rep.

 

Koh Dong-jin's draft of the revision, the Korean Research-based Pharmaceutical Industry Association (KRPIA), the Japan Pharmaceutical Manufacturers (JPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Biotechnology Innovation Organization (BIO), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and the Patent Information Initiative for Medicines (Pat-INFORMED) have shared opposing views.

 

The opposing group argues that adopting only selective features of overseas practices regarding patent term extensions, rather than improving the entire system, could worsen public access to medicines and disrupt international collaboration.

 

Specifically, regarding introducing a patent term cap, they highlight that South Korea recognizes only the 'domestic clinical trial period' for patent extensions, excluding the 'overseas clinical trial period' from the calculation of extension durations.

 

They also argued that the scope of extended patent rights in South Korea is narrower compared to major countries.

 

Specifically, there are conflicting court rulings on whether extended patent rights are limited to the indications approved at initial approval.

 

It also remains to be seen whether the extended rights apply to all approved uses of the extended product.

 

They also stated that there is almost no chance of appealing a rejection decision concerning patent term extension applications in South Korea.

 

Before Rep.

 

Koh Dong-jin's draft of the revision, KRPIA and others have previously opposed the bill proposed by Democratic Party Rep.

 

Jung Il-young during the 21st National Assembly, which was abandoned because the legislative term expired.

 

KIPO disagrees by citing U.S.

 

examples During the 21st National Assembly, KIPO presented counterarguments to the objections raised against Rep.

 

Jung Il-young's bill, advocating for the retention of the original proposal.

 

KIPO will likely maintain the same position regarding Rep.

 

Ko Dong-jin's proposal in the 22nd National Assembly.

 

KIPO states that it cannot accept the opposing arguments, including the claim that South Korea does not include overseas clinical trial periods in calculating patent extension durations and the assertion that the scope of extended patent rights in South Korea is unclear compared to major countries.

 

However, regarding the opposing argument that there is no opportunity to appeal rejection decisions on extension applications, KIPO partially accepted this concern, suggesting the need to review the introduction of a related system.

 

KIPO disputed the claim that South Korea excludes overseas clinical trial periods and uniformly excludes the Ministry of Food and Drug Safety's (MFDS) approval supplementation period when calculating patent extension durations, stating, "Other countries do the same." KIPO explained, "The U.S.

 

system, similar to South Korea's patent extension calculation method, includes only half of the clinical trial period and does not recognize overseas clinical trial periods." It emphasized that "maintaining the current practice for calculating extension durations is appropriate." "Considering the Supreme Court ruling, which excludes the applicant's compensation period during the MFDS's review of approval documents, we believe that the current method for calculating extension durations should remain unchanged," KIPO stated.

 

"The length of the extension period is primarily influenced by variations in domestic clinical trial durations, which are affected by factors such as a country’s drug development capabilities and the size of its pharmaceutical market, rather than differences in extension systems." Regarding the opposition's argument that the scope of patent rights should be expanded to include the 'active ingredient' and included into patent law, KIPO countered by saying that the legislation should proceed as originally proposed.

 

"The Supreme Court, considering the protection of patent holders and the purpose of the extension system, has ruled that the scope of extended patent rights should be determined based on the 'active ingredient and drug use based on the Patent Law,' similar to major countries," KIPO stated.

 

KIPO partially agreed with the opposing view that there is no opportunity to contest rejection decisions on extension applications.

 

"It is necessary to establish various concrete measures to contest rejection decisions to secure procedural rights for patent holders," KIPO stated.

 

"However, these remedies should be introduced alongside measures to address rejection decisions related to delays in registration, which will require a more thorough review."