Limiting new drug patent term extensions would be beneficial

Limiting the drug patent term cap to 14 years and stipulating the number of patent rights that can be extended to a single patent) would benefit the public

The domestic pharmaceutical industry's attention is focused on whether the proposed amendment to the Patent Act, which would limit the drug patent term to 14 years and stipulate the number of patent rights that can be extended to one (singular), will pass the Bill Review Subcommittee of the National Assembly's Standing Committee review.

 

The proposed amendment to the bill aims to address the issue of how pharmaceutical companies with new drugs have been operating a de facto “market monopoly” on new drug patents by 'overlapping' the patent term extension system, delaying the timing of generic launches, infringing on the public's right to choose medicines, and causing losses to health insurance finances.

 

The legislation, which institutionalizes the drug patent system that is being used by a number of countries overseas including the United States, Europe, and China, is expected to harmonize domestic standards with patent laws deemed as world standards while strengthening the foundation for fostering the domestic generic industry.  On the 24th, the Trade, Industry, Energy, SMEs, and Startups Committee announced that it would review the Patent Act amendment bill introduced by Rep Dong-Jin Koh of the People Power Party at a bill subcommittee scheduled for the 26th.  A similar bill had been introduced during the 21st National Assembly by Representative Il-Young Jung of the Democratic Party of Korea but was abandoned upon the NA term expiry.

 

14-year cap set for patent extensions in the US, Europe…Extension limited to 1 patent The main amendments to Rep Koh’s bill, which will soon be reviewed, are ▲ establishing a 14-year cap on the patent term, and ▲ limiting the number of patents that can be extended to a single drug.  The reasoning behind the bill is that the patent term extension system prescribed by Korea’s Patent Act is different from that of developed countries such as the United States and Europe, which may cause reverse discrimination against the domestic pharmaceutical industry.

 

Specifically, the United States, Europe, and China limit the number of patents that can be extended for a single drug to a singular patent - just one.

 

Korea and Japan, on the other hand, allow an unlimited number of patents to be extended for a single drug.  For example, if a drug has a product patent, a use patent, and a formulation patent, the U.S., Europe, and China only allow extensions for the product patent, while Korea and Japan allow extensions for each of the substance, use, and formulation patents.  Korea also does not stipulate a separate cap period for patent extensions.

 

This differs from the U.S., which allows patents to be extended for up to 14 years from the date of approval, and Europe, which allows patents to be extended up to 15 years.  If Koh’s bill passes review, it is expected that Korea's domestic law on drug patent extension will be harmonized with those in the U.S.

 

and Europe, and an environment will be fostered where patients can opt to use cheaper and high-quality generic versions quickly.  If Korea trims Korea’s excessive drug patent protection laws being granted to global pharmaceutical companies in Korea to the global level, patients will have greater rights and access to generics without having the need to pay for expensive original drugs.  Korea’s pharmaceutical industry “New drug patents cause market monopoly side effects...a legislation is needed” The Korean pharmaceutical industry is concerned that the current patent law in Korea grants too wide a right for new drugs patent term extensions, which has caused the unexpected side effect of guaranteeing market monopoly.  The industry has been arguing that legislation should be enacted as soon as possible to limit the new drug patent term extension period to no more than 14 years from the date of approval, and to stipulate the number of patent rights that can be extended for a single new drug as a singular number in order to eradicate the side effects of market monopoly and foster the domestic health and pharmaceutical industries.

 

In particular, their logic is that if the regulations to protect unreasonable patent extension rights for new drugs are improved, the launch of quality generics will be accelerated, expanding the public's choice of medicines while saving healthcare finances.

 

The domestic pharmaceutical industry's position is that international harmonization of the regulations with those of the U.S.

 

and Europe is also needed to allow only a singular patent extension for a single new drug.  The current system that allows multiple patent extensions puts too much pressure on pharmaceutical companies that seek to launch generics early by forcing them to bear litigation costs and long litigation periods until the final invalidation ruling.

 

A Korean pharmaceutical industry official said, “Korea’s patent law has strongly protected the patent extension rights of new drug patent holders.

 

This is the reason why the launch of generics is unreasonably delayed in reaching the market.

 

We should adopt the U.S.

 

and European regulations that limit the duration of the patent to 14 years, including the extension period, and limit the allowed number of extensions to a single patent.”  “If the launch of generics by domestic pharmaceutical companies are delayed due to Korea’s stronger new drug patent protection laws than in developed countries, there is a greater risk of deteriorating public health finances,” the official said, adding, ” To invalidate multiple patent extensions, pharmaceutical companies bear the burden of litigation costs and endure a long time until the final invalidation ruling, which in result lacks practicality.”