On 30 January 2019 the Taiwan Food and Drug Administration (FDA) issued the second version of the Enforcement Rules for Patent Linkage. The inclusion of biosimilar drugs in the patent linkage system has sparked controversy and extensive discussions in the industry.
As published previously in IAM (www.iam-media.com/patent-linkage-system-passed-legislative-yuan), at the end of 2017, Taiwan passed the Amendment of the Pharmaceutical Affairs Act, which introduced the patent linkage system.
Similar to the US system, the Taiwan patent linkage system will change the dynamic between branded drugs and generic drugs by linking patent infringement litigation with marketing approval holders’ applications for generic drugs. Once the amended law comes into effect, generic drug applicants could face infringement litigation before their products have even launched.
Pursuant to the Amendment of the Pharmaceutical Affairs Act, the FDA published the first version of the Enforcement Rules for Patent Linkage on 11 September 2018 and provided details on how patent linkage would be implemented in Taiwan. The FDA held public hearings on 6 and 27 November 2018 and issued the second version of the rules on 30 January 2019.
Inclusion of biosimilar drugs
This latest version states that applications for biosimilar drugs may incur patent infringement litigation. Also, to accelerate the R&D and market procedures, biosimilar drugs, will be included in the patent linkage system in order to meet the requirements for biopharmaceutical patent protection.
Inclusion of polymorphs
The revised version also includes the active ingredient’s polymorph (eg, crystalline and amorphous (hydrated or solvated) variants) in the patent linkage system. There is a new requirement to provide data showing that the polymorph has an equal effect to the active ingredient.
While biologic patent owners will be pleased with the new version, the biotech industry is generally dissatisfied with it, particularly with the inclusion of biosimilar drugs.
Questions have also been raised as to whether ‘generic drugs’ comprise biosimilar drugs. This has prompted concern over whether the Pharmaceutical Affairs Act should include biosimilar drugs in the patent linkage system designed for generic drugs, as the US patent linkage system does not include them. General opinion is that biosimilars should not be included and doing so will negatively affect the pharmaceutical and biomedical industry. For 60 days, the FDA is hearing public opinions on the second version.
Although the implementation date of the Amendment of the Pharmaceutical Affairs Act is not confirmed and the enforcement rules pursuant to the amendment are still being debated, relevant parties should pay attention to the developments and prepare for the patent linkage system in Taiwan.
This article first appeared in IAM. For further information please visit https://www.iam-media.com/corporate/subscribe