New rules in Taiwan pharma to enact patent linkage

In Taiwan, brand names are entitled to patent term extension and five-year data exclusivity, while generics have the benefit of abbreviated new drug applications (ANDA) and experimental exemptions. But Taiwan provides nothing like the US patent linkage or the European 11-year data exclusivity to the pharma industry.

The current regime has long been criticized as providing insufficient protection to an industry that requires tremendous risk and capital investment. After efforts spanning a decade, however, our congress has finally passed a bill on patent linkage, titled the Pharmaceutical Affairs Act.

Patent linkage bill passed

Passed by Taiwan’s congress on 29 December 2017, the Pharmaceutical Affairs Act establishes a patent linkage mechanism in the pharma industry. It was promulgated by our president on 31 January 2018, and is expected to take effect around early 2019.

Brand name firms’ role

Under the new law, an NDA holder bears a legal obligation to list patents relevant to its drugs.

Listable patents include those covering a substance (compound, salt, ester, isomer, polymorph), composition or formulation, and medical use. Claims are required to be identified for medical use patents, but in general only patent numbers need be specified in such lists.

NDA holders need to list patents relevant to drugs under current market approval within three months after the new law takes effect. For market approval obtained after the effective date of the new law, NDA holders have to list relevant patents within 45 days upon receipt of the market approval. The Taiwanese Food and Drug Administration (TFDA) is establishing an IT system for handling future patent listings. Patent listings will be executed online and be publicly accessible.

The legal rule in judging whether a patent can be listed refers to the logic of patent infringement assessment. Those which would be infringed by a brand name firm’s own drugs are entitled to be listed. The more patents that are listed, the better the chance of NDA holders stopping generics from entering into the market, and for a longer duration. But discretion will be necessary as liability for patent misuse could be triggered by wrongful listing of patents.

Roger Chang is a partner at Lee and Li Attorneys-at-Law in Taipei