The Legislative Yuan of Taiwan passed an amendment to the Pharmaceutical Affairs Act on December 29, 2017, to resolve patent issues between generic drug and brand drug manufacturers more quickly. This development is expected to facilitate the growth of Taiwan’s biomedical industry. Promulgated on January 31, 2018, the amendment sought to create a patent linkage system in the country.

The registration system for patent linkage is now in place, effective August 20, 2019, marking the first time such system has been put into practice in Taiwan’s legal circles.

Eligible for the new patent linkage system are patents for compounds, compositions or formulations and those for medical and pharmaceutical purposes in accordance with the indications obtained for market approval.

Under the law, the application for patent linkage must be filed within 45 days from the day of receipt of the new drug approval certificate or before November 20, 2019, if market approval was granted before the registration system was put in place. The individual applying for the approval of the new drug should also be the one filing the application for patent linkage.

Within these 45 days, the holder of a new drug application (NDA) should also submit a list of patents related to their drug to the Taiwan Food and Drug Administration (TFDA). Additional data in connection with the patents should also be included like the expiry date, patent owner, exclusive licensee, patent attorney on record and specific claims according to the indications obtained on the drug approval if the patent is for a medical purpose.

When applying for generic market approval, the abbreviated new drug application (ANDA) filer should also confirm any of the following cases:

1) It has no listed patents,

2) Its listed patents have expired,

3) It is seeking generic market approval until all patents in the list expire, or

4) The listed patents are either invalid or not infringed upon.

If the generic drug manufacturer declares Case No. 4, he should inform the patent holder within 20 days after receipt of notification from TFDA. To slow down the market approval of the generic drug by a maximum of 12 months, the patent holder should file a lawsuit within 45 days. If the court issues its decision favoring the patent holder within these 12 months, market approval for the generic drug will only be granted after patent expiration.

“The new patent linkage law under the Pharmaceutical Affairs Act provides not only stronger patent protection over the innovators’ industry, but also better transparency for generics’ industry,” says Roger Chang, a partner at Lee and Li in Taipei.

Chang enumerates his reasons:

“As of September 26, 2019, 380 marketing approvals have been listed on the TFDA’s patent linkage website. In the past, branded firms may choose to keep the relationship between drugs and patents confidential, especially for biological products and patents covering them. But after patent linkage, everything becomes transparent. It is a big move from the perspective of the public interests.”

After listing patents, under certain conditions, Chang says that the patentees would trigger the one-year stay period against ANDA filers. “It strengthens the degree of patent protection.”

Although there have been some criticisms against patent linkage, Chang says he’s not at all concerned.

“The implementation of the patent linkage will definitely raise the protection strength for pharma IP holders. It is the nature and intended purpose of the policy. Once you strengthen the level of protection, it would certainly increase the operation cost,” he explains.

“For example, if you raise protection over copyright, right holders would be better off, but the freedom of knowledge distribution would be registered. It goes another way around if you lower the copyright protection. It is a policy selection,” he says. “Nothing is perfect.”

Does he believe the patent linkage system will help improve healthcare in Taiwan?

“It’s hard to say on this one,” he says. “Our healthcare issues are extremely complex. I do not think the patent linkage is a major factor to impact the huge and complicated healthcare system. Other factors like national insurance system and decision over drug pricing are much more important. It would be unrealistic to focus on patent linkage only when analyzing the issues involved in our healthcare system.”

Espie Angelica A. de Leon