TIPO fuels debate between brand-name drug companies and generics

The competition between brand-name drug companies and generic drug companies is always intense. In recent years, these companies have seriously debated whether the patent linkage system – as part of the Trans-Pacific Partnership – should be implemented in Taiwan. During Summer 2017, the fiery debate between the two sides was reignited, with the Taiwan Intellectual Property Office (TIPO) supplying the fuel.

TIPO intends to adjust the patent term extension criteria by amending the Patent Act and the guideline for patent term extension. This proposition drew the industry’s attention, as the amendments could dramatically change the term of extension for patents. One of the most debatable amendments is the determination of the domestic clinical period.

In Taiwan, patents relating to pharmaceutical or agrochemical products, and the manufacturing processes thereof, can be extended at the request of the patentee. For pharmaceutical patents, patentees can be compensated for time spent on clinical trials and official reviews of marketing authorisation applications by extending the patent term. The clinical trial can be conducted domestically (domestic clinical period) or abroad (foreign clinical period).

Under existing guidelines, the domestic clinical period starts from the date on which the Taiwan Food and Drug Administration (TFDA) approves the clinical trial and ends on the date on which the TFDA agrees to review the clinical trial report. However, the foreign clinical period is from the date on which the study starts to the end of the study (ie, the last patient visit). TIPO has proposed to adjust the determination of the domestic clinical period to make it consistent with the determination of foreign clinical trials (see the comparison table below).

The reasons for TIPO’s proposal are twofold:

• the determinations of domestic and foreign clinical periods should be consistent; and
• according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 Guideline, a clinical trial is from the date on which the study starts to the end of the study (ie, the last patient visit).

Understandably, brand-name companies expressed strong disagreement with the proposed amendment and the aforesaid justifications. For example, Wade Lin, a patent attorney in the bio-pharma field who attended the public consultation and provided comments, believes that the amendment is a bad idea as it would be against Taiwan’s industrial policy. The main objective of pharmaceutical industrial policy is to encourage new drug development. Thus, it makes no sense to limit the patent term extension benefit as it was designed to compensate losses from new drug patents and encourage innovation.

Further, the two reasons provided by TIPO are not persuasive. If the TIPO’s concern is the inconsistency between domestic clinical periods and foreign clinical periods, should it not consider adjusting the determination of foreign clinical periods to be consistent with domestic clinical periods?

Mr Lin also held that TIPO was wrong to consider the ICH guideline, which is designed for purposes other than those relating to patent term extensions. For instance, the end date of a clinical trial is determined in the ICH guideline because the date is considered as the start of several obligations that must be met by the principal investigator of the clinical trial. However, in view of the core purpose of the patent term extension, the clinical period should not end on the visitation date of the last patient as there are many tasks to complete and considerable time required after that.

If TIPO must amend the determination of the existing guideline, Mr Lin suggests that the end date of a clinical period should be the date on which the clinical report is completed. This would make more sense because the purpose of clinical trials is to provide effective and safe medicine, and conclusions must not be made before the clinical trial data has been fully analysed.

A public consultation meeting took place on September 18 2017. TIPO promised that it would consider the opinions and comments raised in the meeting.