Taiwan Supreme Court takes account of clinical trial period in Pfizer

Patent terms for medicinal products and pesticides, which cannot enter the market without marketing approval from the competent authorities (eg, the Taiwan Food and Drug Administration (FDA)), can be extended upon request. This is based on the duration of clinical trials and the FDA’s review procedure for marketing approval. There used to be a two-year threshold in the old Patent Act, which was removed in 2011. Under the old version of the act, if the total time for obtaining marketing approval exceeded two years, it was possible to obtain an extension.

Extending patent terms directly affects the period in which compensation for damages can be claimed. The validity of this extension is one of the main disputes in the famous Viagra patent litigations, Pfizer v Novartis. Although clinical trials conducted both domestically and in foreign countries were eligible for patent-term extensions, they were determined differently, particularly with regard to the end date of the clinical period. The end date for the domestic clinical period was defined as the date on which the FDA confirmed receipt of the clinical report. However, the end date for the foreign clinical period was not clearly defined.

In the case at hand, Novartis asserted that the end date for the foreign clinical period should be the last dosing date of the clinical trials. Further, the wording of the law applied to the trial (the experiment stage) only. According to Novartis, the time taken did not exceed the two-year threshold and thus the whole extension was invalid.

Pfizer, on the other hand, asserted that the domestic and foreign clinical period should be determined in the same manner; or, at least, the end date of the foreign clinical period should be the report date of the clinical trial. That is to say, as well as the experiment stage, the analysis stage should also be included. The rationale behind Pfizer’s position was that a clinical trial has not ended until the data has been collected and analysed.

The first-instance court and the appeal court confirmed Novartis’s infringement but favoured its position on patent-term extension. Pfizer appealed the case to the Supreme Court on the basis that the patent-term extension was valid.

On 8 May 2019 the Supreme Court remanded the case to the Appeal Court. It reasoned that the product could not be sold without marketing approval because its safety and efficacy must be verified. It is also noted that clinical trials are conducted for the purpose of evaluating a product’s safety and efficacy. Thus, the Supreme Court opined that clinical trials can be considered to be completed only when the data has been collected and analysed, and conclusions can be drawn as to its safety and efficacy. From this point of view, it is reasonable to consider the time spent in the analysis stage as part of the clinical period. In other words, the end date of any clinical trial should be the report date, as long as this includes the time to process the results of the clinical experiments.

This is not only a victory for Pfizer but also a milestone in the Taiwanese patent system. It shows that the Supreme Court has finally gauged how to determine the clinical period for patent-term extensions. Pfizer has been remanded to the appeal court. It is foreseeable that Pfizer will be able to collect further compensation for damages in the near future.

This is an Insight article, written by a selected partner as part of IAM's co-published content. Read more on Insight

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