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Patent Term Extension Determination Based on the Foreign Clinical Trial Period



Although Article 53 of Taiwan’s Patent Act stipulates,

Where a regulatory approval shall be obtained in accordance with other laws and regulations for the exploitation of an invention patent involving a pharmaceutical or agrichemical, or the manufacturing process thereof, if such regulatory approval is obtained after the publication of the concerned invention patent, the patentee may apply for the extension of the patent term of said invention patent based on the first regulatory approval [,]

it also contains a proviso that states,

The extension of the patent term approved shall not exceed the length of time when the patent cannot be exploited because of the filing of a request for the regulatory approval with the central competent authority.

Taiwan Intellectual Property Office (TIPO), under the authorization of the Patent Act, has formulated the "Regulations for Ratifying the Extension of Patent Terms" (hereinafter the "Regulations").  According to Paragraph 1, Article 4 of the Regulations, the patent extension term includes "the foreign clinical trials and domestic clinical trial periods needed for issuance of the regulatory approval by the the central competent authority.

In the "Examination Guidelines for the Extension of Patent Terms" (hereinafter the "Guidelines") that were amended and took effect on April 1, 2018, TIPO further specified that the "conclusion date" of the foreign clinical trial period is the "study completion date defined in the clinical study reports stipulated by the ICH."

 

Different opinions have been repeatedly expressed regarding the judicial practice of calculating the patent term extension based on the "study completion date defined in the clinical study reports stipulated by the ICH" (hereinafter the "completion date") as the "conclusion date" of the foreign clinical trial period.

 

In the 2017 Tai Shang Zi No. 1904 civil judgment made on December 31, 2018, the Supreme Court stated,

Considering that a conclusion of the pharmaceutical clinical trial outcomes cannot be immediately reached after drug administration is given, the conclusion date of a foreign clinical trial should be the “report date” rather than the “completion date” as meaningful results can be obtained only after professional analysis and data processing and the results are to be used by the central competent authority for determining eligibility for market approval.  Hence, the “clinical trial period” mentioned in the aforesaid Regulations should be the period from the commencement date of the clinical trial to the date when the trial results can be presented, which meet the regulatory purpose of the authoritative provision, namely Article 51 of the Patent Act of 1994 (or the Patent Act of 2001).

 

Nevertheless, the aforementioned 2017 Tai Shang Zi No. 1904 civil judgment made by the Supreme Court reversed and remanded the case to the Intellectual Property Court for retrial.  After having gone through the retrial proceeding, the Intellectual Property Court made 2018 Min Zhuan Shang Geng(1) Zi No. 1 civil judgment, holding a view that still differed from that of the Supreme Court.  The Intellectual Property Court affirmed the Guidelines with this statement:

Although the "clinical trial period" may be interpreted as "the period from the commencement date of the clinical trial to the date when the trial results can be presented" according to the legislative purpose, the literal meaning defined in the Regulations shall still prevail so as to balance the interests of patentees and the general public.  In addition, all legitimate international clinical trial institutions would specify the commencement and completion dates of the clinical trial period in the clinical trial report.  The competent authority handling the matters of patent term extension would surely accept this unless an obvious error is encountered.

Said case became final and binding as no appeal was filed.

 

In point of fact, the Supreme Court does not accept the position of the Intellectual Property Court in support of the Guidelines.  The Supreme Court, in 2018 Tai Shang Zi No. 2358 civil judgment for another case made on May 1, 2019, maintained its view in the aforesaid 2017 Tai Shang Zi No. 1904 civil judgment and further pointed out that:

The completion date of the clinical trial is only the date when the subject is given the last dose in the clinical trial, and the results of the clinical trial shall still need to be observed, recorded and interpreted afterwards... The results of the clinical trial will have not been presented yet as of the completion date of the clinical trial period noted in the clinical trial report."

It can be seen that the Supreme Court clearly opposes the view that the "completion date" should be taken as the "conclusion date" of the foreign clinical trial period to calculate the patent term extension period, which is prescribed in the Guidelines.

 

The Intellectual Property Court, soon after the 2019 Xing Zhuan Su Zi No. 15 administrative judgment made on September 26, 2019, finally adopted the same view as the aforesaid two judgments of the Supreme Court and specifically indicated that the "conclusion date" of the "foreign clinical trial period" referred to in the Regulations shall adopt the "report date" of the clinical trial report.  The reasons held by Intellectual Property Court include that, firstly, the "report date" used as the "conclusion date of the foreign clinical trial period" does not conflict with the clinical practice as the clinical trial can only be unblinded to understand the clinical trial results upon the completion of the clinical trial report; secondly, there is no hindrance in the operating practice of adopting the "report date" since the "report date" was also used as the conclusion date of the foreign clinical trial period in the TIPO’s reviews before the amended Guidelines were put in effect; moreover, it is believed that it would not violate the country’s policy to use the "report date" as the "conclusion date of foreign clinical trials" as Taiwan has established a five-year upper limit on granted patent term extensions in consideration of factors, such as public interest, market interest balance of generic drugs, and the purpose of the patent term extension mechanism.  As a result, it is natural to regard the "report date" contained in the clinical trial report as the "conclusion date" of the "foreign clinical trial period" so as to not only meet the legislative purpose of Article 53 of the Patent Act in force, which states "the period during which the patent cannot be exploited because of the filing of a request for the regulatory approval with the central competent authorities," but also meet the requirment of clarity when the competent authority handles the cases of patent term extensions.

 

While the view of the Intellectual Property Court seems to be in line with that of the Supreme Court, the Guidelines have not been revised yet.  Hence, how the administrative and judicial practice differences are reconciled remains to be seen.

 

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