The Taiwan Intellectual Property Office (hereafter referred to as "TIPO") intends to make an overall review of the Patent Act and Patent Examination Guidelines regarding patent term extension, and thus held a meeting for a proposal of amendments to the Patent Act, Article 53 and Patent Examination Guidelines on Patent Term Extension (hereafter referred to as "PTE meeting") on 20 June 2017. The issues raised in the PTE meeting are explained as follows.
1.Proposed Amendment to the Patent Act, Article 53: whether to set a limitation on the length of a patent term from obtainment of a market approval.
The currently effectively Patent Act, Article 53 does not set a limitation on the total length of a patent term after the market approval is obtained; therefore, the extendible period for some drugs results in a monopoly for more than 15-years. In comparison with the 14-year limitation on the length of a patent term from obtainment of a market approval in the USA, and the 15-year limitation to the above-mentioned length in Europe, the extendible time is more relaxed in Taiwan, due to no limitation on the above-mentioned length. Therefore, the TIPO proposes to adopt a 14-year limitation like the USA, or a 15-year limitation as in Europe.
At the meeting, the opinions of the brand-name drug companies were contrary to those of the generic drug companies. The brand-name drug companies contend that such a limitation would reduce their motivation to introduce new drugs to Taiwan. For example, if a market approval is obtained 10 years after the patent filing, a 5-year extension may not be obtained due to the above-mentioned limitation, and the motivation to get an early market approval is thus reduced. Consequently, the use of an innovative drug in Taiwan would be delayed and the launch of new drugs would be reduced, which would also cause a reduction in the launch of generics. Both the brand-name drug companies and the generic drug companies would take a loss. In contrast, the generics agree to set a limitation to shorten the extendible time.
2.Proposed Amendment to the Patent Examination Guidelines on Patent Term Extension (hereafter referred to as "PTE Guidelines"), issue 1: whether to include derivatives of a free form compound for determination of a first market approval.
The current PTE Guidelines define the "active ingredient" as the ingredient having a pharmacological effect in a pharmaceutical or pesticide formulation and provide that at least one claim should correspond to the active ingredient stated in the market approval. However, for a salt or hydrate of a compound as the active ingredient in the market approval, the compound per se is regarded as the active ingredient. To take different market approvals for different salts, hydrates or esters into consideration, the TIPO thus proposes to regard different types of salt, hydrate, ester or isomer of a compound as different active ingredients, so that the market approval for each type is regarded as the "first market approval."
At the meeting, most generics disagree with the TIPO's proposal for the reason that it may cause difficulty for courts in determining the first market approval, confusing the courts and judges. Moreover, the different esters, salts or hydrates of an active ingredient belong to the same compound, and it is unreasonable to give a patent term extension because their development cost is low. Some of the brand-name drug companies also disagree with the TIPO's proposal because the chance is quite slim that other market approvals are issued for different salts, hydrates, esters or isomers.
3.Proposed Amendment to the Patent Examination Guidelines on Patent Term Extension, issue 2: whether to include dosage forms and/or dose amounts for determination of a first market approval.
The current PTE Guidelines define the "first market approval" based on the active ingredient and indication stated in the market approval, which results in a situation wherein the market approval for a new dosage form, new dosage, or new unit amount is not the so-called "first market approval," and a patent term extension based on such a market approval is not feasible. Therefore, the TIPO propose to relax the determination of the "first market approval," and the basis of determining the first market approval would be the active ingredient, indication and dosage form and/or dosage etc.
At the meeting, both the brand-name drug companies and generics disagreed with the TIPO's proposal.
4.Proposed Amendment to the Patent Examination Guidelines on Patent Term Extension, issue 3: whether to consider the "study completion date" to be the conclusion date of foreign clinical studies when determining the period of the study (under current practice, the issue date of the MOHW notification of entry of clinical trial or bridging study results is recognized as the conclusion date).
Under the current PTE Guidelines, the determination of a foreign clinical trial period is different than that of the domestic clinical trial period. For domestic clinical trials, the "start date" refers to the date of the TFDA's notification agreeing for the applicant to conduct the trial, and the "end date" refers to the date of the TFDA's notification confirming receipt of the clinical trial report. However, for foreign clinical trials, the start date and the end date refer to the trial start date and trial end date stated in the clinical trial report. Therefore, the determination of the foreign clinical trial period is inconsistent with that of the domestic clinical trial period.
At the meeting, the brand-name drug companies agree to maintain the determinations provided in the current PTE Guidelines to meet the legislative intent of the patent term extension that compensates the unenforceable period to the patentee. The generics certainly agree to change the determination of the domestic clinical trial period to that of the foreign clinical trial period to shorten the extendible period.
5.Proposed Amendment to the Patent Examination Guidelines on whether the period of prereviewing a pesticide registration can be regarded as a part of the domestic regulatory review period.
The Council of Agriculture (hereafter referred to as the "COA") adopted a pre-review system from 2009 to allow the applicants to submit partial data. If the partial data is insufficient for regulatory review, the COA will issue a notification requiring the applicant to submit sufficient data. If the prereview is passed, the COA will issue a notification indicating that all documents are sufficient. The prereview system can shorten the time required for regulatory review. In fact, the prereview involves examination; therefore, the TIPO proposes that if the prereview occurs before the applicant files a regulatory review application with required documents, the preview period can be listed as a part of the domestic regulatory review period.
Since most participants at the meeting are drug companies, there is no discussion on the issue.。
6.Proposed Amendment to the Patent Examination Guidelines on Patent Term Extension, issue 5: whether to notify a PTE applicant to amend the extension term in the petition if the requested extension term is in excess of the actual time.
Article 9 of the Patent Term Extension Regulations provide that for a patent term extension application, if after the examination, the patent period unenforceable due to the obtaining of a market approval exceeds the period filed for a patent term extension, the allowable period is limited to that filed for extension. However, it is arguable under the practice that the "period filed for patent term extension" refers to that requested at filing or that requested for extension, based on the change of the basis for determining the extendible period. Therefore, the TIPO proposes to add a provision to the PTE Guidelines that when examining a patent term extension application, the examiner should examine whether the requested extension time is true or not; if it is not true, the examiner should request that the applicant change the request for extendible time and then re-publish the period. After the examination, the allowed period cannot exceed the published period.
At the meeting, both the brand-name drug companies and generics disagreed with the TIPO's proposal. The reasons include the situation that the generics will not take the published period into consideration when the generics make a plan to launch a generic drug, and that the TIPO's examination of the extendible time after the application is filed, notifying the applicant to make a change and re-publication of the requested extension time, would waste administrative resources and time.