Taiwan’s patent linkage system has been implemented for more than a year since August 20, 2019, and there have already been quite a few drug patent holders who filed patent infringement actions based on such a system. The patent linkage system allows patent holder to initiate a patent infringement battle against generic drug companies earlier at the time when they submit their applications for generic drug approvals. If an applicant, when filing such application for generic drug approval, declares that one or more of the registered patents for the reference listed drug (“RLD”) are invalid or non-infringed, the applicant needs to notify the patent holder of the RLD, and the patent holder can decide whether to initiate a lawsuit against such applicant. At this stage, as no approval has been given to the generic drug and no such generic drug would be able to launch into the market yet, the patent holder will not be able to obtain the generic drug product to conduct patent infringement analysis and comparison. This may cause certain difficulty for the patent holder to obtain evidence for patent infringement.

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Regarding this issue, the Intellectual Property Court 109-Ming-Sheng-Zi No. 6 Civil Ruling provides a certain level of relief for patent holders. In this case, the patent holder petitioned the court for the permission to visit the factory of the generic drug company to preserve evidence such as the generic drug product, package insert, and other relevant documents that the drug company are required to maintain under the laws such as the final product specifications, production batch records, analysis certificate, product formula, and processing instructions. The court granted part of the petition on the following grounds:

1. As the filing for generic drug approval can be completed by only submitting the application form without providing product samples for testing, the court deemed that the generic drug company may, in order to avoid infringement liability, conceal or change their drug product after the litigation is initiated. Therefore, it is reasonable for the patent holder to claim that there was a necessity to preserve the generic drug products as evidence.

2. Regarding package insert of the generic drug, the court found that, by comparing the package insert of the RLD, the information on the package insert of the generic drug submitted by the generic drug company in the drug approval application is quite abridged, and thus deemed that the generic drug company had an intention to conceal drug ingredient information. Hence, the court agreed that it was necessary to preserve the package insert from the factory of the generic drug company as evidence.

3. As to other relevant documents such as the final product specifications, batch production records, and analysis certificate that that the drug company are required to maintain under the laws, in court’s opinion, those documents are required to be included in the generic drug approval application submitted to the TFDA, and thus the patent holder would not have difficulty to obtain those documents from TFDA during the litigation through court’s order. Hence, there was no necessity to preserve those documents from the factory of the generic drug company (The Intellectual Property Court 109-Ming-Sheng-Zi No. 15 Civil Ruling also shares the same viewpoint). While the product formula and process instructions are not the required documents submitted to the TFDA, those are the essential trade secrets for producing the drugs. The patent holder did not present any evidence showing there is any likelihood that the generic drug company would intentionally destroy such documents and hurt their own interests. Therefore, it is difficult to consider that such evidence could be concealed or destroyed. As a result, this part of evidence was not granted for preservation.

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From the aforesaid Ruling, one can see that the patent holder may obtain relevant evidence through evidence preservation or investigation. However, since the evidence relevant to drug approval registration information may involve the trade secrets of the generic drug companies, generic drug companies also attempted to petition the court to prevent patent holders from accessing to such information or to issue protective orders. With respect to this matter, in the Intellectual Property Court 109-Ming-Sheng-Zi No. 32 & 34 Civil Rulings, the court reasoned that, while there is a large amount of materials in the filing of drug approval registration, such materials are important to both parties in the litigation, so the court would not prohibit the access to evidence so that that the parties may fully debate the evidence and the patent holder’s right to litigate can be preserved. However, the court considered that since such evidence involves trade secrets, it will affect the business of the generic drug company if those trade secrets are used outside of the purpose of litigation. Hence the court granted the generic drug company’s request for a protective order and restricted such documents to eyes of the patent holder’s counsel only.

As of today, there are 14 litigation cases filed via the patent linkage system. It is worthy of our attention to watch for any subsequent litigations arising from such cases.

(Author: Tim Tsai, Esq.)

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