The patent linkage system of drugs has been implemented in Taiwan since August 20, 2019. Now, we have the first judgment of patent linkage litigation, Merck Sharp & Dohme Corp. v. China Chemical & Pharmaceutical Co., Ltd.
Article 96, Paragraph 1 of the Patent Act stipulates that a patentee of an invention patent may demand a person who infringes or is likely to infringe the patent right to stop or prevent such infringement. However, since Article 60 of the Patent Act provides a safe harbor for the regulatory approval of generic drugs, some people are of the opinion that the act of applying for the marketing approval of a generic drug does not, in accordance with Article 60 of the Patent Act, constitute an “infringement” stipulated in Article 96, Paragraph 1 of the Patent Act and thus the patentee cannot file a litigation against the application in accordance with Article 96, Paragraph 1 of the Patent Act regardless whether the application is accompanied with a challenge of Paragraph IV Certification under the patent linkage system.
To clarify the basis of patent linkage litigation, the Taiwan Intellectual Property Office also proposed an amendment to introduce Article 60-1 of the Patent Act, in which Paragraph 1 specifies the basis of patent linkage litigation on Article 96, Paragraph 1 of the Patent Act, but the proposed amendment is still pending at the Legislative Yuan, which somehow encourages the opinion that there is no legal basis for the patentee to file a litigation against the Paragraph IV Certification under the patent linkage system in accordance with the current provisions in the Patent Act. In Merck Sharp & Dohme Corp. v. China Chemical & Pharmaceutical Co., Ltd. (CCPC), CCPC, who applied for a marketing approval for the generic drug Ezetity by referring to Ezetrol of Merck Sharp & Dohme Corp., also argued that it is groundless for Merck Sharp & Dohme Corp. to file a litigation against CCPC’s marketing approval application before the amendment to introduce Article 60-1 of the Patent Act is passed by the Legislative Yuan and formally implemented.
In the present judgment of the Intellectual Property Court, the judge indicated that in accordance with Article 58, Paragraph 2 of the Patent Act, the exploitation of a product invention refers to acts of making, offering for sale, selling, using, or importing that product for the aforementioned purposes, and applying for a generics marketing approval is not one of those acts. Besides, Article 60 of the Patent Act provides a safe harbor for exceptions of “the acts of exploiting a patent.” Since the act of applying for a generics marketing approval itself is not an act of exploiting a patent, it is not an exception stipulated in Article 60 of the Patent Act, either.
Merck Sharp & Dohme Corp. indicated that the Paragraph IV Certification that the generic drug does not infringe the patent right indeed meets the condition “likely to infringe the patent right” stipulated in Article 96, Paragraph 1 of the Patent Act. Accordingly, the judge decided that it is justifiable for Merck Sharp & Dohme Corp. to file a litigation in accordance with Article 96, Paragraph 1 of the Patent Act even before the introduction of the new provision in Article 60-1 of the Patent Act. Ezetity was found to infringe the right of TW I337083 under the doctrine of equivalents.
This is the first judgment of patent linkage litigation in Taiwan, which well demonstrates domestic patent protection in the field of medicine and pharmaceuticals with the mediation of the patent linkage system, and highlights the value of filing patent applications in Taiwan.
Judgment (in Chinese):
https://law.judicial.gov.tw/FJUD/data.aspx?ty=JD&id=IPCV,109%2c%e6%b0%91%e5%b0%88%e8%a8%b4%2c46%2c20201231%2c2