At the beginning of January 2018, a patent linkage system, established in an attempt to resolve disputes on patent invalidity and infringement among brand drug companies and generic drug companies in a more rapid pace, was promulgated and introduced into the newly amended Pharmaceutical Affairs Act.
According to the amended Pharmaceutical Affairs Act, brand drug companies are required to submit, within 45 days from receipt of approval of a new drug, to Taiwan FDA a list of patents associated with the new drug and relating to inventions of compounds, compositions or formulations, or medical uses of the new drug, if any. Taiwan FDA will publish in a patent linkage registration system, known as Orange Book, information regarding the patents associated with the new drug for public inspection. A generic drug company must make one of the following declarations when filing an application for approval of a generic drug equivalent to a new drug:
- The new drug has not been patented;
- the patent for the new drug has already expired;
- drug approval of the equivalent generic drug is not to be issued until the patent for the new drug has expired; and
- the patent for the new drug is not infringed or is invalid.
If there is no existing patent dispute between a generic drug company and a brand drug company (as shown in the yellow area of the figure), a generic drug company will receive drug approval if declaring (i) or (ii); and will receive drug approval upon expiry of a preceding brand name patent if declaring (iii). If declaring (iv), the generic drug company must notify the holder of the new drug approval, the patentee and the exclusive licensee of the patent (if any) of its declaration in writing and with grounds and evidence within 20 days from the day the generic drug company receives a notice from Taiwan FDA that the application for its generic drug has completed. After receipt of the declaration from the generic drug company, the patentee or the exclusive licensee may file a lawsuit within a 45-day time limit and then notify Taiwan FDA that a lawsuit has been filed. If a lawsuit is not filed within the time limit, Taiwan FDA will issue drug approval of the generic drug. If a lawsuit is filed, Taiwan FDA will stay issuance of drug approval of the generic drug for up to 12 months. Should the court render a final judgment in favor of the patentee or the exclusive licensee within the stay period (up to 12 months), the generic drug company will receive drug approval only after the patent for the brand name drug expires. Otherwise, the generic drug company will receive drug approval of the generic drug and further obtain a 6-month market exclusivity, assuming it is the earliest of those that have duly completed the application forms for the generic drug equivalent to the brand name drug. The details of the patent linkage system are shown in the following figure.
Although the patent linkage system has been promulgated, it will not take effect until the Executive Yuan has issued a decree of its implementation.
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