SAINT ISLAND INTELLECTUAL PROPERTY GROUP

It is stipulated in Article 53.1 of the Patent Law that “in the practice of an invention patent which relates to a pharmaceutical or pesticide composition or the manufacturing method thereof, where such practice is subject to regulatory approval pursuant to other laws and where said approval is obtained after publication of the patent grant, the patentee may apply for patent term extension on basis of a “first” certificate of approval.  Under the practice, only one patent term extension may be granted, and only one certificate of approval, namely the “first” certificate of approval, may be used as the basis for applying for a patent term extension.  

According to the Patent Term Extension Examination Guidelines, to determine whether a certificate of approval is the “first” or not needs to take into account both the active ingredients of a drug and its medical uses. In general, by the term “active ingredients”, it means a compound in the drug that exists in “free form” and is capable of exhibiting pharmacological function. On these premises, the salts, esters and derivatives of a compound should all be considered as “active ingredients” despite the fact only one salt or one ester is specified on the certificate of approval.  Assuming that two certificates of approval are now obtained from an authority, both for the same medical use, one being for an A salt of compound X, and the other being for a B salt also of compound X but obtained at a later time, the certificate of approval for the B salt does not qualify as the “first” certificate of approval in view of the certificate of approval for the A salt which was obtained at an earlier time. 

However, a set of revised Patent Term Extension Examination Guidelines were proposed at the end of 2017 and may take effect in early 2018. In said guidelines, the definition of a “first” certificate of approval is expected to be revised to take into account the salts, esters and derivatives of the compound.  This revision would qualify the B salt mentioned above for the “first” certificate of approval when applying for a patent term extension.   It is believed that the proposed revised guidelines will allow drug manufacturers to exercise greater flexibility in choosing which form of their drug is “first”.