According to Article 89 of the Korean Patent Act ("KPA"), the term of a patent for a pharmaceutical invention may be extended, up to five (5) years, for a period taken to acquire market approval of a product covered in the patent.
Further, the Enforcement Decree of the KPA stipulates that the pharmaceutical invention eligible for patent term extension is confined to a first market-approved pharmaceutical product containing a “new substance, as the active ingredient, which has a new chemical structure in the active moiety exhibiting a pharmacological effect.”
It is important to note that the above Decree allows only one extension of patent term with respect to the first market-approved product having a new substance, as the active ingredient, exhibiting a pharmacological effect; but that it is silent on the eligibility of a derivative of the active ingredient which has an improved activity but the same pharmacological effect as its predecessor(s).
▶ Background of the Case
The patentee in the subject case had previously acquired a patent and also obtained market approval of a pharmaceutical product containing interferonbeta-1α as the active ingredient for the treatment of relapsing multiple sclerosis.
Thereafter, the patentee obtained a second patent for the pharmaceutical invention directed to PEGinterferonbeta-1α, and acquired a second approval for the marketing of a pharmaceutical product containing PEGinterferonbeta-1α as the active ingredient for the same purpose of treating relapsing multiple sclerosis. Following the acquisition of the second market approval, the patentee filed an application for patent term extension (PTE) of the second patent for a period to compensate for the time lost to acquire the second market approval.
The Korean Intellectual Property Office (KIPO) Examiner rejected the PTE application for the reason that the PEGylated derivative did not qualify as a pharmaceutical product containing a novel substance since the active moiety exhibiting the pharmacological effect for the treatment of relapsing multiple sclerosis was interferonbeta-1α, and not the new moiety, i.e., the PEG portion.
The KIPO Trial Board endorsed the Examiner’s rejection, and the patentee filed an appeal before the IP High Court.
▶ The IP High Court Decision
However, the IP High Court agreed with the patentee that the pharmacological effect of PEGinterferonbeta-1α was improved as a result of the attachment of PEG to interferonbeta-1α (e.g., increased half-life in the body); and determined that the "active moiety exhibiting the pharmacological effect" in the market-approved product was PEGinterferonbeta-1α, which qualified as a novel substance and could serve as the basis for a term extension of the second patent.
▶ The Supreme Court Decision
On appeal, the Supreme Court reversed the IP High Court decision.
First, the Highest Court took note of the fact that the Enforcement Decree (discussed supra) does not render an ingredient which produces an improved activity to qualify as a “new substance”; rather requires the ingredient to have a new chemical structure in the active moiety exhibiting a new pharmacological effect: for only one extension of patent term is allowed with respect to one, i.e., the first, market approval.
Based on the above statutory reading, the Supreme Court determined that, inasmuch as it is interferonbeta-1α that produces the pharmacological effect of treating multiple sclerosis and not the PEG portion, regardless of any improved activity stemming therefrom, PEG interfronbeta-1α does not qualify as a new substance within the purview of the Decree.
Consequently, the Supreme Court held that the PEG form of interferonbeta-1α does not qualify as a new substance for the purpose of patent term extension; and, ruled that the PEGylated derivative is not eligible for term extension of the second patent.
▶ Significance of the Decision
The above decision clarifies the scope or meaning of a “novel substance” capable of acquiring a term extension of a pharmaceutical patent.
From the decision, one may draw the conclusion that, while an improved activity possessed by a derivative of a market-approved product may meet the inventiveness requirement for patentability, it may not suffice to secure a term extension of the patent directed to the derivative unless the derivative entails a pharmacological effect different from that of the original product, i.e., the first market-approved product.
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