▶ Effect of Patent Term Extension
According to Article 95 of the Korean Patent Act ("KPA"), the effect of a patent right with an extended term reaches only the practice of the patented invention concerning the product that served as the basis for approval of the extension. If a specific use is designated for the product in the approval, the effect may apply only to other product(s) used for that specific use.
Consequently, whether a (new) product falls within the scope of an extended patent right would depend not only on the identity of the active ingredient, but also on whether the therapeutic effect and medical use thereof are the same. Controversies have arisen, therefore, as to whether or not the "use" should be limited to that specified in the first approval under the KPAA.
▶ Background of the Case
The patentee obtained a patent for a pharmaceutical invention directed to chromane-substituted benzimidazole derivatives for use in the treatment of a gastroesophageal reflux disease (GERD), and the exclusive licensee received product approval for the treatment of erosive GERD (hereinafter "Indication ①") and non-erosive GERD (hereinafter "Indication ②"). Based on this market approval, a patent term extension (PTE) was granted for the patent to compensate for the time lost in acquiring the approval. Subsequently, the exclusive licensee applied and received approval for additional indications, including combination therapy with antibiotics for eradicating Helicobacter pylori in patients with peptic ulcers and/or chronic atrophic gastritis (hereinafter "Indication ③").
In response, local generic companies filed a negative scope confirmation trial, arguing that, although the pharmaceutical composition for Indication ③ comprised the same active ingredient, it differed from the indications given in the approval; and, therefore, that it did not fall within the scope of the extended patent right.
The Trial Board dismissed the petition on the ground that Indications ①, ② and ③ were all "acid-related diseases treated by inhibiting gastric acid secretion," and that the therapeutic effect and medical use of these indications were the same. The generic companies appealed this ruling to the IP High Court.
▶ IP High Court Decision
On appeal, the IP High Court held that, for purposes of determining the scope of an extended patent right, the "use" under the KPA should include not only the "first approved indication," but also indications for the prevention or treatment of substantially identical diseases.
In particular, the Court noted that whether or not the "use" is the same should be determined, based on a comprehensive analysis of the technical significance of the patented invention as understood from the patent specification, core technical concepts, pharmacological mechanisms, targeted organs or tissues, diseases, prescription patterns, and other relevant factors. From the patent specification of this case, the Court found that the technical feature of the patent lay in providing compounds for treating "acid-related diseases treated by inhibiting gastric acid secretion," thereby encompassing Indications ①, ② and ③.
Under the circumstances, the IP High Court concluded that the "use" included not only the initially approved Indications ① and ②, but also the subsequently approved Indication ③; and that the indication subject to the scope confirmation fell within the scope of rights of the patent with the extended term.
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