JAPAN Trends and Developments Contributed by: Naoko Nakatsukasa, Katsuya Hongyo, Tatsunori Enomoto and Ronald Kaloostian, Chuo Sogo LPC
tions as the Defendant’s Original Drug in its dos- age and administration. Under the patent linkage system, the defend- ant notified the MHLW that the generic drug manufacturer’s act of manufacturing and sell- ing a biosimilar to the Defendant’s Original Drug would infringe the Defendant Patent (the “Notice in Question”). The plaintiff asserted that it was evident that the Plaintiff’s Biosimilar Drug did not infringe the Defendant Patent, and therefore the Notice in Question by the defendant constituted a clearly false statement. The plaintiff further argued that this act of the defendant amounted to “the act of disseminating or notifying false facts harmful to the business reputation of a competitor” under Article 2(1)(21) of the Unfair Competition Preven- tion Act, posing a potential risk of damaging the plaintiff’s business interests. Consequently, the plaintiff sought a provisional injunction to stop the defendant from issuing the Notice in Ques- tion. Does the Notice in Question Constitute a False Statement? A use invention is an invention characterised by the discovery of an unknown property of a known substance and the creation of a novel use with significant effects based on that prop- erty. Therefore, “implementing” a use invention refers to acts such as manufacturing or using the known substance for the purpose of the novel use. The Court recognised that the Defendant Pat- ent was also a use invention and defined its “implementation” as acts such as manufactur- ing or using a preparation containing the known substance for administration to a specific patient group, among wAMD patients, that satisfies cer-
tain inclusion and exclusion criteria defined by the Defendant Patent. In its assessment, the Court concluded the fol- lowing: • The Plaintiff’s Biosimilar Drug is a biosimilar to Defendant’s Original Drug, its package insert merely includes wAMD as an indication and does not describe the specific patient group meeting the inclusion and exclusion criteria of the Defendant Patent, nor does it mention the significant effects achieved by administering it to such a specific patient group. • Therefore, the manufacture and sale of the Plaintiff’s Biosimilar Drug cannot be regarded as acts of manufacturing or using a prepa- ration containing the known substance for administration to the specific patient group. Accordingly, it does not infringe the Defend- ant Patent. The Court addressed the validity of the Defend- ant’s Patent and noted that the Plaintiff’s Bio- similar Drug is equivalent and identical to the Defendant’s Original Drug. It observed that the Defendant’s Original Drug had been manu- factured and sold before the filing date of the Defendant’s Patent. Additionally, the Defend- ant’s Original Drug was administered to a specif- ic group of patients as part of the general treat- ment for wAMD. Therefore, the manufacture and sale of the Defendant’s Original Drug constituted prior public use, which rendered the Defendant’s Patent invalid. For these reasons above, the Court concluded that the Notice in Question constituted a false statement.
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