JAPAN Trends and Developments Contributed by: Naoko Nakatsukasa, Katsuya Hongyo, Tatsunori Enomoto and Ronald Kaloostian, Chuo Sogo LPC
Determination of unfair conduct Acts by a patent holder under the patent linkage system that involve providing false information about patent conflicts could amount to unfair competition if “exceptional circumstances exist where such acts are deemed grossly inappropri- ate in light of the purpose of the patent linkage system.” Application to this Case The defendant argued that: • It is now common technical knowledge that administering the Defendant’s Original Drug to a specific patient group yields superior therapeutic effects, and such knowledge has evolved since the filing date of the Patent in Question. • Consequently, the manufacture and sale of Defendant’s Original Drug before the filing date does not constitute a prior public use, and the current manufacture and sale of Plaintiff’s Bio-Similar Drug infringes Defend- ant’s Patent. The Court noted that even though the defend- ant’s view above may be considered its own interpretation, it is a potentially arguable position when alleging patent infringement. Therefore, the mere act of adopting this viewpoint does not immediately render the defendant’s argument baseless. Patent infringement disputes require careful deliberation based on expert knowledge, and the limited examination conducted during preliminary injunction proceedings is insufficient to determine that the defendant’s argument is entirely unfounded. Thus, although the defendant’s issuance of the Notice in Question may be considered care- less, it was not the case that “exceptional cir- cumstances exist where such acts are deemed
Unfair Conduct As described, the Court determined that the Notice in Question issued by the defendant constituted a false statement. The Court further examined whether such an act amounts to unfair conduct under the Unfair Competition Preven- tion Act within the context of the patent linkage system based on the following criteria: Scope of statements under the patent linkage system The defendant issued the Notice in Question to the MHLW under the patent linkage system. This system has no specific restrictions on the con- tent of such statements. Patent holders are not prohibited from expressing their opinion regard- ing the existence or absence of patent conflicts between their patented drug and a follow-on generic drug. Purpose of the patent linkage system The patent linkage system aims to confirm the existence or absence of patent conflicts between patented drugs and follow-on generic products during the approval process of gener- ic drugs, ensuring the stable supply of generic drugs. However, this system does not permit patent holders to provide arbitrary or mislead- ing information. Evaluation of false statements If a patent holder makes a false statement claim- ing a patent conflict under the guise of providing information within the patent linkage framework, while the substance of such a statement is to disadvantage the applicant seeking approval for a generic drug and to secure a competitive advantage for themselves, such conduct would disrupt fair competition among businesses.
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