Japan's Intellectual Property High Court has delivered a landmark ruling ordering two pharmaceutical companies to pay ¥21.7 billion in damages for patent infringement involving Toray Industries Inc.'s anti-itch medication containing the active ingredient nalfurafine. The decision represents one of the largest patent infringement awards in Japanese pharmaceutical history.
Court Orders Substantial Damages
The court on Tuesday ordered Sawai Pharmaceutical Co. to pay ¥14.29 billion and Fuso Pharmaceutical Industries Ltd. to pay ¥7.47 billion in compensation to Toray Industries. The ruling addresses patent violations related to Toray's nalfurafine-based anti-itch treatment.
"We're delighted that our claims have been approved" by the court, Toray said, describing the decision as "a key ruling in a pharmaceutical patent lawsuit." The company's statement underscores the significance of the judgment for pharmaceutical patent protection in Japan.
Patent Extension and Generic Competition
The legal dispute originated when Toray applied to the Patent Office for an extension of its patent covering the use of nalfurafine as an itch-alleviating treatment in 2017, coinciding with the original patent's expiration date. Despite this pending extension application, both Sawai and Fuso began manufacturing and selling their own generic versions of the drug in 2018.
The generic manufacturers created their competing products by mixing additives with nalfurafine, the same active ingredient protected under Toray's patent. This approach formed the basis of the patent infringement claims that ultimately led to the substantial damages award.
Industry Response and Appeals
The defendants have expressed strong opposition to the court's decision. The parent company of Sawai characterized the ruling as "unacceptable," while Fuso Pharmaceutical Industries announced its intention to challenge the judgment further up the judicial hierarchy.
"We will thoroughly examine the contents of this ruling and appeal to the Supreme Court," Fuso stated, indicating that the legal battle may continue despite the High Court's definitive ruling on damages.
The case highlights the ongoing tensions between patent holders seeking to protect their intellectual property rights and generic manufacturers attempting to bring lower-cost alternatives to market. The substantial financial penalties imposed by the court may serve as a deterrent for future patent infringement cases in Japan's pharmaceutical sector.
