Eisai's Lawsuit against three Japanese Generic drug manufacturers/distributors regarding the sales of Selbex based on the Japanese Unfair Competition Prevention Law dismissed by Court
Eisai Co., Ltd.
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the lawsuits filed against three generic drug manufacturers, Towa Pharmaceutical Co., Ltd., Taisho Pharmaceutical Industries Ltd. and Sawai Pharmaceutical Co., Ltd., regarding the sales of generic products of “Selbex capsule 50mg” (generic name: teprenone, hereinafter referred to as “Selbex”) based on the Japanese Unfair Competition Prevention Law have been dismissed by the Intellectual Property High Court.
Eisai has previously brought lawsuits against 12 companies and distributors of pharmaceutical products selling generic products of Eisai's gastritis/gastric ulcer medication Selbex in the Tokyo District Court based on the Japanese Unfair Competition Prevention Law. Eisai appealed to the Intellectual Property High Court against Tokyo District Court's decision to reject Eisai's claims. The High Court held today that the lawsuits against Towa Pharmaceutical Co., Ltd., Taisho Pharmaceutical Industries Ltd. and Sawai Pharmaceutical Co., Ltd. have been dismissed. The Court has not made any judgment regarding the other nine companies and distributors at this time.
The claim made by Eisai was not accepted in this trial, as “the indication for goods or business” was not acknowledged since the court found that the external appearance of a PTP sheet or a capsule of Selbex was not significantly unique enough to provide legal protection. The Court also concluded that there are a number of other drugs whose appearance is similar to Selbex including the relevant non-generic (originator) drugs or OTCs.
Selbex, one of the most prescribed drugs in the gastrointestinal area in Japan, has been used by many medical institutions and patients, and more than 30 million prescriptions have been filled annually. Furthermore, since the product launch in December 1984, Eisai has been using the same unique design for the PTP sheet and capsule; a silver PTP sheet with product name printed in blue color and a capsule in the color combination of grayish green and light orange. In addition, the color research conducted by Eisai has confirmed that such unique coloration is distinguishable even among other products using the same color patterns, which was submitted as evidence for this action. Eisai finds the result regrettable as “the indication for goods or business” of the external appearance of Selbex was not acknowledged despite these facts.
Eisai respects the role of generic drugs and fully understands that the objective of the lawsuits is not to cast suspicion upon the generic drugs themselves by the lawsuits. However, according to the result of the research which was submitted to the Court, the risk still remains to medical institutions and patients that Selbex may not be prescribed appropriately as a result of the confusion between Selbex and the generic drugs because of the similarities of the external appearance.
Therefore, it is Eisai's belief that the current situation, where some generic drugs are sold with their appearance resembling the originator products, must be redressed. In fact, the Court acknowledged that the resemblance of the external appearance of Selbex and the generic drugs are extraordinary and suggested that there can be a potential issue of business ethics by stating that its findings are “apart from the appropriateness from a viewpoint of business ethics”.
Eisai will continue to take firm steps against the sales of drugs which are confusingly similar in appearance to well-known drugs, to eliminate the risk of product misidentification and confusion so that patients can accept prescriptions of drugs with full understanding.
[ Please refer to the following pages for the Effect/Indication comparison for the products, Glossary, Names of Defendants, and Photographs of Generic Products ]
Corporate Communications Department
Eisai Co., Ltd.
<Note to Editors>
1. Effect/Indication Comparison between Selbex and Generic Products
Definition of an “unfair competition act” (Item 1, Paragraph 1, Article 2 of the Unfair Competition Prevention Law)
3. Names of Defendants and Generic Products
(The companies for which the Court made a judgment on September 27th are underlined.)