JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
Tablets”). The generic name of Sprycel® Tablets is dasatinib hydrate. Additional PTEs for the Patent were granted for a peri ‑ od of three years, nine months and 15 days based on the partial change approvals of the marketing authori ‑ sation for Sprycel® Tablets. Sawai Pharmaceutical Co., Ltd. (“Sawai”) obtained marketing authorisation for a generic version of Spry ‑ cel® Tablets (“Sawai’s Product”) on 15 February 2022 and began sales on 17 June 2022. On 4 October 2023, Sawai obtained partial change approval of the market ‑ ing authorisation for Sawai’s Product to add “chronic myeloid leukemia” to its indication and usage. Accord ‑ ingly, Sawai updated the description in the package insert and started selling Sawai’s Product with indica ‑ tion and usage for chronic myeloid leukemia. Sawai filed a lawsuit against BMS seeking a declara ‑ tory judgment determining that BMS does not have the right to seek an injunction against Sawai regarding Sawai’s Product or to seek compensation for dam ‑ ages. In response, BMS filed a counterclaim against Sawai seeking compensation for damages allegedly caused by Sawai’s patent infringement, arguing that Sawai’s Product falls within the technical scope of the invention recited in Claim 9 of the Patent (“the Invention”) and that the scope of the Patent during its extended term covers Sawai’s Product. Since the parties do not dispute the fact that Sawai’s Product comprises a compound falling within the technical scope of the Invention, the key issue in dis ‑ pute was whether the scope of the Patent during its The court determined that the scope of the Patent during its extended term did not cover Sawai’s Prod ‑ uct and dismissed BMS’s claim. Criteria of Article 68-2 of the Patent Act The court interpreted Article 68-2 of the Patent Act generally in the same manner as the IPHC’s interpre ‑ tation in Debiopharm Case. The court stated that the scope of a patent during its extended term covers not only the “product” (drug) specified by the “ingre ‑ extended term covers Sawai’s Product. Judgment of the Tokyo District Court
dients, quantity, dosage, administration, indication and usage” stipulated in the marketing authorisation but also those that are substantially identical to it as pharmaceuticals. The court further stated that, even when the allegedly infringing drug differs from the configuration set out in the marketing authorisation, if such differences are merely minor or insignificant as a whole, the drug is considered substantially identical to the drug subject to the marketing authorisation. The court then ruled that, in cases where the patent invention is characterised solely by the active ingredi ‑ ent of a drug, and where some inactive ingredients are added or modified using techniques that were well- known and conventional at the time of the marketing authorisation application, such differences are regard ‑ ed as “minor or insignificant as a whole”. Accordingly, the allegedly infringing drug is considered to be sub ‑ stantially identical to the drug subject to the marketing authorisation as a pharmaceutical. Application of the criteria to the facts In summary, the following facts were found by the court: • the Invention is a patented invention characterised solely by the active ingredient of a drug; • while the active ingredient of Sprycel® Tablets is dasatinib hydrate, that of Sawai’s Product is dasat ‑ inib anhydride; and • while polyethylene glycol (PEG) 400 is used as an excipient in Sprycel® Tablets, it is not contained in Sawai’s Product; instead, carnauba wax is used as a coating agent. The Court also made detailed findings on various tests conducted by Sawai. Based on those findings, the Court further found that: • Sprycel® Tablets, containing dasatinib hydrate as the active ingredient, appear to use PEG as an excipient to suppress the formation of decomposi ‑ tion products in the coating agent during stability testing. In contrast, Sawai’s Product, contain ‑ ing dasatinib anhydride – a substance inferior to dasatinib hydrate with regard to hygroscopicity and
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