Seagen社(旧Seattle Genetics社)の2020年10月30日付Quarterly Report(10-Q)によると、Seagen社は、第一三共による米国でのエンハーツ(ENHERTU)の販売等行為が、Seagen社が保有する米国特許10,808,039を侵害していると主張して、テキサス州東部地区連邦地方裁判所に提訴したとのことです。
Separately from the on-going arbitration against Daiichi Sankyo described above, on October 19, 2020, we filed a complaint in the United States District Court for the Eastern District of Texas to commence an action for infringement of our U.S. Patent No. 10,808,039, or the ‘039 Patent, by Daiichi Sankyo’s importation into, offer for sale, sale, and use in the United States of ENHERTU. This action is seeking, among other remedies, a judgment that Daiichi Sankyo infringed one or more valid and enforceable claims of the ‘039 Patent, monetary damages and a running royalty.(Seagen社2020年10月30日付Quarterly Report(10-Q)より)
米国特許10,808,039はADC(antibody-drug conjugate)に関する特許であり、2020年10月20日に登録されたばかりです。
第一三共は、2020年10月30日に開催されたカンファレンスコール/2020年度第2四半期決算説明会のQ&Aセッションにおいて、第一三共としては同特許の成立性について疑問を持っており、成立したとしても第一三共は侵害していないとの考えを示しました(経営説明会オンデマンド配信)。
ところで、上記訴訟と並行して、Seagen社と第一三共との間では、ADC技術の帰属を巡って訴訟または仲裁が進行中です。
We are engaged in a dispute with Daiichi Sankyo Co. Ltd., or Daiichi Sankyo, regarding the ownership of certain technology used by Daiichi Sankyo in its metastatic breast cancer drug ENHERTU and certain product candidates. We believe that the linker and other ADC technology used in ENHERTU and these drug candidates are improvements to our ADC technology, the ownership of which we contend was assigned to us under the terms of a 2008 collaboration agreement between us and Daiichi Sankyo. On November 4, 2019, Daiichi Sankyo filed a declaratory judgment action in the United States District Court for the District of Delaware, alleging that we are not entitled to the intellectual property rights under dispute, in an attempt to have the case heard in federal court. On November 12, 2019, we submitted an arbitration demand to the American Arbitration Association seeking, among other remedies, a declaration that we are the owner of the intellectual property rights under dispute, monetary damages, and a running royalty. On March 25, 2020, a District of Delaware magistrate judge issued a stay of Daiichi Sankyo’s court action pending determination by the arbitrator of whether the suit should be heard in court or arbitration. On April 8, 2020, Daiichi Sankyo filed objections to the magistrate judge’s order. On October 27, 2020, the presiding District Court Judge overruled Daiichi Sankyo’s objections and affirmed the magistrate judge’s stay of the Daiichi Sankyo court action. On April 27, 2020, the arbitrator confirmed the dispute should be resolved in arbitration and that the arbitration process should progress.(Seagen社2020年10月30日付Quarterly Report(10-Q)より)
以下過去関連記事「第一三共がADC技術の帰属を巡り訴訟提起」(2019.11.05):
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