Nov 16, 2018

中外製薬が抗C5抗体ALXN1210(ravulizumab)を開発するアレクシオン社を特許侵害で提訴

2018年11月16日付の中外製薬プレスリリースによると、中外製薬は、2018年11月15日(米国現地時刻)、Alexion Pharmaceuticals, Inc.が開発中の抗C5抗体「ALXN1210」(ravulizumab)が、中外製薬が保有する抗体改変技術の一つである米国特許第9,890,377号に触れるとし、「ALXN1210」の米国における製造および販売を含む侵害差止めを求める訴えを米国デラウエア州連邦地裁に提起したとのことです。

一方、Alexionは、その2018年11月16日付のSEC filing Form 8-K Report of unscheduled material events or corporate eventによると、以下のとおり、中外の主張に対して反論していくとのことです。
On November 15, 2018, a complaint was filed against Alexion Pharmaceuticals, Inc. by Chugai Pharmaceutical Co., Ltd. in the U.S. District Court for Delaware alleging that ALXN1210 infringes a U.S. patent held by Chugai. We believe that we have valid legal defenses against Chugai’s infringement claims. Accordingly, we intend to oppose these claims and intend to proceed with our business plans for ALXN1210.

参考:
  • 中外製薬 press release: 2018.11.16 「当社抗体改変技術に関する米国における特許権侵害訴訟の提起について
  • 米国特許第9,890,377号 claim1: A method of removing an antigen from plasma, the method comprising:
    (a) identifying an individual in need of having an antigen removed from the individual's plasma;
    (b) providing an antibody that binds to the antigen through the antigen-binding domain of the antibody and has a KD(pH5.8)/KD(pH7.4) value, defined as the ratio of KD for the antigen at pH 5.8 and KD for the antigen at pH 7.4, of 2 to 10,000, when KD is determined using a surface plasmon resonance technique in which the antibody is immobilized, the antigen serves as analyte, and the following conditions are used: 10mM MES buffer, 0.05% polyoxyethylenesorbitan monolaurate, and 150mM NaCl at 37.degree. C.; and
    (c) administering the antibody to the individual, wherein the antibody binds to the antigen in plasma in vivo and dissociates from the bound antigen under conditions present in an endosome in vivo, and wherein the antibody is a human IgG or a humanized IgG.
  • Alexion SEC filing Form 8-K: 2018.11.15 Report of unscheduled material events or corporate event


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