Japan: Argument With Emphasis On "Particular" Combination Of Salts Invoked Prosecution History Estoppel

Last Updated: 20 August 2019
Article by Yuki Onoe

「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言(審査経過に基づくエストッペル)が適用された事例

出願審査において拒絶理由に応答する際には、そのクレーム補正や反論内容が、後で特許権利行使に不利に働かないよう注意する必要があります。クレーム範囲を狭める補正を行ったり限定解釈につながるような反論を行ったりしたことが原因で、特許権利からある内容を放棄したとみなされてしまう場合があるからです。出願人が審査中に放棄したとみなされる内容に関して特許後に均等論侵害を主張することは出願人自身の先の言動に反し、禁反言が適用されて侵害主張が認められないことになります。

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993 (Fed. Cir. July 29, 2019)において、Amgenのクレーム中の「特定の」塩の組み合わせについて何度も繰り返し強調して反論を行ったことで、他の塩の組み合わせを明確に間違いなく放棄(clear and unmistakable surrender)したと言えるかが争点となりました。Amgenは蛋白質をクロマトグラフィで精製する方法をクレームしており、バッファに使用する特定の塩の組み合わせをクレームに記載していましたが、地裁、CAFC共に、審査中の反論により他の塩の組み合わせを放棄したと判断し、均等論侵害の主張を認めませんでした。

CAFC判決は以下の点に言及しており、Amgenにとって不利な事実となりました。

- 「特定の(particular)」を強調して、その特定の塩に繰り返し(2頁に渡って3回)言及して引例との差異を主張した。

-          応答書と共に提出した宣誓書においてその特定の塩の組み合わせに言及し、その組み合わせに起因する効果を主張した。

-          応答書において宣誓書を引用し、”[u]se of this particular combination of salts greatly improves the cost-effectiveness of commercial manufacturing …”と述べた。

Amgenは下記主張を行いましたが、いずれも認められませんでした。

-          反論の際に引例と区別できる理由を複数挙げており、他の理由で差異を主張した。引例に「特定の」塩の組み合わせの開示が無いという事は事実として述べたにすぎないから、他の塩の組み合わせを明確に間違いなく放棄したとは言えない。

-          包袋禁反言が適用するか否か判断する際、許可通知を受ける前の最後の応答書に書かれた反論内容に焦点を絞って分析すべきである。本件の許可通知を受ける前に提出した応答書では、特定の塩の組み合わせが非開示であるという議論を再度行わなかったため、エストッペルは適用されない。

CAFCは、反論として複数の主張を行った場合、各主張の内容に関してエストッペルが適用する可能性があるという判例を挙げて、Amgenの上記の主張を退けました。 PODS, Inc. v. Porta Star, Inc., 484 F.3d 1359, 1367 (Fed. Cir. 2007). また、許可通知前に他の論点で反論していたとしてもその前の主張が消えるわけではないと述べ、許可を得るために必要な反論であったかどうかに関わらず、明確な主張にはエストッペル適用可であるとしました。 PODS, 484 F.3d at 1368.

本件事例に見られるように反論内容を繰り返し述べることは必ずしも良い結果をもたらすわけではなく、クレームで明確に差異を「見せる」ことに注力する方がより効果的と考えます。

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