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Patent eligible Laboratory methods
| July 13, 2016
Rapid Litigation Management Ltd. v. CellzDirect, Inc.
July 5, 2016
Before Prost, Moore and Stoll. Opinion by Prost.
Summary
Patented claims at issue were directed to a method of producing a desired preparation of hepatocytes (liver cells) useful for laboratory tests such as drug safety tests. The claimed process was invented based on the discovery that liver cells are capable of surviving multiple freeze-thaw cycles, which provides desired pool samples of hepatocytes from multiple donners. The district court held that the claims were invalid under 35 U.S.C. §101. CAFC vacated the decision, holding that the claimed process is not directed to a patent-ineligible concept.
ドラッグテスト等に有用な肝細胞プールを調製する方法を記載した特許クレームが、101条の特許対象要件を満たすか否かを争われたケースである。従来は、肝細胞の冷凍保存は1回が限度であると認識されていた（一度解凍したら使い捨てとなる）。しかし、本件発明者は肝細胞を複数回冷凍保存しても使用できることを発見し、少なくとも2回の冷凍－解凍の工程を記した方法に特許を受けた。複数回の冷凍-解凍を繰り返せること利用して、異なるドナーからの肝細胞プールを無駄なく適宜に調製できるという利点がある。
近年最高裁判決の下、自然法則または自然現象を優位に超える特徴をクレームに記載しなければ特許対象にはならない。地裁は肝細胞が冷凍保存可能であることはその細胞の自然能力の発揮にすぎず、本特許の方法は自然法則の利用を優位に超える特徴を記載していないとして同特許を無効にした。高裁はその地裁判決を破棄し、従来の知見反して肝細胞の冷凍を2回以上繰り返す工程を記載した本特許の方法は従来の方法にはない利点があるから特許可能対象であると判示した。複数回の冷凍保存を行うことができるという科学的発見に基づくシンプルな発明コンセプトであるが、新規で有用な結果をもたらす方法は特許対象になりえることが示された。このケースは発見を利用する発明を新規な「方法」として記載することで特許対象になり得ることを示しているが、その肝細胞を「プロダクト」としてクレームした場合は自然物の寄せ集めであり特許対象になりえないことも示唆された（Funk Bros判決参照）。一方で、101条の特許対象要件の判断において従来技術との対比が重要な意味を持ち得ることを示した判決でもある。
Category: Case Summary
Tags: laboratory technique > law of nature > method claims > patent eligibility
Tags: laboratory technique > law of nature > method claims > patent eligibility
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