アメリカでは以前からビジネス方法特許に関してはPrior Use Defence、いわゆる先使用権が認められていましたが、今回の改正でプロセス・機械・生産物・組成物に係る特許にも先使用権が認められるようになりました。
ただし、この先使用権の抗弁をしようとする者は、有効出願日又は§102(b)の例外に該当する公表のうち早い方の１年以上前から米国において商業的に使用していることを立証する必要があります。
また、この立証は”clear and convincing evidence”という高い基準で立証する必要があります。
この改正事項は、2011年9月16日以降に発行された特許に対して適用されます。
§273 Defense to infringement based on prior commercial use
(a) IN GENERAL. A person shall be entitled to a defense under section 282(b) with respect to subject matter consisting of
a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if
(1) such person, acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm’s length sale or other arm’s length commercial transfer of a useful end result of such commercial use; and
(2) such commercial use occurred at least 1 year before the earlier of either
(A) the effective filing date of the claimed invention; or
(B) the date on which the claimed invention was disclosed to the public in a manner that qualified for the exception from prior art under section 102(b).
(b) BURDEN OF PROOF. A person asserting a defense under this section shall have the burden of establishing the defense by clear and convincing evidence.
…
(a) IN GENERAL. A person shall be entitled to a defense under section 282(b) with respect to subject matter consisting of
a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if
(1) such person, acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm’s length sale or other arm’s length commercial transfer of a useful end result of such commercial use; and
(2) such commercial use occurred at least 1 year before the earlier of either
(A) the effective filing date of the claimed invention; or
(B) the date on which the claimed invention was disclosed to the public in a manner that qualified for the exception from prior art under section 102(b).
(b) BURDEN OF PROOF. A person asserting a defense under this section shall have the burden of establishing the defense by clear and convincing evidence.
…
