Senator Thom Tillis (R-NC)が、Patent Eligibility Restoration Act of 2022という特許法101条適格性に関連する改正案を議会に提出したそうです。
The-Patent-Eligibility-Restoration-Act-of-2022.pdf (gjassets.com)
改正案ですが、まず100条の定義の"process"に、known or naturally-occurring processも含むことが明記されました。Ariosa事件やCareDx事件のように、known or naturally-occurring processを適用した場合の101条適格性が否定される事件が多く起きていることから有効かもしれません。
また、"usuful"にもa specific and practical utilityの限定が入っています。
§ 100. Definitions
* * *
(b) The term "process" means process, art or method, and includes a new use of a known process, includes a use, application, or method of manufacture of a known or naturally-occurring process, machine, manufacture, composition of matter, or material.
* * *
(k) The term 'useful' means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.
101条に移ると、101条(b)(1)で数式、必修飾の遺伝子、必修飾の天然物等が適格性がないものとして挙げられています。特に、(b)(i)(B)(i)で非技術的なものは101条適格性がないとされていますが、こちらは欧州のCOMVIKアプローチのような適用が今後されないか不安が残るかもしれないですね。
一方、101条(b)(2)では、ヒト遺伝子または天然材料のうち、人間の活動によって単離、精製、濃縮またはその他の改変がなされたもの等は101条適格性が認められることが明記されています。これはMyriad事件等で生じた問題を解決できるものかもしれません。
§ 101. Patent eligibility
(a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in section (b) and to the further conditions and requirements of this title.
(b) ELIGIBILITY EXCLUSIONS.—
(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:
(A) A mathematical formula, apart from a useful invention or discovery.
(B) A process that—
(i) is a non-technological economic, financial, business, social, cultural, or artistic process;
(ii) is a mental process performed solely in the human mind; or
(iii) occurs in nature wholly independent of, and prior to, any human activity.
(C) An unmodified human gene, as that gene exists in the human body.
(D) An unmodified natural material, as that material exists in nature.
(2) CONDITIONS.—
(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform.
(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified.
101条の判断にあたっては、(c)(1)(A)でクレーム全体を考慮、(c)(1)(B)で、クレームがknown, conventional, routine, or naturally occurringであることや、consideration in section 102, 103, or 112はしないなどと明記されていることは、よいことかもしれないですね。
その他訴訟における検討の仕方も法文化されているそうです。
(c) ELIGIBILITY.—
(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—
(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and
(B) without regard to—
(i) the manner in which the claimed invention was made;
(ii) whether a claim element is known, conventional, routine, or naturally occurring;
(iii) the state of the applicable art, as of the date on which the claimed invention is invented; or
(iv) any other consideration in section 102, 103, or 112.
(2) INFRINGEMENT ACTION.—
(A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact.
(B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.
