美國專利法第103(b)條

此段規定，主要是講說如果生物科技(biotechnology)方面的專利如果符合102的規定，應可核准，不受103(a)的阻礙

Sec. 103. - Conditions for patentability; non-obvious subject matter
(b)
(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if -

(b)(1)儘管有103(a)進步性的核駁理由，但適時使用此條103(b)，符合以下情況，使用或是基於符合102新穎性規定的生物科技的程序仍會被認為非顯而易見─

(A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and
包含於相同申請案(the same application)或是不同申請案但有相同有效申請日(separate application having the same effective filing date)的程序與物質成分申請範圍

(B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.
在此程序或是物質成分發明當下由同人擁有(owned by the same person)或是有義務讓與給相同人(obligation of assignment to the same person)
在相同日期的申請案或是同人發明案的生物科技，若有新穎性，雖有103(a)的規定，仍可為非顯而易知

(2) A patent issued on a process under paragraph (1) -

(A) shall also contain the claims to the composition of matter used in or made by that process, or
(B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.

(b)(2)在(b)(1)的規定下的領證專利應包括使用或是於該程序製作的物質成分，或是若有該物質成分在其他專利的請求範圍，專利期限應於同一天到期

(3) For purposes of paragraph (1), the term ''biotechnological process'' means -

(A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to -
(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
(iii) express a specific physiological characteristic not naturally associated with said organism;

(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

(b)(3)上述"biotechnological process"意指
(A)基因改變或是包括單細胞或多細胞的有機體，如(i)(ii)(iii)所述
(B)生產繁殖的程序
(C)由(A)或(B)，或其組合的程序產生的產品的使用方法

Ron