Page:United States Statutes at Large Volume 109 Part 1.djvu/367

 PUBLIC LAW 104-41 —NOV. 1, 1995 109 STAT. 351 Public Law 104-41 104th Congress
 * AnAct

, To amend title 35, United States Code, with respect to patents on biotechnological Nov. 1, 1995 processes. [g mi] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. BIOTECHNOLOGICAL PROCESS PATENTS; CONDITIONS FOR PATENTABILITY; NONOBVIOUS SUBJECT MATTER. Section 103 of title 35, United States Code, is amended— (1) by designating the first paragraph as subsection (a); (2) by designating the second paragraph as subsection (c); and (3) by inserting after the first paragraph the following: "(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— "(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 "(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. "(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. "(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). ".

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