I just don't see how United States patent law allows researchers to patent naturally-occurring gene sequences. 35 U.S.C. 102 requires the thing to be patented, here the gene sequence, to be novel - so a genetically-engineered or altered gene can be patented because it is novel, but something which is naturally occurring isn't novel. You can't patent air or sunshine or water. How can you patent something that every human has in their DNA?
The relevant definition from 35 U.S.C.A. õ 103(b) (West Supp. 1997).
(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).
|
