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The legal scope of biotechnology is reflected in the "biotechnological process" and the Biotechnology Patent Process Protection Act. The biotechnological process, in short, is a procedure or process of genetic alteration.

Biotechnology Patent Process Protection Act, is a 1995 Federal Statute that made biotechnological processes per se patentable if either the process or the resulting material is novel and non obvious. It is considered non obvious if

• 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

• 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.

"Biotechnological process" means 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 [35 USCS § 103].