Why are genetically engineered crops considered “substantially equivalent” to conventional crops at the FDA yet “markedly different” at the U.S. patent office? It seems they cut both ways depending on which government office you are standing in (if you represent a biotechnology company, that is).
If the same rules were applied by the FDA to approve Genetically Modified Orgnaisms (GMOs) as the U.S. Patent Office uses, the FDA approval would be revoked until a full, independent formal review of safety is undertaken.
Genetically engineered (GE) crops intended for food are able to be lawfully marketed today without having been formally reviewed by the FDA and without being the subject of a food additive regulation. Genetically engineered crops have been approved with no formal pre-market review by the FDA to assure their safety “because the nature of the substance and the information generally available to scientists about the substance are such that the substance simply does not raise a safety concern worthy of premarket review by FDA.”
The FDA has ruled that “In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food ... With respect to transferred genetic material (nucleic acids), generally FDA does not anticipate that transferred genetic material would itself be subject to food additive regulation. Nucleic acids are present in the cells of every living organism, including every plant and animal used for food by humans or animals, and do not raise a safety concern as a component of food. In regulatory terms, such material is presumed to be GRAS [generally recognized as safe].” [emphasis added]
Yet the biotechnology companies have obtained patents on their GE seeds on the basis that they are novel and non-natural with “markedly different characteristics from any found in nature!”
It is illegal for the U.S. Patent Office to grant a patent for naturally occurring substances. Title 35 of the United States Code, section 101 (35 U.S.C. 101) explicitly forbids patents on natural phenomena, including living organisms. In 1980 the Supreme Court “held that microorganisms produced by genetic engineering are not excluded from patent protection by 35 U.S.C. 101. It is clear from the Supreme Court decision and opinion that the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability. The test set down by the Court for patentable subject matter in this area is whether the living matter is the result of human intervention.”
“Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions. Here, respondent’s microorganism is the result of human ingenuity and research. Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” [emphasis added]
Thus a plant found in the wild is not patentable, but a non-naturally occurring plant is. In order for a genetically engineered seed to be patentable, it must conform to the definition of novelty as set forth in 35 U.S.C. 102 and non-obvious as set forth in 35 U.S.C. 103(b), “ a process of genetically altering or
otherwise inducing a single- or multi-celled organism to
express an exogenous nucleotide sequence,
inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
express a specific physiological characteristic not naturally associated with said organism ” [emphasis added]
If, according to the patent laws, GMOs are non-natural and “markedly different” from natural food plants, then how is it that the FDA can rubber stamp them without formal review because they are substantially similar to natural food? Why are the biotechnology companies subject to different rules depending on which government agency is making the determination?