The Most Difficult Definition: Considerations for Defining “Genetically Modified Organism"

August 17, 2017
Post by Blog Staff

A patent applicant is free to act as their own lexicographer in drafting an application and may define terms as they see fit. Should a word not be defined explicitly in the application, the Patent Office will then give the term “the broadest reasonable interpretation according to a person having ordinary skill in the art” -- they will broadly define the word as someone of equal training in the field would. When it comes to GMOs, however, defining such terms in the application is complicated by marketing and regulatory considerations, particularly when “Non-GMO” or “Made with Genetic Engineering” is now required by Vermont law.

Two regulatory bodies oversee safety and labeling of such consumer products—the Department of Agriculture (USDA) and the Food and Drug Administration (FDA). The USDA uses the following definitions to make a clear distinction between genetically engineered and genetically modified:

Genetic engineering: Manipulation of an organism's genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.

Genetic modification: The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.

Similarly, the FDA currently considers “genetic engineering” to be a more precise term referring to techniques utilizing modern biotechnology, whereas “modification” can occur naturally without human interaction. However, the scope of the FDA definition could be changing as the comment period for use of genome editing in plants intended for food closed on June 20, 2017. In particular, the FDA sought data/information to determine whether new genome editing techniques present the same or new food safety risks from other plant development methods (e.g., hybridization, chemical or radiation-induced mutagenesis, non-targeted genetic modification, etc.).  It should be noted the FDA has routinely found such plant development methods to be safe for human consumption. In reviewing comments submitted by the Crop Science Society of America, the National Corn Growers, and others, the consensus seems to indicate there are no adverse risks associated with these new technologies. Final guidelines on this issue are expected to be published in 2018.

Patent applicants should be aware of these and other possible definition changes and consider how these changes may impact terms defined in the patent application from a marketing and regulatory perspective. Considering this during the drafting stages of application can help lead to cohesive marketing and regulatory strategy.

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