Patentability of Genetically Engineered Microorganisms

BEFORE the development of genetic engineering technologies, it was questionable whether microorganisms that theoretically could be produced by application of such techniques would legally qualify for patent protection.

Section 101 of the Patent Act, 35 USC §101 (1976), authorizes the Commissioner of Patents and Trademarks to issue a patent to one who "invents or discovers any new and useful process... manufacture, or composition of matter." In Funk Brothers Seed Co v Kalo Inoculent Co, 333 US 127 (1948), the US Supreme Court had held that nonengineered microorganisms were "products of nature," and not subject to patent claims of one who "discovers" them as naturally occurring. Patents had been issued for the application of microorganisms to produce chemicals such as antibiotics and agents to remove environmental pollutants—uses patentable as "processes" within the terms of the Patent Act—but the US Patent and Trademark Office had rejected patent claims to the microorganisms themselves.