Timelines: 1991

A patenting controversy

J. Craig Venter and colleagues at the National Institute of Neurological Disorders and Stroke introduce the expressed sequence tag (EST) method for identifying active genes. ESTs are DNA sequences that have been upregulated and expressed in cells. They may be useful for diagnostic purposes – they may serve as beacons to medical researchers and drug developers attempting to navigate through genomic and cellular mazes toward therapeutic targets.

Venter begins to file patent applications on the tags, on behalf of NIH, even though the functions of the genes are mostly unknown, the precise utility of the inventions can be only vaguely comprehended, and the proprietary status of protein-encoding sequences indicated by the markers is unclear. The practice is controversial. Bruce Alberts, President of the National Academy, says disparagingly: “It involves very little effort and almost no originality.” David Botstein, Chairman of the Stanford University Genetics Department and former Scientific Director at Genentech, worries that EST patents may discourage innovation across broad areas of biomedical research. “It is dangerous,” he says, “to go into a situation where you have these potential blocking patents hanging over you.” Proponents of EST patenting insist that ESTs are useful as biochemical probes and tools for research.

The U.S. Patent Trademark Office (USPTO) grants the first EST patents in 1997, but in 2001, issues new 'Utility Examination Guidelines.' On the basis of the revised standard, the reviewers begin to reject applications filed on ESTs that mark genes of unknown function.  Scientists at Monsanto appeal such a rejection in Federal Court, but a 2005 decision goes against the group. The NIH has abandoned its EST patents.