Children learn that April showers bring May flowers. For farmers around the world, however, May flowers are affected by other factors as well, such as weather, disease, and insects. In 2008 (the last year that statistics were published), the United Nations’ Food and Agricultural Organization estimated that 13 percent of the world’s population – a full 850 million people – were undernourished.
Fortunately, scientists have created new generations of plants that are less vulnerable to these variables, decreasing the risks associated with farming. New seed varietals incorporate features such as drought and pest resistance, higher nutritional content, and higher crop yields. A 2010 article in the journal Nature Biotechnology compared 49 peer-reviewed studies reporting on farmer surveys from 12 countries both in the developing and the developed world, and concluded “74 percent of results comparing yields of biotech and conventional crops showed positive results for adopters of biotech technology versus non-adopters.”
Such innovation, however, comes at a price. A September 2011 study by CropLife International found that the cost of discovery, development and authorization of a new plant biotechnology trait is approximately $136 million, and it takes, on average, 13.1 years from conception to launch date. Just as pharmaceutical companies need patents so they can pay the cost of developing and bringing to market new drugs and other treatments, agricultural companies hope to recoup that substantial investment through seed patents. Having a clear patent process, as well as a clear process for what happens after a patent expires, is critical to continued development and progress in this vital field.
Yet the field of seed biotechnology is relatively new – so new, in fact, that the first U.S. seed patents issued aren’t even set to expire until 2014. As such, there isn’t a framework in place to address how agricultural researchers should transition their products to the generic market. With many seeds now incorporating multiple traits, it’s unclear what happens to seeds that contain some protected components and some generic components. Furthermore, how can – or should – newly generic traits be incorporated into future products? When generic traits are combined with other proprietary traits that have already been approved, does that necessitate a new regulatory approval process, or is it considered a natural extension of the already approved product? Nobody knows.