April 10 2012
Nicole Kurokawa Neily
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.
Unsurprisingly, this uncertainty poses a danger to the industry’s vitality. Today, farmers can choose from a number of seed types to determine the mix of traits that work best for their specific situations – but in the future, will there be more choices, or fewer? Will new seeds be brought to market, or will regulatory burdens slow the process? And will companies continue to innovate, creating new traits, or will they find their profit margins too narrow to merit further research and development?
It’s crucial that we establish a clear framework for using these seed traits after their patents expire – not only for American farmers and seed companies, but also for the world’s farmers and consumers. As the Nature Biotechnology article notes, “The benefits (of genetically modified crops), especially in terms of increased yields, are greatest for the mostly small farmers in developing countries, who have benefitted from the spillover of technologies originally targeted at farmers in industrialized countries.” At a February 2012 USDA conference, seven former U.S. secretaries of agriculture unanimously agreed that feeding the world’s growing population is a challenge that must be addressed.
America’s farmers feed the world, thanks to a combination of hard work and a broad array of innovative products at their disposal. Clearly defining the rules governing seed patents will help make sure that farmers everywhere will have even more products and seed types to use in the future so that there is enough available for people around the globe.