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Gene patent practice across plant and human genomes

Gene patent practice across plant and human genomes

In human medicine, a successful new product or process can create a strong economic incentive to pay whatever it takes to be healthy, with the potential profit in conventional business models correspondingly very high. This huge value-capture opportunity is used to justify high-capital and high-risk innovation and investment, with corresponding patenting strategies.

The uses of genetic sequences to inform, enable or create products or services for human biomedicine are substantially different from their uses in crop-based agriculture.

For instance, inventions that enable the development of small-molecule pharmaceuticals that associate with protein or nucleotide targets (such as receptors) or of direct biological interventions such as vaccines, RNA or protein-based therapeutics are attractive and potentially lucrative commercial pursuits. Similarly, diagnostics that detect allelic variation in human genes or proteins or detect and discriminate between genetic variants of human pathogens or beneficials have high potential value.

In plant-based agriculture, however, the unit value of a single plant or even a cultivar is generally very low, and profit margins for most commodity crops are modest. With little new acreage to cultivate, and with so much of broad-acre crops already biotech enhanced, many markets are nearly saturated, and farmers simply cannot pay much more for next-generation technologies. With current business models, therefore, and such low-margin targets, the scope of patent claiming of new inventions may need to cover an entire variety, species, very broad-use cases or new functionalities that enable potential new crop uses or novel crop-management tools such as herbicides or insecticides.

For each of these uses, patenting of both nucleotide and amino acid sequences may be important but will be done with different strategies and economies in mind. We have previously described1 the scope and type of patenting that disclosed and/or claimed genetic sequences on the human genome. Here, we explore what similarities and differences may emerge in patent use and strategies, and map patent-disclosed sequences onto three important plant genomes: maize (corn), rice and soybean. We focus on those referenced in the granted patent claims to compare their uses to the approach used in human gene patenting.

Mapping biological sequences disclosed in patents using a 95% homology threshold shows 2.8 million patent sequences each for the maize and soybean genomes and 2.5 million on the rice genome, versus 31 million patent sequences mapped on the human genome as of 13 November 2014. We chose the 95% homology threshold to maximize the likelihood that allelic differences between a patent-disclosed sequence and a related canonical reference genome would not exclude the sequence as a likely homolog of that reference sequence.


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