Abstract
More than 20 years ago, the first genetically modified (GM) plants entered the seed market. The patents covering the first GM plants have begun to expire and these can now be considered as Off-Patent Events. Here we describe the challenges that will be faced by a Secondary Party by further use and development of these Off-Patent Events. Indeed, the conditions for Off-Patent Events are not available yet to form the basis for a new viable industry similar to the generic manufacturers of agrochemicals or pharmaceutical products, primarily because of (i) unharmonized global regulatory requirements for GM organisms, (ii) inaccessibility of regulatory submissions and data, and (iii) potential difficulties to obtain seeds and genetic material of the unique genotypes used to generate regulatory data. We propose certain adaptations by comparing what has been done in the agrochemical and pharmaceutical markets to facilitate the development of generics. Finally, we present opportunities that still exist for further development of Off-Patent Events in collaboration with Proprietary Regulatory Property Holders in emerging markets, provided (i) various countries approve these events without additional regulatory burdens (i.e., acceptance of the concept of data transportability), and (ii) local breeders agree to meet product stewardship requirements.
Highlights
The first genetically modified (GM) plants were produced early in the 1980s by means of Agrobacterium tumefaciens as a vector to introduce a new gene into the plant as a trait of interest (Bevan et al, 1983; Herrera-Estrella et al, 1983)
We discuss the difficulties faced by any potential Secondary Party who wishes to use or further develop these Off-Patent Events, among which are (i) lack of harmonization of the global regulatory requirements for GM crops, (ii) limited accessibility to regulatory submissions and data, and (iii) potential obstacles to obtain material of the unique Event upon which the regulatory dossier was created. Notwithstanding this problematic context, we present existing opportunities to further develop Off-Patent Event plants in collaboration with PRP Holders in new markets, provided that the concept of data transportability becomes widely accepted and that the product stewardship and the regulatory requirements are observed by all users at the global level
At the time an Event becomes Off-Patent in the major agricultural markets, the PRP Holder will have developed a global data package and obtained approvals for commercialization in countries in which the GM crop is intended for cultivation and for export in countries in which the harvested Eventcontaining plants, parts or GM plant-derived products will be imported
Summary
More than 20 years ago, the first genetically modified (GM) plants entered the seed market. The conditions for Off-Patent Events are not available yet to form the basis for a new viable industry similar to the generic manufacturers of agrochemicals or pharmaceutical products, primarily because of (i) unharmonized global regulatory requirements for GM organisms, (ii) inaccessibility of regulatory submissions and data, and (iii) potential difficulties to obtain seeds and genetic material of the unique genotypes used to generate regulatory data. We present opportunities that still exist for further development of Off-Patent Events in collaboration with Proprietary Regulatory Property Holders in emerging markets, provided (i) various countries approve these events without additional regulatory burdens (i.e., acceptance of the concept of data transportability), and (ii) local breeders agree to meet product stewardship requirements
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