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The Biotechnology Industry Organization (BIO) and the American Seed Trade Association (ASTA) announced today that the Generic Event Marketability and Access Agreement (GEMAA) is now effective… “It is imperative there be a transparent and predictable mechanism to maintain regulatory authorizations after patent expiration and to obtain any necessary, new authorizations in order to keep U.S. agriculture export markets open… To this end, the GEMAA creates a process that is based on binding contractual relationships so that regulatory and stewardship obligations are maintained.”
This agreement driven by the private sector and created within the framework referred to as The Accord was developed to address the transition of commercial biotechnology events as they go off patent… “The expiration of patents for biotechnology events not only creates opportunities for growers and the seed industry, but also creates challenges that must be addressed.. The most pressing challenge presented by patent expiration of biotechnology events is the maintenance of global regulatory authorizations for these events as well as associated stewardship obligations so that farmers can continue to cultivate their crops grown from seed varieties containing off-patent events without jeopardizing U.S. export markets. The GEMAA is now effective and addresses this challenge.”
Under the GEMAA section of the Accord, signatories to the agreement that have developed proprietary regulatory information to support the authorizations for events globally would be required to provide notice of patent expiration three years before the last patent on the biotechnology event expires and provide access to the generic event at patent expiration. Additionally, the regulatory data owner must elect to either maintain regulatory responsibility on its own for the whole marketplace for at least four years after the last sale of the product, or share or transition this responsibility with other users. If no interest is expressed by other signatories, the owner could discontinue the event…