BIO and ASTA Announce That GEMAA Is Now Effective

by McDonnell Boehnen Hulbert & Berghoff LLP
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[author: Donald Zuhn]

ASTAThe Biotechnology Industry Organization (BIO) and American Seed Trade Association (ASTA) announced today that the Generic Event Marketability and Access Agreement (GEMAA) has received four signatories, and as a result is now effective.  The GEMAA is one of two agreements -- the Data Use and Compensation Agreement (DUCA) being the other -- that form the Accord, a private-sector driven framework for dealing with the transition of regulatory and stewardship responsibilities for genetically modified seed technology (i.e., seed varieties containing "biotechnology events"), after patent expiration.  The GEMAA, which was launched late last month, has thus far been signed by five agricultural biotech companies:  BASF Plant Science, Bayer Crop Science, Dow Agro Sciences, DuPont Pioneer, and Monsanto Company.

Biotechnology Industry Organization (BIO)According to BIO's statement on the GEMAA taking effect, the agreement "will provide confidence to growers, breeders and grain handlers in the use of generic biotechnology events [and] benefit the entire agriculture value chain by ensuring the maintenance of foreign regulatory authorizations and stewardship obligations following the expiration of patents for biotechnology events utilized in seed varieties."  The Accord website (www.AgAccord.org) notes that nearly 90% of cotton, corn, and soybean acreage in the U.S. is planted with seed varieties containing biotechnology events, and that grain from these crops accounts for more than $40 billion in global trading annually, making the U.S. the largest global producer and exporter of crops and grain derived from biotechnology.  With the first genetically modified seed patents set to go off patent by 2015, such patent expirations present challenges such as the maintenance of global regulatory authorizations for biotechnology events and associated stewardship obligations so that farmers can continue to cultivate seed varieties containing off-patent events without jeopardizing U.S. export markets.

Under the GEMAA, companies that have developed proprietary regulatory information to support the global authorizations for biotechnology events (known as Proprietary Regulatory Property (PRP) Holders under the agreement) will provide notice of patent expiration three years before the last patent on the biotechnology event expires, provide access to the biotechnology event at patent expiration, and opt for one of three choices with respect to regulatory responsibility.  Those choices include Independently maintaining regulatory responsibility for the event at no cost to users of the generic event for at least four years after the last sale of the product, seeking to share regulatory responsibility, or discontinuing regulatory responsibility (If no interest is expressed by other signatories).

The GEMAA will be overseen by a Committee of Signatories that will be formed, and will hold its first meeting, within three months.

Additional information regarding the Accord can be found here.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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