By Matt Reese
It will not be long before the first Roundup Ready soybeans will lose patent protection in 2014 and farmers will need to remember a few things when that happens.
“That is the first technology trait that is coming off patent, but it is not the last. One thing soybean farmers need to realize is that they are buying a technology trait and they are also likely buying a genetic trait. Those are controlled by separate patents,” said Rob Joslin, with the American Soybean Association. “They may not be able to keep the seed in 2015 even though the patent has expired. They need to be aware of that and check with their seed provider if they are going to keep seed back.”
And, more importantly, it will be important that, as seed transitions from patented to generic, the proper registrations remain in place for export.
“People need to be aware that the overseas registration needs to be maintained,” Joslin said. “Monsanto has voluntary agreed to maintain and oversee this for several years, but we need to make sure we maintain this so we continue to have the ability to export our soybeans overseas. There is a lot of complexity to the issue.”
As more patents expire, there will be more challenges along these lines.
“This creates a challenge for the industry,” said Bernice Slutsky, American Seed Trade Association (ASTA) vice president of science and international affairs. “Even though an event comes off patent here in the United States, it’s still highly regulated around the world.”
Moving forward, there is a need for a mechanism to ensure that international regulatory approvals and proper product stewardship are maintained so that U.S. commodity exports are not impeded. Working closely with its stakeholders, ASTA and the Biotechnology Industry Organization (BIO) decided to take a proactive approach to help address this challenge. The two organizations put together a joint working group comprised of seed companies big and small, trait providers and those who license traits. Stakeholders such as the North American Export Grain Association and American Soybean Association have regularly been invited to provide input to ensure their concerns could be addressed.
“While there is an immediate need to develop a framework to enable a clear and predictable transition to generics, the U.S. value chain needs a long-term and sustainable solution and we wanted to make sure everyone was on board with our efforts,” said Matt O’Mara, BIO Food and Agriculture Section director of international affairs.
A framework called the Accord Agreement is being developed to create a smooth transition from proprietary events to generic events in the seed industry.
“Our main goal is to make sure we protect the entire value chain from trade disruptions,” O’Mara said. “In addition, we needed to provide a clear path forward for the transition from proprietary to generic events, provide business opportunities and support innovation, which includes protecting intellectual property rights and providing fair compensation for intellectual property. The Accord Agreement is intended to cast a wide net to allow stakeholders to become signatories. Once a Signatory, stakeholders will be able to engage in a process with a series of steps and with each step comes increased responsibility.”
A few key elements of the Accord Agreement are:
• It is a contractually binding process.
• It is voluntary and open to any entity to become a signatory.
• There is increasing responsibility dependent on whether the Accord signatory has a patented biotech event or intends to commercially utilize the event once its patent expires.
“The Accord Agreement provides transparency, predictability and all parties know what is expected,” Slutsky said. “For seed companies, it provides a clear means for them to take advantage of commercial opportunities of off-patent biotech traits while ensuring domestic and international regulatory approvals are maintained. For farmers, this means that access to international markets will be unchanged, keeping trade doors open and helping to increase profitability for you, while creating economic activity in rural communities across the country.”