Policy must be in place when biotech patents expire
By Jean Caspers-Simmet
simmet@agrinews.com
Date Modified: 04/08/2010 9:03 AM
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ANKENY, Iowa —A panel of farming, seed industry and legal experts looked at what policy should be in place when Roundup Ready and other biotech traits begin going off patent in 2015 at the recent Department of Justice/USDA workshop on market competition in agriculture in Ankeny.
"it really comes to be the uncertainty in the market, the uncertainty in license agreements, the uncertainty in the breeder's ability to continue to use Roundup Ready lines," said Corning farmer Ray Gaesser. "We're concerned whether registrations for the Roundup Ready 1 will continue around the world. Who will be in charge of that?"
Jim Tobin, vice president of industry affairs for Monsanto Company, said Monsanto registers the Roundup Ready trait with more than 40 countries. A registration package, which includes about 50 reports and is about a foot and a half high, is involved and expensive.
When Roundup Ready goes off patent for the 2015 crop, if someone licenses from Monsanto, the company will maintain the regulatory packages needed around the world for at least three years, or until the end of 2017, Tobin said.
"Beyond that, Monsanto has put a proposal together and provided it to the bioindustry organization where trait developers work on stewardship policies and said, 'If you want to use this, we'll make it available. If you can pay the cost of registration, share that cost, we'll continue that as long as you want us to do it,' " Tobin said. "We think an industry approach is an appropriate way to go but we're open to a lot of ideas and approaches to make sure that farmers get to use this."
Diana Moss, vice president and senior fellow with the American Antitrust Institute, said that when Roundup Ready 1 goes off patent, it will be the first opportunity to have competition in biotech seed, and that's a big thing.
"The window has to open long before 2015 because pipelines take a number of years to populate with new products," Moss said. "Rival biotech developers need to get access long before the patent expires."
If the right set of policies isn't in place, generic competition is in jeopardy, and seed companies and consumers will suffer.
"We all deserve to benefit from generic competition," Moss said.
Monsanto needs to do more to make data available and the registration extension needs to be longer than three years. She supports a generic biotech seed organization, much like the generic pharmaceutical association to work on these issues.
Neil Harl, Charles F. Curtiss distinguished professor in agriculture and emeritus professor of economics at Iowa State University, said regulatory action is needed.
"I think there should be a process by which the best minds pull together, but I think it really needs the enforcement power of government," Harl said.
Dermot Hayes, an ISU economist, said a third party institution needs to accept the offer from Monsanto to take the data and start a five-year registration process.
"If anything good comes out of this whole conference, it would be that third-party institution," Hayes said. "Monsanto has made a pretty generous offer. I think it's time to move."
"Time is of the essence if we want to have the ability to use Roundup Ready generically in the United States and around the world," said Gaesser.