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Democritus_of_Abdera

12/06/09 11:06 AM

#62 RE: DewDiligence #61

Re: Delayed release of Optimum GAT...

This is a second major disappointment for Pioneer Hi-Bred's Optimum GAT.... Earlier this year, DuPont implied that the GAT technology did not meet their efficacy expectations for glyphosate tolerance when they decided to stack GAT on Roundup Ready... This plan led to the patent dispute with Monsanto that is currently in the courts. See: http://www.monsanto.com/dupontlawsuit/timeline.asp for a concise timeline of DuPont PRs related to Optimum GAT and Monsanto’s complaint regarding this use of Roundup Ready trait.

As background: Optimum GAT bundles DuPont’s glyphosate tolerance trait with the ALS trait. ALS (acetolactate synthase) renders the plant resistant to sulfonylurea and imidazolinone herbicide families. Monsanto's Roundup Ready trait contains an altered EPSPS synthase enzyme that does not bind to glyphosate. Whereas, with Optimum GAT, the glyphosate is metabolized by a modified glyphosate acetyltransferase (GAT4601).... It was originally hoped that Optimum GAT would allow for higher glyphosate application rates and a wider application window than Roundup Ready (see http://vocuspr.vocus.com/VocusPR30/Newsroom/Query.aspx?SiteName=DupontNew&Entity=PRAsset&SF_PRAsset_PRAssetID_EQ=101062&XSL=PressRelease&Cache= ).

One of the possible consequences of the delayed release of Optimum GAT is rendering of the Monsanto suit against DuPont moot. This question was raised, but not explicitly answered, in the Dec 4 CC, i.e.:

<Q – David Begleiter>: Thank you. Good morning. Paul, does this announcement impact at all the litigation between DuPont and Pioneer on the stacking of Roundup on the Optimum GAT trait?
<A – Paul Schickler>: That is a separate issue. We are proceeding aggressively with continuing to test Optimum GAT soybeans. And as I said in my remarks, both the combination of product efficacy for glyphosate and ALS is leading our expectations and the product performance is excellent. We’re very excited about the combination of efficacy and product performance for soy.

<Q – Jeffrey Zekauskas>: I think I’ll ask David’s question in another way. Does the postponement of the launch in soybeans to 2014/2015 render the patent dispute moot – that is, it doesn’t matter what happens with it because you’ll be introducing your product after the Monsanto glyphosate patent expires? And when does their patent expire in corn and glyphosate tolerant corn?
<A – Paul Schickler>: I’m not going to comment on the lawsuit. But again, go back to the point I was making when the previous question from David was asked, and that is our Optimum GAT soybean from an efficacy and product performance standpoint is very strong and exciting. But even before that, we’ve got excellent high yielding industry leading soybeans in the marketplace today that will continue in the marketplace that have glyphosate tolerance.


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Democritus_of_Abdera

12/06/09 11:46 AM

#63 RE: DewDiligence #61

Re: What the heck does this mean?

Optimum GAT soybeans are expected to be commercialized about two to three years later than the anticipated 2011 introduction [i.e. 2013-2014 (maybe)] due to changes in regulatory policy in key import markets and increasing complexity in managing grain stewardship. [What the heck does this mean?]

Dew, the meaning of the the above statement was addressed to some extent in the Q&A of the Dec 4 CC. (see below).... Searching under “stewardship” at the Pioneer website suggests that this term is used to designate the ethical and quality control procedures associated with a biotechnology product from its conception to its discontinuance... As such in the context above, managing grain stewardship probably just means that bringing Optimum GAT to market is a complicated process that takes time.

<Q – Kevin McCarthy>: Yes, good morning. In your press release, you cited changes in regulatory policy in key import markets as a reason why the Optimum GAT soybean product will be delayed by two to three years. Can you elaborate on what you were referring to there? Is it related to Japan, Europe, China, other countries, and what have been the changes that have caused this deferral?

<A – Paul Schickler>: That’s a good question because as you know, regulatory practices and regulations in some areas are nonexistent or evolving and changing. So that’s sort of the situation that we and others in the industry face. Specifically, regarding Optimum GAT soybean, the issue comes down to a couple of countries that are key export markets for growers in the United States and Canada. We adhere to industry practices and standards to make sure that export approvals for key countries are achieved before cultivation in the United States and Canada occurs. And in the case of soybeans, there’s two on that list that are critical – one is China, the other is Europe. In China’s case, what we have is a situation where Pioneer is the first company to bring a stacked trait to the market. And as a result, in addition to the individual trait components needing approval, subsequent to that the stacked combination also requires approval. So that adds to the timeline. Secondly, in Europe, another key market, we have a challenging, changing and unpredictable environment there. I think everyone is familiar with that situation. But the nuance here is that the requirements or the importance of Europe in soybeans is much different than what it is for corn. Thus, the export market of Europe is very critical and important to U.S. and Canadian growers. And for that reason, import approval in European countries by both EFSA and the European Commission needs to be accomplished before cultivation can occur in the United States and Canada. Those regulations in Europe continue to ebb and flow, and recent changes put that timeline back somewhat.


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Democritus_of_Abdera

02/12/10 5:36 AM

#99 RE: DewDiligence #61

Limited hybrid diversity is slowing SmartStax introduction...

The efficiency of technology used to introduce new traits into a diverse array of hybrid germplasm will continue to be a rate-limiting step in the realization of the full economic potential of new bioengineered traits. The technology for speeding hybrid incorporation of new traits will become more and more important as the traits relate to factors that affect yield under different environmental stresses. That is because the individual farmer’s initial experience with a new seed will depend not only on the presence of the trait-specific stress, but also other local factors that are optimally addressed by specific hybrid selection.

The importance of hybrid diversity was emphasized in Brett Bregemann’s presentation at the Goldman Sachs Agricultural Biotech Forum on Feb 10, i.e.:

Let’s start by taking a look at SmartStax. SmartStax is really the opportunity for our farmer customers to plant a product with the benefits of Triple on 95% of their acres instead of 80% of their acres. And as I sat here today looking at where we are in our order book, and I sat here looking backwards to what we said in November we expected for this year of somewhere around four million acres of SmartStax, I still feel good about somewhere around four million acres of SmartStax, albeit it hasn’t been easy with the challenges that we faced in the market.

Some of those coming, for example, when you think about a portfolio of products that we offer to the farmer, as with any launch, we don’t have the full portfolio of hybrids available to us to capture the farmers full farm because it’s critical that he use a diversity of genetics across that farm, and given the handful of hybrids we have, that’s difficult to do. But we understood that going into it, and we will not push hybrids beyond their means just to try to capture a farmer’s farm. We will position those hybrids one at a time with those key farmers to make sure that they get the experience that they’re expecting from SmartStax.

Limited hybrid diversity was also used to explain the “challenging” comparison of last year’s Roundup-Ready-2 yields to those of Pioneer Hi-Bred’s soybean seed yields.

<Q>: Brett, what did you learn from the experience with Roundup Ready 2 soybean last year that might refine the way you’re going to market with SmartStax this year? How do you ensure you don’t have to describe the SmartStax launch as challenging?

<A – Brett Begemann>: Yes I think there is – I think there are things that I would look back on with Roundup Ready 2 Yield that we have learned that we are taking into account in SmartStax. For example, as you’re positioning, and we only had 15 varieties in the marketplace, and we can’t control where every one of those bags of seed goes. That’s the farmer that makes that choice and they can buy it freely and openly in the marketplace, and they can plant them wherever. But what I will tell you is we’re putting a lot more rigor into our sales focus, helping the dealers work with the farmers to make sure we put the right hybrids in the right fields. Now that said, part of last year’s issue was variety position. Part of it was unique weather year and for example, disease where you wouldn’t typically see disease. Those are hard things to prevent. But at the same time, there are clearly learnings from that. The other thing that’s been reinforced with Roundup Ready 2 Yield as we are trying to implement in SmartStax is something we already knew. Broad-based trial is far more important in the early years than broad-based adoption. You get a lot of people trying it, they’ll have those good experiences as reflected in Roundup Ready 2 Yield where we’ve got a significant number of Roundup Ready 2 Yield users from last year had a good experience planting up to three times as much as they did the year before. So it’s getting broad distribution and getting the products positioned specifically on the farm with the farmer.

The importance of the hybrid varieties that include new traits when introducing the product to the marketplace was also emphasized when Pioneer recently delayed its introduction of Optimum GAT seed (see #msg-44228263).
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DewDiligence

06/15/11 4:49 AM

#278 RE: DewDiligence #61

DuPont Admits Defeat in Soybean-Seed Spat with MON

[DD’s own PR is at http://finance.yahoo.com/news/DuPont-Expects-Strong-2011-prnews-688500028.html?x=0&.v=1 ; note how DD tried to bury the bad news amid an array of other information about its seeds business.]

http://online.wsj.com/article/SB10001424052702303714704576386193733224206.html

›JUNE 15, 2011
By SCOTT KILMAN

DuPont Co. said Tuesday that it is indefinitely delaying the commercial launch of the genetically-modified soybean seed at the center of a long-running court battle with archrival Monsanto Co.

DuPont's Pioneer Hi-Bred seed unit had been telling Wall Street that it would launch the Optimum GAT soybean line in 2013 or 2014.

The seed, the launch of which has been delayed before [#msg-44228263], is controversial because DuPont, a Wilmington, Del., chemicals concern, is using a Monsanto gene in the soybean plant against the wishes of Monsanto, a crop-biotechnology giant based in St. Louis.

DuPont's Pioneer unit said Tuesday that the soybean plant is in limbo because Monsanto refuses to give foreign regulators access to data necessary for the genetically modified crop to win import approvals. The interest of U.S. farmers in growing Optimum GAT soybeans would be severely limited if foreign countries don't accept them: about half of U.S. soybeans are exported.

Scott Partridge, a Monsanto vice president, said Tuesday that Monsanto offered more than a year ago to give DuPont permission to use the Monsanto gene in Optimum GAT soybean seed, as well as access to regulatory data, in exchange for compensation.

"That offer is still on the table, and we remain open to dialogue with DuPont," Mr. Partridge said.

Monsanto filed a patent-infringement suit over Optimum GAT in 2009 against DuPont [#msg-37575974, #msg-45585003], which then made anticompetitive allegations against Monsanto in the same St. Louis federal courthouse [#msg-48349725, #msg-40779236].

The court fight, which is still under way, attracted the attention of the Obama administration's Justice Department, which in January 2010 opened a formal antitrust investigation into Monsanto's handling of the most widely planted genetically modified crop in the U.S., herbicide-tolerant soybeans.

DuPont's Optimum GAT seeds are genetically modified to grow into soybean plants able to survive exposure to glyphosate-based weedkiller as well as another herbicide called acetolate synthase.

DuPont initially touted Optimum GAT to farmers as an alternative to them buying seeds equipped with Monsanto's gene for surviving glyphosate, the active ingredient in Monsanto's Roundup weedkiller. But Pioneer scientists ended up stacking Monsanto's Roundup Ready gene with their own glyphosate-tolerate gene.

Monsanto argues in its lawsuit that the 2002 licensing agreement giving Pioneer access to Monsanto's Roundup Ready gene prohibits Pioneer from stacking it with any other company's glyphostate-tolerant gene in the same plant
.

DuPont interprets the 2002 contract differently and argues that any such gene-stacking prohibition would be illegal.

"Monsanto has never made a good-faith offer to settle this case," said Doyle Karr, a spokesman for DuPont's Pioneer Hi-Bred unit. "Pioneer negotiated for, and received, broad stacking rights in 2002. There is no reason to pay twice for rights Pioneer has already acquired."‹