Postscript for Patents

As active ingredients and traits mature, patent expiration is an eventual stage in the lifecycles of most agricultural brands.

Postscript for Patents illustration
The ongoing development of newer, more sophisticated products is essential for any industry to thrive. Agriculture is no exception. Over the past two decades, the call to produce higher-yielding crops has spurred a wave of unprecedented innovation that has resulted in such revolutionary technologies as mesotrione, the active ingredient in Callisto® brand corn herbicides, and traits such as Roundup Ready® soybean.

Both of these products, as well as several other broadly used tools, will either be coming off patent or losing exclusive data protection in the next couple of years, which compels the people who distribute, sell and use them to ask, "What does patent expiration mean to my farm or business?"

Lifecycle Protection

Given the stringent regulatory approval process, the average time it takes to bring a new crop protection product to market can exceed 10 years and cost more than $100 million. Patent protection and the exclusivity it affords are critical to helping companies recover the costs of research and development, incentivizing them to make future investments that

The average time it takes to bring a new crop protection product to market can exceed 10 years and cost more than $100 million.

will lead to continued industrywide growth and advancement.

Over the next few years, Syngenta has several active ingredients coming off patent. They will join other key active ingredients in its portfolio, including atrazine, metolachlor and lambda-cyhalothrin, with patents that have already expired. For each of these products, the company's post-patent approach follows the same overarching plan.

"Our primary focus on all our products, especially those coming off patent, is performance," says Rex Wichert, post-patent strategy manager for Syngenta. "We want to make sure farmers and retailers have a consistent supply of industry-proven technologies that will help them overcome challenges, such as resistance, and maximize opportunities."

Product-Preserving Strategies

When patents expire and generic competitors enter the market, Syngenta continues to make sure key brands still deliver the results growers have come to expect.

For example, as the patent on the herbicide metolachlor approached expiration, Syngenta introduced Dual II Magnum® herbicide, a formulation containing the more active isomer s-metolachlor. This formulation reduced use rates by approximately 33 percent because of the isomer's enhanced activity.

"From the time we introduce a new active ingredient, we look for ways to enhance its value to growers and retailers," Wichert says. "Improving its formulation and incorporating it into new products are ways we can better meet their changing needs."

Syngenta is using both approaches with mesotrione, whose data exclusivity under FIFRA expires in June. Originally launched as a single corn brand, the mesotrione or Callisto herbicide family now includes multiple brands, 90 percent of which are premixes. Callisto GT, a combination of Callisto and Touchdown® herbicides, is the latest mesotrione premix on the market. And coming soon to corn are mixtures with a new active ingredient, bicyclopyrone, which, upon registration, will offer improved residual control of large-seeded broadleaf weeds.

Enhanced formulations are also bringing new life to the Callisto family. Lumax® EZ and Lexar® EZ herbicides, with their patented capsule-suspension formulation technology, provide easier handling and more flexible application.

"We are constantly challenging ourselves to look at how the market is changing and see how we can evolve our product line to better fit farmers' needs," says Wichert. "We want our customers to see Syngenta as more than just the supplier of one new chemistry or active ingredient."

Biotech Trait Milestone

While patent expiration is nothing new to crop protection products, no major biotech trait has had to face this milestone - until now. The first generation of the Roundup Ready soybean technology (RR1) will be off patent in 2015, making this season its last as a patent-protected trait. Introduced in 1996, this technology hit the market by storm with its potential to make weed management easier, more convenient and effective. The technology also made conservation tillage practices more practical to implement.

"From the time we introduce a new active ingredient, we look for ways to enhance its value to growers and retailers. Improving its formulation and incorporating it into new products are ways we can better meet their changing needs."

—Rex Wichert

Fast forward nearly 20 years, and growers now use herbicide-tolerant technologies on more than 95 percent of soybeans planted across the U.S. It's no wonder that the imminent patent expiration of the RR1 trait is a hot topic throughout the industry. Fortunately, companies like Syngenta have plans in place to help minimize market disruption.

"Seeing an opportunity to improve performance and manage growers' needs, we transitioned much of the NK® soybean portfolio to the more advanced Genuity® Roundup Ready 2 Yield® technology," says Ross Weikel, head of soybeans for Syngenta. "We plan on launching additional herbicide-tolerant traits in the near future to further improve weed management performance and offer options for sustainability."

Saved Seed

For those growers who will continue planting RR1-traited soybeans, their right to save and replant the seed is often not fully understood. Other intellectual property protections may apply to some RR1 soybean seed varieties, so even if the trait patent has expired, certain seed may be protected by a patent on the seed's germplasm. Growers who are interested in replanting saved RR1 soybeans will need to check with their seed supplier to find out if the variety they are interested in can be saved and replanted without legal repercussions.

Weikel explains that current NK soybean varieties are protected by a variety of intellectual property rights; therefore, saving seed for replanting the following year could be an infringement of these rights.

"Syngenta invests millions of dollars every day into R&D for new products like NK soybeans, which are covered by patents or plant variety protection, no matter which herbicide-tolerant traits are included," he says. "These help Syngenta continue to deliver better products to growers."

Impact on Overseas Markets

In this new age of patent expiration for traits, an issue that impacts the entire industry is off-patent trait maintenance in overseas markets.

To address the transition, the Biotech Industry Organization, the American Seed Trade Association and a wide range of other stakeholders, including grower groups, grain handlers and government officials, are taking action. Their goal is to identify and create solutions that provide clarity and enable ongoing grower choice of these traits following patent expiration.

Not surprisingly, one grower group involved in the dialogue is the American Soybean Association (ASA). Its leadership is actively pursuing ways to develop pathways that will facilitate the continued availability of traits to soybean farmers as single generic traits or as part of stacked traits after patent expiration. The association breathed a collective sigh of relief when Monsanto confirmed that it supported the short- and mid-term marketability of the RR1 trait for the next three to five years and pledged to maintain full global regulatory responsibility for RR1 through 2021. ASA President Ray Gaesser believes longer-term assurances are needed.

"It's a two-way street," says Gaesser, who is also a soybean producer from Corning, Iowa. "We need to remember that while safeguards may be in place to cover farmers' worries today, we need to make sure that the corn and soybeans we grow will continue to be accepted overseas now and into the future. There will be an incredible cost if grain is refused."

What Comes Next?

For the long-term success of all products, Syngenta understands that making timely, accurate deliveries is essential to its supply chain partners that bring these products to the farm. Regular, ongoing communication between manufacturers and retailers is essential to maintaining proper supply throughout the season. But as more generic products hit the market, the retailers that choose to sell them will work with more manufacturers to predict product supply needs for the coming year. With so many conversations taking place, the dialogue to make sure growers get what they want when they need it is bound to become more confused and less focused.

Despite these challenges, Wichert believes the post-patent world has a silver lining. "Innovating, upgrading and delivering are the keys to evolving in the post-patent marketplace," he says.

A case in point is the decision by Syngenta to transition its corn seeds product line to the newest, highest-performing genetics and traits. For 2014, Golden Harvest® and NK brand corn touts one of the most diverse corn genetics line available. The Syngenta corn hybrids include such breakthrough traits as Agrisure Artesian®, Agrisure Duracade, Agrisure Viptera® and Enogen® trait technology - all launched over a 5-year period, a rate unparalleled in the industry.

"We know the market is continuing to evolve," says Wichert, "and as a company, we are investing in our portfolio to help drive market growth and create new opportunities for farmers, retailers and dealers alike."