Post Patent Biotech Traits: The Time Is near.

In anticipation of the first biotech products coming off patent, many important stakeholders in the agriculture value chain are heavily advocating for the development of a generic market for biotech seeds.  Syngenta believes a generic market can have beneficial effects on competitiveness and innovation cycles in the seed industry.  However, it is critical that generic use in the seed & biotech sector is not based on solely on copying existing events and germplasm by propagation.  Prior to generic use of biotech products, clear, science-driven policies regarding the use and stewardship of post-patent traits is required.   The current regulatory and legal environment is not well adapted to address post-patent scenarios for GM products.  Poorly thought out generic use can affect technology users, growers and commodity channels due to the uncertainty of continued legal use of such generics (due to the uncertainty whether regulatory approvals remain in place), as well as technology providers (due to ongoing responsibilities and legal obligations). Systems for the use of generic biotech seeds need to ensure third party compliance with state and federal environmental regulations as well as proper stewardship in efficacy preservation through sound resistance management approaches.  Under the existing framework for protected GM traits a significant effort goes into serving both the local markets (countries) and growers that cultivate the trait and the global trade channels.  These efforts include maintaining stewardship obligations and meeting local and global regulatory requirements.  The local and global support needed to effectively commercial biotech products do not vanish with the expiration of IP. Syngenta believes that in a post-patent scenario, rights and obligations need to match and there can be no gaps in stewardship or global regulatory requirements without jeopardizing the rights of all parties in the agricultural supply industry.  In this context, there is not a one-size-fits-all solution due to varying stewardship requirements (i.e. IR traits), regulatory and farm-saved-seed practices for certain crops (i.e. maize vs. soybeans).

It is the position of Syngenta that when establishing a framework for the development of a generic market, policymakers and/or market participants should strive to balance rights and obligations and ensure that third party providers of GM seed have a defined framework to operate in that does not jeopardize the industry or grain trade.

A generic market depends on innovation, so it is critical that post-patent policies ensure that all the parties in the channel have the incentive to continue bringing new innovations forward.