Securing Meaningful IP For Gene-Edited Crops

A recent Federal Circuit decision touches on the enablement standard for prior art v. under the standard to obtain patent protection.  While the case focuses on gene editing technology and the varying legal standard, the practical lessons apply to a major area of innovation in the agricultural industry: gene editing.

Gene editing in agriculture, particularly using CRISPR Cas-9 technology, allows for precise and rapid changes to plant DNA to improve traits like disease resistance, drought tolerance and improved nutrition.  IP protection for these crops is critical to commercialization and monetization of such IP can provide companies with robust licensing opportunities. But challenges in obtaining such IP remain, and especially focus around whether the patent claims being pursued are enabled to their full scope.  

While larger companies in this space may have resources to support the patenting process, smaller companies and startups should focus on best practices to support patent applications. These include ensuring all proposed edits are carefully documented, tested and sufficient data is collected with resulting phenotypes, including tracking sequence information and mutations. Importantly, even “failure edits” should be included in any patent application and may support patentability later on.  This requires diligence during the research and development phase to ensure this information is properly cataloged and collected and presented to IP teams for robust drafting options. General “research plans” describing edits and proposed modifications without implementation and phenotype data may not withstand the enablement test for patentability.

Thus, entrepreneurs working on gene-edited crops should consult with an IP attorney early on in the R&D phase to ensure alignment and set up data packages with the best chance of successfully generating meaningful IP.  The ultimate goal being IP that allows capture of the market for potential commercial products or provides an opportunity for revenue generation as a licensable asset.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.