Freedom‐to‐operate analysis of a transgenic multivitamin corn variety

Abstract

SummaryIn this article, we explore the intellectual property (IP) landscape relevant to the production and commercialization of Carolight TM , a transgenic multivitamin corn variety created on humanitarian grounds to address micronutrient deficiencies in low-and-middle-income countries. The successful production of this variety requires IP rights risk management because there is a strong protection on inventions and processes via patent portfolios in both developing and industrialized countries. The IP framework is complex, and specialist patent lawyers are usually employed to perform such analysis, but the costs cannot always be met by small, publicly funded projects. We report an alternative strategy, a do-it-yourself patent analysis, to produce a review with limited legal value that can nevertheless lay the foundations for a subsequent more in-depth professional freedom-to-operate opinion.

Transgenic Pro-Vitamin A Biofortified Crops for Improving Vitamin A Deficiency and Their Challenges

“…The IPR arrangement affects affordability of a pVA crop, allowing it to be free-of-charge under a humanitarian aid or fee-based under a market principle. As recommended, developers should allocate resources for IPRs investigations and partnership-building with patent licensors to minimize future conflicts [71]. Although often overlooked, efficacy of existing VAD interventions in target regions must be factored in; when the current interventions work well within the healthcare system with low costs, approval of transgenic pVA crops is not a political priority.…”