The “stacked” pipeline of biotech specialty crops and regulatory/market barriers to coexistence

Abstract

Biotech specialty crops face a number of potential barriers. Regulatory uncertainty over new plant-breeding methods and costly overseas approvals could complicate plans for commercialization. Stacking a generic crop aids innovators in the marketplace, but generic crops may need the regulatory data held by patent holders to achieve regulatory approval. Sustainability standards may arbitrarily deny use of biotechnology. Any innovator heading into this sector will need to be aware of all the potential threats awaiting these exciting opportunities in genetic engineering of biotech crops.