The Protocol establishes a new legal framework to govern access to and utilization of genetic resources, including genetic material and any naturally occurring derivative compound.
With entry into force of the Protocol, a number of countries have adopted new laws and regulations that will impact the development of, and intellectual property rights (IPR) surrounding, an array of products.
Such products include pharmaceuticals, biotech products, agricultural products, nutritionals, supplements, cosmetics, perfumes and fragrances, and industrial enzymes.
Although the United States has not signed or ratified the Nagoya Protocol, US companies and universities that utilize genetic resources from other countries for scientific research or commercial purposes will be subjected to these new requirements and restrictions.
Indeed, companies and universities utilizing genetic resources from plants, animals, bacteria and other organisms must be especially mindful of these new and emerging international and domestic requirements. The same is true for scientific and commercial activities relating to the use of traditional knowledge held by indigenous and local communities. With many countries already vigorously enforcing such restrictions, the consequences of not fully complying may be draconian. In addition to being tarred in the international media as a "biopirate," those who allegedly fail to comply may be subject to enforcement actions brought by a government authority challenging the right to study and commercialize a product. Governmental authorities may also threaten criminal prosecutions. And, in certain countries, patent applications that non-complying researchers and companies file for products derived from genetic resources or traditional knowledge may be jeopardized if they do not comply with applicable "disclosure of origin" provisions.