Inventors in the fields of biology and biotechnology will no doubt be familiar with the decisions of the US Supreme Court to exclude naturally occurring products and natural laws from patentability. Such decisions have had ramifications for scientists and researchers pursuing patent protection in the US. However, there are legislative reforms occurring in Europe that will also affect inventors researching natural products, particularly those involved in nutraceutical and primary/secondary metabolism research.
The Convention on Biological Diversity (CBD) obligates inventors to adhere to certain principles and undertake certain measures to ensure the conservation and sustainable use of biological diversity. The primary objective of the CBD is to prevent inventors from using natural resources from developing countries to develop commercially-valuable products, without sharing any derived benefits with the origin of the resources (often referred to as “biopiracy”).
The obligations of the CBD are realised through the Nagoya Protocol, which has now been implemented into European law, and requires inventors to enter into access and benefit sharing agreements with the countries from which natural resources are obtained, and imposes both civil and criminal sanctions for non-compliance with such requirements. The Nagoya Protocol basically makes it illegal to carry out research and development on any material of plant, animal, microbial or other origin that has actual or potential value, but has not been accessed in accordance with the Nagoya Protocol.
All inventors using natural resources or derivatives – including researchers in academic and small and medium-sized enterprises, in particular in the pharmaceutical, cosmetic, and food and beverage fields – are required to exercise due diligence to ascertain whether natural resources and associated traditional knowledge have been accessed in accordance with applicable legal or regulatory requirements, and to ensure that any benefits are fairly and equitably shared. Importantly, any recipients of research funding involving the utilisation of natural resources will be asked to declare that they do indeed exercise due diligence.
Researchers should, therefore, ensure internationally-recognised certificates of compliance (IRCC) are sought and kept in order to fulfill this requirement. Registered collections will provide an IRCC to researchers accessing natural material through recognised collections. However, researchers obtaining natural material from non-registered sources must obtain such certification from the Access and Benefit-Sharing Clearing House, which has been set up to co-ordinate the implementation of the Nagoya Protocol. To obtain an IRCC, researchers must provide information and relevant documents on the date, place, permission, and source of access; a description of the resource; details of subsequent users; and any rights and obligations regarding commercialisation. Researchers must also keep this information for 20 years after the research and development on the genetic and/or biochemical composition of natural resources has ended. This requirement does not apply to any natural resources acquired before 12 October 2014, but you must be able to provide evidence to show that such were obtained before that date.
The US is not party to the CBD and therefore is not bound by the Nagoya Protocol; leading to speculation that natural resources obtained from the US are not subject to these obligations – although this cannot be confirmed until the implementing rules have been published. What is certain is that these new requirements impose a considerable administrative burden on researchers to collect and retain a detailed paper trail of information related to resources obtained in the natural world, and that the development of naturally-derived inventions truly has become a more complicated affair.