Patenting natural products (part 4): biopiracy

Biopiracy is described as the unjust practice of commercially exploiting naturally occurring biochemical or genetic material, especially by obtaining patents, while failing to pay fair compensation to the community from which it originates (such as indigenous peoples). It can be an emotive subject, provoking strong opinions on both sides. Various groups have been founded to combat alleged instances of biopiracy, such as the Peruvian National Commission Against Biopiracy and France Libertés - Fondation Danielle Mitterrand. Patent applicants who are accused of biopiracy may experience negative publicity and, in some instances, may even face revocation of their patent. With the commercial importance of natural products growing, particularly in the cosmetics and personal care sector, applicants for patents to natural products may wish to consider measures to avoid or mitigate allegations of biopiracy.

In part 1 of our series on patenting natural products, we saw that European law may allow patents to natural products that are isolated for the first time from the natural environment. In part 2, we saw that known isolated natural products may still be patentable if found to have a new use. In part 3, we saw that known isolated natural products may be patentable if provided in a new combination that shows a synergistic effect. In each of these cases, the invention relates to a natural product that previously existed in nature but may be patentable due to a new technical aspect of its isolation, form or use. For this reason, such patents should not, strictly speaking, be considered "biopiracy", because the patent is granted to a new technical endeavour that goes beyond the naturally occurring product or traditional knowledge. However, in practice, there are complications.

A first complication is that it can be very difficult for patent offices to assess the patentability of inventions to natural products that involve traditional knowledge. In an example that was reported by BBC News, a European patent directed to an anti-fungal product derived from neem (a natural herb that comes from the neem tree native to the Indian subcontinent) was initially granted to the US Department of Agriculture and the chemical company W.R. Grace. However, the Indian government opposed the grant of the patent and successfully argued that the medicinal neem tree was part of traditional Indian knowledge and therefore not new and not patentable. The patent was revoked. A global coalition of environmental groups, including the EU's Green party, the Indian Research Foundation for Science, Technology and Ecology and the International Federation of Organic Agricultural Movements, celebrated this as a major victory in their fight against biopiracy.

The European Patent Convention already requires that inventions must be new over "everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application." Traditional knowledge would generally be considered public knowledge and thus unpatentable for not being new. However, it can be difficult for patent offices to identify traditional knowledge, because patent office search and examination largely relies on documentary evidence, whereas traditional knowledge tends to be transmitted orally from generation to generation, taking the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices, that are not easily searchable. For this reason, it is perhaps unsurprising that patent offices may inadvertently grant patents to non-patentable traditional knowledge due to the limited availability of documentary evidence. However, the European Patent Office's post-grant opposition procedure provides a safeguard by allowing third parties to contest the patentability of an invention.

In an attempt to solve the above problem, India has set up The Traditional Knowledge Digital Library (TKDL), which is a digital repository of traditional knowledge, especially concerning medicinal plants and formulations used in Indian systems of medicine. The objective of the library is to protect ancient and traditional knowledge from exploitation through biopiracy and unethical patents, by documenting it electronically and classifying it according to international patent classification systems. This should make it significantly easier for patent offices to identify non-patentable traditional knowledge when examining patent applications.

A second complication is that not all allegations of biopiracy concern non-patentable inventions. In more complex cases, an invention may take its starting point from traditional knowledge but will go on to make a new and inventive technical contribution that may be patentable. Even in these cases, where the invention meets the requirements of patent law, allegations of biopiracy can still arise for failing to acknowledge and compensate indigenous peoples from which the traditional knowledge originated. An example of this is the Simalikalactone E case. In 2016, the French Institute for Development Research (IRD) was accused of patenting the new malaria drug Simalikalactone E without acknowledging indigenous and local communities.

The patent was directed to Simalikalactone E, which can be extracted from the plant Quassia amara, and its use as a medicament, particularly in the prevention and treatment of malaria. The inventors had undertaken a knowledge attitudes and practices study¹ in French Guiana interviewing people from five different groups and nationalities (Créole, Palikur, Galibi, Brazilian and European) on their use of traditional remedies, mode of preparation and administration. Quassia amara (whose antimalarial activity was known) was identified as the species most frequently used by the indigenous peoples as an antimalarial for curative and preventive purposes, which the inventors took forward as the most promising candidate for their further study. Following this, the Simalikalactone E molecule was ultimately found, isolated and patented. The patent explained that "We have identified, from a species of the family Simaroubaceae, Quassia amara (L.), used in traditional medicine throughout north-west Amazonia and as far as Central America against fevers and malaris, a new molecule, Simalikalactone E (SkE), which has been shown to be active against malaria. An ethnopharmacological investigation² and biological tests had made it possible...to identify preparations based on mature leaves of Quassia amara as advantageous for treating malaria."

France Libertés - Fondation Danielle Mitterrand issued a strongly worded statement denouncing "the unethical practices" of the IRD and filed an opposition against the patent at the European Patent Office under grounds of lack of novelty, lack of inventive step, exclusion of patentability as an invention for which commercial exploitation would be contrary to "ordre public" or morality, and lack of sufficient disclosure. The opposition was rejected at first instance and is currently under appeal. Nonetheless, perhaps due to negative press or other obligations discussed below, the IRD has now issued a statement saying it will work out a protocol with Guianan authorities to guarantee the fair sharing of the scientific and economic benefits if the drug makes it to the market and to ensure that people in Guiana can get it at an affordable price.

The European Patent Convention (EPC) can deal with the patentability of an invention, but it does not explicitly recognise the concept of biopiracy. For this, other legal instruments are in place, including The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity ("The Nagoya Protocol"), which aims at the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The Nagoya Protocol entered into force on 12 October 2014 and has been ratified by 128 parties, including the European Union and the UK. Contracting Parties to The Nagoya Protocol are expected to take measures to ensure indigenous and local communities' prior informed consent, and fair and equitable benefit-sharing, keeping in mind community laws and procedures as well as customary use and exchange.

Article 5 of The Nagoya Protocol concerns Fair and Equitable Benefit-Sharing and states that "Each Party shall take legislative, administrative or policy measures, as appropriate, with the aim of ensuring that benefits arising from the utilization of genetic resources that are held by indigenous and local communities, in accordance with domestic legislation regarding the established rights of these indigenous and local communities over these genetic resources, are shared in a fair and equitable way with the communities concerned, based on mutually agreed terms... Benefits may include monetary and non-monetary benefits, including but not limited to those listed in the Annex." The annex of monetary and non-monetary benefits lists "Joint ownership of relevant intellectual property rights". This appears to suggest that access and benefit sharing agreements (ABS) used to define a fair and equitable sharing of benefits arising from the use of genetic resources could involve joint ownership or licensing provisions of intellectual property rights, including patents. The World Intellectual Property Organization (WIPO) in cooperation with the ABS Capacity Development Initiative have issued guidance on how intellectual property issues arise in such cases.

In summary, biopiracy encompasses a variety of aspects, not only for patentability, but also for access and benefit-sharing agreements, licensing and managing public relations. Applicants for patents to natural products should take care to consider all of these aspects and may wish to seek expert guidance.

For further information, contact Frederick Nicolle, Managing Associate (Patent Attorney), Intellectual Property at Simmons & Simmons.

¹Antimalarial remedies in French Guiana: A knowledge attitudes and practices study; Vigneron et al; Journal of Ethnopharmacology; Volume 98, Issue 3, 26 April 2005, Pages 351-360

²Ethnomedicine is the study of traditional medicine based on bioactive compounds in plants and animals.