Challenges in natural product development – Intellectual property issues and biopiracy

Key questions: What is biopiracy? How is it prevented?

Protecting intellectual property in natural products can be complex. In many jurisdictions, naturally occurring substances cannot be patented unless they are isolated, purified or synthetically modified and so determining patentability can be difficult when products are derived from nature.

However, intellectual property protection can be crucial for encouraging research, innovation and investment in the sector. Producers can also use trademarks to protect their name and logo that help consumers to recognise the brand.

In the food and drink industries, Geographical Indications are protected food and drink names. A Geographical Indication is a sign used on goods that have a specific geographical origin and possess qualities, reputation or characteristics that are essentially attributable to that place of origin. Most commonly, a Geographical Indication includes the name of the place or origin of the goods.

Agricultural products typically have qualities that derive from their place or production and are influenced by specific local factors, such as climate and soil. Geographical Indications identify, protect and promote products such as wines, cheeses, meats, olives, balsamic vinegar. In Ireland, terms such as Irish whiskey, Connemara Hill Lamb and Waterford Blaa (bread rolls) are protected.

While IP protection is important for companies and investors, it is also important for countries and communities. Natural products can be developed based on the traditional knowledge of indigenous peoples or discovered from the unique biodiversity of an area and benefit-sharing agreements should ensure that local communities and countries of origin receive fair compensation.

Case study: The neem tree – an example of biopiracy

The neem tree is native to India with a long history of use in traditional medicine and agriculture. Neem is used as a natural pesticide and insect repellent. In the 1990s, the US Department of Agriculture and a pharmaceutical company were granted a patent by the European Patent Office on a method for extracting neem oil that also covered the antifungal properties of neem.

The antifungal properties of neem had been recognised in India for centuries. Granting of this patent potentially limited Indian farmers’ access to neem and was seen as appropriation of indigenous knowledge without acknowledgement or compensation. The patent was legally challenged on the basis that it lacked novelty and after a prolonged legal battle the patent was revoked in 2000 as it was indeed judged to be not novel and based on prior art.

Patenting of neem is one of many examples of biopiracy. Biopiracy is the unethical or unauthorised appropriation or commercial exploitation of biological materials or indigenous knowledge by corporations, researchers or governments. Indigenous communities possess knowledge about the uses of local plants and animals.

Biopiracy often involves taking biological resources or traditional knowledge from developing countries or indigenous communities without proper compensation or recognition. It leads to economic disparity, the countries exploiting the resources profiting significantly while the community or country of origin receives little or no benefit.

Cases such as neem highlight the need to protect traditional knowledge from appropriation and the need for robust legal and ethical frameworks to ensure the benefits of natural resources are shared equitably.

How can we combat biopiracy?

The goal of bioprospecting is to discover new products or processes that have commercial potential and frequently collaboration with local communities is key to discoveries. Countries can protect their biological resources and traditional knowledge through legislation requiring benefit-sharing agreements and prior consent for access and work.

Such agreements outline the terms under which bioprospecting can take place and ensure that benefits are shared with the origin countries and communities. Patents should only be granted when novelty can be demonstrated and patents based on traditional knowledge should be prevented. Database collation of traditional knowledge may help in demonstrating prior art or evidence that an invention is already known, particularly for oral tradition.

Researchers and companies should be responsible in recognising country and community contributions and ethical practice in accordance with ethical research guidelines should be expected. Bioprospecting is also governed by international treaties such as the Convention on Biological Diversity.

The Convention on Biological Diversity and the Nagoya Protocol

The Convention on Biological Diversity is an international treaty that was adopted at the Earth Summit in Rio de Janeiro in 1992. It has three overarching objectives:

*Conservation of biological diversity – protection of ecosystems, species and genetic resources to maintain the natural variety of life on Earth. *Sustainable use of biodiversity components – ensuring biological resources are used in a way that does not lead to their decline so that they can meet the needs of present and future generations. *Fair and equitable sharing of benefits – ensuring that benefits derived from the use of genetic resources are shared fairly, particularly with the countries and communities that provide these resources.

The Nagoya Protocol, adopted in 2010, is a supplementary agreement that provides a legal framework for the fair and equitable sharing of benefits arising from the use of genetic resources, including traditional knowledge associated with genetic resources.

Bioprospecting in the ocean

Nearly half the Earth’s surface is covered by international waters beyond national jurisdictions. Comprising approximately two-thirds of the ocean, the majority of these waters are effectively unregulated. These waters and seabeds are teeming with biodiversity and natural resources but they are also under threat due to ecosystem degradation, biodiversity loss and climate change caused by human activity.

• How can marine ecosystems be protected?
• How can bioprospecting in international waters be regulated?

The Treaty of the High Seas or the Biodiversity Beyond National Jurisdiction (BBNJ) Agreement is a landmark agreement in global efforts to protect marine biodiversity. Its main purpose is to take stewardship of the world’s oceans for present and future generations, care for and protect the marine environment and ensure its responsible use, maintain the integrity of undersea ecosystems and conserve marine biological diversity’s inherent value.

The treaty establishes rules for accessing marine genetic resources and sharing the benefits. This includes financial benefits, scientific knowledge and technology. It provides for the establishment of marine protected areas to enhance the protection of marine ecosystems and biodiversity and promotes the sustainable economic use of marine resources.