Genomics is turbo-charging traditional plant and animal breeding. But can new varieties get patent protection, ask Nicholas Jones and Rachel Wallis of Withers & Rogers LLP.
A new ‘low-risk’ peanut without the harmful proteins which cause an allergic reaction is great news for millions of sufferers worldwide, and could bring huge financial benefits to the researchers who developed it.
However, seeking patent protection for such inventions may not be a straightforward matter.
The American Department of Agriculture’s Food Allergy Research Group, which led the peanut research, identified three proteins they believe to cause the majority of allergic reactions. The scientists then combed 900 different varieties of peanut, looking for naturally-occurring mutations with lower than expected levels of the dangerous proteins, and used traditional cross-breeding techniques to produce the low-risk nut.
To exploit the full commercial value of their activity, whilst also ensuring that competitors do not infiltrate the market with a similar nut variety, the research team initially needs intellectual property protection. But the scope for obtaining patent protection for new varieties of plants or breeds of animal is limited in most countries.
In Europe, for example, a patent may only be obtained if the technical feasibility of the invention is not limited to the specific variety for which protection is sought. In other words, it must be possible to produce the invention in more than one variety.
The most famous case in this area relates to the “Oncomouse”, a mouse genetically modified to develop tumours. This was deemed a patentable invention because other species could also be modified to develop tumours using the same technical process.
A purely biological process
If the new peanut had been developed as a result of an inventive genetic modification it would have been eligible for patent protection. However, under current European patent law, any plant and animal variety developed by a purely biological process, such as cross-breeding, is not regarded as a technical invention and is therefore outside the scope of patent eligibility.
The application of genomics to turbo-charge traditional breeding means that the anti-allergy peanut is likely to be joined by an array of new varieties of plants and animals that result from crosses made on the basis of rapid genotyping of existing varieties to pinpoint desired genes.
For example, a public-private partnership in the UK is currently revolutionising commercial barley breeding in this way. The project has studied 1,000 barley cultivars, identifying natural gene variants that can improve important economic characteristics such as yield and resistance to pests and disease.
But if new varieties developed with a helping hand from genomics fall outside the scope of patent protection, other forms of intellectual property protection are available. However, research scientists and commercial breeders need to think more creatively about how to wring the commercial value from their inventions.
Plant variety rights
One approach is to apply for plant variety rights, which may be obtained for new botanical varieties. Such rights protect the breeder of a new plant against other breeders producing, conditioning, selling or marketing a similar variety. To qualify for a plant variety right, the new plant must be distinct from other known varieties, as well as being uniform. It must also be stably reproducible with the characteristics that provide its distinctiveness.
A plant variety right protects a specific variety and, in this case, the right could apply to the specific variety of peanut. Were the peanut patentable, the patent could have also applied to other types of nut sharing the same characteristics. However, whilst narrower in scope, plant variety rights can provide up to 30 years protection - a decade more than a patent’s lifespan.
Registered trademarks
A trademark acts as a badge of origin of the goods or service provided by a company or individual. With such a commercially viable product, the researchers of the ‘low-risk’ peanut could develop a brand which is widely recognisable to consumers. This could be in the form of a distinctive name, logo, symbol or a combination of these elements. Non-conventional trademarks also include colour, smell or sound.
The trademark should serve as a distinction of origin rather than a descriptor of the product. For example, it is unlikely that ‘nutty’ would gain successful trade mark status. On the other hand, invented words, such as KODAK for films or Lego for toy bricks, have proved to be two of the most distinctive and successful brands.
In the 1960s, a mould called Fusarium venenatum was discovered and developed by researchers who were tasked with finding alternative protein-rich foods. It was patented as a ‘mycoprotein’ in 1985 and launched to consumers in 1994 by Marlow Foods, then part of the AstraZeneca group. The company created a brand for the purpose of selling it to consumers, which is protected by a trademark. Today the trademark, ‘Quorn’ is one of the UK’s leading brands in the meat-replacement food market and is estimated as accounting for 60 per cent of the market.
A registered trademark can have an indefinite life and protection in other countries can also be obtained via a Community or International trade mark. The brand recognition and reputation that comes with a well-known registered trademark, such as Quorn, can provide market protection regardless of the patent position.
Community design / registered design rights
Community and registered design rights can also be extremely useful for protecting inventions that are not eligible for patent protection. For example, should the inventors of the anti-allergy peanut decide to develop a fully marketable product, they may decide to design distinctive packaging or a logo for their peanut variety. If so, they could protect the appearance of their product for up to 25 years with a registered design right.
Patent rights
Although essentially biological processes are not currently eligible for patent protection, there are two cases, at least one of which will be heard this summer by the European Patent Office’s Enlarged Board of Appeal, which could re-define this section of patent law in Europe.
In 2002 and 2003, the European Patent Office granted patents to varieties of broccoli and tomatoes respectively. Both had been developed through conventional breeding techniques. Oppositions were filed against the granted patents and questions relating to the cases have been referred to the Enlarged Board of Appeal for consideration. The anticipated decisions of the Enlarged Board will hopefully give useful and definitive guidance to industry on the patent eligibility of such inventions in the future.
Dr Nicholas Jones is a partner and patent attorney at Withers & Rogers LLP, specialising in biotechnology and pharmaceutical research and development. He is a member of the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry.
Rachel Wallis is also a partner and patent attorney at the firm. She has a degree in Medical and Veterinary Sciences from Cambridge University.
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