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26 May 2022GeneticsSarah Speight

Gene-editing bill: encouraging innovation or adding complexity?

The Genetic Technology (Precision Breeding) Bill, announced in the Queen’s Speech this month, aims to take advantage of the UK’s post-Brexit position and relax the regulation around precision breeding.

Announcing the legislation in a press release on May 25, the Department for Environment, Food and Rural Affairs (Defra) made the claim that the new legislation “will make the UK the best place in the world to invest in agri-food research and innovation”.

It went on to say that the bill will “remove unnecessary barriers to research into new gene-editing technology, which for too long has been held back by the EU’s rules around gene editing, which focus on legal interpretation rather than science – hindering the UK’s world-leading agricultural research institutions”.

Ultimately, “enabling the development and marketing of precision-bred plants and animals will drive economic growth and attract investment into agri-food research and innovation in the UK”, the government said.

Impact on IP

While patents or intellectual property were not mentioned in the announcement, legal professionals await further detail from the government on the implications of the regulatory changes on the patent landscape.

Robyn Trigg, knowledge lawyer at Osborne Clarke, says more clarity is needed: “We do not have certainty that the plants and animals contemplated by the bill could be entitled to patent protection and plant breeders’ rights (PBRs) (in the case of plants). It would be good to get more clarity on this and it will be interesting to see if any IP issues are raised as the bill moves through the various Parliamentary stages.”

Without such clarity, though, what do specialists working in the field think the new legislation means for patenting gene-edited organisms?

It is well established that plants and animals can be patented where they are not "exclusively obtained by means of an essentially biological process" and if the invention is not confined to a particular plant or animal variety.

With this in mind, Trigg is confident of patentability under the new legislation. “It appears that the precision-bred organisms falling within the scope of the bill could be patentable—provided the patentability criteria are satisfied,” she says.

“This means that plants or animals produced by a technical process [including technology such as CRISPR/Cas] that modifies the genetic characteristics of the plant or animal are patentable.”

“And,” she adds, “if the offspring of a plant or animal that has been produced by a technical process contains the modified genetic characteristics, then the offspring is also not produced exclusively by an essentially biological process and is therefore patentable.”

Beatriz San Martin, partner at Arnold & Porter (a member of the Bio Industry Association) chimes with this in the belief that the new legislation will have a positive overall impact on patenting gene-edited products.

“In terms of what it means for patenting, the patenting community, and the industry, the new bill isn't going to impact the ability to obtain patents directly. So the circumstances in which technology using gene editing, or deploying gene modification may be patentable, does not change because the legislation is not proposing to change that.

“What it proposes to do is to change the way you regulate what can be placed on the market, and what compliance measures you need to take, or hoops you need to jump through, in order to be able to do the work that you want to do,” explains San Martin.

She adds that this could also have indirectly positive consequences for innovation with a concurrent expansion in patent filings, which would cover gene-editing technologies.

“Businesses will explore new opportunities that have been facilitated by this change, so there will be more investment and more money, which means that there'll be more R&D for new applications that perhaps couldn't get into the market before.

“So that investment will also mean an investment in patent protection and increased patent portfolios in this space.”

San Martin explains that the new legislation will not change the patenting process or add red tape, although it would streamline the path to market for products.

“In the US, they regulate the product, not the way that it is made. So this change isn't really changing the system in that way. It's a way of reducing what is deemed to be a GMO,” she says.

“It may be enough in terms of enabling sufficient innovation, but it may be that in the long run, we should be changing to a system which regulates the product.”

Plant variety rights

An added bonus is that, beyond patent protection, plant varieties can also be protected by plant variety rights, says Trigg.

“Post-Brexit plant variety protection in the UK can be obtained from the Animal Plant and Health Agency in the form of PBRs. PBRs are available for new plant varieties, including those that have been genetically modified.”

She goes on to explain: “In order to get PBRs a new plant variety must be distinct, uniform, and stable. To be considered ‘precision bred’ under the new bill, the relevant organism's genome must be stable. This lays the groundwork for potential new gene-edited plant varieties being eligible for PBRs.”

In the wider life sciences, this may lead to an increase in patents covering gene-edited plants or animals and PBRs, Trigg points out. “Given that the new bill seeks to establish a new regulatory framework for bringing gene-edited plants and animals to market (including food and feed products produced from them), we might well see these rights being actively enforced,” she says.

Daniel Rowe, senior associate at Dehns, agrees: “What's possibly going to happen is you'll see plant variety rights (PVRs) becoming more and more important when people realise that actually patent protection is a nightmare for their new product, but actually, they could register it as, for example, a new variety of maize.”

This is because, explains Rowe, the plants that you can get a PVR for can be obtained by natural processes, unlike when you’re seeking patent protection.

Potential pitfalls

Despite the benefits, there are still potential grey areas.

Just this week, scientists at the John Innes Centre in Norwich unveiled a gene-edited tomato that contains as much vitamin D as two eggs—exactly the type of “precision-edited” organism that the legislation will seek to encourage.

However, less clear would be where a breeder introduced a trait into their patent-protected cultivars but subsequently, natural breeding or evolution resulted in the same trait from the same underlying genetic sequences.

So how would this affect patentability? Would the patent be invalidated or what would be the burden of proof required by either party in a dispute?

Rowe agrees that this scenario presents an element of complexity. “If a gene-edited tomato that doesn't have a very recognisable piece of DNA in it flags up that it was part of that initial patented plant, then you are in a tricky situation because you don't have anything structural to point to and say that these plants are definitely the progeny of the patented tomato plants. So the evidential burden would be on the patentee.”

He adds: “With gene editing, the whole point is that you're making really subtle changes to what's naturally there, you're not putting in nasty, weird bits of DNA.”

San Martin highlights the position for patents granted before the European Patent Office (EPO), namely that “European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof” (Article 53b, European Patent Convention (EPC).”

“Note that the EPO is not an EU institution and the EPC is not an EU legal instrument, it is an international legal instrument that has been implemented into UK national law by amendments to the Patents Act 1977,” she explains.

“There are ways round this exclusion which means that you could still obtain patents for innovation from gene editing of animals and plants. You can seek to protect the specific DNA sequence that you have ‘edited’ for a use in a particular way. So, you are not ‘patenting’ the animal or plant itself but the feature within an animal or plant.”

Genetic modification vs genetic editing

While the legislation intends to streamline regulation in the field, the debate over what defines genetically modified—or edited—organisms is still very much alive.

“There's lots of EU-retained law that we still have to comply with,” explains San Martin. “Part of that framework relates to the regulation of genetically modified organisms [GMOs]. There was a decision in 2018 from the Court of Justice, which basically said, any genetic modification of an organism was included within the definition of genetically modified organisms.

“There have been arguments to say that if it was a modification that could have happened in nature, then that might fall outside the scope. The Court of Justice said no, all of this is a GMO. And then because of Brexit, the UK government has seen that as an opportunity to diverge from the EU.

“Then in March this year, there was a change to a statutory instrument regarding the use of GMOs for non-marketing purposes—ie research—and then the law was changed, such that if the gene editing that you have conducted could have been done using traditional breeding techniques, then it's not considered to be a GMO.

“And now we have the announcement from yesterday, which is going to expand that to the commercial space.”

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More on this story

Biotechnology
11 May 2022   The UK government will implement the Genetic Technology Bill which promises to “remove unnecessary barriers” inherited from the European Union to bolster gene-editing technology.
Africa
21 March 2019   World Health Organization (WHO) experts have called for central registry on human genome editing research is needed, among a committee consensus that it would be irresponsible for any scientist to conduct gene-editing studies in people.

More on this story

Biotechnology
11 May 2022   The UK government will implement the Genetic Technology Bill which promises to “remove unnecessary barriers” inherited from the European Union to bolster gene-editing technology.
Africa
21 March 2019   World Health Organization (WHO) experts have called for central registry on human genome editing research is needed, among a committee consensus that it would be irresponsible for any scientist to conduct gene-editing studies in people.

More on this story

Biotechnology
11 May 2022   The UK government will implement the Genetic Technology Bill which promises to “remove unnecessary barriers” inherited from the European Union to bolster gene-editing technology.
Africa
21 March 2019   World Health Organization (WHO) experts have called for central registry on human genome editing research is needed, among a committee consensus that it would be irresponsible for any scientist to conduct gene-editing studies in people.