Innovation And Regulation Of Gene-Edited Vegetables: An Interview With IP Lawyer Chris Holly

Chris Holly is a practicing intellectual property lawyer with extensive experience helping clients leverage IP portfolios in the agriculture, food, microbiology and biotechnology industries. Intellectual Property Watch’s David Branigan interviewed Holly to gain his perspective on the technological, regulatory and intellectual property considerations of next generation plant breeding techniques, in particular those that involve gene editing using CRISPR technology.

Chris Holly

Chris Holly is an Associate of Cooley LLP, a law firm in the United States specialising in corporate, litigation, regulatory and intellectual property practice. More information on Holly’s background can be found here.

INTELLECTUAL PROPERTY WATCH (IPW): Plant and seed innovation through next generation breeding techniques, in particular gene editing, has become a hot issue. Your firm Cooley LLP is doing work in this area, and is a member of the Seed Innovation and Protection Alliance (SIPA), a key player in promoting IP for this innovation. Can you briefly describe the work of SIPA?

CHRIS HOLLY (HOLLY): The American Seed Trade Association (ASTA), is the parent organisation of the Seed Innovation and Protection Alliance (SIPA). ASTA is the industry’s leading advocacy group for plant and seed innovation, and SIPA is the IP advocacy and educational arm of ASTA. So SIPA falls under ASTA, and its goal is basically to educate its members on IP and best practices regarding protecting their plant innovations.

IPW: Can you speak on some of the main points of your presentation on behalf of SIPA at the recent ASTA Vegetable and Flower Seed Conference, “IP Strategies for Protecting Plant Innovation: Next Generation Breeding Technologies From Molecular Markers to Gene Editing”?

HOLLY: The talk was geared toward helping companies understand how to develop and implement IP portfolios surrounding next generation breeding technologies, which are larger than just gene editing. They include the use of molecular markers and marker-assisted selection. The talk aimed to help companies understand how they could go about protecting that type of innovation, including what type of data they would need from their scientists, in order to allow us, the attorneys, to do our job, to get some broad coverage and a lot of exclusivity.

One of the unique aspects about plants is that there are three ways to protect IP. There are traditional utility patents, which is what most people think of when they think of IP in the US. There are also plant patents that cover specific germplasms that are asexually reproduced, and the US is the only country in the world that has plant patents. These two types of IP protection are administered by the US Patent and Trademark Office (USPTO). There is also a third way, called plant breeder’s rights or plant variety protections (PVPs), which are administered by the US Department of Agriculture (USDA).

So these are the three different ways to protect the innovation. All of them interact, and all of them have pros and cons. You layer these three forms of protection if you’re doing traditional plant breeding, next generation plant breeding or gene editing. It’s a lot to work through and a lot to think about.

IPW: Can you describe the innovation of vegetable plants that is emerging through next generation breeding techniques, such as gene editing?

HOLLY: Next generation plant breeding based on molecular markers and marker-assisted selection is very popular in the vegetable world. That’s because it’s similar to traditional plant breeding in the sense that you’re making traditional crosses, and you’re not utilizing any type of gene editing mechanisms. Compared to traditional plant breeding, it offers a lot more granularity – it’s a lot more refined once you’re looking at the actual genes, the markers that are associated with different phenotypes.

In the vegetable industry, gene editing is just now starting to catch on, and people are starting to think about what they would do with this technology given the regulatory landscape. There is a lot of innovation in gene editing, and a lot of start-up companies that haven’t yet commercialised crops. For example, tomatoes have traditionally been bred one of two ways – there are the heirloom tomatoes that are bred for flavour and taste, and tomatoes that have been bred to withstand being shipped across the country. Gene editing is going to allow breeding tomatoes for shipping as well as for taste.

There is a lot of innovation happening in the industry writ large. In terms of commercial gene edited vegetable crops, there are none currently on the market that I am aware of, but there are a lot in the pipeline. I think that’s just the result of the fact that a lot of these companies are hesitant or curious to see how gene editing plays out on the regulatory landscape. While the regulatory landscape is currently favourable in the US, it is most importantly an issue of public perception, which is really where the battles are going to be fought and won in this industry right now.

IPW: Are there particular examples you can provide that illustrate the societal benefits of these next generation breeding technologies?

HOLLY: The tomato example is a neat one from a consumer perspective, but the real societal benefits of gene editing are going to be much broader and much more applicable to the world’s population, which is drastically expanding. Drought tolerant crop species are going to be huge, especially given climate change. A lot of research groups and a lot of companies are working on breeding plant varieties that are more drought tolerant, that can live in different growing zones, that are tolerant of warmer temperatures, and that utilize water more efficiently. That’s going to be huge – that’s where the humanitarian impact of gene editing will be felt.

Also, gene editing will have an impact on pathogen resistance. There are a lot of pathogens in different crop species – different types of fungal pathogens and viral pathogens. With gene editing, people are figuring out ways to make those crops less susceptible to the pathogens. We’re also going to have cool new vegetables like the tomato example. We’re going to have that for consumers here in the US, but as far as helping the global food supply, you’re going to see a lot from drought tolerance and pathogen resistance.

IPW: Are there any examples that illustrate potential risks or downsides of these technologies, such as increased herbicide or pesticide use, and how are these being addressed?

HOLLY: When a lot of people think about gene edited crops, they think about old examples of GMOs [genetically modified organisms]. There’s a fundamental difference between transgenic [GMO] crops, like glyphosate resistant or Roundup-ready varieties that Monsanto came out with in the mid 90s, versus gene editing. With transgenic crops, you take a genetic segment, a piece of DNA from one organism, and you place it in another organism, so it becomes transgenic. All of that early technology, besides it being a public relations disaster how it was handled, was all about increasing yields. This technology enabled a farmer to increase yields by making plants resistant to certain herbicides or pesticides that you could just spray on top of the crops. It wasn’t marketed well to the larger public and a large segment of the population developed a negative association with transgenic crops.

What we have now with gene editing is very different. You’re not introducing foreign DNA from another species into the plant. You’re literally just editing, rewriting the native DNA that’s already there, and you could have arrived at the end product through traditional plant breeding. It would just take you a thousand years, and a lot of luck, but you could get there through the traditional process.

So are there any downsides? There are no downsides in the sense of enabling you to spray more herbicides or pesticides like the glyphosate resistant example. There hasn’t been any published scientific downsides such as making a crop that isn’t safe to eat. It’s really just a matter of public perception. Can the public really appreciate the fact that these gene edited crops are much more like traditionally bred crops than they are like GMOs? Only time will tell that, and it will depend on how the industry and scientists teach the public about this.

IPW: What do you see as the intellectual property-related advances that have taken place to support innovation in next generation breeding technology?

HOLLY: I would say the IP-related advances follow hand in hand with the technological advances. So when we saw CRISPR [gene editing technology] come out a few years ago, the patent applications and the IP to protect those technologies were filed first. With each incremental change or advancement that you see in the science, there’s also a mirror image advancement in the IP. So as the science progresses, the IP surrounding that science also progresses.

IPW: How has the regulatory landscape around gene editing advanced or hindered innovation? Can you describe any differences between the regulatory landscapes of the US and other countries or regions?

Wheat

HOLLY: The US regulatory landscape right now is very favourable for gene edited crops. The USDA basically came out with an official position that they are not going to regulate gene edited plants, or any kind of plant that otherwise could have been developed through traditional plant breeding. In the US, it’s a very favourable landscape, and is encouraging innovation.

As a point of reference, for transgenic crops it could take about 10 years to bring a transgenic plant or trait to market, due to the regulatory burden and all of the studies you would have to do to get through the regulatory red tape. Now in the US with gene edited crops, that path to market can be anywhere from 3 to 5 years. A lot of that is due to the technological advancements that don’t have the same regulatory red tape. In the US, regulators are looking at the end product, with a product-focused regulatory scheme. So the US is taking the position that if this product could otherwise have been developed through traditional plant breeding techniques, they’re not going to regulate it.

The European approach is a lot different. In Europe, instead of a product-focused regulatory scheme, it’s a process-focused regulatory scheme. This past July, the European Court of Justice came out with a ruling that said they are not going to look at the end product, and it doesn’t matter if the gene edited products are indistinguishable from traditionally-bred plants. They are going to look at the process that is used to get to that end product, and if that is a gene editing process, they are going to regulate it just how they regulate transgenic GMOs. So that was very unfavourable to the industry, because now you’ve got drastically different regulatory schemes in two of the world’s biggest markets, and people are wondering how that’s going to play out.

Certainly the Asian countries and other developing markets are also going to be important from a regulatory perspective, because those are huge markets, and the ways that those countries decide to regulate these products is going to be hugely important. You don’t want to spend all of this money getting a product to market, to only be able to sell it in certain places. One good thing about the gene editing technology, though, is that it has democratized plant breeding. We’re seeing a lot more start-ups popping up in the US because we don’t have those huge regulatory burdens that we had with transgenics. So we’re seeing a lot more innovation.

IPW: What advice would you give to innovators and regulators?

HOLLY: For regulators, I would say the most important thing is just to get educated. Educate yourself about the science, and how it’s different from past years. Learn the differences between transgenics and next generation breeding technologies such as gene editing. Really dive into how they are drastically different, and whether or not it makes sense to regulate gene edited crops differently, when we could arrive at the same crop through traditional plant breeding. For regulators, the most important thing is to get educated, and once that happens I think we’ll have a regulatory scheme that everyone’s happy with.

For innovators, it’s really cool because it’s a wide open landscape as far as the traits that we can target now. We don’t have to just talk about increasing yields anymore. Now the genome is wide open. Any phenotypic trait that a plant breeder cares about now theoretically can be reached with these new gene editing tools. And so traits that we never would have thought about tinkering with in the past, we can now do targeted changes on those, and bring those new traits to market. So, for innovators, think creatively about new traits that people have never worked on in the past because now we can actually reach them with these tools.

IPW: Thank you.

Image Credits: Cooley LLP, Seed Innovation and Protection Alliance