From Idea to Intellectual Property – Season 1 Episode 2: Synthetic Biology: Redesigning Organisms for Innovation

Lisa Leong:

Lab grown meat and gene snipping are no longer far flung ideas from the future. Instead, a lot of the technology is already here thanks to synthetic biology. So is it ethical to have your lab grown cake and eat it too? Hello, I’m Lisa Leong. This is From Idea to Intellectual Property, a podcast about today’s big ideas and the IP considerations behind them.

Karen Sinclair is a principal at Griffith Hack, and specialises in synthetic biology, and is the go-to person to help navigate this booming area of innovation. Now, before we get into futuristic ideas of synthetic biology, let’s rewind the clock and go back to the labs in 1990, where scientists were mapping the human genome. Can you tell me about that?

Karen Sinclair:

So this was like the holy grail. And for many years leading up to 1990, scientists had been trying to work out how to solve really gnarly human health problems, major diseases and genetic disorders, and the technology had gradually become available whereby parts of the human genome could be mapped. But there were some breakthroughs in the late eighties that allowed that to happen at pace.

One particular research group had this breakthrough, and started to map the human genome really, really quickly. And what that did was open up solutions to, like I said, some of those gnarly problems.

Interestingly enough, while everyone thought it would make information readily accessible to the world to solve problems quickly, we’re still using that information, and we’re still trying to understand exactly what it means, and we’re still only just starting out on that process of using the human genome to help us solve some of those gnarly issues.

Lisa Leong:

And how did those discoveries impact patents in this space?

Karen Sinclair:

Patents are governed all around the world by three basic principles. The technology that’s covered by the patent needs to be new. That is, it needs to have never been protected, or seen, or announced anywhere before. It needs to have a spark of genius about it, which is what we call inventiveness. And it needs to have some sort of usefulness, like it can’t just be a piece of information that has absolutely no utility whatsoever.

So with the human genome, whilst we all knew that there was a human genome, we didn’t know actually what was inside it. So as they started to map it, they started to discover it had particular sequences, particular codes. And as they gradually worked their way through, started filing patents directed to particular parts of the sequence. And at that stage, of course, they didn’t know what the significance of those sequences were. They just knew that one day, someday, they might be useful. And what they were trying to do was get the commercial leading edge on everyone else in the field.

What’s happened over the last 30 years is that, in fact, we do actually get patents for genetic sequences. And indeed, some of those sequences do correlate to sequences out of the human body. But the rules have developed over the years to say that you can’t get protection generally for pieces of information or genetic sequences that have the same information in them as what would be in the human sequence.

Lisa Leong:

So this is where synthetic biology comes in, doesn’t it, Karen?

Karen Sinclair:

That’s right. So you take bits of what you know and what you’ve sequenced, either from the human or from anything else, because all living things are made up of genetic sequences, so you take bits of those sequences and you stick them together. And that’s literally what synthetic biology is, is bits of genetic sequence stuck together to produce something which might be a replica of a biological outcome, or it might be an adjusted version of a biological outcome.

Lisa Leong:

Can you give me a practical example of one, please?

Karen Sinclair:

Well, look. The list is endless. Some Australian examples are for the use of engineered microorganisms to be able to eat pollution in waterways, the marking of male chicken eggs, so that in the egg industry, those male chickens are not culled. Once they’re hatched, those eggs, if they’re marked in a certain way to say flu arrest, because there’s a certain gene that marks the male chicken eggs can then be diverted off for other purposes, so for example, in vaccine therapies. And another really well known one is around what are referred to as vegan type foods.

Products that are built up out of protein sequences that are vegan friendly, because they’re not directly taken from animals, and substitute for food products that you and I would normally buy that come from an animal origin.

Lisa Leong:

Well actually, Karen, I’ve been working on something in my garage recently, and I was just wondering if you could talk me through how I might intersect a patent protection for my wonderful invention, if you don’t mind. So there is a signature dish that I’m quite well known for, and it’s also a published dish in an ABC recipe book. It’s called Lisa’s Lentil Slops. I’ve also cooked it for Yotam Ottolenghi, and he’s helped me really hone it. So I’m branching out, and I’ve made a burger patty. It is made from the proteins derived from this lentil dish. And I feel like this is the fake meat that we’ve all been searching for. So I want you to talk me through, please, the commercialisation aspects of this amazing invention. How would I go about patenting this imitation meat?

Karen Sinclair:

Yeah, well congratulations. Australian science and innovation is well known for its blue sky research, and it sounds like you’ve done some great stuff in your garage. So are you quite right… The key now is to get that to market, so you can get a return on all the investment that you’ve made, all those flights to London that you’ve made to meet with Yotam Ottolenghi.

So the first thing is that we need to make sure that no one’s done this before. Because as I said, there’s these three fundamental rules about getting protection of IP, and one of them is that it has to be new. So the first thing I would say to you is you said you’ve developed this recipe with Yotam, but did you leverage anything from Maggie Beer, or from Curtis Stone, or something? And is it really different from what they’ve done? So I’m going to assume that it’s really different. So it’s new, and you said that it’s taken quite a lot of work in your garage, it’s taken you a long time. I imagine you had a few flasks boiling away there.

Lisa Leong:

And weird smells, I must admit.

Karen Sinclair:

Weird smells and curly proteins that are actually invisible, but we can see them in the bottom of your flask. And so I’m going to say that it’s taken you a lot of effort and then a few hairpin turns and right hand turns from the normal, and we’re going to say it’s inventive. And we know it’s useful because you’ve made these amazing lentil burgers. So what we need to do is we need to work out what those proteins that you developed actually are. So I’m going to tell you to go off to a bit of a lab, and they’re going to do some sequencing, and we’re going to get the sequence of the proteins that make up that lentil burger.

And then, the process around the world for getting IP protection or patent protection is pretty much the same. And fundamentally, we have to write down in a document that we call a specification exactly how you’ve made your invention. So exactly what it is, so we need that sequence of your protein, and we need to be able to describe how someone else can make that again in future. And we need to describe how it’s useful and we need to prove that, let’s say, it’s tasty, it’s not toxic, it’s going to stick together in a lentil burger, so it’s got some utility.

And we do all those things in this specification. And then, all around the world, there are regulatory authorities set up by governments which test whether this specification measures up against the particular patent laws in that country. And so, over a space of at least months and generally speaking years in some places, quite a long time, it goes through that process. And at the end of the day, a government will say, “Sure. That specification in which you described your invention actually measures up to our regulatory standards, and you can have a patent on this.” And what that means is that you have the right to stop Curtis Stone copying your lentil burgers.

Lisa Leong:

I’m calling them Lisa’s Leef Burger, because it’s like lentil and beef mushed together.

Karen Sinclair:

Oh, very creative.

Lisa Leong:

Now, as you mentioned, it’s highly competitive, and it’s a bit like trying to land someone on the moon. We’re all trying to perfect the greatest fake beef burger on this planet. With your experience, what are some of the key obstacles facing Aussie companies like mine trying to operate in such a competitive space?

Karen Sinclair:

So the first thing I would say, Lisa, is you need to know who’s who in the zoo. So the first thing I like clients to do is actually do a bit of a landscape review, so see if Curtis Stone or someone else is actually generating the same technologies. And that’s not just in Australia, that’s all around the world. So Australians like to jump in feet first, and it’s not inexpensive to do these things, so quite often, they skip that first step. But I think doing that first step really gives you not just a good perspective on whether your business has got a product which is going to be unique, but it also tells you who else out there you might be competing with. And that’s really important, so that you know where to go, and who to partner with, and how to price it.

And then the next thing is to find someone who’s going to back your business, who’s going to help you raise the money that is going to allow you to scale this product, and who’s going to have contacts that allow you to meet the right people who are going to sell your product. Because after all, you’ve already got a really good day job, so you need other people to help you get this product into the marketplace in a way that is at sufficient volume, so that you can get a return on your investment.

So some of the obstacles that Australians face are around trying to find that capital investment. In Australia, particularly in the technology sectors, our companies tend to have to go to the stock exchange much faster than they do in other parts of the world. And in raising capital through the stock exchange, it can tend to be a bit impatient. Investors want a return on their investment really quickly, and technology such as synthetic biology can take a long time to come on stream, and market investors don’t necessarily have the patience to wait that time out.

And it also comes with a lot of governance requirements. There’s all sorts of obligations that you have to fulfil to the ASX and under the Corporations Act, and they can take up a lot of time and money too. And I would prefer to see more companies delay going to the stock market more than they do. But then, where else do you go? The government has some good support for startup technologies, but it’s fairly limited. And so then, classically, people go to the triumvirate that’s fondly known as friends, family, and fools. Finding the right money, which is going to be patient enough and which is going to leave you with some equity in your own business is really important thing to do.

And then, trying to find those partners that are going to help you take it to market. And finding a partner is really important. It’s very hard to do this by yourself, and particularly from Australia, where we’re a reasonable market, and particularly in food. We go back to Lisa’s Leef Burgers, the food market is one in Australia which is sizeable enough for a company to do good business. But for more complicated forms of technology, so for medical versions of synthetic biology, for example, there’s no way a company here could get a return on their investment, so they need to go offshore. So finding those offshore partners is really important.

Lisa Leong:

What are the ethical issues I need to be aware of starting a business in this synthetic biology space, to make sure that my Leef Burgers are all above board, of course?

Karen Sinclair:

Yeah. So there’s probably not too many ethical issues around your Leef Burgers, I’ve got to say.

Lisa Leong:

I have to harvest lentils, though.

Karen Sinclair:

Well, what I was going to say is that actually, your classic vegan burger, which is not derived from lentils, but in fact is derived from animal cells, I think that’s probably one of the ethical issues that perhaps hasn’t been really well understood in the marketplace. Your average vegan eats vegan because they have a view about the ethics of eating products derived from animals. But in fact, synthetic biology-created fake meat burgers are in fact derived from animal cells. It’s just that they’re cultivated in a laboratory environment, rather than being taken from an animal. So there’s kind of an ethical issue there, which is perhaps not widely understood.

But if you go to other products, if you go to medical products for example, there’s lots of ethical issues around whether it’s morally appropriate, ethically appropriate to be allowed to take bits of genomes and stick them together. There might be side effects that might be negative. So for every faulty gene you might fix, you might break other genes in other part of the genome.

There are ethical issues around, for example, things like if you then allow gene editing, which is becoming much more common, at least scientifically, does it open it up for people who are, let’s say, on the margins of society to start, for example, selling the proposition that they can select for blue-eyed babies, or fair-haired babies, or tall babies, or short babies. We go back to the days of eugenics in the Second World War and some really uncomfortable concepts about whether it’s right or not to be artificially creating biological species, not just humans, but obviously animals as well.

Lisa Leong:

So you’ve been in this industry for a long time. You’ve seen it develop over the years. What excites you the most about where we’re headed?

Karen Sinclair:

What I love is just being at the leading edge of technology all the time. And in 30 years, this is going to really date me, when I studied what was called biotechnology at university, it was about the mass fermentation of E. coli and a big vat. Technology-wise, biotechnology these days extends into all these potentially amazing applications and synthetic biology, being able to cut and dice gene sequences to, like I say, save some of the world’s endangered species or resolve terrible diseases. So what really excites me about working in this industry is seeing that pipeline of positive change come through our community all the time, and knowing that it’s incentivized, at least in some small part, by that IP system, brings you back to work every day.

Lisa Leong:

What makes you nervous about developments in this space that we should look out for?

Karen Sinclair:

That’s a really good question. I think that probably, again, in the medical space is the most capacity for abuse. And I don’t mean in trying to create babies with blue eyes. I mean get synthetic biology into the hands of some of the world’s craziest people, and you start to be able to create crazy synthetic nerve gases or something like that. Take COVID to its extreme, and a crazy dictator could release a synthetic biology product into a community and create havoc.

So it’s going to be really important that these technologies have a strong regulatory regime around them, and patents is one very, very, very small part of that. There are already global treaties and conventions that deal with, for example, nuclear weapons, and there’s probably going to come a day where we need to have similar things around biological weapons. I think there maybe already are nascent treaties and conventions around biologic weapons, but that sort of thing is probably going to have to really ramp up to be able to deal with some of the extremes.

And we need to make sure that, like I said, we’re not getting offsite effects of some of these changes that we’re making to genetic sequences. But scientists are pretty good at making sure they do things very, very thoroughly, and human beings are naturally cautious and conservative, so I’m optimistic that we’ll work our way through that.

Lisa Leong:

And Karen, just wanted to make sure that you got the early offer for investing in my Leef Burger company. Are you in?

Karen Sinclair:

Yep, I’m in.

Lisa Leong:

Excellent news.

Karen Sinclair:

I wonder which category I come under. I’m not family, so maybe I’m a friend or maybe a fool.

Lisa Leong:

I wasn’t going to say, Karen. Thank you so much, Karen.

Karen Sinclair:

It’s been an absolute pleasure, Lisa. Thank you.

Lisa Leong:

That was Karen Sinclair, principal at Griffith Hack. Thanks to our producer, Kara Jensen McKinnon. And this podcast is brought to you by IPH, Asia Pacific’s leading intellectual property services group, helping you turn your big ideas into big business. I’m your host, Lisa Leong. Bye for now.