SynBioBeta had the privilege of talking with Terri Shieh-Newton, life sciences patent attorney and partner at Mintz Levin, who discussed with us her background and expertise, as well as advice for entrepreneurs in the synbio space.

What are some of the challenges that early stage bioentrepreneurs have to deal with that their academic training has often not prepared them for?

One of the most significant challenges is adjusting to the very different approaches to information sharing taken in academia and business. An academic’s instinct is to share discoveries, protocols, and maybe even reagents. When starting a company based on that same type of information, it should not be shared until it has been vetted for intellectual property protection. The IP protection can be a very valuable asset available to the business and helps to avoid misunderstandings in the future that could be costly. The idea that one has to patent something or hold off on disclosing something before sharing that information is part of the education process of switching over to an early-stage company setting. For the entrepreneurs who haven’t dealt with IP before, that can be kind of challenging. They need to understand that the long-term health of the company requires this adjustment. Investors want to see a strong IP position, so protecting innovations is important to fund-raising efforts. They will also want to see that entrepreneurs are filing patents strategically and coming up with a long term plan for their IP. Investors will do their due diligence to determine what you are filing on, the strength of your IP protection and assess if you have what you really need to protect in order to be a successful commercial enterprise. It’s fine to collaborate with others, but only after some of this protection has been set up.Correlated with that is the sharing of data in situations where people have their buddies at other institutions run certain experiments and get data from them. From a pure academic setting, it doesn’t seem like there’s anything wrong with that, but we’ve had to help companies untangle ownership of the data when the other university is coming in saying, “Hey, we own part of that new company now because you took information that belonged to us or you took our data or you took some reagents from our professor, and even though that professor gave it to you freely they are under an obligation to us. So we own part of your new company.” I think that’s something that is definitely a hiccup that some academics-turned-entrepreneur don’t anticipate.

So what do you think about the potential for open-source biology? As in certain genetic sequences that aren’t patented, foundational tools that aren’t patented, or a community that tries to create a pool of royalty-free intellectual property. Do you think there is any room in the biology space for some sort of open-source framework to emerge that value can be then built on top of?

If you overlay that question with existing case law that basically says that genomic sequences per se can’t be patented (e.g., Myriad Genetics), then that begs the question, if you can’t patent the sequence anyway, can it be open source so that everybody can benefit from it? Maybe you have to take that sequence and you have to tweak it in some way to get it to work for what you intend for it to do—maybe you have to codon optimize or you have to put it in a different vector and use different types of promoters—but basically you’re changing the sequence to be different than what it would be in nature and have a different functionality. The subsequent product that is engineered synthetically is patentable, but the underlying information (the genetic code) could be freely shared. That’s a possibility that seems to make sense in the context of existing case law.

Can you describe some specific situations in which you and/or Mintz Levin have helped clients take advantage of opportunities in this space, intellectual property and corporate law in particular?

One of the things that we’ve worked with multiple clients on is helping them understand the IP landscape and what is and isn’t out there in terms of protection of, for example, an entire pathway or certain enzymes or certain substrates. As you know, a lot of this metabolic engineering has upstream and downstream effects. By just focusing on one enzyme that is part of a complex pathway, maybe you’re creating cytotoxic byproducts that are going to kill the cell anyway, so you have to do something else. So I think having a big-picture understanding of the different biological pathways helps inform the company of their resources as they’re deciding their R&D plans and how time and money will be allocated. As we all know, it’s not easy to engineer a biological pathway in an organism. You don’t just go into a lab for a couple of weeks and make a couple of tweaks and poof, you have it! There are a lot of different effects that are not anticipated. We help clients understand the potential impact of those effects by providing insight into the overall IP landscape and knowing where other companies are operating. For example, a company may have IP upstream from where you are tinkering downstream, and as a part of your process you affect something upstream - your company is then inadvertently infringing. The same thing can be said about downstream effects.Depending on what sort of IP is out there, we ask whether it makes sense to go down a particular path. This is especially helpful if the company is early stage and still has the flexibility to take different paths to minimize hitting patent roadblocks in the future.With respect to corporate law, right now I’m working on the formation of a company based on their IP. The type and structure of company and the source of its IP sort of go hand-in-hand. Different structures can be used based on whether a good chunk of IP must be licensed, whether the company is creating it themselves, or they have to work with an institution and what kind of royalties (if any) have to be paid to third parties. How the company is going to operate is affected by what’s out there in the IP space. What kind of IP landscape do they have to navigate? Is the IP landscape a total minefield or is it a pretty clear field? That will help determine which paths the company can take, and depending on that path, they will have to use a different corporate structure.

What is your training in biology and what other training or degrees do you have?

My bachelors’ degree is in Biochemistry from Rice University. After Rice University, I spent time doing research in the laboratories of two Nobel Laureates. Then, I went to Johns Hopkins School of Medicine where I got my PhD in Cellular and Molecular Medicine and Immunology. After graduate school, I went to law school. So those are my degrees, but a lot of my training is just being in the biotech field for almost 20 years and working with lots of different technology and inventions, including the genetic engineering of different organisms. There are companies I’ve worked for which are doing a lot of metabolic engineering to make target products.

How did you find your way into the field of law?

I discovered in grad school that I really loved the science and learning about the new discoveries of science and the underlying mechanisms and theories of how and why it worked, but that I just wasn’t the type of person to be working at the bench. I wanted to translate my technical background and love for scientific knowledge into helping companies bring their technology to fruition and to help other people. Patent law was something that seemed like a natural transition. It allows me to use my rigorous scientific training and apply it to helping companies and universities.My experience working at the bench helps me solve problems when working with clients in order to put together a strong portfolio. I am able to help them think about what else they need to protect or what other data they need to gather. I can actually help suggest experiments that can be run to help them get the most robust patent protection possible. I think if you don’t have that graduate school experience of doing lab work at the bench, then it’s hard to have that conversation with a scientist. In addition, it is more efficient and easier for the scientists because the scientists don’t have to spend time to explain the technology to me - they can just speak like they would to their other scientific colleagues and I can follow the technical discussion easily with my scientific background.

What kind of projects are you currently working on and which do you enjoy the most?

We are engineering different microorganisms to produce different target chemicals for making rubber, polymers, plastics, fragrances or food. I also do a lot of CRISPR work with cell therapy, both ex vivo and potentially in vivo cell therapy.Want to learn more about Terri and the work that she does? Join us at SynBioBeta SF 2017, where Terri will be speaking on the Biomaterials and Consumer Products Panel (sponsored by Mintz Levin) alongside other industry leaders.