Dr. Terri Shieh-Newton’s expertise in both legal and bioscience domains has made her a leader in synthetic biology intellectual property. Her practice at law firm Mintz Levin focuses on building valuable patent portfolios with creative patent strategies and portfolio management. She has also worked with venture capitalists on due diligence assessment for investments and landscape analysis for formation of new funds and companies. What’s more, she is a strong proponent for gender equity in bioscience, law, and synthetic biology specifically. Here’s my conversation with Terri, edited for brevity and clarity.

You hosted the Women Leaders in Synthetic Biology breakfast at SynBioBeta. What were your big takeaways from that meeting?

One of the things that struck me was that it was pouring rain, and I was thinking, “Oh my gosh, nobody’s going to come.” It was also early in the morning and there was an event late the night before. And yet, the room was packed. That tells me there's a lot of interest and support for this topic.The participants were incredible. Christina Agapakis (Creative Director at Ginkgo Bioworks) and Una Ryan (an angel investor from ULUX)) were very animated and had very different viewpoints and interesting career experiences. Una shared some stories about the multiple opportunities that she has taken to mentor young women. I think it’s great to have that willingness to help the next generation.One thing that resonated was making sure that you connect with other passionate, like-minded individuals, and not necessarily other women. Although was mostly women, I was thrilled to see men in the room. I think it's great that there were male supporters making sure that we do what we can to create opportunities and advance awareness for women in the synthetic biology industry.

Is it a good time to start a biotech?

It does seem like a great time here to start a biotech company. New technology is always welcome. The challenge comes with the cyclical nature of funding -- there'll be times when there are huge booms, and funding will be easier. It also depends whether we’re talking about angel investments or more established companies going into the capital markets.I think this year’s JP Morgan (JPM) conference was a little bit more subdued, with the market not as good as it was a year ago and less attendees. So if you're at that point of your company where you need money and you were hoping that JP Morgan was a good time to get some deals done, then it may not have been a great outcome for those types of companies. However, meeting with your network of supporters and contacts in the investment space during JPM can be very helpful to get the conversation moving for possible deals.

What funding challenges do you see for biotech companies?

When we talk about the challenges of starting a company, it's not just about the science.

There are plenty of companies that have great science, but you also need the right management team and investors (many of whom will become board members). Sometimes investors come in and don't agree with the leadership of the company. In that case, we see that a huge amount of time and energy spent on those internal disputes rather than advancing the company’s technology. Another challenge is that governmental shutdowns, which can affect the deal flow. Deals were put on hold with the SEC closed during the partial government shutdown. Once the SEC re-opened, there was a huge uptick in capital market deals. Thus, companies are subject to events over which they have no control so they need to have contingencies plans.You might say that these types of problems are only for public companies and it doesn’t matter for start-ups, but I think it has a trickle-down effect. It's really part of a big ecosystem and they all feed each off other.

How tightly linked is the synthetic biology industry to the broader, more established pharma/biotech industry?

I don't think they necessarily track each other, but they are related by the general market’s appetite for different technology and new solutions. we see more interest in synthetic biology and newer technologies these days. If you’re talking about synthesizing a new small molecule, that’s not as sexy or cool as evolving a a technical advantage over traditional CRISPR or other new gene editing technologies. In synthetic biology, you're not going to be competing against pharma companies who are reporting on positive clinical trials results at JP Morgan. But to the extent that are trying to get solutions out to the market to help patients, then I do think the two are part of a larger life sciences ecosystem and can affect each other.

Is it harder for a woman to get startup funding?

When a company is trying to raise funds and is having trouble, it's hard to pinpoint why that is. Is it because the general market is not great for fundraising? Is it because of the company technology? Or is it something else? Those are question marks.

There is a perception that - whether right or wrong -- the investment network might be exclusionary, and maybe that’s not intentional.

There are investors in the synthetic biology space who are more mindful by saying that we're supporters of women and synthetic biology, we believe that gender diversity in the industry is important, and one way that we can be part of the solution is to be more intentional and more thoughtful about how we want to invest. It's not only about a cool new technology or science, but also the people behind it.

You are active in your local school board. How well do you feel your district is doing in preparing children for tech careers as well as being aware of gender equity issues?

I sit on different school committees and citizen’s advisory boards in the Cupertino area. The Cupertino School District and Fremont Unified High School District do a really great job of preparing our children for tech careers in a gender-independent manner. They have teaching synthetic biology. What they're teaching now in middle school and high school seems far more advanced than the education that I received when I was my child’s age. The classes in the school districts also apply the teachings towards real life, so they'll have programs (as early as middle school) where you can create and run a startup company. Growing up, there's no way that I would have ever had an entrepreneurship class where you can take your startup idea and create a business model, build a prototype, pilot it, and then pitch it to potential investors. I think that’s very uniquely Silicon Valley.

What qualities do you feel are most important for women mentors?

I am lucky to have had a great mentor much of my career, a woman with a sense of quiet confidence and authority that allowed her to do excellent work at a really high level while mentoring the next generation. She was confident enough in her own abilities that she was willing to help other people, like me. You would think that would be pretty self-evident for a business to groom the next generation of leaders, but many people will act in their own self-interest, even if it is to the detriment of the company overall. For some people, if they're in a position of power and/or rank, they will try to hold on to that power and rank and not help those around them because that mentee might pose a threat to their hold over power and rank in the future. That’s sad but it’s the unfortunate reality. It takes a very special person with a generous spirit to be able to have the confidence in their own abilities to help someone else develop to their full potential. For my mentor, that classy and generous attitude made a pretty loyal following on her part.One lesson that I learned from my mentor is that you can still continue to do good work and help other people at the same time. You don't have to knock other people down to get ahead. That's one of the things that we talked about at the SynBioBeta Women Leaders breakfast. You can help other people and still be successful yourself.

Thinking about patent thickets and high-profile patent disputes among overlapping claims, can patents serve to hinder innovation?

The subject matter covered by the patent is important. So where the patents can potentially serve to hinder innovation is when they're not drafted very well and the claims are not articulated very well and the patent holder aggressively asserts the patent in a way to hinder research. One patent involved in the subject matter eligibility issue is the BCRA2 gene. There is not any dispute that it is very useful as an early predictor of breast cancer, but there was controversy of the patent claims and how the patent holder used the patent. Legal challenges came in, and you started to hear people say, “Wait a minute, you can’t claim that gene, that’s in my body.” So then the Patent Office and the courts weighed in, saying that you can't patent natural phenomena and attempted to give some guidance. To this day, the case law is not fully settled so there is unpredictability for inventors still.The whole quid pro quo of patents is that you get a 20-year monopoly in exchange for sharing your knowledge. If you have to sink $700 million to bring a drug to market, then there needs to be some incentives for that investment. The patent system provides that incentive by preventing other competitors swooping in and copying the invention without doing any of the hard work of research and development done by the patentee.

How can we improve the USPTO examination of biotech claims?

It's about consistency between the examiners. In the biotech art units, you can get a very different response from one examiner to another examiner. Some examiners will apply a very strict interpretation of the case law and USPTO rules while other examiners will be much more relaxed and allow just about any claims without subjecting those claims to the same rigors of other examiners . So you want a system that's fair for all patent applicants.

You don't want to start prosecution feeling like, “Well, it's the luck of the draw.” You want something that’s decided on the merits, not the examiner to whom your case has been assigned.

So if there could be more consistency and quality control, even within a specific biotech unit, for example, then I think there would be a little bit more confidence in the patent system.

What’s the most exciting thing in biotech for you these days?

One thing I'm pretty excited about and spoke to last year at SynBioBeta 2018 is how much artificial intelligence (AI) and biology are intermixing now. They used to be pretty separate, but now they are coming together in many areas from better diagnosis to better protein design or enzyme design or drug design itself. We’re using machine learning to design the drugs as opposed to using only high throughput screening. There's a learning process that makes the process much more efficient. I think that's just going continue forward into targeted therapeutics; for example, how to get drugs through the blood brain barrier for addressing neurodegenerative disease like Alzheimer’s. There is specific learning that the application of AI can use that previously, human beings weren't really seeing before. That, to me, seems very exciting and something I'm definitely keeping an eye on and blogging about as well.