In our continuing series on lucrative micro-niche practice areas for lawyers, we examine synthetic biology and how lawyers and law firms can find a way to mine for business in this rapidly growing field.
“Biology is already changing the way we live, eat, manufacture, and treat human health. In the next few years, synthetic biology — a $40 billion industry — will be the premier technology of the 21st century that will be used to solve real-world problems facing millions.”
— Meagan Lizarazo, EVP at iGEM
What is synthetic biology? At a fundamental level, synthetic biology is an interdisciplinary area applying engineering principles to biology to better design and fabricate complex, biological components and systems having functions that do not exist in nature. The technology is quickly evolving, greatly expanding the utility of biotechnology for a variety of industries.
For law firms this field offers opportunities to help clients in legal questions over intellectual property; regulatory compliance; risk assessment; environmental concerns; and biosafety and biosecurity among other areas. For many law firm clients, such legal challenges related to biotechnology will be unfamiliar, and strategies relied upon by traditional biotechnology companies may not be a good fit for such clients.
Take intellectual property, for example. The pharmaceutical industry has traditionally widely invested in biotechnology for development of new drugs, such as biologics. In doing so, pharmaceutical companies invest heavily on building robust intellectual property portfolios, particularly large patent portfolios, for long-term protection of what is hoped to be a blockbuster drug. The length of time and financial investment required to bring a drug to market, combined with the significant anticipated revenue to be drawn from exclusivity of a blockbuster drug motivates such companies to invest both time and money to build robust patent portfolios.
Synthetic biology, however, has applicability in industries with significantly faster product turnover and even commodities-type products. Lega strategies for protection of synthetic biology innovations will need to be adapted to the market in which such products will be used.
Turn to Synthetic Biology for Innovation
Synthetic biology represents what I have come to label a tech-driven hybrid capable of being a technology disruptor to many conventional industries and particularly industries that are not even typically utilizing biotechnology.
If you are serving clients in a particular industry, you do not want to be the attorney who is asked “What do you know about synthetic biology?” and not have some kind of reasonable answer.
Here are some brief examples where the application of engineering principles to biology (via manipulation of DNA and other methods) are already having an impact:
- Industrial Chemicals — engineering bacteria to produce paints, adhesives, and cleaners;
- BioFuels — creating new renewable energy sources from microbes;
- Software — using more efficiently designed DNA sequencing (g. CRISPR editing);
- AgriBusiness — developing enzymes to improve crop yields and pest resistance;
- Consumer Products — manufacturing bacteria capable of producing collagen, which is then bundled to produce a leather hide;
- Food & Drink — producing synthetic wine without grapes; and
- Healthcare — discovering new pharmaceuticals and treatment diagnostics.
For example, in healthcare today, genetic engineers want to make bio-pot — a syntheticly engineered strain of marijuana — for fun and health. Synthetic-biology company Amyris believes it can genetically engineer organisms to manufacture cannabinoids, the active molecules in marijuana, more cheaply than by growing plants. If it works, cannabinoids could end up everywhere, in new forms, and reaching new people. Despite some moral qualms, the biotech industry is increasingly embracing the legal cannabis sector, which is growing rapidly on the back of spreading legalization in the U.S. and beyond.
Meanwhile, we can also view synthetic biology as its own emerging industry wherein innovative entrepreneurs are exploring how new cell-produced products might replace traditional industrial and chemical processes. Here are but a few examples of the kinds of companies you could be working with if you were developing a practice in this particular micro-niche:
- Ambercycle is working on cell-based alternatives to many of our polluting petroleum products, including plastics, by trying to make plastic recycling profitable and sustainable by using synthetic biology to engineer custom-tailored organisms that can degrade plastics into its chemical components.
- A bacteria found in the gut of a rabbit, identified by biotech start-up LanzaTech, can now help cars run in a more eco-friendly way by turning factory carbon emissions into ethanol, an alcohol that is blended with gasoline to reduce the amount of fuel used by cars.
- Similarly, C16 BioSciences, is making a lab-grown alternative to palm oil, which it claims is 20% cheaper and isn’t as destructive as the environmentally-devastating palm oil that is a common ingredient in many consumer products.
- Geltor is using synthetic biology techniques to engineer micro-organisms to produce animal-free collagen for the cosmetics industry. And, a German company, AMSilk introduced a liquid-silk coating (made from modified E. coli bacteria), for use in medical and cosmetic implants.
- Zymergen researches, develops, and manufactures microbes for Fortune 500 companies in areas of agriculture, chemicals, materials, pharmaceuticals, electronics, personal care, and more.
- Ecovative Design is a biomaterials company that provides sustainable alternatives to plastics and polystyrene foams for packaging, building materials, and other applications by using mushroom technology.
- Calysta is chiefly involved in the development of industrial processes that utilize micro-organisms to convert methane into protein for seafood and livestock feed and other useful products like fuel and plastics.
- Bolt Threads focuses on harnessing proteins found in nature — mostly using spider silk — to engineer renewable fibers and fabrics with both practical and revolutionary uses.
Indeed, this particular micro-niche even has its own annual international forum, SynBiTech, for experts engaged in synthetic biology research, commercialization, investment and policymaking in this area. SynBiTech 2019, held this past June in London, focused on the key opportunities and challenges for building a multibillion-dollar synthetic biology industry that will contribute to the fast-growing bio-economy.
The June event offered two days of intense presentations, even featuring a few presenters from the investment community… but not a single lawyer at the podium — a true sign of this still being an “emerging” micro-niche.
This article was co-authored by Jennifer Burnette, a partner at Marshall, Gerstein & Borun LLP in Chicago. Burnette’s practice focuses on patent prosecution and strategic intellectual property portfolio development and counseling for companies innovating in the areas of chemical sciences, materials sciences and biotechnology. She holds engineering degrees from Northwestern University and a law degree from University of Minnesota.