Before You Begin: Commercial Potential and Freedom-to-Operate

Takeaway: Before launching a synthetic biology startup, it is crucial to thoroughly assess the commercial potential of your idea and conduct a freedom-to-operate (FTO) search to avoid infringing existing patents, which are particularly complex in this field.

Starting a new business as an entrepreneur in life science and healthcare introduces a new level of legal considerations, which are important even at the earliest stages of your company. Your initial actions as a founder can have lasting implications. Therefore, creating a strategy early on to protect your ideas, finances, and opportunities will better prepare you throughout your company's lifespan.

Assessing Commercial Potential

The first step in launching your synthetic biology startup involves an honest and in-depth assessment of the commercial potential of your research. This means studying the potential market need and size for your prospective product. Identifying a viable and ultimately profitable customer base, or "total addressable market," is essential. Scoping out the potential "upside" of your business is a key factor for attracting investors and justifying your idea's overall value. Academic founders often start this assessment by disclosing their idea to their university's Technology Transfer Office (TTO).

Understanding Freedom-to-Operate (FTO)

Parallel to assessing commercial potential, it is paramount to conduct a Freedom-to-Operate (FTO) search. An FTO search determines whether your idea, which could eventually become a product or process, would infringe any existing patents held by others. It is important not to confuse the patentability of your own findings with FTO; your patents might block others from doing the same thing, but an FTO search provides assurance that you are not blocked by others from practicing your invention.

The intellectual property (IP) landscape in synthetic biology is particularly intricate. There are problematic foundational patents that, if licensed or enforced inappropriately, could hinder the technology's potential. Additionally, there is a proliferation of patents on basic synthetic biology "parts," which can lead to complex "patent thickets." These patent thickets are especially problematic when they apply to standards that synthetic biologists aim to establish. The FTO search is valuable because it can also help identify a path to develop a workaround if existing patents pose a challenge. While some companies may rely solely on proprietary know-how without patent filings, this is less common in the biotech field.

Prioritizing IP protection, including patents, licenses, and trade secrets, is crucial for life science and healthcare startups. This protection safeguards your core innovation, such as a medical device design or a drug formulation, and helps preserve your startup's brand identity and control over its reputation. IP protection is an ongoing process; as your business refines through research, testing, or clinical trials, you may need to revisit your IP portfolio.

If the FTO search and market opportunity assessment are encouraging, and you and your institution's TTO are in agreement, this forms the crucial initial momentum for establishing your new company. Integrating legal hygiene into your daily business operations from the start can prepare your startup for future filings, audits, and key events, ultimately saving time and costs.