IP as an Ongoing Process: Adapting Through R&D and Clinical Trials
Takeaway: Your intellectual property strategy is not a static document locked in a vault; it's a living, breathing part of your R&D process that must be continuously updated to protect the new discoveries you make on the path to commercialization.
Many founders treat their initial IP filing as a one-and-done event. They secure their foundational patents and then turn their full attention to the lab, believing their IP is "handled." This is a dangerous misconception. In synthetic biology, your most valuable discoveries and most defensible patent claims often emerge after the initial company formation—during the iterative cycles of R&D, process scale-up, and preclinical or clinical trials.
An IP strategy that doesn't evolve with your science is a strategy that is failing. It leaves value on the table and creates vulnerabilities for competitors to exploit. Protecting your innovation requires treating IP management as an ongoing, active process that is deeply integrated with your scientific and clinical milestones.
Integrating IP into Your R&D Cadence
The key is to create regular checkpoints in your R&D workflow to pause and ask, "Have we created something new and valuable that we need to protect?"
Quarterly IP Reviews: Establish a routine of meeting with your scientific leaders and your patent counsel every quarter. The agenda should be simple:
What new discoveries have we made?
Have we developed a new, more efficient process?
Have we generated surprising or unexpected data?
Have we identified a new application for our core technology?
Invention Disclosure Forms: Foster a culture where scientists are encouraged and trained to formally document their discoveries using a simple invention disclosure form. This creates a clear record of the invention, the inventors, and the date of conception, which is invaluable for your legal team when drafting new patent applications. This internal disclosure process is also a critical safeguard; it ensures that a formal record of an invention is created before any public disclosure (like a scientific abstract or conference presentation) that could jeopardize your ability to obtain patent rights in many jurisdictions.
Adapting Your Strategy Through Clinical Development
As you move your product toward the market, particularly in the therapeutic space, your IP strategy must adapt to protect the specific data and formulations that will define your commercial product.
Protecting New Formulations: The formulation you take into clinical trials may be different from your initial lab prototype. These new delivery methods or compositions are themselves valuable inventions and should be protected with new patent filings.
Patenting Methods of Use: Clinical trials often reveal new and unexpected uses for your technology. If you discover your therapeutic is effective against a different indication than you initially anticipated, you can and should file a "method of use" patent to protect this new application.
Leveraging Data for Broader Claims: The data from preclinical and clinical studies can be used to strengthen and broaden the claims in your existing patent applications. This data provides the evidence needed to support claims about your invention's efficacy and utility.
Your IP portfolio should tell the story of your company's scientific journey. It begins with a foundational patent on the core idea, but it grows and strengthens over time with supplemental patents that protect the iterative improvements, the hard-won manufacturing know-how, and the specific clinical applications that ultimately create a successful product. By embedding IP review into the rhythm of your R&D and clinical programs, you ensure that every step of progress is a step toward a more valuable and more defensible company.
Disclaimer: This post is for general informational purposes only and does not constitute legal, tax, or financial advice. Reading or relying on this content does not create an attorney–client relationship. Every startup’s situation is unique, and you should consult qualified legal or tax professionals before making decisions that may affect your business.