Protecting AI-Generated Inventions: Navigating a New IP Frontier

Takeaway: While current U.S. law requires a human inventor for a patent, you can and must still protect your AI-driven discoveries by strategically patenting the novel inputs, AI-modified outputs, and the inventive ways humans use AI as a tool.

Synthetic biology and artificial intelligence are a potent combination, representing two of the most powerful technology platforms of our time. Startups that can successfully merge these fields—using AI to design novel proteins, predict metabolic pathways, or analyze complex biological data—are poised to create immense value. But this fusion also creates a profound and unsettled legal question: if an AI invents something, who owns it? Or can it even be patented at all?

The U.S. Patent and Trademark Office (USPTO) and the federal courts have been grappling with this question, and the current legal landscape is both challenging and evolving. For a founder in this space, navigating this new IP frontier is critical.

The Core Problem: The Human Inventorship Requirement

The central issue comes down to a fundamental principle in U.S. patent law: an "inventor" must be a human being.

In a series of landmark rulings, the USPTO and the U.S. courts have definitively stated that an AI system cannot be named as an inventor on a patent. The rationale is that the Patent Act consistently refers to an inventor as an "individual," a term that has been interpreted to mean a natural person. This was famously tested in the case of the AI system DABUS, where patent applications naming the AI as the sole inventor were rejected.

This creates an immediate challenge for companies at the cutting edge of generative biology. What happens when your AI model, after analyzing a billion protein sequences, designs a novel enzyme with incredible catalytic properties entirely on its own? If the AI is the "inventor," and the AI can't be an inventor, is the discovery simply unpatentable?

The Solution: Focus on Human Contribution

The current guidance from the USPTO provides a strategic path forward. While an AI cannot be an inventor, inventions that are created with the assistance of AI are patentable. The key is to focus on the significant contributions made by the human scientists who are using the AI.

A human’s contribution must be more than just recognizing the output of an AI model. To be considered an inventor, a person must have:

  1. Contributed significantly to the conception of the invention.

  2. Made a contribution to the claimed invention that is not insignificant.

This means you must shift your IP strategy from trying to patent what the AI did on its own, to patenting the novel ways your team used the AI as a sophisticated lab tool.

How to Protect AI-Assisted Inventions in Practice:

  • Patent the Input: Did your team develop a novel way to curate or structure the training data for the AI? The inventive step may have occurred before the AI was even turned on.

  • Patent the Human-Modified Output: Did the AI generate a thousand potential protein sequences, from which your scientists, using their own ingenuity and expertise, selected and then modified the most promising candidate? The resulting engineered protein is a human-led invention.

  • Patent the Process: Did your team design a novel process that integrates AI into a larger discovery or manufacturing workflow? For example, using an AI to guide a directed evolution experiment is an inventive process created by humans.

  • Rely on Trade Secrets: For the purely AI-generated discoveries where human inventorship is difficult to prove, or for the architecture of the AI model itself, trade secret protection may be your most powerful tool.

The law surrounding AI and inventorship is still in its early days and will undoubtedly continue to evolve. For now, the message is clear: focus on human ingenuity. By carefully documenting the intellectual contributions of your scientists in designing experiments, prompting the AI, interpreting the results, and refining the outputs, you can build a robust patent portfolio that protects your AI-driven discoveries and secures your place at the forefront of this technological revolution.

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.