How Life Sciences Companies Can Best Protect and Monetize Their AI-Driven Innovations

The life sciences industry is among those most dramatically affected by artificial intelligence, and that innovation has reached an inflection point, Quinn Emanuel partner Sandy Haberny writes in Law360.

Dr. Haberny, who holds advanced degrees in molecular pharmacology from the New York University School of Medicine, offers an urgent and detailed analysis of the legal framework for that innovation, and suggests what companies in this area need to be thinking about – and doing – to advance and protect their intellectual property.

She notes that AI has become essential for screening molecular candidates, identifying biomarkers and personalizing treatments. This innovation is shaking up a patent system long centered on human creativity, she says, forcing the industry to revisit long-settled questions of what can be patented, who qualifies as an inventor and what counts as prior art.

Dr. Haberny is ideally positioned to survey this fast-changing terrain. She has litigated, advised clients, and tried cases on a range of complex technologies, including molecular diagnostics in the cancer, transplant, and prenatal fields, DNA sequencing, CRISPR therapies, and many more.

In her article, she looks at the new challenges of proving human inventorship, since an AI system cannot be a named inventor on a U.S. patent. She also examines the tension over patent eligibility between the more restrictive legal framework built on a pair of landmark Supreme Court decisions from more than a decade ago and a high-impact, more permissive decision last year in U.S. District Court for the District of Delaware.

And she writes that we may be missing one of the biggest threats to life sciences IP portfolios in the proliferation of AI-generated prior art, and how the central questions of what legally constitutes obviousness and a “person of ordinary skill in the art” are shifting beneath our feet in the age of AI.

This surge of developments in the life sciences means companies must make AI patent strategy a board-level concern, Dr. Haberny counsels. She ticks off the steps to take right now to best protect and monetize your company’s AI-driven innovations.

Her crystal-clear analysis is here.