In a fast-evolving pharma space, artificial intelligence (AI) has proven to be a two-pronged tool. The technology is aiding drug discovery at an accelerated pace but is also complicating patent acquisition, something that could deter billions in investments. One of the key issues is that AI’s capacity to generate ‘prior art’ or pre-existing evidence that a new invention isn’t novel, thereby negating its eligibility for patenting.
Many legal practitioners have started seeing AI-generated prior art present challenges in their clients’ patent application processes. The problem lies in the fact that AI can quickly churn out a multitude of potential molecules and subsequently create a large pool of prior art. This can hinder downstream innovation before scientists and companies even determine the utility of the prior art, as observed by Robin Feldman, a professor at the University of California College of the Law, San Francisco.
The implications of this are significant, as elucidated by Nicholson Price, a health law and intellectual property professor at the University of Michigan. He suggests that if pharma companies see that AI-generated prior art is blocking their efforts to patent the active pharmaceutical ingredient in a drug, they could be less inclined to invest in early-stage R&D that can lead to fresh treatments. As Price stated, “No one’s going to develop a drug if they can’t patent a drug,” pointing to the existing industry norm.
The human implications are not lost either. Without these investments, potential new medicines may never reach the public and the people who need them. This sentiment is corroborated by Joshua R. Rich, a partner at McDonnell Boehnen Hulbert & Berghoff LLP, who suggested that many new drugs that the public could potentially benefit from might never see the light of day due to these challenges.
The US Patent and Trademark Office (PTO) issued guidelines this February stating that while AI can aid inventors, wholly AI-generated inventions do not qualify for patenting. Yet, clarity on how AI-produced materials impacting prior art will be dealt with remains pending, though the office has pledged to examine the matter.
AI’s influence on drug discovery isn’t limited to potential obstacles. The pharmaceutical industry has been investing heavily in R&D to develop new pharmaceutical products and treatments. Firms such as Pfizer Inc., Sanofi SA, and Merck & Co have partnered with AI companies to utilize the technology for drug design. Morgan Stanley has estimated that AI and machine learning might generate an additional 50 new therapies over the next decade, opening up opportunities worth over $50 billion.
The potential stumbling block of AI-generated prior art does not render pharmaceutical companies powerless. For starters, patent applications based on AI content can be relatively easy to spot due to the absence of traditional research methods and the presentation of purely computational experimental data. Potential countermeasures include using the computational data as “defensive publications” to prevent other companies from patenting similar discoveries.
Legal professionals are also finding ways to navigate the AI landscape, including alternative means to describe inventions and establishing comprehensive evidence trails to validate AI-generated prior art. As the PTO deliberates on its course of action, the industries affected are busy advancing their strategies.
For more detailed insights, you can read the full report on Bloomberg Law here.