Who Holds the Rights to AI-Developed New Drugs?

As the craze for creation and development using artificial intelligence (AI) continues, AI is being actively introduced into new drug development. However, as discussions about who holds the copyright for AI-generated images, music, and other works are gradually expanding socially, debates have also begun regarding to whom related patent rights should be granted in new drug development, where recovering development costs through stable patent rights is essential.

[Image source=Pixabay]

The Korea Bio Association's Bioeconomy Research Center published an issue briefing titled "The U.S. Begins Full-Scale Discussion on Granting New Drug Patents to AI Developers" on the 25th, covering these discussions.

According to the briefing, the United States Patent and Trademark Office (USPTO) collected opinions until the 15th on whether AI should be recognized as an inventor in pharmaceutical development. The inquiry included questions such as: ▲ How are AI and machine learning currently used in the invention process? Do they contribute at the level of a co-inventor? ▲ If AI contributes at a co-inventor level, can it receive a patent under current patent law? ▲ If AI contributes at a co-inventor level, does ownership belong to the natural person who invented the AI system, or does the person who created, trained, maintained, or owns the AI system also have ownership? ▲ If AI contributes to an invention, should current guidelines for inventors be expanded, and how should the importance of the contribution be evaluated? ▲ Are there laws or practices in other countries that effectively address inventions to which AI systems have made significant contributions? and so on.

Recently, as AI-based new drug candidate discovery and AI-driven drug development have gained attention, related patent discussions have begun in earnest. At an expert meeting related to the AI and Emerging Technologies Partnership operated by the USPTO, it was pointed out that new AI models are being used in new drug development, personalized medicine, and chip design, and that in some inventions today, AI and machine learning can contribute at the level of co-inventors.

AI helps new drug development by utilizing vast data sets to quickly identify patient response markers and develop drug targets more cheaply and efficiently. Global bio companies such as Bayer, Roche, and Takeda are also engaging in new drug development through collaborations with external companies possessing AI capabilities.

In particular, the pharmaceutical and bio industries regard patent rights as crucial because the new drug development process is "high risk-high return." It often takes more than 10 years from candidate discovery to commercialization, requiring significant resources. However, if successful in developing a first-in-class or best-in-class drug, the business can generate enormous sales protected by patent rights for a considerable period.

Therefore, the discussion on whether patent rights for AI-developed new drugs should be jointly granted not only to the drug development companies but also to AI developers is a significant issue for new drug companies. Moreover, if such joint patent rights are granted in the U.S., it is expected to have a substantial impact on patent laws and rulings in other countries.

Beyond new drug development, issues regarding patent eligibility for AI-developed inventions are being raised globally in various fields. Currently, major patent offices and courts in countries including Korea, the U.S., Europe, and the UK recognize only humans (natural persons) as inventors through patent laws or precedents and do not recognize AI as inventors.

The Biotechnology Innovation Organization (BIO) in the U.S. also defined AI as a "tool that facilitates human invention" in these discussions and submitted opinions to the USPTO stating that AI does not possess the purpose, motivation, or inventive capacity necessary to establish the concept of invention under current law, and therefore only humans can be inventors, not AI.

Meanwhile, the global investment bank Morgan Stanley forecasted that AI and machine learning-based new drug development will create a market value of $50 billion (approximately 66 trillion KRW) over the next decade. They analyzed that even a modest improvement in early-stage drug development success rates using these technologies could lead to the development of 50 additional new drugs, generating this market value. Furthermore, if AI is utilized in the preclinical stage following drug discovery, it is expected to reduce costs by 20% to 40%, enabling the successful development of an additional 4 to 8 new drugs.

In fact, investments related to this are rapidly increasing. According to market research firm Deep Pharma Intelligence, investments in AI-based new drug development companies have tripled over the past four years, reaching $24.6 billion (approximately 32 trillion KRW) as of last year. In January last year, Sanofi paid $100 million (approximately 13.19 billion KRW) as a contract fee to the UK-based Exscientia and agreed to pay up to $5.2 billion (approximately 6.86 trillion KRW) to develop up to 15 candidate drugs in oncology and immunology using AI systems.

This content was produced with the assistance of AI translation services.