The use of 3D printers to create living tissues and organs is revolutionising medicine - but University of Queensland research reveals the legal system is struggling to keep up as the technology races ahead.
Lead researcher Dr Pratap Devarapalli from UQ's Law School said there are about 1,850 Australians on the organ transplant waiting list, with bioprinting emerging as a promising solution if supported by clear and flexible global patent laws.
"Patent law hasn't kept pace with what's scientifically possible," Dr Devarapalli said.
"The implications extend beyond medicine to fundamental questions about innovation policy.
"Ironically, the more realistic and medically useful a bioprinted organ is, the harder it becomes to patent because laws often require it to be clearly different from what exists in nature."
In 2025 the bioprinting market is estimated at $5.5 billion and is projected to reach $20 billion by 2034.
Patents give inventors temporary protection from copying and without them companies may be less willing to invest, slowing down progress in developing lifesaving medical tools and treatments.
The research compares how major jurisdictions including the US, Europe and Australia assess the patentability of bioprinted inventions.
Dr Devarapalli said the lack of consistency across borders creates legal uncertainty, especially when ethical concerns intersect with innovation.
"For instance, some patent offices may reject applications on the grounds that bioprinted tissues could resemble early-stage human embryos, invoking moral objections in decision making," he said.
Australia has adopted a new classification regulating bioprinted devices containing human cells as 'medical devices with biological components'.
Dr Devarapalli said this progress brought Australia's framework in line with European and US standards.
"While this requires stricter oversight, it also provides clearer pathways to commercialisation," he said.
"There needs to be balance between incentivising funding research and the greater good."
Dr Devarapalli will travel to Geneva this month to present on the topic at the United Nations.
The research was published in Nature Biotechnology and in Dr Devrapalli's book published by Springer Nature.
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