Patentability of 3D bioprinting technologies
<p dir="ltr">The patentability of biotechnological inventions has been hinged on the dichotomy of discovery and invention. This entry examines the example of 3D bioprinting used in healthcare and applies relevant patent rules to its application, debating whether a 3D bioprinted human...
محفوظ في:
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| منشور في: |
2025
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| الملخص: | <p dir="ltr">The patentability of biotechnological inventions has been hinged on the dichotomy of discovery and invention. This entry examines the example of 3D bioprinting used in healthcare and applies relevant patent rules to its application, debating whether a 3D bioprinted human body part is an <i>invention</i>. I draw on the discussions primarily from the European and the UK contexts while comparative cases from other jurisdictions (US and Australia) are drawn as appropriate.</p><p dir="ltr">A 3D bioprinter is a robotic device instructed by customised blueprint of a patient’s scanned data as software, using living cells with a view to recovering wounds on the human body. The production of bioprinting typically involves three phases: pre-printing, printing and post-printing stages. The patenting cycle of producing a 3D bioprinted human organ involves the biomaterials or bioink used as starting materials in a bioprinter, software, the bioprinting method/process, and the final surgical implantation onto the human body (Li 2014). Below are the relevant issues to consider:</p><p dir="ltr">(1) The <i>morality</i> exclusion when using human embryonic stem cells for the bioink culture.</p><p dir="ltr">(2) The hurdle of patenting software or algorithms for printing will be assessed via the technical contribution and the problem/solution approach.</p><p dir="ltr">(3) The robotic 3D bioprinter as a medical device could be patentable as it is an apparatus for treating illness.</p><p dir="ltr">(4) The <i>in vivo</i> bioprinting process may not be patentable if practiced on the human body due to the medical treatment exception.</p><p dir="ltr">(5) <i>In vitro</i> bioprinted (functional or cosmetic) human organs may be patentable.</p><p dir="ltr">(6) The implantation process of a bioprinted organ should be caught under the medical treatment exception as it is a surgical/therapeutic method on the human body.</p><p dir="ltr">Patents can be granted to both products and processes when applications fulfil the requirements of novelty, inventive step, industrial application, and not excluded from patentable subject matter. The WTO TRIPS Agreement and the European Patent Convention (EPC) recognise the <i>morality</i> or <i>ordre public</i> exclusion and the medical treatment exception when human life or health is at stake. The medical treatment exception is set out in the EPC Art 53 where methods for treatment of the human body by surgery or therapy and diagnostic methods practised on the human body are excluded from patentability. However, medical products, such as substances, compositions, apparatuses (such as bioprinter, electrocardiogram, ECG, prosthetic ball and socket joints or pacemakers), are not excluded. This entry considers the above selected examples of patenting bioprinted human organs as product patents (item 4) and the bioprinting processes as relevant to the medical treatment exception (item 5).</p> |
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