Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D  Bioprinting

Introduction:  

In the last few years, 3D bioprinting has emerged as one of the most mind-boggling technologies  in the intersection of both the medical and the biotechnological field. By combing engineering,  biology, and advanced computer assisted designs, this technology makes it possible to create living  tissues and potentially even full functional organs such as the company Organovo which established a liver known as ExVive Human Liver tissue. It is known as the first commercially  available 3D- bioprinted human liver tissue which enables advanced drug toxicity testing and  others. (¹)

Such innovations hold immense promise for regenerative medicine, organ transplantation, and  drug testing, which offers possible solutions to supersede the challenges that arises from organ  transplantation. (²)

However, with every scientific innovation comes a set of legal and ethical challenges. One of the  most fundamental areas that I am going to tackle throughout this research paper in 3D bioprinting  is intellectual property (IP) law.

As bioprinters, bio inks, and digital models becomes increasingly sophisticated, questions arise  regarding what aspects of these innovations can be legally protected and who has the right to own  or control them. This issue can be complex when human cells or patients’ data are used as these  ownerships belongs to only the human person that owns them. 

This paper aims to explore the relationship between 3D bioprinting and intellectual property law.  It will examine definitions, scope and challenges that arises from IP protections in this complex Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

field. By analyzing patents, and case laws, the paper seeks to highlight both the opportunities and  challenges of intellectual property as it applies to 3D bioprinting. 

Definition Of 3D Bio Printing

A formal definition, written by Dr. Sakthi Kumar – an advanced nanoscience and nanotechnology  expert and a professor in organ on a chip technology has defined 3D bioprinting as: “computer  assisted technology that involves the rapid printing of bio functional materials and their supporting  components in a layer-by-layer manner on a substrate or a tissue culture dish to create complex  living tissues and organs having the desired 3D cellular architecture and functions.” (³) 

In simpler terms, 3D bioprinting uses high tech, and computer-controlled process that creates  living tissues or organs they are designed to act just like real human tissues. This mainly works by  using a special kind of ink called bio ink )الحيوي الحبر ),which is made from living cells and  supportive materials. (⁴)

What is Intellectual Property Law? (propriete intellectuelle) 

Intellectual Property is a law that aims to protect and enforce rights of the creators and owners of  inventions, writing, music, designs and other works, known as the “intellectual property”. There  are several areas of intellectual property including copyrights, trademarks, patents, and trade  secret. (⁵(حقوق الملكية الفكرية) (

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

It’s important, before we delve into this point, to differentiate between copyright law and patent  law. Copyright law protects the rights of creators in their works in fine arts, publishing,  entertainment, and even computer software. The laws protect the owner of the work if others copy  it, or present it, or even display it without permission of the author. While Patent law grants  protection for new inventions, which can be products, processes, or designs, and provides a  mechanism for protection of the invention.

The patent law promotes the sharing of new developments with others to foster innovation. Here,  the patent owner has the right to protect others from producing, using, and distributing the  protected item. (⁶)

A question arises: what is the difference between both copyright law and patent law?  

The difference between patent law)االختراع براءات قانون )and copyright law ( النشر و الطبع حقوق)is  that they protect different types of intellectual property. 

Patent law protects inventions and technical innovations such as machines, and this occurs by  granting the right to make, use, or sell their invention but for a limited time usually 20 years (⁷).  On the other hand, copyright law protects original creative expressions like books, music, and  software.

This arises automatically upon creation and typically could last for the author’s lifetime which is  70 years plus. So, here it could be derived that patents protect functional ideas, while copyright  protects expression of ideas. (⁸) 

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

To link this to 3D bio printing, let’s say a company invents a new type of 3D bio printer that can  print human tissues clearly. This invention can be protected by patent law because it is a functional  innovation. (⁹) 

At the same time, let’s say this company creates an instructional video on how this bio printer  could be used this is a creative material which can be protected by copyright law as it is an  expression, not an invention. So, to conclude, inventions are protected by patents, while  expressions like how to use it are protected by copyright law. 

What can be patented in 3D bioprinting? (ce qui peut etre brevete en bio- impression 3D)

Bioprinters are advanced 3D printers and they are designed for a specific purpose, which is to print  living cells and tissues. This requires a lot of care, such as a precise temperature to allow the cells  to stay alive, and because of their complexities and innovation, many of these machines can be  patented. 

Bioinks are a fundamental part to talk about regarding patent law, as they are a mixture of both  living cells and materials that are able to mimic real human tissues.

The support materials help hold the printed shape together and, after it does its job, it can be  removed later. Making new types of bioinks that can be protected under patent law, but a problem  arises as it may involve human cells. There are key IP issues that we are going to tackle separately:  (¹⁰)

Hardware Protection:

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

Special parts of the bioprinter can be patented, as they are key innovations that involve functional  innovations. As patents give inventors rights, a legal dispute may arise as to who really invented  the protected item. ( ¹¹)

Bio inks

Bio inks can also be patented if they are something new and essential in the field. But it is a bit  complex, as the ink contains living cells and also derived materials from human cells. This raises  ethical questions, as many of those against it believe that living parts of a human body should not  be owned, as this means you would be granting ownership over something that is human.

There was a ruling in the U.S Supreme court in the case of Myriad Genetics V Association for  molecular Pathology (2013). Courts there ruled that when something exists naturally in the human  body, it’s not an invention, which means it could not constitute a patent and that natural DNA  cannot be patented. 

In this case, Myriad Genetics discovered the exact location and genetic sequence of two genes  (BRCA1 and BRCA2). Myriad then patented those DNA sequences of the genes. This means that  the ownership would belong to them once removed from the body, which would allow them to  control testing and research on the genes. Then, the Association for Molecular Pathology argued  that genes are natural products, meaning they cannot be patented. (¹²)

The Supreme Court then decided that natural DNA, even if it was isolated from the human body,  cannot be patented and noted that DNA that is created in a lab could be patented because it did not  occur naturally. This case is extremely important, as it stopped companies from owning human  genes. (¹³)

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

It’s important to add that to get a patent for bio inks, this bio ink must be new and useful – meaning  if the bio ink uses human cells without any major modification or any innovation, it would not  meet the standards of patent law.

However, if those cells are engineered or combined, then this might be protected under patent law.  So, to conclude, new bio printing methods or special use of bio inks can be protected by patent  law. This translates that using such files without permission from the innovator would constitute  patent infringement. 

Digital Files in Bioprinting 

(¹⁴) Digital files in 3D bio printing are computer designs that act like a blueprint for printing the  tissues and organs. They include things like the material, shape, or even the cell arrangement. They  often use real patient data to make the tissue personalized for that person. The design of those  functional parts can be copyrighted, as this is a creative expression, while the functional parts  cannot be protected under copyright law. (¹⁵)

A range of concerns arises regarding the digital models, as they are often made from private  patient data.)الخاصة المريض بيانات )The bio ink uses personal biological and medical information,  which needs a specific person. This is often used to create custom bio inks for custom tissues and  organ printing. This creates serious legal concerns (¹⁶) such as: 

1. Who owns the data?
2. Did the patient consent for this data to be used?

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

3. Whether the company can claim rights over a model based on someone else body? For example, if a company uses a person’s data like DNA to create a 3D model using bioprinting, can they legally own that model?  

In my opinion, possible solutions could be that patients may own the original biological data, but  the company could own the model, as they invested time, money, and effort to establish it. This  could be described as a shared ownership )مشتركة ملكية )between the company and the patient.  In the United States, digital tools such as software and algorithms could be patented if they are  new, useful, and non-obvious. They cannot be just ideas. (Novelty, non – obviousness, and  utility). 

The USA has established an additional test under the Alice decision, which excludes abstract  ideas from being patentable. This is a key case law. In 2014, the Supreme Court issued a ruling in  the case of Alice Corp V CLS Bank international. 

In this case, Alice Corp owned patents for a computer-based system to reduce financial risks in  online transactions. CLS bank argued that the patent is invalid and supported their argument that  this was a basic financial idea and not an invention. The supreme court then decided that abstract  ideas, like basic financial or mathematical concepts, cannot be patented unless the patent adds  something more that is significant. Which created a two-part test: (¹⁷)

1. Is the patent about an abstract idea?
2. Does it add something innovative enough to give it the ability to be protected under patent law?

This test is fundamental as many software’s and biotech patents were rejected as they failed the  Alice test. 

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

In Europe, according to the European Patent Office (EPO) under the guidelines stipulated in  2024, the invention must solve a technical problem in a technical way which ensures that it is not  just an abstract idea.

E.g., a program that controls a bioprinter or processes biological data to create bioinks may be  patentable. The example means that if there are any special programs that manage how the bio  printer works like adjusting speed or temperature, they can be patentable, as they solve a technical  problem regarding how this machine operates. If the item also goes beyond just data analysis, like  producing a better and more accurate bio ink, it could also be patentable. (¹⁸)

For bio printing, the software tools that enable the design, customization, or optimization of bio  inks and 3D printed tissues are prime candidates for CII (Computer Implemented Invention)  patenting.

The EPO’s Guidelines (¹⁹) means that software used in bioprinting, especially for: designing  bioinks or tissue models and customizing them based on patient data, can be considered Computer  Implemented Invention (CII). (²⁰) 

The reason behind this is that it goes beyond abstract ideas and has a technical purpose, such as  improving the printed tissue quality while personalizing the printed tissue or organ more to the  patient. So, adding something useful and new might satisfy the Computer Implemented invention  requirements and then you can apply for a patent on it. (²¹)

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

For example, taking a CT scan of patient’s kidney, then this automatically creates a 3D model of  that kidney using the bio ink formula to match the patient’s accurate tissue type. Then the formula  is used and printed using a bioprinter. Here we can see that this software is doing an actual technical  job by creating a real, working, printed kidney and not just blue prints or pictures. This is all based  on the European patent law. (²²)

A problem then arises on who owns this digital models?

This is a serious issue, as normally patients would own their biological data, but if it turns into a  digital model, ownership becomes grey. who owns this digital model? The hospital that collected  the data, the company that built the model, or the patient himself? 

A question arises on why privacy matters in Bio printing?

Bioprinting normally uses very sensitive and personal information of patients, such as genetic data  or DNA. If this data is leaked or not used in an ethical way, this could lead to ethical violations.

That’s why the GDPR in Europe and HIPAA in the United States requires three elements:  Patient consent, data anonymization, and strong security. (²³) This means, according to Article 15 of the GDPR, patients must know how their data is being used, and a copy of that data and any  details must be shared – like how the data be used and how long it will be kept for, …etc. (²⁴)

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

Problems even arise if this data is shared worldwide, as data could be collected in another country  with strong privacy laws and used in another country where privacy laws are weak, which causes  major conflicts.

Another problem that arises is: what happens if this data is changed later by modification? it is  unclear on who owns this new version, and if it is the same file or a totally new, different file  (invention), and if it could be patented.

This is why the agreement between the parties must denote who owns what, and if any  modification occurs, what will happen will there be a requirement for a new agreement, or should  the agreement exclude modifications?

This leads us to our recommended message in this research paper regarding the usage of patient  data in bio printing, which is the strong requirements for strong laws to tackle all those problems  and the requirement of fair and appropriate consent. This here protects the patient’s rights and  encourages innovation by allowing safe, trusted collaboration. 

There are tools to protect those digital files, and they are: DRM (Digital rights management) this  controls who can see, copy, or edit the file. Watermarking which adds a hidden mark to show who created or owns the file. Finally, blockchain which keeps a secure history of who changed  the file. (²⁵)

Findings:

– Patents can cover hardware parts of bioprinters and engineered bio inks but ethical issues limit  protection of naturally derived human materials.

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

– Digital Models and software innovations can be patented but only if they provide a clear  technical solution, meaning it cannot be patented if it involves abstract ideas. – The ownership of the patient data still remains unclear, this requires legislative intervention.  – Current privacy laws such as the (GDPR, HIPAA) provide a foundation, but global interference  is needed to prevent conflicts internationally. 

Conclusion:

3D bioprinting presents fundamental opportunities for medicine, but it also raises complex legal,  ethical, and ownership challenges. A balance must occur between protecting patient rights and  encouraging innovation.

Legislators must focus on:  

– Defining what constitutes an ownership.

– Ensuring Patient Consent.

– Setting regulations to strengthen data privacy.

By establishing clear and strong regulations, policymakers can protect patients, encourage safe  collaboration, and foster innovation in the bioprinting industry.

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

Reference and Bibliography

Books: 

1. 3D Bioprinting and Nanotechnology in Tissue Engineering and Regenerative Medicine (Second Edition), 2015.

Research Papers: 

2. Cortina, M.; Arrizubieta, J.I.; Ruiz, J.E.; Ukar, E.; Lamikiz, A. Latest Developments in Industrial Hybrid Machine Tools That Combine Additive and Subtractive Operations. Materials 2018, 11, 2583.
3. Dharmaraj, J.J.J.; Navasingh, R.J.H.; Krolczyk, G.; Pitchumani, S.V. Extrusion-Based Bioprinting in a Cost-Effective Bioprinter. Machines 2024, 12, 518.
4. Fay, C.D. Computer-Aided Design and Manufacturing (CAD/CAM) for Bioprinting. In Methods in Molecular Biology; Springer: New York, NY, USA, 2020; pp. 27–41. ISBN 9781071605196.
5. Kantaros A, Ganetsos, and others, MDPI, Bioprinting and Intellectual Property: Challenges , opportunities , and the road ahead, 15 January 2025 , <https://www.mdpi.com/2306-5354/12/1/76#B63-bioengineering-12-00076 > date  accessed 23/8/2025.

Websites 

6. Ben Shepherd, 3D bioprinted therapeutic liver tissue, (September 20,2017), < https://organovo.com/3d-bioprinted-therapeutic-liver-tissue/ > accessed 21/8/2025.
7. Georgetown law , Intellectual Property law, < https://www.law.georgetown.edu/your-life career/career-exploration-professional-development/for-jd-students/explore-legal careers/practice-areas/intellectual-property-law/ > date accessed 21/ 8/2025.

Intellectual Property Rights in the face of the Biotechnological Revolution: The Case of 3D Bioprinting

8. Science Direct, 3D Bioprinting (material science), (2022), <

https://www.sciencedirect.com/topics/materials-science/3d-bioprinting > date accessed  21/8/2025. 

Legislations: 

9. 3.9 Claims directed to computer – implemented inventions <https://www.epo.org/en/legal/guidelines-epc/2024/f_iv_3_9.html > date accessed  22/8/2025.

10.Article 15 of the GDPR “Right of access by the data subject” < https://gdpr-info.eu/art 15-gdpr/ > date accessed 22/8/2025.

11. European Patent Office, where is a patent valid and how long does it last?, < https://www.epo.org/en/service-support/faq/patents-and-ip/where-patent-valid-and how-long-does-it-last > date accessed 22/8/2025.
12. European Patent office, Guidelines for examination in the European patent office, April 2025 edition < https://www.epo.org/en/legal/guidelines-epc > date accessed 23/8/2025.
13. European Union, Regulation (EU) 2016/679 of the European parliament and of the council (2016), < https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng > date accessed 22/8/2025.

Case Laws: 

14. Association for Molecular Pathology V. Myriad Genetics, Inc 569 U.S. 576 (2013). 15. Alice Corp V CLS Bank Int’l, 573 U.S. 208 (2014).

¹ Ben Shepherd, 3D bioprinted therapeutic liver tissue, (September 20,2017), < https://organovo.com/3d bioprinted-therapeutic-liver-tissue/ > accessed 21/8/2025. 

² An Organ transplant involves removing an organ from a donor and placing it into someone who is unwell  with organ failure.

³ 3D Bioprinting and Nanotechnology in Tissue Engineering and Regenerative Medicine (Second Edition),  2015. 

⁴ Science Direct, 3D Bioprinting (material science), (2022), < https://www.sciencedirect.com/topics/materials science/3d-bioprinting > date accessed 21/8/2025. It’s important to denote that Bioink is a mix of a living cell  with a soft gel this mixture forms bioink. 

⁵ Georgetown law , Intellectual Property law, < https://www.law.georgetown.edu/your-life-career/career exploration-professional-development/for-jd-students/explore-legal-careers/practice-areas/intellectual property-law/ > date accessed 21/ 8/2025.

⁶IBID

⁷ European Patent Office, where is a patent valid and how long does it last?, < https://www.epo.org/en/service support/faq/patents-and-ip/where-patent-valid-and-how-long-does-it-last > date accessed 22/8/2025. 

⁸IBID

⁹ A functional innovation is something that can solve or preform a task in a new way.

¹⁰ Cortina, M.; Arrizubieta, J.I.; Ruiz, J.E.; Ukar, E.; Lamikiz, A. Latest Developments in Industrial Hybrid  Machine Tools That Combine Additive and Subtractive Operations. Materials 2018, 11, 2583.

¹¹ Dharmaraj, J.J.J.; Navasingh, R.J.H.; Krolczyk, G.; Pitchumani, S.V. Extrusion-Based Bioprinting in a  Cost-Effective Bioprinter. Machines 2024, 12, 518.

¹² Association for Molecular Pathology V. Myriad Genetics, Inc 569 U.S. 576 (2013). 

¹³ IBID

¹⁴ Digital files in general are normally any information stored in a computer. 

¹⁵ Fay, C.D. Computer-Aided Design and Manufacturing (CAD/CAM) for Bioprinting. In Methods in  Molecular Biology; Springer: New York, NY, USA, 2020; pp. 27–41. ISBN 9781071605196.

¹⁶ IBID

¹⁷ Alice Corp V CLS Bank Int’l, 573 U.S. 208 (2014).

¹⁸ European Patent office, Guidelines for examination in the European patent office, April 2025 edition <  https://www.epo.org/en/legal/guidelines-epc > date accessed 23/8/2025. 

¹⁹ 3.9 Claims directed to computer – implemented inventions < https://www.epo.org/en/legal/guidelines epc/2024/f_iv_3_9.html > date accessed 22/8/2025. 

²⁰ Computer Implemented inventions (CIIs) are inventions that use a computer, computer network, or other  programmable device to perform at least part of their processes. Such as: Software programs they can be like  online payment methods that runs on a server. 

²¹ IBID

²⁴ Article 15 of the GDPR “Right of access by the data subject” < https://gdpr-info.eu/art-15-gdpr/ > date  accessed 22/8/2025.

²² It’s important to note the difference between the USA and Europe. While the USA requires that the item must  be new, useful and not obvious to be patented meaning it cannot be an idea only. In contrast, in Europe to patent  a software it must solve a technical problem in a technical way. Like improving a machine. 

²³ European Union, Regulation (EU) 2016/679 of the European parliament and of the council (2016), <  https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng > date accessed 22/8/2025.

²⁵ Kantaros A, Ganetsos, and others, MDPI, Bioprinting and Intellectual Property: Challenges , opportunities  , and the road ahead, 15 January 2025 , < https://www.mdpi.com/2306-5354/12/1/76#B63-bioengineering-12- 00076 > date accessed 23/8/2025.