A Leap of Faith into the Future of 3D-bioprinting: A Patenting Perspective

Seminar By Dr. Jamil Ammar,

Visiting Scholar, Rutgers Law School.

 

On March 31, 2017 Dr. Jamil Ammar delivered a presentation at the University of Detroit Mercy Law School as part of Windsor Law Faculty Seminar Series. Dr. Ammar’s presentation focused on the use of 3D printing and biotechnology and its relation to IP law. Dr. Ammar is an Assistant Professor in Law from the University of Damascus Law School and joined Rutgers Law School as a visiting scholar in 2015.

 

The focus of Dr. Ammar’s presentation were the legal issues surrounding the printing of 3D biocompatible materials, such as cells and supporting components to create completely functional printed organs. A printed organ is produced using 3D printing techniques and is most often constructed for partial or total organ replacement. The process first begins with the 3D scanning of living cells, tissues, or organs. Computer software is then used to create a 3D digital file (CAD file) that is encoded with the specific geometry of the living structure. This 3D (CAD) file allows for scientists to build functional artificial organs by using layer-by-layer construction of a particular organ structure to form a cell scaffold. This cell scaffold can then be used for the formation of new viable tissues for medical purposes. The technology behind these procedures involves modified inkjet printers, which are used to produce the 3D biological tissues used in creating cell scaffolds. Specialized cartridges are utilized in these printers, consisting of a suspension of living cells, and gel materials for added structure. The printer creates alternating patterns using the live cells and gel material. The gel material is cooled and washed away, and the live cells eventually fuse together to naturally form tissue that can be used for organ transplantation.

 

Before discussing the law and its application to 3D printed organs, Dr. Ammar emphasized the medical and economic advantages of the use of 3D printing to generate functional three-dimensional human organs. The primary advantage of 3D printed organs is that they significantly mitigate the imbalance that currently exists in many healthcare systems in the world, in which the demand for organs greatly exceeds the supply of human organs. Further, 3D printed organs and tissues cost significantly less money to produce and transplant, which has the potential to make them more widely accessible to low-income people all over the world.

 

Throughout his presentation, Dr. Ammar addressed the scope of patent law and how product liability law interacts with the patenting of 3D printed human tissues and organs. Dr. Ammar stressed that product liability is likely to be one of the most significant risks that come along with the use of 3D printed organs. For example, 3D printed organs have the potential to be defective for a variety of reasons, whether it is because of a corrupt digital file or human error in

using the 3D printer to create the product. Because of these substantial risks, it is imperative to understand who to hold legally liable, since there are many different people involved in the production of 3D printed organs, such as the digital designer of the product, the retailer of the printing software, the computer technicians responsible for copying and communicating the 3D CAD files, in addition to the healthcare provider. Dr. Ammar further spoke about how product liability is further complicated due to the very nature of 3D printing technology, as most of the information needed to build 3D devices is available on the internet in the form of open-source software.

 

To illustrate the complexity arising from the use of 3D printed organs, Dr. Ammar presented recent legal cases from the United States and the European Union which have ruled on the patentability of 3D bio inventions. In this regard, Dr. Ammar argued that, in the United States, claims are likely to be eligible for patentability if they are directed to one or more of the (i) processes, (ii) methods or (iii) substances that are used in the bio-printing processes. As to the printed organ itself, Ammar added that the 3D-printed organ is a man-made invention that is “markedly different from any similar organism” in nature. While it is possible for a 3D-printed organ to look similar, or even identical, to another organism in nature, it can still be “markedly different” in terms of its characteristics, quality or functionality.  The European Union by contrast has taken a more direct approach when it comes to patenting 3D bio-printed organs where “an element isolated from the human body or otherwise produced by means of a technical process… may constitute a patentable invention, even if the structure of that element is identical to that of a natural element”.[1]

 

In the course of discussion, Dr. Ammar noted that the absence of legal precedents regarding 3D printed organs in both American and Canadian law means that the law will have to develop and adapt accordingly as 3D printing becomes more common and accessible. Until then, issues of patentability and liability will have to be resolved on a case-by-case basis. Further, current product liability laws and regulations do not actively address the unique issues of 3D printed organs and biotechnology. Accordingly, Dr Ammar concluded that these regulations, laws and policies need to be thoroughly reviewed and adapted by policymakers in order to better address the legal problems that arise from the use of 3D printed biomaterials.

 

 

 

Madiha Khan

LTEC Lab student writer

 

[1] https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_5_2.htm