In this article, Preetham Kumar J pursuing Diploma in Entrepreneurship Administration and Business Laws from NUJS, Kolkata discusses Legal Issues in 3D Printing and Product Liability.

Introduction

Technology has always been the touchstone of human progress. It has revolutionized the way of living, communicating and trading. Every decade since 1950 has had a marquee technology that further boosted human progress. The narrative with most technological inventions right from cloning to the Internet and to the recent mobile phones has been same-initial euphoria of the benefits of the invention and the establishment of the regulatory structure to prevent misuse or infringement. Going by the precedents, it is likely that this pattern of the narrative will apply to future technological inventions too.

3D Printing technology

• One such technological invention that has fallen into the fold of this narrative albeit in the early stage is the additive manufacturing technology or more commonly known as 3D printing technology.
• The application of this technology ranges from Industrial tooling to Bioprinting which involves the printing of human tissues from human cells.
• 3D printing refers to processes in which material is joined or solidified under computer control to create a 3-dimensional object by adding material together.[1]
• This technology emerged in the 1980’s largely for industrial applications and has hence expanded to various fields which include food and medicine.
• The 3D printing process involves a digital file also referred to as CAD(Computer Aided File) in which the object to be printed is digitally formatted using either a 3D printer software or a 3D scanner.
• The file is exported to a 3D printer using dedicated software which transforms the digital model into a physical object through a process in which material is built up layer upon layer, in an additive manner, until a finished object emerges. [2]

Advantages of Applications

The impact of this technology has grown across industries and is only set to grow manifold in the future. Below is only an indicative list of most popular and contentious uses of this technology.

Product Prototyping

By helping create a 3-dimensional prototype of a product, it helps high intensive innovation and research industries to clearly visualize, test and iterate the product before mass production thereby reducing costs significantly.

Food Industry

It helps in food customization and automation of time-consuming aspects of preparation and assembly in large food processing setups. Also, it has been used in extracting and converting alternative ingredients like proteins from algae, beet leaves and insects into tasty meals. [3]

Medical Industry

Medical technology is set to create the maximum impact in this industry. The applications range from Bioprinting human organs from human tissues for drug trials to printing customized medical devices for patients. It has also been used for creating customizable composite drugs by mixing one or more drugs in specific combinations.

Recently a drug called “spritam” a completely 3d printed pill was approved by the Food and Drug Association of USA to be sold by a private company called Aprecia pharmaceuticals. [4]

Need for Regulation

1. This technology was initially envisaged for industrial purposes only. However, due to widespread demand of this technology from different industries and individuals, the affordability and accessibility to this technology via the 3D printers have increased thus leading to an unregulated, unauthorized and sometimes illegal printing of products that has resulted in the violation of various laws like:
   1. Intellectual Property Right
   2. Patent law
   3. Copyright law, and
   4. Design law apart from those relating to product liability laws.
2. Therefore, it has become exigent for the lawmakers to carefully study the legal issues resulting from the various aspects of the use of this technology by all the stakeholders concerned.

The Legal Issues

As outlined above, the main legal issues resulting from the use of 3D printing technology by various stakeholders which includes Industries and Individuals. Most problems arise because of the use by these Individuals or Hobbyists which lead to violations of law. The laws violated broadly are as follows:

Intellectual Property Laws

It includes:

• Patent
• Copyright, and
• Design law violations.

Tort Law Violations

Tort Law violations which result due to product liability issues arising from the end ‘printed’ product.

The IP law issues

The IP laws violations arise largely due to the following components of the technology:

3D Printer

• The 3D printer which is used to create or print the objects whether this printer can print objects under patent protection or whether the printer itself can be patented.
• The access to 3D printer to private individuals has raised concerns about the printing of those products which are under patent protection which can lead to increase in counterfeit products.
• This has been a difficult problem to reign in largely because it is difficult to track individuals who print these protected objects inside the confines of their home.
• However, the printer itself can be patented if the printer fulfills the criteria required for patenting viz novelty and capable of industrial application.

CAD file

• The CAD file or the digital software which has the design/model or the scan of the object to be printed whether this leads to copyright infringement of reproducing software without authorization.
• The more contentious legal issue with 3D printing is related to copyright infringement resulting from the use of the CAD file or the digital software used for modeling or scanning the object.
• The CAD is the key to creating the prototype product and is considered as software hence protected as artistic work under copyrights law.
• The Indian copyrights act, 1957 offers protection from the infringement of artistic work under the provisions mentioned under section 14 of the act.
• The provision for protection with respect to 3D printing is mentioned section 14 (c) (i) which restricts to reproduce the work in any material form including in three dimensions of a two-dimensional work or vice versa.[5]
• Therefore, by scanning of an object and creating a 2D file and then printing the 3D object amounts to copyright infringement as copyright persists in the CAD file itself and the 3D print of it amounts to infringement of the author’s copyright of the file.

Final design

• The final design of the product printed whether the design of the final product infringes on the design of a design protected product.
• In case of Design of the final printed object, only the visual features, as severed from the functional part of the printed object can be subject to copyright protection.
• Therefore, if for instance there is an intricate pattern in a 3D printed chair, only that pattern would be protected and not the chair itself. Also, the word design itself does not fit into the legal definition under the act in all cases.
• Section 2(d) of the Designs Act, 2000 requires that visual features be applied by an industrial process. However, the courts have interpreted the industrial processes as those that are carried out on large scale. Therefore, making it difficult to bring those objects that are printed using portable 3D printing devices at home and offices under the ambit of the statute. [6]

Tort law/Product liability issues

• Product liability regulations refer to the manufacturer as an entity liable for damages arising through the use of products.
• However, the application of product liability principles is uniquely challenging in the 3D printing space largely due to the supply chain and the business models involved which makes it difficult to pinpoint the liability. [7]
• At any given time, the people who may liable for a defect in the product created from a 3d printing process are as follows:
  • The manufacturer or the supplier of the 3D printer.
  • The manufacturer or the supplier of the 3D printing material.
  • The printer owner.
  • The person who designed or sold the original project on which the 3D printing design is based.
  • The person who created or shared the CAD blueprint of the object.
  • The person who created the object using the 3D printer. [7]
• Thus the above list indicates the difficulty in placing liability leading to legal vacuum thus leading to protracted litigation to ascertain the responsibility for any mishap resulting from the 3D object created from the 3D printer. As of now, the courts have not laid out any guidelines to answer the above questions.
• In India product liability is governed by the following laws:
  • The Consumer Protection Act,1986.
  • The Sale of Goods Act,1930.
  • The law of Torts.

None of the above statutes address any of the issues arising from the use of the 3D technology yet.

The way forward

1. The narrative/position of the 3D printing technology with respect to issues raised is not unique and it has been the case with many path-breaking revolutionary technologies before it.
2. The gaps in the law are taken note of and new ones (gaps) will emerge with the growing demand and use of the technology.
3. However, the lawmakers and the legal community should take into consideration the gravity of the situation especially given the technology’s impact in sensitive sectors like medicine and pharmaceuticals.
4. Given the impact and the application of the technology, this technology is here to stay, hence it is only prudent that these issues are addressed at the earliest.

References

[1]www.wikipedia.org

[2] http://www.wipo.int/wipo_magazine/en/2017/01/article_0006.html

[3] http://www.wipo.int/wipo_magazine/en/2017/01/article_0006.html

[4] http://www.wipo.int/wipo_magazine/en/2017/01/article_0006.html

[5] Indian Copyright Act,1957

[6] https://spicyip.com/2014/01/guest-post-3d-printing-and-indian-copyright-law.html

[7]http://www.lawjournalnewsletters.com/sites/lawjournalnewsletters/2016/09/01/emerging-legal-issues-in-3d-printing-and-product-liability-2/?slreturn=20180030081923