COVID-19 Showed the Benefits of 3D-Printing in Healthcare. Can IP get out of the way?

COVID-19 Showed the Benefits of 3D-Printing in Healthcare. Can IP get out of the way?

Gregory Hong is an IPilogue Writer and a 1L JD candidate at Osgoode Hall Law School,

Many of you are likely familiar with 3D printing. The process is as follows:

  1. Add a digital model of a 3D model to a slicer;
  2. The slicer “slices” the model and generates toolpaths layer by layer;
  3. Upload the toolpaths to the 3D printer; and
  4. Start the machine and wait!

Within hours, you will have a physical rendition of the object you modelled. During the early days of the pandemic, supply issues forced society to adopt any available means to source medical supplies. 3D-printing was able to fill some of the supply gaps faced in medicine, in an important but limited capacity.  It began with simpler things like  face shield holders, but over time, the 3D-printing community expanded its applications to things like nasopharyngeal swabs, replacement ventilator parts, and even a whole inexpensive ventilator.

A mounting concern, however, was that the ability for anyone to download a physical 3D object may pose problems for IP rights. While the pandemic made it unattractive for patent holders to enforce their rights, it was important to consider possible avenues to ensure that IP does not hinder emergency response.

I will summarize here two published views on existing solutions to this IP problem: in a May 2022 article in The Journal of World Intellectual Property, Muhammad Z. Abbas explored exceptions that potentially allow IP to be freely used in emergencies: the right to repair exception, the private and noncommercial use exception, and the experimental use exception, while in a September 2022 article in International Review of Intellectual Property and Competition Law (IIC), Ballardini et al. examined two existing ways to tackle the problem: compulsory licensing and voluntary licensing.

Compulsory licensing is the straightforward authorization of licensing by force outlined in the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is regarded, as it should be, as a last resort — administrative burdens make this route largely unviable as a fast way to enable and deploy an emergency response. Voluntary licensing, then, should be  the best existing means of promoting patented ideas in an emergency. Ballardini et al. looks specifically at IP pools and IP pledges as successful means in the response to the pandemic. Two very important examples of IP pools include the Medicines Patent Pool and the COVID-19 Technology Access Pool, which includes 3D-printing repositories. An IP pledge is effectively a patent holder announcing a limited-time public license of their patent. A prominent example of this is the Open COVID Pledge, where many large technology companies have pledged “to make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.” While IP pledges are powerful tools, it is still limited by patent holder goodwill. This is a problem because pledges are conditional and limited in scope, leading to confusion and uncertainty.

The right to repair exception is the right of an owner of a patented article to make repairs to preserve its useful life. Abbas argues that “A more robust and explicit right to repair exemption needs to be incorporated in patent law in response to the COVID-19 health emergency… This clear exemption is important so that consumers of medical devices and 3D maker communities can confidently engage in humanitarian efforts to repair critical life-saving medical equipment without risking patent infringement.”

The private and noncommercial use exception varies and is generally intended to prevent a patentee’s rights from restricting non-commercial activities that don’t conflict with the legitimate interests of the rights holder. Abbas also asked WTO Member-States to “adopt a reasonably broad noncommercial use exception to make it practically significant,” so as to allow medical device users to repair their devices without undue concern for IP problems.

The experimental use exception exists to support the advance of science and technology. Unfortunately, in Madey v. Duke, the Court  limited this exception’s scope significantly. Furthermore, as a common-law rule, experimental use is not defined by international agreement. Abbas calls for WTO members to clarify the experimental use defense and extend coverage to repairs, arguing that “facilitating increased experimental and repair activity by creating a safe harbor for experimentation with medical devices will better prepare countries to deal with a future pandemic.”

The pandemic has shown possible benefits to relaxing patent enforcement in emergency situations. It is thus imperative to explore how the IP system can avoid standing in the way of saving lives. The ideas outlined by Ballardini et al. and Abbas are a start – hopefully more ideas will be expressed and adopted going forward.