Malaphor: Digital Health Law in Canada

health + tech in law = mixing chalk + cheese

Is a wave of digital health patent litigation coming?

Representative drawing of Canadian Patent No. 2,233,794, entitled “ Method and apparatus for the management of medical files”

At least since the last century, the introduction of significant advances in technology is often accompanied by patent litigation. Many people will be aware of the numerous lawsuits brought in relation to computers or connectivity in the last couple of decades. However, they may not be aware that before that, there had been patent lawsuits in relationship to the incandescent light bulb, the electric steam iron and even zippers.

Although some digital health technologies have been in development for about half of a century now (check out this article from 1974 relating to patient medical records), many are now only beginning to be widely adopted. Consequently, it might be expected that we would start seeing patent litigation in this field. Indeed, recently in Canada there was a case in one of the first areas of digital health, namely electronic health records (EHR or EMR, electronic medical records)

The government of Quebec gets sued

On April 2, 2019, the Federal Court found that the Quebec government (specifically the Minister of Health and Social Services and the Régie de l’assurance maladie du Québec [RAMQ]) infringed two patents relating to electronic health records in Bessette v. Attorney General (Quebec) (decision here, only in French at this time). In the same proceeding, Quebec counterclaimed, alleging that the patents were invalid, but the Court disagreed. Quebec is now appealing the decision.

The patents in this case cover certain systems and methods for managing medical information and are owned by the inventor Dr. Luc Bessette. Dr. Bessette has said that he conceived of the system covered by the first patent, the ‘794 Patent, from his experiences in emergency medicine at the Centre hospitalier de l’Université de Montréal (CHUM) in the 1990s. The second patent in the litigation, the ‘598 Patent, relates to automatic updates of medical information in the system of the ‘794 Patent. His efforts to work with the Quebec government to implement his inventions failed. However, Quebec then proceeded to develop its own e-health system, the Dossier Santé Québec (DSQ), because of federal government initiatives. Dr. Bessette asserted that the DSQ infringed his patents.

The infringing technology

The patents date from 1998 and 2000, just at the forefront of the widespread of information technologies, and it is worth  considering the language used in the patents. The ‘794 Patent protects (in Claim 1):

A computer readable storage medium holding a data structure, said data structure comprising at least one record associated with a certain individual, said record including:
    – A collection of data elements containing information of medical nature for the certain individual;
    – At least one pointer, said pointer including a first component and a second component, said first component being indicative of an address of a location containing additional medical data for the individual, said second component being indicative of the basic nature of the medical data at the location pointed to by the first component, said address being in a form such that a machine can access the location and import the medical data from the location.

The Court reviewed the DSQ system, and it actually contains quite a bit of information and includes a multitude of functions. The preamble and first point in the claim above would probably describe any EHR system, so the interesting question is what aspect of a patient record in the DSQ system was described by the second element (such that it would infringe the ‘794 Patent)? Without going into too much detail of the analysis, it seems what the Court found was described by the second element were the individual links to test results in a list of diagnostic or imaging results in a given patient record; specifically, each link contained a certain identification number (presumably thus interpreted as being “indicative of an address of a location”) and provided certain medical information on mouseover.

This result might be somewhat shocking since these days we might consider this kind of functionality to be standard, or at least not unexpected, in a database (including a health information database). However, it should be remembered that Dr. Bessette came up with this idea just about 20 years ago and the ‘794 Patent has already expired (the ‘598 Patent will expire 2020).

What does this mean?

This case should be a warning to those working in the digital health space. It is not uncommon for digital health innovators not to think about the potential existence of patents in their products. Nonetheless, even in the more “established” area of EHRs, a quick search in the Espacenet database shows patent applications are still being filed (such as this one).

In addition, many of the terms being used in digital health are contextual, are new, and/or may not have a commonly understood definition. Thus, searches may not reveal relevant patents, or patents may be interpreted in ways not originally contemplated by the inventor.

Therefore, we can likely expect more digital health patent litigation in the future. To reduce risk, digital health innovators may still consider doing some  patent searches, even if no search can be perfect. Moreover, if a technology is vital to a company’s product, the company should consider filing a patent, both as an offensive strategy to prevent  copycats, and as a defensive measure to ensure they will not be blocked by a patent filed later by another party.