The advent of interconnected networks to control devices and make life easier, if not simpler, has seen an escalation of such innovations in every possible field of innovation. The same stands true in the field of medicine and medical devices. Inventors are hovering the space of the Internet of Things (IoT) and making hefty investments for developing their versions, thereby aiding in the growth of the said market. It has been predicted that by the year 2025, roughly eighty billion devices will be inter-connected, leading to an estimated economic impact of $3.9 trillion to $11.1 trillion per year.

Understanding Internet of Things (IoT) & How it Works

IoT, an abbreviation for the Internet of Things, is a system of computing devices that are interrelated to one another. These devices can be mechanical or digital in nature, which can be equipped by or for humans or animals by attaching a Unique Identifier (UID) that facilitates the access and transfer of data without human to human or human to computer interaction since it happens automatically over a network. When the same technology is applied in the field of medical science, it is often termed as Internet of Medical Things (IoMT).

An IoT ecosystem entails a series of web-enabled smart devices, which utilize embedded systems like a processor, sensors, and other devices to collect, transmit, and process data that each of these acquires from the collective system. These devices communicate with one another as there is an exchange of data and therefore, most of the work is done without human intervention and intrusion, thereby making it more or less free of error.

 

 

The following are a few examples of IoT, specifically pertaining to the field of medical science and healthcare:

  • Remote patient monitoring, which includes the automatic collection of health metrics like heart rate, blood pressure levels, body temperature, etc., eliminates the need of being physically present in a healthcare facility or even traveling to avail certain medical facilities;
  • Automatic and continuous monitoring of Glucose Levels – It comes in handy and is useful since about 537 million adults are estimated to be living with diabetes;
  • Reminder to sanitize and maintain hand hygiene – Such devices instruct on how to best sanitize hands, especially if they are inside a healthcare facility;
  • It also aids in monitoring and collecting data about a person’s mood, which is why these devices are termed ‘mood-aware’ IoT devices. They can scan through the heart rate, blood pressures, and the movement of the patient’s eye; and
  • Ingestible sensors that collect data from the inside of the human body without incisions as they do so by ingestion.

 

How is IoT Linked with Intellectual Property Rights (IPRs)?

Giants in the industry, like Dell, LG, Samsung, Qualcomm, Google, Rolls Royce, etc., have invested substantial sums towards IoT. Since the entire creative process utilizes inventions, there is a lot of potential for Intellectual Property Rights (IPRs) in this sphere. Let us have a look at each one of these:

 

  1. IoMT & Patents: Any novel and non-obvious invention that involves an inventive step and is industrially applicable can be patented. However, in the field of IoMT, it is imperative to carefully draft the claims of the Patent Application while ensuring they do not get caught in the radar of being an ‘abstract idea.’ The Supreme Court, in the famous Alice case, clarified that mere implementation of an ‘abstract idea’ on a computer would not be eligible for the grant of Patent Rights. On the contrary, an invention that results in control over a physical object or provides substantial improvement to an existing technology or is not just a routine and a conventional solution to a known or already existing problem is not ‘abstract’ as per law and shall be eligible for patenting.

 

Therefore, drafting claims with a unilateral perspective stating how they can improve the prevalent practices and the healthcare industry may be one way to draft a comprehensive patent application. The issue of infringement is rather significant in this field since all the devices are supported due to interoperability.

 

  1. IoMT & Software Patents: While some countries prevent patenting of software, the same can be availed by embedding the software to a device or product to enable the protection of rights. These are termed Computer-Related Inventions (CRIs) since the software is coupled with the hardware to elope the provisions of law. However, it is the software that should meet the basic requirements of obtainingPatent Protection, i.e., it should be novel, non-obvious, industrially applicable, and involve an inventive step.
  1. IoMT & Copyright Protection: Copyright protects an original creative work, which includes art, music, cinematographic films, photographs as well as computer software. To safeguard underlying software utilized by the IoMT device would mean an extensive lifecycle in favor of the creator. Copyright Protectioncan be extended to computer programs, the graphical user interface, along with the data collected and organized by it.
  2. IoMT & Industrial Design Protection: The first impression of a product is the appeal or feel of the product, even though most of it comes down to its functional features. Therefore, it is crucial to create and develop IoMT devices that do the job while appealing in shape and style. It helps create an edge in the present competitive market and prevents tinkering and copying of such designs in coming up with infringing goods.
  3. IoMT & Trade Secrets: If a novel implementation in the form of IoMT tilts more towards specialized analytics or is rooted in a software logic underlying a service, it is best to keep the details of the same confidential. Entering into a Non-Disclosure Agreement (NDA) while interacting with third parties and recruiting employees using such technology or those primarily aware of it within the organization may help.

 

Potential Risk for Inventors of IoMT

IoMT, as discussed above, utilizes varied technologies ranging from sensors, actuators, and even wired and non-wired networking. While tracing the landscape, it can be deduced that some of these inventions are new while others have survived the test of time. Therefore, the scope of Intellectual Property (IP) for each player differs. Where an existent inventor may have broader and much more significant rights, the other may have narrower rights, which is why there may be a chance of infringing the prior’s rights.

Hence, a new entrant (inventor) must consider these infringement risks and ways to resolve such legal complications. Ensuring a strongly drafted indemnity clause in a contract with one’s vendors and suppliers is a good solution. Also, obtaining licenses, and if not, creating a strong base of invalidity defense can be helpful. Additionally, before drafting a patent application, assessing the scope of the IoMT product while conducting a thorough Freedom to Operate (FTO) operation can prove to be beneficial.

 

Conclusion

The onset of this newfound technology has led to great demand and supply from the consuming audience, as well as sparked intellectual minds to make the most of these opportunities. The ever-growing sector can benefit from IPRs and aid in the governance and regulation of such IoT technology. We shall be expecting more profound development of technology and more complicated litigations in this sector because the issue of interoperability equates to sharing of data, which, in turn, results in tinkering with privacy rights. Therefore, the interoperability and inter-working of technology can result in multiple unthought-of issues like cyber-terrorism, blackmailing, bullying, etc.

For preventing such profound issues, the entities will have to develop technologies to effectively handle data and the inter-communication thereof while deploying all necessary security measures to safeguard the users of such technology from any possible negative impact. It will be interesting to see how the legal developments influenced by the legislature, policymakers, investors, and other related entities formulate the laws and regulations that would shape the industry to ensure a seamless utilization of the IoT technology.