By: Haris Z. Bajwa JD [intellectual property lawyer with a focus on medical devices and digital health]

In order to protect innovative ideas, acquiring intellectual property (IP) is essential. Generally speaking, in the medically related tech field, there is a high level of awareness that procuring IP (specifically patents) for medical devices is important, yet many digital health companies fail to fully deploy a robust Intellectual Property (IP) strategy related to their technology, or unfortunately attempt to pursue their IP rights after some irreversible damage has already been caused. It is imperative to fully and timely protect your ideas in the form of IP, but there are limitations on the kind of ideas that you can protect.

As an illustrative example, at the United States Patent and Trademark Office (USPTO), if a digital health app simply uses a computer to assign a health metric to a patient which is normally assigned by a human calculation, it may not be patentable. On the other hand, a truly innovative app that uses 2-D images to generate 3-D models which may be used for health diagnosis and treatment is likely to be found patentable.

This series of articles dealing with IP for digital health developers will provide a basic framework which may be used in developing a company’s IP strategy. Technologists and other individuals involved in digital health may leverage the information included within the articles to further their understanding of what they can patent, when to file for patents, how to evaluate legal counsel, how IP may be strategically utilized in the growth of a company, in addition to considerations as to whether IP is important to their overall business goals.

The basics of what you can patent

If products have an innovative hardware component, it is intuitively known by the general public that they are patentable. Many technologists in the field of digital health get discouraged when they conduct preliminary research regarding patents by learning that software itself cannot be patented. However, the key is to understand that while software itself cannot be patented in its intangible form, it is patent­ eligible when it is disclosed and claimed in the context of methods of interacting with a computer or mobile device.

In plain words, the process that your software conducts, such as data analysis and data generation, occurring on a computer may be protected. Recent Supreme Court rulings have narrowed down what functions of software may be patented. Broadly speaking, software may still be patented if it is truly innovative and use of a computer is necessary for performing the methods. Beyond, the illustrative example mentioned earlier about the 3-D image generation app, other patentable software features may include unique user interface interaction and/or innovative back end data analysis which requires the use of a computer.

For digital health developers, the key take away is that software claimed in the context of interacting with a computer or mobile device is likely patentable subject matter if it necessitates use of a computer. Therefore, like any patentable subject matter, a digital health application’s patent eligibility continues to be dependent on whether a mobile app satisfies the main requirements that it be both new and nonobvious, in addition to meeting other thresholds set by case law. The USPTO does this by scrutinizing patent applications for whether the claimed invention has in fact, not been previously used, published, or patented, and whether it involves more than an obvious combination of prior uses, publications, or patents.

Why Acquire Intellectual Property? Is it worth it to patent your medical app?

There are various considerations as to why a company should acquire Intellectual Property tied to their products:
If the core of the business is tied to technology or technological innovation, it is imperative that that the core concepts are protected. For example, being the first mover in a market may not always be the key to securing a large market share. Instead, a digital health application may be copied easily and companies with substantially larger marketing budgets may be able to muscle their way in to capture the public’s attention as the top app for a particular function. Accordingly, acquiring patents may be helpful in precluding competition but may also create unique licensing opportunities for the patent holder if bigger competitors seek to enter the market.

Investors or acquirers of startups will often look at company patent portfolios in making acquisitions.
Even if you do not intend to aggressively enforce your patent rights, patents tied closely to your technology can serve valuable defensive purposes. As many digital health developers may have already experienced, there are numerous entities (often referred to as patent trolls) constantly looking for opportunities to threaten patent suits whenever new products are launched. Accordingly, if you do not acquire patents for your product, a patent troll or a competitor may acquire patents tied to the underlying technology, and may seek to enforce those patents against you.

If you have specific questions about specific app types that can or cannot be patented, feel free to ask them in the forum section we have created at iMedicalApps for this particular topic.

The next article in this series will discuss the best strategies to file for patents for your medical app — including an overview of costs related to various approaches, how to pick legal counsel, and if absolutely necessary, how to pursue IP protection for your idea yourself.

Disclaimer: This article solely represents Haris Z Bajwa’s opinions and should not be taken as legal advice.