Patients, privacy and progress – IP in the future of medical devices

Let us review and interpret the most significant data and provide industry context through case studies.

The medical forefront on your forearm

The product category of smartwatches, home health monitors and personal fitness trackers has seen more than 30,000 patent applications every year since 2015. This indicates key patterns within the sector — perhaps most notably the rise of personalized medicine and home healthcare, both of which are driven as much by technological as biomedical advances.

Devices that put healthcare in the patient's hands also help reduce the demand for resources in an industry that is frequently stretched thin. This allows physicians to add at-home diagnostic tools to their repertoire, saving extremely limited time and thereby promoting access to primary care. Along the way, these medical devices can also minimize some of the system-wide burden associated with forgone checkups and screenings — problems of patient cost, access and convenience that can exacerbate preventable conditions.

Despite the numerous benefits on the medical side, these innovations are hugely significant from a technological perspective. Thus, will it be healthcare researchers or electronics companies that spearhead the future evolution of medical devices? The implications here are significant, as each field has different priorities, methods, distribution channels and even relationships with insurance providers and medical practitioners.

The biological vs. the digital

Dennemeyer's research would seem to put this ambiguity to bed. For the period 2017-2022, the top patent awardees in wearable medical devices were all technology companies:

1. Apple: 2,671 granted patents
2. Samsung Electronics: 1,223 granted patents
3. Huawei Technologies: 886 granted patents
4. Google: 631 granted patents

Nevertheless, this fact creates its own doubts about the direction, motivation and sustainability of medical device growth. For instance, while technology companies must comply with a variety of data protection and privacy laws, their processes may not be built for the exceptionally stringent requirements of the medical industry, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States.

IP Trend Monitor 2023 respondents agreed that this was an area of concern, with 64% ranking data security for medical devices as "extremely important." Another 30% deemed it "very important," and the remaining 6% indicated it was "somewhat important." This did not, however, translate into innovative hesitancy; experts consistently ranked wearables as the top priority for robust IP protection among medical devices. General legal experts were most confident here, with 63% indicating this prioritization; numbers dropped slightly among trademark specialists (55%) and patent specialists (52%).

Respondents were perhaps less motivated by other technologies in this field, including surgical and diagnostic tools, nanotechnology and 3D printing. This speaks to the fact that though these technologies may be life-saving, they have not permeated the wider consciousness by dint of their restricted use cases.

Stepping back from the particularities of individual product classes, panelists underscored the value of IP law to the industry at large. An impressive 40% of respondents said that the main reason for IP protection in medical devices was the enablement of commercialization and profitability — a familiar value proposition in the patent world. Nearly as many (37%) indicated that exclusive rights encourage research and development and 20% said they protect against infringement.

Contextualizing data for medical device innovators

Inventions in this field can have an especially high value per patent, where it is clear that a particular patent directly covers a given medical device responsible for a traceable, substantial revenue stream. However, in the subfield of wearables, there will typically be many different patents covering various innovative aspects of the same product. Thus, unlike the example of an artificial heart valve, which may only have a few patents covering it, the technology in a wearable medical device may be covered by tens or even hundreds of patents, depending on the technology. This tally is inflated further if wireless communication and charging standards are involved. Therefore, as indicated by the number of survey answers favoring wearables, obtaining robust IP protection in this area is markedly important to maximize coverage and safeguard income generation.

Healthcare and patent protection

In addition to their economic returns, medical devices are more weighty than many other innovations in the world of IP simply because they can change or save lives. Yet this same gravity has the potential to recontextualize and complicate patent protection.

Infringement, clarity and the letter of the law

Beginning in the early 1980s, major players in the U.S. market — Medtronic and Eli Lilly and Company — legally debated what could be considered infringement in medical device patent protection. The argument concerned language used in 35 U.S.C. § 271(e)(1), which authorizes the utilization of a patented device if a party is developing and submitting information required by federal law. The United States District Court for the Eastern District of Pennsylvania decided that the exemption did not apply to medical devices, but the Court of Appeals for the Federal Circuit reversed this decision, stating that activities related to securing regulatory approval could not constitute infringement.

This case emphasizes an issue that is even more relevant in a world where medical devices are increasingly designed, manufactured and distributed by non-medical companies: Do patents help or hurt strict regulatory compliance? As in the instance of Eli Lilly and Company vs. Medtronic, Inc., when it eventually arrived before the Supreme Court, the answer often comes down to specific legal readings of language and the flaws therein. "No interpretation we have been able to imagine can transform § 271(e)(1) into an elegant piece of statutory draftsmanship. To construe it as the Court of Appeals decided, one must posit a good deal of legislative imprecision; but to construe it as [Eli Lilly and Company] would, one must posit that and an implausible substantive intent as well."

Though the exemption was found to apply to medical devices, the underlying issue is broader than any literary quibble. There is an argument to be made that patents safeguard exclusivity, market monopolies and financial interests over consumer needs — which, in the context of healthcare, are often matters of survival. The questions, as yet unresolved, become whether IP law protects economies or human life and whether patents alone can or should have the power to make such crucial determinations.

The role of the user in patent infringement

Between 2020 and 2023, Medtronic was back in court for another patent infringement case. Plaintiff Colibri Heart Valve alleged that certain uses of Medtronic's devices infringed on one of its patents covering an artificial heart valve deployment method. Though some of the patent claims in the original complaint were found to be invalid, Medtronic was ultimately ordered to pay Colibri $106.5 million USD for inducing infringement on the part of doctors.

This lawsuit brings up a provocative dilemma in some jurisdictions regarding the implicit role of the user in upholding IP protections. Should doctors in countries such as the United States, Russia and Australia perform their work in certain ways, even if they are not the most effective or efficient, simply to safeguard IP rights? And, as home healthcare becomes more prominent, will these same issues apply to consumers as much as medical practitioners?

One answer is to obviate the question entirely. In many jurisdictions, including European Patent Convention (EPC) countries, South Korea, Japan, China and Canada, patents cannot be granted for methods of treating the human or animal body through surgery. For example, Article 53(c) of the EPC excludes surgical, therapeutic and diagnostic methods for humans and animals from patentability while allowing patents for the products or compositions used. However, the distinction between methods and products can be surprisingly academic.

While there may not yet be definitive solutions from every perspective, it is clear that the relationship between health and IP is only becoming more intricate with time.

Preventative care for medical device innovation

As medical devices, particularly at-home and wearable options, increase in complexity and importance, so too will the patent laws protecting them. Therefore, the obligation to understand and leverage these regulations will not be limited to any one industry; instead, medical, technology, legal and business experts will have to work together to shape a healthier future.

Medical devices are an excellent example of the growing influence of IP, but there is always more to discover. Review the other articles in our IP Trend Monitor series and download your copy of the full report for additional insights.