Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for medical problems are now evolving into data platform companies, offering a more comprehensive glimpse into the habits and health of their patients and customers. Many of these solutions leverage artificial intelligence (AI) and machine learning (ML), for which intellectual property tends to be more challenging to protect through traditional approaches.
Investor and strategic partner mindsets have shifted toward optimal ways to protect their intellectual property (IP) requirements, especially given evolving laws and social concerns.
Having had decades of experience working with medtech companies, we have identified the top 5 IP considerations they should be aware of in their product development lifecycle. This is especially true for medtech-enabled data platforms
Medtech companies should consider the following IP protection strategies in the emerging fields of software as a medical service (SaMD), software in a medical device (SiMD), and AI in medical technologies.
1. How to strategically diversify IP protection
2. Whether to patent or keep innovations as trade secret
Generally speaking, the ability to reverse engineer is the key inquiry in deciding if patent or trade secret is the appropriate mode of protection for a company’s data-enabled invention, along with the evolving laws around eligibility of patenting of such inventions (See IP Point 4, below).
3. If patenting, how to balance breadth and abstraction in patent claims to maximize protection
Claiming software uses necessary functional language to describe the invention… which can be too abstract for protection by patent law if at too high of a level. Nevertheless, patentees will always seek to broadly cover their invention, thus resulting in the tension that exists between breadth and abstraction levels in software patent drafting.
*What is Functional Language? – Functional language explains what the invention does rather than what it is.
4. Keeping up with the evolution of subject matter eligibility in patents
U.S. law does not allow patenting of abstract ideas** or laws of nature.*** In 2014, the U.S. Supreme Court broadened this concept, giving the U.S. Patent Office additional ways to reject applications for AI-based patents and for trial courts to invalidate them. This decision has made it more challenging to obtain software and AI-based patents in the United States. There are creative ways to use the evolving case law and to present inventions to fall outside of this prohibition, but it is important to remain diligent of the volatile state of the industry.
**Abstract ideas include (i) mathematical concepts, (ii) methods of organizing human activity and (iii) mental processes.
***Laws of nature include natural phenomena and products of nature;a discovery of something that is a natural law, not an invention.
5. Artificial intelligence considerations: Permission, assignments, copyleft and open source
Photo: stocknshares, Getty Images
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