Introduction
The Royal College of Surgeons' "Future of Surgery" report recently identified a number of advances in technology that are radically changing the way surgery will be delivered, with the aim of making surgery more personalised, less invasive and ultimately to improve patient outcomes. This area of technology encompasses, in particular, surgical robotics, virtual and augmented reality systems and machine learning, which we refer to in this report as subsectors of "computer-aided surgery".
The rapid pace of innovation in this area is reflected in rapidly growing patent filings across all subsectors of computer-aided surgery.
However, as described below, these technologies fall at the intersection between a number of complex and changing areas of European patent law, meaning that applicants face significant challenges in navigating the various legal restrictions to achieve the broadest protection justified by their innovation.
Recognising the rapid pace of innovation and the specific challenges faced by applicants in this field, GJE's MedTech team have been focussing throughout 2021 and 2022 on developing resources to support innovators seeking to protect computer-aided surgery inventions in Europe. The aims of the report are therefore to (1) present the findings of our research into the current patent landscape; (2) explain the latest important legal developments in Europe and (3) provide practical guidance on preparing strong patent applications to achieve the broadest protection for inventions in this area.
The first part of this report presents the results of our research into the present patent landscape across computer-aided surgery. By looking into published patent application data we identify the companies investing most heavily in protecting their technologies and we assess their filing strategies and the likely motivation behind them. We identify subsectors in which patent filings have been particularly concentrated, in particular robotics, artificial intelligence and augmented reality.
The second part of the report discusses the key patent law provisions that it is essential to understand to achieve strong protection for these technologies in Europe, in particular: the methods used by the European Patent Office (EPO) to assess computer implemented inventions and the current restrictions on patenting medical methods.
We discuss an important recent decision of the Board of Appeal, in which the restrictions on patenting medical methods were applied to computer implemented inventions in a much broader way than the present Guidelines for Examination suggest. This decision has important implications for applicants for computer aided surgery inventions and we set out the crucial patent drafting considerations which must be carefully followed to ensure the broadest protection is achieved in Europe.
Finally, we look at specific patent strategy considerations in two of the most important growth areas of computer aided surgery technologies that were identified in our patent landscape research: artificial intelligence and augmented reality.
The Computer-Aided Surgery Innovation Landscape: A Pivotal Moment in the Field
The computer-aided surgery sector is at a crucial stage in its maturity. The efficacy of many computer-aided and robotic surgery techniques has now been demonstrated with many systems now in use in hospitals and the widespread adoption of the techniques inevitable over the coming years. Significant investment has also been deployed in the field over the last year. Notable examples include CMR Surgical raising $600 million in a Series D financing round and Memic Innovative Surgery, which focuses on a robotic-assisted surgical platform, raising $96 million in a Series D financing round. The sector is forecast to grow by almost 25% to over $24 billion by 2025.
This comes at a time when the early broad patents in the sector, filed around 20 years ago, are beginning to expire, opening the door to a new generation of innovative companies developing and protecting new approaches, utilising recent advances in related fields such as AI and machine vision.
As the graph on the next page illustrates, from a small number of early patent filings in the sector twenty years ago, innovation has accelerated in the last five years with this trend looking set to continue.
This combination of factors means there will be significant opportunities over the coming years, with those companies developing and effectively protecting the next dominant technologies likely to establish themselves in the market during the widespread adoption of robot assisted surgery in hospitals around the world.
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