Computer-aided Surgery: Patent Strategy in Europe

Driven by the rapid pace of innovation across a number of emerging digital technologies, the coming years will see radical changes in the way surgery is delivered, promising more personalised, less invasive procedures and the potential for huge improvements in patient outcomes.  However, the field of computer-aided surgery falls across a number of complex and shifting areas of patent law, meaning innovators face specific challenges in achieving the broad protection in Europe that their innovation warrants.

Recognising the need for greater clarity and support for applicants and their legal advisors, GJE’s MedTech team have been focussing throughout 2021 on developing the resources to support innovators seeking to protect computer-aided surgery inventions in Europe. Our aims are to:

  1. Present the findings of our research into the current patent landscape and review the filing strategies followed by the leading companies in this field.
  2. Explain the latest important legal developments in Europe.
  3. Provide practical guidance on preparing strong patent applications to navigate the complex and shifting legal restrictions in Europe specific to this subject matter.

The Royal College of Surgeons’ “Future of Surgery” report recently identified a number of advances in technology that are already changing the way surgery will be delivered, with the sector likely to be transformed over the next 20 years. These advances encompass, but are not limited to, surgical robotics, virtual and augmented reality systems, AI and machine learning. We refer to these technologies as subsectors of the overarching “computer-aided surgery” sector.

As we have recently reported, the last few years have seen significant commercial activity in the field with a number of high-profile funding rounds and mergers. The rapid pace of innovation has been reflected in an equally rapid growth in patent filings across the subsectors of computer-aided surgery, as companies look to ring-fence what they hope will become the dominant technologies in this emerging field.

Of particular interest is the shift in filing behaviour among firms in the sector from patents relating to surgical hardware towards patents aimed at protecting the software and computer-implemented aspects of these innovations. While this represents an exciting development of this rapidly maturing sector, the technologies involved 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 for their innovations.

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Protecting Computer-aided Surgery Inventions: The Legal Framework in Europe

When looking to develop an IP strategy to protect computer-aided surgery innovation, it is essential to consider not just which aspects of your innovations can be protected, but if this protection can be defined in a way which brings value to support the commercial aims of the business. This requires an understanding of the current relevant restrictions to patentability under European patent law. There are a number of important provisions that applicants must be aware of when seeking protection in this area, in particular:

  • The restrictions on patenting software that does not provide a “technical solution to a technical problem”.
  • The restrictions on patenting mathematical methods that may apply to certain machine learning innovations where not correctly defined.
  • The restrictions on patenting the simple presentation of information, which are likely to be relevant to innovation in the AR surgery sector.
  • The exception to patentability of methods of treatment by surgery or therapy, which can be relevant to software implementing such methods and where there have been significant recent developments in the case law that applicants must be aware of.

There can also be complex interactions between these areas of law. For example, where a new software controlled method may need to cite the technical effect of the method in terms of the treatment outcome for the patient, but doing so may lead the invention towards the restrictions on patenting methods of treatment.

GJE have been monitoring the legal developments and have prepared a number of resources for applicants preparing applications in this area.

One notable development in the law in this area was the Board of Appeal decision in T 0944/15. Conventionally, the practice of the European Patent Office (EPO) has been to invoke the exclusion of medical methods only against applications in which the claims require performing one or more method steps that constitute an excluded kind of treatment or surgery. This is reflected in the current edition of the EPO’s Guidelines for Examination in G‑II, 4.2.1, which states unambiguously that “only method claims may fall under the exception” and that the exclusion therefore does not apply to computer programs or devices.

In T 0944/15 the EPO’s Boards of Appeal held, contrary to the approach set out in the Guidelines, that the exclusion may apply to claims for computer programs and methods that do not explicitly require any treatment or surgical steps where the overall teaching of the patent specification suggests that the benefits of the invention manifest only when performing such a method. Furthermore, the Board in T 0944/15 was clear in expressing its view that the exclusion cannot be avoided simply by a change of claim category from a method to a computer program. This is a significant departure from the clear approach set out in the Guidelines discussed above.

In view of this decision, GJE’s MedTech group have prepared a guide to applicants explaining the key drafting considerations that must be accounted for when preparing patent applications for inventions relating to surgical and therapeutic methods, in particular those that have features implemented by software.

We have also prepared guides on the important considerations in protecting innovation in a number of the high growth areas of computer-aided surgery, including AI/machine learning, augmented reality systems, and robotics.

 

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How Can GJE Help You Protect Your Computer-Aided Surgery Invention?

In order to secure the value that your innovation justifies, you need advice from the right experts on how to develop an IP protection plan that navigates the complex legal landscape and is correctly tailored to support your specific business plan. GJE’s expertise in this technical field will ensure that you are implementing the correct approach to ensure that your business is in the best possible position for future success.

Whether you are a fledging start-up seeking seed funding, a fast-growth SME scoping Series A or B funding opportunities, or an established company looking to streamline its IP portfolio or secure a lucrative exit, we have the relevant commercial and technical expertise in the team to help you.

We can help you:

  • Develop an IP protection plan aligned with your business objectives.
  • Secure the strongest protection possible for your innovations, brands and designs.
  • Help you assess third party IP rights and your freedom to operate.
  • Challenge obstructive third party IP rights.
  • Ensure your IP portfolio is in order for investor due diligence.
  • Assess and manage your existing IP portfolio and ensure cost efficiency.
  • Regularly review your IP strategy to ensure it remains aligned with your commercial objectives as your business grows.

We have developed ConsultIP™ to help you achieve these objectives. ConsultIP™ helps business owners – at whatever stage of their lifecycle – maximise the commercial value of their intellectual property. Visit our ConsultIP™ page here to find out more.

Download resources:

Computer-aided Surgery

The Computer-Aided Surgery Innovation Landscape: 2021 Update

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