THE medical devices market is a major contributor to the overall healthcare industry. Continuing escalation of conditions and diseases in areas such as cardiovascular medicine, oncology, neurology and respiratory medicine is driving the search for new and improved devices for use in treatment, prevention and/or diagnosis. Cardiovascular, orthopaedic and diagnostic imaging devices are the main revenue generators for the industry at the moment.
As a consequence, this sector has experienced considerable growth over the past few years, with global revenues reportedly expected to be worth approximately £206 billion in 2017, an increase of about 6 per cent since 2011.
At the same time, medical technologies are at the forefront of patenting activity in Europe. The 2014 Annual Report recently published by the European Patent Office (EPO) ranks medical technology as the top technical field with 11,124 patent applications filed in that period. In terms of development, medical technology also shows significant progress with a 3.2 per cent increase in the number of filings in 2014 over the previous year.
This substantial growth demonstrates that, in this sector, the pursuit of patent protection remains a crucial part of the asset portfolio. Indeed, many applicants are successful in obtaining patent protection for their innovations in the field of medical devices.
In the medical field, patents routinely embrace new compounds, compositions and medicines but in Europe there are constraints on what can be protected. Specifically, under European law, methods of treatment of the human body are excluded from patentability. For example, a European patent cannot relate to a method of treating cancer by surgically removing a tumour. However, the exclusion can be circumvented by directing a patent application in the use of a particular “substance or composition” (for example a medicine) in a method of treatment. In this way, a new drug for use in the treatment of cancer could be patentable.
It is also possible to obtain patent protection in Europe for the new use of a known medicine. However, there is currently a disconnect where a known substance/composition or medical device is used in a new method of treatment. While current legal provisions make it possible to protect a medicine when used in a new method of treatment, those same provisions may not apply to medical devices.
This question was considered in depth during a recent case brought before the EPO. The technology related to a dialysis membrane to reduce the levels of free light chain molecules (a constituent of immunoglobulins), a particular substance found in a patient during blood dialysis. Although dialysis membranes of a similar construction have been publicly disclosed in the past, the entity applying for patent protection argued that the specific use of this membrane for the treatment of a specific medical condition was in fact new and should be considered for patent protection.
In short, the key question was whether or not the dialysis membrane could actually be considered to be a “substance or composition” (in which case its new medical use may be patentable) rather than purely a device (in which case its new medical use would not be patentable).
The decision reached by the EPO was that the term “substance or composition” does not extend to a medical product. Of course there will be exceptions. One would be if the medical product contained an active ingredient which provides a specific therapeutic effect and the device simply served as a carrier for it.
If the EPO had reached a different conclusion it could have paved the way for patenting new therapeutic uses of known medical devices. However, as things are, this possibility appears to have been eliminated – at least until the next twist in the tale. For most people working in the field of medical devices, this will simply confirm what was previously understood to be already the case.
Many consider the options available to obtain patent protection for medical devices to be adequate to protect innovative ideas. With the recent trends in the growth of patenting in the medical technology sector in Scotland and the UK, the medical industry should be confident as it looks to the future.
• Yann Robin is a Chartered and European Patent Attorney at Marks & Clerk. www.marks-clerk.com