This article was first published by Bio Science Today in March 2019
The duration of patent protection for medical devices is up to twenty years, as for any other type of device. Pharmaceuticals, on the other hand, may be entitled to an extended duration of patent protection. The justification for this is to allow an adequate return on investment following the time and cost for pharmaceuticals to be granted regulatory approval. The patent system is there, after all, to reward innovation not prevent it. This article examines the emerging grey area between medical devices and pharmaceuticals, and asks whether the current system is fair.
There are two main ways of extending patent protection for a pharmaceutical – filing so-called “second medical use” applications, and obtaining a “Supplementary Protection Certificate” (SPC). As the name suggests, a second medical use application claims a new therapeutic use for a known pharmaceutical, whereas an SPC may extend the life of a patent directed to a new pharmaceutical by as many as five years (and a further 6 months for paediatric drugs).
Increasingly, pharmaceuticals and devices are integrated, and nano and biosorbable device technologies blur the lines with pharmaceuticals, and all may require similarly lengthy and expensive regulatory approval. Attempts have been made to use existing legislation to protect these devices, but so far, these attempts have largely been unsuccessful.
Patents directed to therapeutic methods are excluded from patentability in Europe and many other countries, so as not to restrict the freedom of medical practitioners. There is an exception for a new therapeutic use of a “substance or composition”, even if already known. The term “substance or composition” has been defined in case law as the active material that achieves the therapeutic effect in a treatment.
Attempts have been made to define medical devices to fall within the above definition, but it has proven difficult. A very recent case related to a filler material that is injected between tissues prior to radiation therapy in order to reduce radiation exposure of secondary tissues. The filler was a known material, but the medical technique was new.
It was decided that the therapeutic effect was achieved by physical displacement of the sensitive tissue and not due to the chemical composition of the filler. The spacing effects were present for any filler material, which further underlined that the effect was physical and independent of the filler’s particular chemistry. It was thus concluded that the filler was a device and not a substance or composition, and the patent was denied.
As “substance or composition” can be summarized as a product that achieves a direct therapeutic effect by a chemical, as opposed to physical, interaction with the body, it is still possible to protect non-pharmaceutical devices and substances which are effective by nature of their chemistry, for example a surgical dye for use in eye lenses. Furthermore, protecting the new use of a pharmaceutical, where the new use requires a particular device, may be possible.
SPCs are not available for standalone medical devices, but could potentially be available for device-drug combinations. However, recent case law makes this unlikely.
In order to get an SPC, you need both a patent and a marketing authorisation. Whether or not you get a marketing authorisation depends if the drug-device combination is regulated through the Medicinal Products Directive (MPD) or the Medical Devices Directive (MDD). Marketing authorisations are sought through the MPD and are explicitly entitled to be used for the purposes of obtaining an SPC, however regulatory approval obtained by the MDD are not. It was recently held that Boston Scientific, whose patented coronary stent released a sustained dosage of cytochalasins (approved under the MDD), was not entitled to an SPC even though assessment under the MDD was equally as arduous as that of the MPD.
The intention, and interpretation, of the law was to permit extra protection for pharmaceuticals to protect investment in view of the regulatory hurdles. This however seems to unfairly penalise those who operate on the boundary between devices and pharmaceuticals, who face the same time and cost challenges, and is therefore something that needs to be reconsidered.