Refusing supplementary protection certificates could restrict medical device investment

The German Federal Patent Court (BPatG) recently declined an application by a medical device innovator for a supplementary protection certificate (SPC).

SPCs are granted in the EU, typically in the life science sector, for medicinal products which are likely to require a long time in the market approvals process. They allow the patent term to be extended by up to five years, thus making investment a more attractive prospect.

The device in question, referred to as “aminosilane-coated iron oxide nanoparticles”, is an innovation from the Leibniz-Institut für Neue Materialien Gemeinnützige.

Iron oxide nanoparticles can be used to target and kill solid tumours in the prostate and brain, according to research in clinical trials. Ultrasound is used to guide them towards the target site, and magnetic fields are applied to generate heat, which is the mechanism that enables them to destroy or weaken the tumour.

Lexology, a news feed for the legal sector, recently published a blog by Jonathan Myers, associate patent attorney at IP law firm Barker Brettell on the ruling.

Myers explains in his blog that the German Patent and Trademark Office rejected the original SPC application on the grounds that the product is a medical device, rather than a medicinal product. SPCs are typically granted to pharmaceuticals, or products with a pharmacological action.

The Leibniz Institute appealed against the decision. According to The SPC Blog (a blog dedicated to issues surrounding SPC rulings), Leibniz acknowledged that in one sense the product is a medical device, as it is administered by a physical means. On the other hand, it argued that it could be classed as a medicinal product, as it is “administered in view to restoring or improving physiological functions in humans”.

The institute also argued over semantic fields. One of the regulatory criteria involved in the application for SPCs for medicinal products mentions active ingredients. The institute raised the argument that the term ‘active ingredient’ hasn’t been defined as being limited to products with a pharmacological action.

Ultimately, the BPatG rejected the appeal, citing a previous, separate ruling from the European Court of Justice, that, in the court’s opinion, clarified that the term ‘active ingredient’ refers only to “substances producing a pharmacological, immunological or metabolic action of their own”, as Myers writes in his blog.

So what does this case mean for medical device manufacturers? Myers writes: “Patent term extensions for such medical devices will likely only become available if new laws are drawn up, driven by a desire to recognise the regulatory burden that a medical device must go through for market approval.”                                            

But there is good news, he says.  He cites reports that allege the EU may be considering measures that could help broaden the use of SPCs.

The Leibniz case is just one of many such failed attempts to acquire an SPC for a medical device.

In 2009 a case brought before the UK Intellectual Property Office involved a stent using the drug paclitaxel to prevent restenosis (a condition where arteries or valves narrow after corrective surgery). Despite the inclusion of a drug in this device, the SPC was not granted.

This is perhaps a better example of a grey area in the semantics of SPC rulings. With drugs companies increasingly engaging medical device firms for innovative new delivery methods, the distinction between ‘medical device’ and ‘medicinal product’ is less and less clear.

What do cases like this mean for investment? The real function of an SPC is to make a medicinal product more attractive to investors, as they can compensate for the risks associated with long times to market. So for investors, the already labourious and time-consuming regulatory approvals process could be enough to deplete the appetite for innovation.