Planning white paper: what it means for developer contributions and costs of development
Out-Law Analysis | 23 Mar 2017 | 11:02 am | 6 min. read
The European Commission is conducting a review (6-page / 218KB PDF) of the extensions, which are granted via supplementary protection certificates (SPC), and will consider whether the legal framework for SPCs needs to be modernised. The Commission intends to open a consultation on the topic before the end of June this year.
The Commission should recognise the length of time it can take for manufacturers of high-risk medical devices to generate a return on the investment they put into developing their products in the same way existing rules recognise the lengthy drug approvals process pharmaceutical companies have to go through before being able to market their product.
However, it appears the focus of the Commission's review will be on issues with the SPC system that relate to medicines. It is vital that the review also considers improvements for medical devices as the current SPC system is harsh and arbitrary for medical technology (medtech) companies.
Supplementary protection certificates
SPCs serve to extend the life of a patent by up to a maximum of five years in the field of medicinal products. SPCs are provided for under an EU Regulation which is directly applicable across the whole of the EU, although they have to be applied for separately in each EU country.
The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy drug approval process. Patent protection lasts 20 years but it often takes drugs companies around a decade to develop new medicines and gain marketing authorisation.
Under the SPC Regulation, SPCs are only permitted in respect of medicines. The majority of medical devices are not entitled to SPC protection despite often facing similar levels of regulation to pharmaceutical products.
The lack of access to SPCs is less of a problem for manufacturers of non-invasive and low-risk devices – so-called 'class one' devices – as those devices face minimal regulatory hurdles before they can be marketed.
However, the issue is more of a problem for more complex and more invasive devices as they generally require substantial clinical trials and assessments before approval to launch is granted, all of which costs money and eats into the time that patent protection applies. This makes it difficult for medical device manufacturers to recover substantial research and development investment.
Current SPC rules and their application to medical devices
The current position is that SPCs extending patents covering drug-combination medical devices can be granted, albeit only if certain criteria are fulfilled.
SPCs for such devices can be granted provided that the drug included in or used with the medical device is considered a medicine on its own, and has not previously been the subject of a SPC; and the therapeutic effect of the device is achieved by pharmacological, immunological or metabolic means.
Drug-combination medical devices are regulated under EU medicines law, specifically the EU Medicinal Products Directive or Veterinary Medicinal Products Directive, and so are eligible for an SPC.
Examples of medical devices which are treated as medicinal products and thus are eligible for SPC protection include pre-filled syringes, aerosols containing a medicinal product, transdermal drug delivery patches, intrauterine contraceptives releasing progestrogens, plastic bead implants containing an antibiotic, and wound dressings containing an antimicrobial agent.
Medical devices where the therapeutic effect is not achieved by pharmacological, immunological or metabolic means are not regulated under the EU medicines legislation. They are therefore unlikely to be eligible for a SPC, although there are examples of anomalies in this regard.
Indeed, national intellectual property offices, which assess SPC applications, commonly reject applications because they consider that the therapeutic effect of a device is not achieved by pharmacological, immunological or metabolic means. As such they deem that the device is not a medicinal product, as required by the SPC Regulation, but rather a medical device.
Another common reason why applications are rejected is because those authorities do not consider a so-called 'conformity assessment', endorsing medical devices as having fulfilled the requirements of EU medical device legislation, as being a 'valid marketing authorisation', as the SPC Regulation requires.
Anomalies and inconsistent interpretations of the rules
The interpretation of the rules has, however, not been consistent across the EU.
A striking example of this is the case of Leibniz's NanoTherm device. The company successfully applied for an SPC for the device in the Netherlands, but its applications in the UK and Germany were rejected.
The NanoTherm device is designed to help in the treatment of tumours. An iron-oxide formulation is injected into a tumour before a magnetic field is then applied to the tumour, causing the iron-oxide formulation to heat up and kill the tumour cells. The therapeutic effect of the NanoTherm device was produced solely by physical means and was not of a pharmacological, immunological or metabolic nature, and was held to have failed to have met the criteria for an SPC in the UK and Germany.
Applications for an SPC for the Cerus Intercept device and Taxol stent were also rejected in the UK on a similar basis.
Other examples of devices where the therapeutic effect is by physical means, which are therefore likely to be excluded from SPC protection, include catheters coated with heparin or antibiotic agent, bone cements that contain an antibiotic, root canal fillers with ancillary medicinal substances, soft tissue fillers containing local anaesthetics, drug eluting coronary stents, and wound dressings coated with an antimicrobial agent.
However, along with the NanoTherm example, there have been other anomalies where SPCs have been granted to medical devices even though those devices were approved as medical devices and not medicinal products.
SPC applications were approved after applicants were able to show that the safety and efficacy testing that they had to do to secure approval for that class of medical device was analogous to that required under the EU medicines legislation and that the mode of action of the device was achieved by pharmacological, immunological or metabolic means. They also demonstrated that the substance on its own would have been regulated under the Medicinal Products Directive and were thus eligible for an SPC.
The successful SPC applications in Germany and the Netherlands for the Yttrium implant device for the treatment of cancer are examples of the anomalies that have arisen. Similarly, the Synvisc device, a replacement joint fluid for body joints such as the knee, was also granted an SPC in the Netherlands.
Changes should be considered for high-risk devices
Where lengthy and costly clinical trials are required to secure marketing authorisations for medical devices, and the approval process itself is time consuming, this will reduce the effective patent term the developer of those products can benefit from, once their product is approved.
Given that these delays and the loss of effective patent term is the primary justification for SPCs on medicinal products, there is arguably a case that medical devices should also be eligible for an extension of patent protection where safety and efficacy testing is required in order to secure approval.
The inconsistent and divergent treatment of combination medical devices by the national offices leads to uncertainty and could act as a barrier to trade in the internal market. This is not least because the EU's highest court, in a 2013 ruling, held it is possible for a product to be concurrently classified as a medical device in one EU member state and a medicinal product in another, and thus the availability of SPC protection will vary between EU countries.
Regardless of the mode of action of a medical device, if it is classified as a 'class three' high-risk medical device, then it is already subject to the high standards of medical device assessment in order to obtain the requisite conformity assessment certificate. This includes verification of the safety, quality and usefulness of both the device and usually the substance, series of clinical and non-clinical testing.
In these circumstances, given that the same delays are the primary justification for SPCs covering medicinal products, there should arguably be a mechanism by which patent term can be extended if the developer of the product can demonstrate that they have incurred lengthy delays as a result of obtaining the conformity assessment.
Medtech companies should seize the opportunity to feed in comments to the European Commission's consultation when it is opened or even engage with the Commission now to ensure patent term extensions for medical devices is on the agenda.
Allison Sadick is an expert in intellectual property law and life sciences at Pinsent Masons, the law firm behind Out-Law.com.
Planning white paper: what it means for developer contributions and costs of development