EU: The SPC eligibility issue

28-01-2019

EU: The SPC eligibility issue

(Source: PharmaTimes 2019-01-29)

The Court of Justice for the European Union's (CJEU) recent decision that medical device patents should not be eligible for Supplementary Protection Certificates (SPCs), which would extend the term of their monopoly by five years or so, is another setback for innovators in this fast-growing field of research and development.

In October last year, the CJEU handed down a decision in response to a preliminary ruling request by the German Federal Patents Court in what has become known as the Boston Scientific case (C-527/17). The medical device manufacturer was attempting to challenge European legislation, which prevented it from securing an SPC for a novel combined device used to help reduce the risk of restenosis – a condition that occurs when blood vessels or valves narrow after corrective surgery. A certificate of conformity had been obtained for the device in accordance with the Medical Device Directive.

The Court decided that the combined device was not eligible for an SPC on the grounds that it could not be defined as a ‘medicinal product’. It also concluded that when applying for an SPC, the prior authorisation secured for such devices is not equivalent to the market authority approval, which is required for a medicinal substance.

This case has disappointed many innovators involved in the development of new therapies and drug treatments – medical device makers and pharmaceutical manufacturers alike. In recent years, there has been a rapid increase in medical device innovation, particularly in fields such as drug delivery systems, which has grown rapidly and is expected to be worth $300bn by 2025, according to Research & Markets. The investment required to bring these patented inventions to market is significant and necessarily involves long periods of delay as a result of both complex development programmes and the lengthy clinical trial process. However, whilst these delays are common to both the drug and medical device industry, the benefits of SPC protections, which include a compensatory additional five years or so of patent monopoly, are not available to device manufacturers.

As the line separating medical device and pharmaceutical inventions becomes increasingly blurred, (particularly with the arrival of more sophisticated, combined medical devices - which often involve integrated medicinal substances), the legal framework that grants or denies SPC eligibility appears increasingly arbitrary.

This arbitrary distinction between traditional drugs and medical devices has not kept pace with advances over the last few decades. Drugs have become more like medical devices and vice versa. Moreover, in the absence of a more nuanced legal framework that recognises this reality, it seems likely that companies operating at the boundary between medical devices and drugs will continue to pursue expensive legal challenges in an effort to acquire SPC protection. Inherent ambiguity as to what is, or is not, classed as "a drug" (coupled with the strong incentive of an extended patent term) could commercially justify further legal challenges.

One prolific area of innovation that exemplifies this problem is nanomedicine technology. The miniaturisation of medical devices and the use of nanoparticles has led to many remarkable possibilities. One application is the use of contrast agents in Magnetic Resonance Imaging. This technology can be used to facilitate the dynamic imaging and analysis of the heart and circulatory system. Based on current legislation, such nanomedicine technology is unlikely to be eligible for SPC protection, even though lengthy and costly testing must be completed before the product can even be sold. It also doesn’t account for the high failure rate associated with bringing effective products to market.

Recent case law has shown how difficult it is to successfully argue that certain new medical technologies are eligible for SPC protection. Whilst this may seem unjust, ultimately, it is not the job of the courts to make the law more equitable for medical device manufacturers - that responsibility lies with the legislature. Therefore, at a time when the boundaries that exist between medical therapies and drug treatments are becoming less clear, it makes sense for innovators to press for change.

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