The ultimate purpose of a Supplementary Protection Certificate (SPC) is to compensate a patentee for the time lost due to lengthy regulatory approval processes.
The EU legislation governing SPCs does not explicitly cover medical devices, but only pharmaceuticals and crop protection products. One reason for this may be that medical devices only undergo a rather lean approval process that is merely supervised by a notified body instead of a regulatory authority. Consequently, there have been only exceptional cases where patentees obtained an SPC for a medical device in some EU member states. Most requests are denied.
In May 2017, the new Medical Device Regulation (MDR) and In vitro Diagnostic Medical Device Regulation (IVDMDR) entered into force. There seems to be a general consensus that the Regulations will raise the bar for market approval of medical devices. For example, the Regulations establish a new pre-market scrutiny mechanism, including a pool of experts, that ensures stricter ex-ante control for high-risk devices. One unintended consequence could be that the new Regulations will slow down market approval for medical devices, prompting even more manufacturers to reach for an SPC as compensation.
The ever-growing field of precision medicine, i.e. administration of the most suitable drug for each individual patient, promises improved medical treatments in the future. A crucial aspect of precision medicine is the use of companion diagnostics, defined according to the IVDMDR as a medical device essential for the safe and effective use of a corresponding medicinal product. Before granting market approval for companion diagnostics, the notified body shall "consult" a competent regulatory authority, which could potentially complicate and slow down the approval process.
Further, for highly innovative first-in-class drugs, the companion diagnostic will ideally be co-developed together with the drug, since its early use for patient stratification in clinical trials facilitates monitoring the effects of the new drug. However, the commercial value of the co-developed companion diagnostic is entirely dependent on regulatory approval of the first-in-class drug. It would thus be fair to not only award an SPC for the first-in-class drug but also for its companion diagnostic.
In summary, the regulatory hurdles for the market approval of many medical devices are being set higher, and we may see more cases where an SPC for medical devices may seem reasonable and just (despite medical devices not being explicitly covered by the current SPC regulations). Especially for the emerging field of precision medicine, it remains to be seen if and how the time loss due to regulatory processes can be compensated for and whether SPCs for companion diagnostics could play a part in that compensation.
Jan van Dieck |
Maiwald Patentanwalts GmbHElisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64 24info@maiwald.euwww.maiwald.eu
