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
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 GmbH
Elisenhof, Elisenstr 3
D-80335, Munich, Germany
Tel: +49 89 74 72 660
Fax: +49 89 77 64 24