In case your company has received a refusal for an application
for an SPC certificate (supplementary protection certificate for
pharmaceuticals) from the Danish Patent and Trademark Office
(DKPTO), there is now good reason to consider whether the deadline
for appeal has passed.
A number of recent Office Actions from DK PTO indicates a change of
practice. A practice that is aligned with decisions from other
European authorities.
Earlier, the DK PTO refused applications for certificates based on
patents which related to pharmaceutical formulations. But recent
Office Actions indicates that the DK PTO no longer regard it for
problematic that a patent, which concerns a pharmaceutical
formulation, may be the subject of a certificate.
DKPTO still requires that the certificate is granted based on the
first marketing authorisation for one or more active ingredients,
and that no prior certificate has been granted. In certain cases it
may be accepted that the effect of the medicinal product is due to
a combination of the ingredients in the medicinal product. The
decision to grant is thus based on case-by-case evaluation.
The increased European harmonisation within the SPC-area can also
provide good reason for reconsidering your company's SPC
strategy. Since SPC normally protects a marketed product, the
optimisation of the SPC strategy can thus provide cost effective
protection.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
