3. Alternative means of protection
Given the concerns
about the restrictions on competition and access to medicines further
imposed by both new-use patents and patents on product derivatives, and doubts whether they present a real
incentive for innovation, you may wish to exclude these subject matters from patent protection altogether. Obviously, this decision would depend on your country's preferences and its level of technological development.
Remember
Should you wish to exclude
new uses from process patent protection, you could draw on a broad interpretation of Article 27.3 (a), TRIPS Agreement (see
chapter 1.2). Product patents on new uses could only be denied by strictly applying the
patentability criteria (see
chapter 2.4).
Product derivatives of existing medical products could be excluded from patentability, unless the variants have important effects on the medical efficacy of the respective drug, either by following the Indian approach (see chapter 1.3) or by strictly applying the novelty requirements as under the US approach (see chapter 2.5).
As an alternative to patent protection, you could protect new uses and product derivatives through
utility models (see below). A better approach could
entail building upon proposals for so-called "
compensatory liability", i.e. use and pay regimes (see below).
Please note
On the compensatory liability approach, it was suggested to entitle innovators to a brief period of market exclusivity,
say, one or two years, prior to the use and pay regime, in order to encourage local investment in R&D on incremental
innovations. This way, innovators would have time to establish their brands in the market before facing competition.
