Posted by Michael Wonder on 20 Apr 2017
Full Federal Court confirms an application to list medicine on the PBS prior to patent expiry is a non-infringing act
19 April 2017 - Late last week, the Full Federal Court of Australia confirmed that the mere act of filing a PBS application for a generic pharmaceutical product is not, of itself, an act of infringement provided that the generic product will not be made available for sale to wholesalers or pharmacists until after the relevant patent has expired.
This decision clears any uncertainty for generics proposing to apply to list on the PBS prior to patent expiry for post patent launch.
