In a move that has been threatened for some time, legislation has been introduced into the Australian parliament to create a further exception to the patentee’s rights. This will allow for the manufacture of patent protected medicines in Australia where the products are going to be exported to address a public health issue either in the context of an emergency (or other extremely urgent circumstances) or by the public non-commercial use of the relevant product. The exception applies to both product patents per se and also process patents.
The move has been driven largely by generic companies, on the back of the need to be able to manufacture in Australia, to level the playing field with countries with little or no patent protection, when it comes to establishing manufacturing facilities.
The proposed regime is essentially one of court endorsed compulsory licensing. From the patentees’ perspective, their role in triggering access to the regime only applies in the case of public non-commercial use of the relevant product, and is to the effect that no agreement was reached within 30 days. The patentee also has the right to be party to the court proceedings.
Whilst the process outlined in the draft legislation is reasonably complex, to the point that it might almost be considered impractical, the concern for patentees is that it represents another assault on their monopolies and comes at a time when these sorts of issues are on the agenda as part of the Trans Pacific Partnership negotiations.