A delegation led by the US Chamber of Commerce is in Australia for discussions with government over intellectual property.
The delegation, led by Mark Elliot, executive vice president of the Chamber's Global Intellectual Property Center, and former head of public affairs at Pfizer Australia, includes senior representatives of the US-based pharmaceutical and biotechnology sectors.
It has meetings with a range of political and policy stakeholders in Sydney and Canberra.
It is expected to raise ongoing concerns about intellectual property protection in Australia, including in relation to pharmaceuticals, and comes at a sensitive time for the issue.
The Turnbull government recently released its response to the Productivity Commission's report on intellectual property arrangements.
In its recent response to the controversial 2016 report, government rejected most of its more controversial recommendations, including for the effective abolition of the five-year patent term extension for pharmaceuticals and the exclusion of intellectual property from negotiation of bilateral trade agreements.
However, it backed changes to the inventive step and gave in principle support for the introduction of a system of monitoring settlements between originator and generic pharmaceutical companies to detect potential so-called 'pay-for-delay' agreements.
While the research-based pharmaceutical sector welcomed its rejection of the report's most controversial recommendations, there is concern over the general direction of policy in Australia, with a series of reviews calling for the winding back of key intellectual property protections.
The delegation is also expected to raise concerns over implementation of Australia's commitments under its bilateral free trade agreement with the US. In that agreement, Australia committed to introduce a system of patent notification, under which patent holders must be notified of any request for the approval of a generic.
The US FDA maintains a list of products and current uses under patient in its 'Orange Book'. It will not grant marketing approval for a generic copy of a product that would potentially infringe a patent listed in the 'Orange Book'.
In contrast, the system introduced in Australia following ratification of the FTA does not involve any substantive role for the TGA and gives patent holders virtually no capacity to challenge a product until after it is registered.
The system requires companies seeking marketing authorisation to simply declare to the TGA their application does not breach any patent. The TGA will not register a product if a company declares it will infringe a patent. Yet the regulator has no obligation to test an applicant's declaration.
The research-based sector argues the current system falls short of Australia's commitments in the FTA. It also argues the adoption of a US-style system would facilitate early resolution of patent disputes. It believes early resolution of patent disputes, at the start of the regulatory approval process rather than the end, might help avoid many of the issues that have led to the current court cases in which the commonwealth is seeking damages from a number of research-based companies for delaying the entry of generics through court actions.