Australia plans to review pharmaceutical patents
As debate continues over access to medicines and intellectual property rights, the Australian government has decided to review its procedures for granting patents on prescription medicines.
And so a special panel has been formed to take “practical steps to ensure the system is delivering effective outcomes for consumers and industry.”
Why now, though? The government explains that the Patents Act of 1990 – which allows patents to be extended, under some circumstances, for up to five years beyond the standard 20-year period – were introduced in 1998 and are now due for review, according to IP Australia, a branch of the government that oversees intellectual property.
“The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, while fostering innovation and supporting research. In particular, the extension of term provisions will be reviewed,” according to a statement from the department.
The move also comes in the wake of debate over free trade agreements and, specifically, controversy that these deals are being used by multi-national drugmakers to wrest favorable provisions that would make it more difficult for countries to make medicines more readily affordable to their citizens. The issue has figured in the Trans-Pacific Free Trade Agreement talks that include Australia (read here).
And so, IP Australia notes that the review, which is expected to be completed in April 2013, will “also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants,” according to the statement, which notes Australia’s obligations under international agreements will be scrutinized.
“In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market,” the department explains.
The review will also examine the availability of competitively priced medicines in the Australian market; the role of the patent system in fostering innovation and bringing new drugs and medical technologies to market; the role of the patent system in providing employment and investment in research and industry; and the range of international approaches to extensions of term and arrangements for pharmaceutical inventions (here is the statement).
The trade group that represents drugmakers had this to say: “A new federal government review of Australia’s patent system should consider the compelling case to extend the patent life of innovative medicines,” said Medicines Australia chief executive Brendan Shaw, in a statement. “Extensions to the patent life for health technologies like pharmaceuticals was important because the regulatory and reimbursement processes consume years of patent life.
“We look forward to contributing to this review because there is a growing argument that patent terms in Australia are too short,” he continued. “Given it takes as long as three years to get a new medicine listed on the Pharmaceutical Benefits Scheme, and rejection rates by the Pharmaceutical Benefits Advisory Committee are increasing, it’s timely to look at whether patent terms are long enough.
“In light of some of the recent deterioration we have seen in patent protection in some countries, the review provides the opportunity for the Australian Government to give a clear signal about its approach to intellectual property to those countries and to Australian technology companies,” he said.
By Ed Silverman