Time to increase patent terms for new medicines

Patent terms for innovative medicines should be extended to compensate for increasing delays in regulatory approval, Medicines Australia chief executive Dr Brendan Shaw will tell Federal Government review of Australia’s patent system at a public hearing on Monday (11 February).

Pharmaceutical patents are currently granted up to five years’ extension to account for regulatory delays.

Dr Shaw said there was a strong argument to be made for increasing patent term extensions given that Therapeutic Goods Administration approval processes had lengthened significantly since 1998, when patent term extensions were introduced, and delays in listing on the Pharmaceutical Benefits Scheme had almost doubled.

“This review should certainly be looking at the option of increasing the term of patent extension,” Dr Shaw said.

“There’s compelling evidence that patent extensions are too short. The Government’s own standard for an effective patent life is 15 years, but nearly half of Australian pharmaceutical patents fall short of that.

“Extensions to the patent life for health technologies like pharmaceuticals are important because the regulatory and reimbursement processes consume years of patent life.

“Given it takes as long as three years to get a new medicine listed on the PBS, and rejection rates by the Pharmaceutical Benefits Advisory Committee are increasing, it’s timely to look at whether patent terms are long enough.

“For many years Australia has been widely regarded as having a world-class IP system that supports innovation. It will be important to ensure that Australia maintains this reputation in the future.

“A strong, stable and predictable IP system is critical to Australia’s ability to attract investment in R&D and high-tech manufacturing. It is also critical to Australian patients’ ability to receive the latest treatments as quickly as possible.

“This review is timely given the opportunities awaiting Australia’s innovative medicines and biotech companies in international markets and their need for a robust patent system that appropriately protects companies’ technological knowhow both in Australia and internationally.”


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