Generic Biosimilar Medicines Association

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You are here: Home / Generic Medicines Facts / Topics / Intellectual Property

Intellectual Property

GBMA supports intellectual property rights in the pharmaceutical sector that enable timely access to generic and biosimilar medicines. However, GBMA does not support the strategic misuse of the patent system.

In Australia, intellectual property laws provide up to 25 years’ patent protection for new medicines. When the patent expires, companies can apply to bring another brand of that same medicine to the market. These new generic and biosimilar brands trigger savings to the Pharmaceutical Benefits Scheme (PBS) and provide consumers with the opportunity to choose a lower cost alternative.

Intellectual property protection should be focussed at the cutting edge of innovation and not merely used as a commercial strategy to deny market entry of competitors.

The Australian generic and biosimilar medicines industry relies on domestic policy makers to “get the balance right” between patentee monopoly interests and public interest considerations.

The situation in Australia has been imbalanced for far too long, resulting in persistent and inappropriate market entry barriers to the launch and manufacture of generic and biosimilar medicines in Australia, which do not exist in our closest trading partners.

The Australian public and the Australian Government continue to bear the cost of delayed access to affordable medicines in Australia, and through lost opportunities to build and utilise world class manufacturing facilities in Australia for the export market.

Data exclusivity and patents have very different purposes and should not be confused.

Data exclusivity is independent of the patent system and is not designed to reward innovation.  Rewarding innovation is the role of the patent system.

Data exclusivity does not incentivise innovation. Rather, data exclusivity motivates a company to introduce a medicine into the Australian market.

Medicines must meet stringent safety and efficacy standards in order to be approved by the Therapeutic Goods Administration (TGA).  This requires the creation and submission of detailed ‘data’ packages to support an application for approval by the TGA to market in Australia.  Originator companies undertake research and development and create the original, detailed data in order to have their new medicines approved.

In order to reduce the overall cost of medicines to the public, the TGA allows generic medicines to be approved provided that they meet stringent regulatory requirements.  Less ‘data’ is required as the TGA cross-checks it against the original data supplied by the originator.

Data exclusivity provides the original applicant the exclusive use of information/data it has prepared and provided to the TGA in that the TGA will not use that data to process another application for marketing authorisation for a limited period of time.

In Australia, data exclusivity stops the TGA from using originator data for an initial five year period from approval of the originator medicine.

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