Intellectual property

What is the issue:

  • Intellectual Property (IP) allows an appropriate period of exclusivity to market an invention and recoup the costs of upfront investment and risks with innovation. Australia’s position to support the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver for COVID-19 vaccines is a threat to future innovation.
  • Data exclusivity (also referred to as Regulatory Data Protection (RDP)) operates in parallel to any patent term and commences at the time a new pharmaceutical product is registered with the regulator. Data exclusivity incentivises innovative companies to invest in developing new medicinal products and generating, and making public, the extensive body of data required for the approval of innovative products. Australia’s data exclusivity period (5 years), particularly for biologics, is less than other similar countries like the US and EU.

Why is it important:

  • The more Australia is aligned with other countries, the more effectively it can compete in the global race for foreign investments in research, biotechnology and commercialisation of innovative medicines, which benefits both Australian patients and the economy.

Recommendations:

  1. Increase data exclusivity provisions to align with our international trading partners and comparable jurisdictions.
  2. Implement an effective patent notification system as intended under the WTO Agreement on TRIPS, and the Australia/US Free Trade Agreement (AUSFTA)
  3. Reverse the policy of seeking Commonwealth market sized damages as a party to patent disputes between innovator and generic companies.
  4. Oppose the adoption of the WTO TRIPS Waiver for COVID-19 vaccines, tests and treatments and recognise that the pace of development and scale of private investment that drove the global roll out of the COVID-19 regimens was underpinned by the IP protection system and the strong collaboration of patent holders, not hindered by it, maintain a strong and stable IP environment that meets Australia’s International obligations and maintains Australia’s competitiveness as an innovative country.
  5. Maintain a strong and stable IP environment that meets Australia’s International obligations and maintains Australia’s competitiveness as an innovative country.

Background

Intellectual property (IP) rights, particularly patents, are a universally accepted mechanism for the recognition of the value of innovation. Australia has a generally strong IP system, however, maintaining a stable and reliable IP regime is critical as it creates new jobs and industries; and enhances quality of life.

Key Fact:

Comparing 132 economies, Australia’s Global Innovation Index ranking has slipped from 23rd (2019) to 25th (2021)1. In 2018, Australia’s ranking was 20th

Issue:

Australia is lagging behind comparable countries with regard to Regulatory Data Protection (data exclusivity) that creates a disincentive for innovative IP to be retained in Australia. Canada, Japan and the EU have a minimum of 8 years Data Exclusivity while the United States has up to 12 years for Biologics2.

Key Fact:

Animal and Agricultural data protection is 10 years compared to 5 years for human pharmaceuticals. Therefore, in Australia, animal and plant IP is valued higher than IP that improves human lives3

Medicines Australia Recommendation:

Increase data exclusivity provisions to align with our international trading partners and comparable jurisdictions.

Issue:

Australia adds a further disincentive for legitimate patent holders to defend their IP through the lack of adequate patent notification and the subsequent pursuit of market sized damages.

In October 2020, the Government announced its plan to introduce legislation to create an earlier patent notification framework. The change was designed to create an opportunity for earlier negotiation and resolution of disputes on potential patent infringements before the follow-on product (generic/biosimilar) is listed in the PBS. However, as of June 2022, no new legislation had been proposed4.

Medicines Australia Recommendation:

Implement an effective patent notification system as intended under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the Australia/US Free Trade Agreement (AUSFTA) and;

Reverse the policy of seeking Commonwealth market sized damages as a party to patent disputes between innovator and generic companies.

The linking of the approval of follow-on biopharmaceutical products to the exclusivity status of a reference product is an effective way of ensuring that any disputes are resolved prior to the marketing of a follow-on product. Patients also benefit from the increased certainty, as they avoid the risk of having to change treatments depending on the outcome of a patent lawsuit5.

Issue:

The Australian Government supports the waiver of the patent protections on COVID-19 vaccines, tests and treatments provided by the TRIPS Agreement to which Australia is a signatory.

Medicines Australia has joined many industry groups around the world in opposition to the TRIPS Agreement, noting that a strong and reliable IP system is crucial to encourage the large-scale private investment into the pandemic response, and will disincentivise future investment as the pandemic evolves. Along with many other voices, we have expressed our deep disappointed by the decision made at the WTO Ministerial Conference in Geneva, to adopt an IP waiver for COVID-19 vaccines.

Medicines Australia Recommendation:

The Government should oppose the adoption of the TRIPS Waiver for COVID-19 vaccines, tests and treatments and recognise that the pace of development and scale of private investment that drove the global roll out of the COVID-19 regimens was underpinned by the IP protection system and the strong collaboration of patent holders, not hindered by it.

Issue:

Comparing 132 economies, Australia’s Global Innovation Index ranking has slipped from 23rd (2019) to 25th (2021)6. In 2018, Australia’s ranking was 20th

Medicines Australia Recommendation:

Maintain a strong and stable IP environment that meets Australia’s International obligations and maintains Australia’s competitiveness as an innovative country. In the context of IP Australia’s Strategic Roadmap to 2030, their Plan sees a multi-year program of legislative change designed to ensure a more effective and balanced IP system.

Additional References

  1. https://www.globalinnovationindex.org/analysis-economy
  2. Medicines Australia submission to the Productivity Commission Review of Intellectual Property Arrangements in Australia https://medicinesaustralia.com.au/ wp-content/uploads/sites/52/2010/02/20151130-sub-PC-Review-IP-Arranagements-FINAL.pdf
  3. Agricultural & Veterinary Chemicals Legislation Amendment Act 2013 2014 introduced 10-year term for agricultural & veterinary chemicals from July
  4. https://www.valueingenuity.com/wp-content/uploads/ip-index-2022/au.pdf
  5. https://www.valueingenuity.com/wp-content/uploads/ip-index-2022/au.pdf
  6. https://www.globalinnovationindex.org/analysis-economy
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