Module 4: Intellectual property and commercialisation

Case Study : Gardasil® – an example of university licensing

This case study is provided as an example of the licensing pathway as outlined in Topic 2, Subtopic 2.2

Case study description

GARDASIL® is the world's first vaccine to prevent cancer. It protects women against four strains of the human papillomavirus virus (HPV) – types 16 and 18, which account for about 70 per cent of cervical cancer cases (the second most common cause of cancer death in women) and types 6 and 11, which account for about 90 per cent of genital wart cases. Cervical cancer is one of the few cancers known to be caused by a virus. Worldwide, it is the second most common cause of cancer death in women, with about 250,000 women dying from cervical cancer annually.

The vaccine was developed at The University of Queensland (UQ) by the 2006 Australian of the Year, Professor Ian Frazer and the late Dr Jian Zhou, who began working on the basis of the HPV vaccine in the late 1980s. In the early 1990s, the pair developed recombinant virus-like particles which could be used to train the body to fight the virus. Professor Frazer had concentrated on HPV because it was known to cause genital herpes and had links to cancer.

The commercialisation story

Conscious of the commercial potential of their research, Professor Frazer approached UniQuest to protect the HPV vaccine technology intellectual property before it was disclosed at a conference. As a result, UQ's main commercialisation company, UniQuest Pty Ltd, filed a patent application claiming the HPV vaccine technology in 1991.

Industry funding for the development of the HPV vaccine was provided by CSL Limited. In 1991, CSL funded a research and development collaboration which included an option to license the vaccine technology via UniQuest. CSL Limited then on-licensed the HPV vaccine technology to Merck & Co, Inc, while still retaining the rights to market the vaccine in Australia and New Zealand. Merck subsequently funded the successful Phase II and Phase III clinical trials of the vaccine. Additionally, CSL entered into a cross licensing and settlement agreement with GlaxoSmithKline (GSK) in 2005.

The Merck vaccine, Gardasi®, was commercially released in 2006. Under the licensing arrangements, milestone and royalty payments from the sale of the Merck and GSK vaccines will be payable to UniQuest and will ultimately flow back to UQ and the researchers. Industry is projecting that Gardasil&ref; will be a 'blockbuster?drug with sales of between US$1-3 billion annually. The vaccine will be one of the first Australia pharmaceutical successes to result in a fair share of economic benefit flowing back into the country.

To help make the vaccine accessible in developing countries, Professor Frazer is working with the Gates Foundation and is a consultant to the World Health Organisation's Expanded Vaccine Initiative. In addition, Merck will be introducing a differential pricing structure to help ensure the vaccine is available at a reduced price in developing countries.

Case study commentary

The Gardasil® case study is an example of the successful commercialisation of university research via the licensing pathway. Licensing the technology outsourced the risk and cost of developing the vaccine commercially, with Merck financing the extremely expensive Phase II and Phase III clinical trials necessary to achieve regulatory approval for the vaccine to be marketed.

The Gardasil® vaccine also set a new reference point for Australian commercialisation opportunities with pharmaceutical companies.

Lessons learned

Key points to be taken from this case study include:

• The researchers discussed their research with the university commercialisation office before any disclosures were made (such as publications, conference presentations or abstract submissions);
• The researchers were actively involved in protecting the IP and complied with requirements such as keeping detailed, up-to-date and signed laboratory notebooks. These notebooks were later used in a US lawsuit to uphold the patent;
• The IP was substantially developed before it was licensed;
• UniQuest negotiated a strong licensing deal to ensure UQ and the researchers received an appropriate share of profits from the vaccine; and
• Professor Frazer remained committed to the commercialisation of the vaccine through the entire process and played an important role in marketing the vaccine.