Gardasil - a vaccine for cervical cancer
A vaccine targeting human papillomavirus (HPV) - there are many strains of HPV and some can cause cancer.
The vaccine Gardasil prevents infection from HPV strains 16 and 18 if individuals are vaccinated before exposure to these strains.
Gardasil is administered as a series of three injections over seven months. In 2006, the Therapeutic Goods Administration approved Gardasil for females aged nine to 26 years and males aged nine to 15 years.
The inventors
Dr Ian Frazer, Australian of the Year in 2006, and the late Dr Jian Zhou filed a provisional patent application on their research into the vaccine in 1991.
The intellectual property
In Australia
Drs Frazer and Zhou had 12 months from the provisional patent filing date to determine whether the vaccine had sufficient commercial potential to warrant a complete patent application. The major advantage of a provisional application is that it establishes a 'priority date' the day it is lodged. Protection begins from this date on the granting of a complete standard patent.
Under a provisional application, public disclosure of an invention doesn't affect the validity of a patent application, provided the application is filed inside 12 months. Three days after lodging their provisional application, Frazer and Zhou presented their preliminary findings at a conference in Seattle USA secure in the knowledge that their IP was safe.
In July 1992 they applied for a complete standard patent under the Patent Cooperation Treaty (PCT), claiming the priority date from their provisional application. The PCT allows simultaneous applications for patents in nominated countries.
In the US
A month before Frazer's and Zhou's PCT application in the US, Drs Schlegel and Jenson filed a US patent application for a vaccine essentially the same as the Frazer-Zhou product.
In Australia, the first person to file an application will own any resulting patent. However in the US at the time whenever a patent was disputed, it would be owned by whoever invented it first. This means Australian innovators who wanted patent protection in the US must have ensured they kept effective records detailing developmental stages of their invention. The US is currently implementing a number of major patent reforms, one being the adoption of a "first to file" rule similar to that applying in Australia and other countries.
Frazer and Zhou applied for a US patent in January 1994, claiming the priority date from their provisional and PCT applications. The examiner of the 'Frazer' US patent application cited the Dr Schlegel and Dr Jenson 'Schlegel' patent application. The question was who invented the vaccine first: Frazer or Schlegel?
Frazer's Australian provisional application stated that two proteins needed to be expressed together to produce the vaccine. His later PCT and US patent applications revealed that only one protein was needed. As a result of this difference, the US Patent and Trademark Office found Dr Frazer could not claim the earlier priority date, making Dr Schlegel the official owner of the patent.
Frazer appealed against the decision to the US Federal Court. The court found in his favour, ruling that the later discovery didn't negate or contradict his initial application which involved an unpredictable technology in the early stages of development. This had provided Frazer's peers with specific information about the stage of development and was not merely an unproved hypothesis - particularly relevant because Dr Schlegel attended the 1991 Seattle conference where the Australian team presented its preliminary findings.
The court's decision in August 2007 overturned the ruling of the US Patent Office Board of Appeals and granted the patent for the vaccine to Drs Frazer and Zhou.
Did you know?
Zhou and Frazer's ultimate success highlights the value of using the Australian patent system as a means of protecting potentially valuable IP. However, the case highlights the importance of a careful, comprehensively drafted provisional application.
More than 65 million doses have been distributed worldwide since Gardasil was released onto the market and it's since been approved in 121 countries. The University of Queensland has also waived royalties on sales to 72 developing countries least able to afford vaccines.
Total Gardasil sales peaked at US $1.5 billion for the year ending December 2007.
Media enquiries to:
David Henderson
Managing Director
UniQuest Pty Limited
(07) 3365 4037
Case Study Photography: University of Queensland
Last Updated: 15/9/2012
