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Gardasil: From University Discovery to Global Blockbuster Drug

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biotechnology management case

Alan Collier1, Mark J. Ahn2 and Brendan Gray1
1University of Otago; 2Atkinson Graduate School of Management, Willamette University

Summary and key issue/decision: This case presents two key decision points in technology transfer and commercialization: first, a typical dilemma faced by university-based inventors on whether to publish or commercialize their discovery; and, second, a decision faced by a patent licensee of whether to risk the costs associated with pursuing patent rights in the face of an early legal defeat. All human papillomavirus (HPV) variants have an 8 kb circular genome enclosed in a capsid shell composed of the major and minor capsid proteins L1 and L2, respectively. Purified L1 protein will self-assemble to form empty shells that resemble a virus, called virus-like particles (VLPs). Frazer and Zhou at the University of Queensland discovered and, in 1991, reduced to practice the production of VLPs for one HPV serotype that is a principal cause of cervical cancer. At the time of their discovery, Frazer and Zhou were young researchers intent on building-up their research profile and peer esteem. They did not know if their discovery would have any commercial potential, but they did know that other researchers in the United States were close to a similar breakthrough. They were faced with the decision of whether to seek early publication and gain kudos for the discovery, or possibly to delay publication and seek a patent. The early research had been supported by CSL when it was a government agency involved in manufacturing blood plasma and other products, but planning on broadening its product portfolio. CSL was floated as a publicly listed company on the ASX (Australian Stock Exchange) in 1994. The Frazer and Zhou patent, as well as patents by three separate research groups in the United States, were deemed by the United States Patent and Trade Mark Office to contain valid claims to a single patentable invention. The resulting interference proceedings lasted eight years and finally granted patent priority to Georgetown University over CSL. CSL, as the principal licensee, and still a young public company, had to make a decision at the commencement of this interference on whether to risk a significant portion of their capital to pursue its patent rights in United States courts.

Companies/institutions: Merck, CSL, National Institutes of Health, University of Queensland, University of Rochester, Georgetown University

Technology: Human papillomavirus (HPV) vaccine

Indication/therapeutic area: Prophylactic vaccine for the prevention of human papillomavirus and anogenital warts caused by HPV serotypes 6, 11, 16 and 18.

Geography: U.S., Australia

Keywords: Gardasil, human papillomavirus, virus-like particles, cervical cancer, genital warts

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