Table 1: Timeline of patenting and licensing of HPV L1-VLP–based prophylactic vaccines

Nature Bio Technology

From Intellectual property, technology transfer and manufacture of low-cost HPV vaccines in India

Journal name: Nature Biotechnology

Volume: 28,

Pages: 671–678

Year published: (2010)

DOI: doi:10.1038/nbt0710-671

Technologies underlying the L1-VLP based prophylactic vaccines emerged from research conducted at the University of Rochester, the NCI, Georgetown University and the University of Queensland. The NCI initially nonexclusively licensed the technology to MedImmune and Merck. MedImmune also acquired worldwide exclusive rights to IP from Georgetown University and the University of Rochester. The University of Queensland licensed its patents to CSL, which in turn licensed the technology exclusively to Merck. GSK eventually acquired exclusive rights to MedImmune’s entire IP portfolio for HPV vaccine development. Owing to a first-to-invent system in the United States, patent interference proceedings were triggered at the USPTO when claims overlapped from different patent applications filed by four different groups of inventors. The interference proceedings involved various L1-antigen HPV-related claims. Six two-way patent interferences between the four parties continued for nearly a decade, presumably at significant cost to the institutions or their primary licensees, and were partially resolved in 2005. Given the uncertainty surrounding the ownership of enabling vaccine technologies and the possibility of mutually blocking exclusive rights (that is, neither firm could be sure its products would not infringe on patent rights held by the other), Merck and GSK cross-licensed their respective IP holdings in 2005 to ensure unfettered access to these technologies. They consequently secured their market position in the United States and Europe and other OECD nations such as Canada and Japan. As part of the financial settlement of the patent interference, the nonexclusive licenses awarded by NCI, NIH to MedImmune and Merck were converted to co-exclusive licenses, thus allowing both GSK and Merck access to this IP. Merck brought Gardasil to market in the United States in 2006 and Cervarix was introduced in the United Kingdom in June 2008. USPTO, US Patent and Trademark Office; CAFC, US Court of Appeals for the Federal Circuit.

See Timeline Graph