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.
|July 19, 1991||Frazer et al. (Queensland) file international patent application in Australia|
|June 25, 1992||Schlegel et al. (Georgetown) file patent application in US|
|September 3, 1992||Schiller and Lowy et al. (NCI, NIH) file patent application in US|
|March 9, 1993||Rose et al. (Rochester) file patent application in US|
|February 1995||University of Queensland's commercial arm UniQuest licenses HPV vaccine technology to CSL (Melbourne)|
|October 5, 1995||MedImmune acquires exclusive license to HPV vaccine technology from University of Rochester|
|1995||Merck licenses HPV vaccine technology from CSL|
|June 26, 1996||MedImmune in-licenses key HPV IP from German Cancer Research Center|
|January 7, 1997||NCI non-exclusively licenses HPV vaccine technology to MedImmune|
|June 24, 1997||USPTO declares initial interference|
|December 1997||NCI nonexclusively licenses HPV vaccine technology to Merck|
|December 11, 1997||MedImmune and SmithKline Beecham form worldwide HPV vaccine alliance|
|January 16, 1998||MedImmune finalizes vaccine agreement with SmithKline Beecham|
|October 24, 2001||USPTO declares patent interference 104,771 between Rose and Lowy|
USPTO declares patent interference 104,772 between Rose and Schlegel
USPTO declares patent interference 104,773 between Rose and Frazer
USPTO declares patent interference 104,774 between Lowy and Schlegel
USPTO declares patent interference 104,775 between Lowy and Frazer
USPTO declares patent interference 104,776 between Schlegel and Frazer
|February 2005||Merck and GSK enter cross-license agreement for HPV patents|
|May 2005||NCI's nonexclusive licenses convert to co-exclusive licenses|
|September 20, 2005||USPTO Board of Interference announces decision and awards priority to Schlegel et al.|
|December 29, 2005||Frazer et al. appeal USPTO decision, case docketed in CAFC|
|August 20, 2007||CAFC reverses USPTO decision and awards priority to Frazer et al.|
Swathi Padmanabhan, Robert Cook-Deegan and Subhashini Chandrasekharan are at the Center for Genome Ethics, Law & Policy, Institute for Genome Sciences & Policy, Duke University, Durham, North Carolina, USA.
Tahir Amin is at the Initiative for Medicines Access and Knowledge, New York, New York, USA.
Bhaven Sampat is at the Mailman School of Public Health, Columbia University, New York, New York, USA.
Competing financial interests
The authors declare no competing financial interests.