By Norma Erickson, President of SaneVax Inc.
April 5, 2011
The first papillomavirus was discovered in the 1930’s by Dr. Richard E. Shope. It was the cottontail rabbit papillomavirus, or the Shope papillomavirus, which occurred in warts that frequently developed into cancerous tumors1. Dr. Shope was able to isolate the virus, inject it into other rabbits and produce similar cancerous tumors, thus providing evidence (an animal model) of cancer in mammals apparently caused by a virus.
Although the viral nature of human warts had been noted as early as 1907, little research was done regarding human papillomavirus (HPV) until the development of DNA sequencing technology in the mid 1970’s. Dr. Harald zur Hausen suspected human papillomavirus may exhibit the same progression (warts to cancer) in people that Shope papillomavirus did in rabbits.
After ten years of searching, Dr. zur Hausen discovered HPV 16 and 18 DNA in human invasive cervical cancers. Using the virus DNA retrieved from cervical cancers, he was able to successfully clone HPV 16 and HPV 18 in 19842.
The successful cloning of HPV 16/18 led to research projects aimed at producing the HPV antigens and finding a way to elicit antibodies to them in animals first, and ultimately humans. Research conducted at the University of Queensland (Australia), Georgetown University, the National Cancer Institute, and the University of Rochester culminated in patents filed between 1991 and 1993 by each organization.
Between 1995 and 1998, various pharmaceutical companies obtained rights, or partial rights to these patents. Much of the intellectual property (IP) patented involved knowledge and techniques that overlapped each other with various pharmaceutical companies having the rights to only part of the technology necessary for them to do anything with it.
The United States patent system works on a first to invent basis rather than a first to file system. A patent interference claim arises when two parties have patented similar information. It is basically a priority contest to determine who has the ultimate right to license the patent to other parties. Six two-way patent interference claims between the four inventors were declared by the U.S. Patent and Trademark Office in 2001.
Not knowing which inventing organization would ultimately win the patent interference battle, many pharmaceutical companies who had purchased partial or exclusive rights from one of the four organizations gave up the battle. Merck and GlaxoSmithKline each ended up with rights to utilize the patented information from different organizations.
Given the uncertainty surrounding the ownership of the patented technology enabling the production of HPV vaccines and the possibility that each could block the other’s production, they decided to enter into a cross-license agreement with each other in February 2005. Their market position was now secured in the United States, Europe, and 32 other countries belonging to the Organization for Economic Co-operation and Development3.
In a 2001 article, titled Vaccines: The Next Step to Cervical Cancer Prevention, Journal of the National Cancer Institute, Mark Schiffman, MD, National Cancer Institute Division of Cancer Epidemiology and Genetics responded to this question:
“Once we know how to use information from human papillomavirus tests to effectively test and treat women for cervical abnormalities, what is next?”