Cheaper HPV Vaccines for India May be Possible in Spite of Patents

Vaccine manufacturers in India and other developing countries may be able to produce a lower-cost HPV vaccine in spite of the complicated array of patent protections on the technology, say researchers at the Duke Institute for Genome Sciences & Policy (IGSP).

Their study, “Intellectual property, technology transfer and manufacture of low-cost HPV vaccines in India,” was published in the online journal, Nature Biotechnology in July. The lead author is Swathi Padmanabhan, a 2010 graduate of the Sanford School of Public Policy. Co-authors are Tahir Amin, Bhaven Sampat, Robert Cook-Deegan and Subhashini Chandrasekharan.

The leading HPV vaccines, including Gardasil® from Merck and Cervarix® from GlaxoSmithKline, are some of the most expensive ever introduced, at $300 for the three-dose regimen. Emerging vaccine manufacturing companies in developing countries, especially in India, are creating their own manufacturing methods and have the potential to produce lower-cost vaccines.

India has 25 percent of the world’s cervical cancer cases, so broad distribution of low-cost HPV vaccine could have a tremendous public health impact there. Universities also play a large role in development of the intellectual property that underlies many new drugs and technologies. The availability of their research and intellectual property licenses influence which methods and drugs are developed.

Regional manufacturers can produce high-quality vaccines similar to the expensive products produced by Western companies, Padmanabhan said. However, Western companies are increasing their patent filings on enabling technologies in India, so there is a need for policy changes to address barriers to access for these vaccines. In recent years, developing countries, including India, have signed on to World Trade Organization agreements designed to narrow the gaps in the way intellectual property rights are granted around the world.

In this study, the researchers gathered and analyzed all of the HPV vaccine-related patents that have so far been granted in the U.S. and internationally. That IP landscape is complex, with at least 81 U.S. patents granted to date. The researchers focused their attention on India, where 19 of 86 international patent applications had been filed by the close of 2008. India is of special interest because of its high rate of cervical cancer and its role as a main supplier of childhood vaccines to agencies such as the World Health Organization.

The researchers' analysis suggests that vaccines that are identical in formulation or HPV strain coverage to those now on the market are not covered by patent claims granted in India. That would appear to leave the door open to production of “biosimilars” offering protection against the two HPV strains that account for nearly 70 percent of all HPV-induced cancer.

Padmanabhan’s involvement in the study began in her freshman year, when she decided to take a FOCUS program on The Genome Revolution, which offered a combination of classes on the topic in biology, ethics and policy. She studied with Cook-Deegan, research professor of public policy and director of the Center for Genome Ethics, Law and Policy (GELP), which led her to being selected for the undergraduate research program at the center.  

Co-authors Tahir Amin of the Initiative for Medicines Access and Knowledge and Bhaven Sampat at Columbia University had created databases of the patents registered in India. During her public policy internship, Padmanabhan worked with the databases to determine whether the patents would block Indian development of medicines.

She made research trips to Hyderabad, India, in December 2007 and again in the summer of 2009 to visit three vaccine manufacturers: the Serum Institute of India, Bharat Biotech and Indian Immunologicals. 

“Drug development in the past focused on safe and effective first,” said Padmanabhan. She hopes this study will add affordability to the process.

The study has gained media attention in India and the United States. The team says their findings should not be taken as legal advice, but as a starting point for legal analysis by interested parties.

The research was funded in part by the National Human Genome Research Institute and the Department of Energy.  Padmanabhan was supported by travel awards from the Alice M. Baldwin Scholars program at Duke University, the Janet B. Chiang grant from the Asian and Pacific Studies Institute at Duke University, the Dannenberg Awards, the Stay In Focus grant from the Focus Program and the Sanford School of Public Policy at Duke University.

Portions of this article were adapted from an article by Kendall Morgan previously published at http://www.genome.duke.edu/press/news/07-09-2010/index.php.