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Patents no barrier to producing cheaper HPV vaccine

By Wai Lang Chu, 12-Jul-2010

Related topics: Processing equipment, Ingredients, Globalisation

A new study believes vaccine manufacturers from developing countries may be able to produce a HPV vaccine at a lower cost without infringing on the numerous patents drug makers have taken out on the vaccine technology.

The researcher’s findings have particular relevance with India as it shoulders almost 25 per cent of the global cervical cancer burden and is a main supplier of childhood vaccines to agencies like the World Health Organization. Its growing middle class is also a potentially large market for the sale of human papillomavirus (HPV) vaccines.

Currently, blockbuster HPV vaccines, such as Gardasil [HPV quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant] from Merck & Co and Cervarix [HPV bivalent (types 16 and 18) vaccine, recombinant] from GlaxoSmithKline command at least $300 (€238) for a three-dose regimen.

Gardasil’s private market price can exceed $500 in several developed and developing countries, which few can afford in most low- and middle-income countries.

Researchers at the Duke Institute for Genome Sciences & Policy began by gathering and analysing all HPV vaccine-related patents that had been granted in the US and internationally.

Patents in India

The researchers specifically focused on India, who in 1995 signed on to World Trade Organization agreements that tightened efforts in granting intellectual property rights worldwide. Researchers identified 19 of 86 international patent applications filed in India by the end of 2008.

The resultant data suggested that vaccines identical in formulation or HPV strain coverage to those on the market were not covered by patent claims granted in India.

Researchers speculated that the production of follow-on biologic drugs could be viable, which could provide protection against the two HPV strains responsible for almost 70 per cent of all HPV-induced cancer.

Whilst access to the HPV vaccine would become easier as a result of this, Subhashini Chandrasekharan, a researcher within the IGSP's Centre for Genome Ethics, Law and Policy stated that circumstance is unlikely to hold for future vaccines, including second-generation HPV vaccines.

"Some of the enabling technologies were patented in the 1990s before companies had begun seeking patents in vaccine-making countries like India," she said. "The fact that a number of HPV vaccine patents have been filed in India as well as other developing countries suggests a new trend."

Cutting costs

Virtually all cervical cancer cases, 99 per cent, are linked to genital infection with HPV, a family of virus types which also causes genital warts and other forms of cancer.

Pharmaceutical companies such as Merck and GlaxoSmithKline hold patents on the vaccine and the majority of the underlying development technologies making the cost of manufacturing the vaccine prohibitive in developing countries.

Vaccine manufacturing companies are emerging in developing countries, especially in India, that are creating their own manufacturing methods and have the potential to produce lower-cost vaccines.

With the Polio vaccine manufactured for less than $2 per dose, the researchers commented that prices must fall below this $2 per dose to make broad access possible in low-income populations, especially in countries where gross domestic product per capita is below $1,000.

The researchers concluded that it was unlikely that Merck or GSK could reduce vaccine prices to match these affordability targets because of the high production costs associated with their vaccines. They identified company donations as a way to improve access.

Big pharma actions

Through the Gardasil Access Program, Merck has pledged to donate at least 3m doses of Gardasil to qualifying organisations in eligible lowest-income countries, where 80 per cent of the world's cervical cancer cases occur.

Approval has been given for donation of 496,000 doses of Gardasil for Bhutan, Bolivia, Cambodia, Cameroon, Georgia, Ghana, Haiti, India, Kenya, Lesotho, Moldova, Nepal, Nicaragua, Papua New Guinea, Tanzania, Uganda and Uzbekistan.

Likewise, GSK is supporting HPV pilot projects; donating more than 133,000 doses of Cervarix to PATH-led projects in Uganda and India.

GSK's HPV vaccine, Cervarix has also been made available at substantially reduced prices, with reductions of up to 60 per cent in Colombia, South Africa and some countries in Southeast Asia.

The study: “Intellectual property, technology transfer and manufacture of low-cost HPV vaccines in India,” appears in the July 9 edition of Nature Biotechnology and is available to view here .