09 Sep Study claims breakdown in biotech patent system
Ottawa, Canada – The world’s intellectual property system is broken, stopping lifesaving technologies from reaching the people who need them most in developed and developing countries, according to a report released in Ottawa today by an international coalition of experts.
“We found the same stumbling blocks in the traditional communities of Brazil as we did in the boardroom of a corporation that holds the patent to a gene that can determine the chance a woman will develop breast cancer,” said Dr. Richard Gold, from McGill University and chair of the International Expert Group that produced the report. “Most striking is that no matter where we looked, the lack of trust played a vital role in blocking negotiations that could have benefited both sides, as well as the larger public.”
The authors base their findings on revelations that came out of discussions with policy-makers, industry representatives, scientists and academics from around the world, as well as the outcomes of a series of case studies involving Brazil, Canada, Kenya the United States, the European Union, Japan, Australia, and India. Conclusions often grew out of group sessions that allowed former opponents to talk to each other and revealed information that explained to both sides the failure of their efforts to find common ground, according to the authors. Drawing on data collected over the past seven years, the study portrays a crucially important but increasingly dysfunctional industry that relies on a business model based on outdated conceptions of IP.
“For better or for worse, biotechnology is at the heart of current debates about health care, the environment, food, and development,” Gold said. “It offers the promise of producing plants to resist drought and nourish the world’s poor, and to offer new medicines and energy sources. Biotech is at the heart of not only today’s economy but its security and well-being as well.”
While biotech’s potential seems unlimited, so do its problems. The report finds that a fixation on patents and privately controlled research has frequently given rise to controversy and roadblocks to innovation. Recent examples include: the $612 million patent suit that almost shut down the world’s Blackberries; Myriad Genetics’ inability to introduce its breast cancer screening test in Canada and Europe; a pharmaceutical industry with an increasingly bare medicine cabinet; an ongoing failure to deliver life-saving medications to developing countries.
“The old IP approach of the biotechnology community has failed to deliver on its potential to address disease and hunger in both developing and industrialized nations. We need to do better, and the IT world has shown us part of the solution,” Gold said. “Look at the way change has swept through the IT world, and the sharing of ideas has brought benefits to millions.”
Chad Gaffield, president of the Social Sciences and Humanities Research Council of Canada (SSHRC), which funded the research activities that led to the report, noted the work of the same group in helping international organizations that are struggling with ways to improve access to biotech breakthroughs for poor countries. Most recently for UNITAID, an international governmental group, Gold and his colleagues have created the design for a patent pool to unblock patents so that needed fixed dose combination and pediatric antiretroviral medicines reach those suffering from HIV/AIDS.
“The end of our old way of doing business does not mean we don’t need a system for protecting intellectual knowledge,” Gold said. “We need an IP system that will support collaborations among researchers and partners in industry and academia worldwide so that knowledge gets to those who need it most. This means the laws may have to be changed, but more importantly, it means that we have a lot of work to do to change behaviors and build trust among all the players. How people behave – in other words, their practices – and the effect of practices on innovation is critical. Public and private institutions also play an essential role in shaping the IP system.”
The report released today, Toward a New Era of Intellectual Property: From Confrontation to Negotiation, documents a series of failed attempts to expand access to both traditional knowledge and the products of modern biotechnology. The authors, members of the International Expert Group on Biotechnology, Innovation and IP make a number of concrete recommendations to address their findings. Pointing to governments, the private sector and universities as crucial players, they call for better management of scientific knowledge and new ways to measure whether technology transfers are working. The following are among their key recommendations:
Seek other ways to encourage innovation—not just IP—health and environmental regulations, the judicial system and tax rules, for instance.
Work with industry to help create respected and trusted entities whose members that can be counted on to mediate disputes fairly and encourage indigenous and local communities in policy development.
Develop Public-Private Partnerships to conduct early stage research including through the sharing of health related data to allow the sharing of risk across industry.
Patent offices should:
Collect standardized patent-related information, including license data as they are doing in Japan.
Assist developing countries and NGOs in finding out which patents exist in order to enable licensing.
Establish an independent, non-profit technology assessment organization to evaluate new biotechnology products from developing countries.
Participate actively in the creation of Public-Private Partnerships and other collaborative mechanisms.
Be transparent about patent holdings.
Develop new business models that promote partnerships and collaborations.
Develop clear principles relating to the use and dissemination of intellectual property and promote greater access and broad licensing.
Develop measures of the success of transfer of technology based on social returns rather than on the number of patents hold.
Enter into collaborations between developed and developing countries to ensure that developing country doctoral and post-doctoral students have opportunities to study and work at home.
TIP is an independent non-profit consultancy with experts in developed and developing countries specializing in the understanding, use and management of intellectual property. TIP’s mission is to foster innovation and creativity through the better use of intellectual property and its alternatives.
TIP was created in 2007 by a group of experts, who spent seven years working together on a study of the role that patents and other intellectual property rights play in determining social, economic and cultural outcomes of biotechnology. Funded by the Canadian government and organized through McGill University’s Centre for Intellectual Property Policy, the International Expert Group on Biotechnology, Innovation and Intellectual Property concluded that government, industry and NGOs lack independent, empirically-based expertise on how best to adapt intellectual property to the needs of modern society.