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By Donna Young
Washington Editor
WASHINGTON - The pharmaceutical and biotechnology industries' heavy reliance on patents and aggressive enforcement of intellectual property (IP) are creating an environment of intimidation that prevents scientists from using tools vital to innovation, researchers from McGill and Duke universities contended Tuesday during a Capitol Hill briefing.
Richard Gold, chairman of the International Expert Group on Biotechnology, Innovation and Intellectual Property at McGill, said biotech and big pharma are stuck in an "old IP" business model based on obtaining numerous early stage patents and aggressively using them, which, he argued, has been counterproductive to innovation.
Too many biotechs have been using their patents and IP rights in ways that decrease the size of their markets and undermine their long-term viability, Gold and his colleagues asserted.
The most productive innovation occurs when researchers, companies, government and nongovernmental organizations work together to ensure that new and effective products reach those for whom they are intended to help, Gold argued. However, if industry fails to adopt the philosophy of cooperation and collaboration, he said, it "will suffer financially and we, the public, will suffer by having fewer products that otherwise could have been produced."
Gold emphasized that he and his colleagues are not opposed to firms gaining patent protection of their products and discoveries. Rather, he said, the group of researchers, known as the Innovation Partnership, is concerned that the biotech and pharmaceutical industries are caught in a cycle of "hoarding and distrust," which Gold said has led to the breakdown of the biomedical field, resulting in fewer new drugs and an increase of so-called "me too" drugs on the world market.
"Although there have been market successes and products on the market that would not be on the market but for IP, there's also other products that are not on the market because of the way we have been using IP," Gold said.
For example, he said, even though Salt Lake City-based Myriad Genetics Inc. won patents for the BRCA1 and BRCA2 genes, which are associated with a high risk of breast and ovarian cancers, because the firm took an overly aggressive approach to defend its patents and control how its diagnostic tests based on the firm's technology were performed, the company found itself locked out of markets in Canada, Europe and elsewhere.
Myriad not only ran into resistance from the scientific and medical communities, but its business model clashed with the way in which the public sector made decisions about the provision of health care, said Robert Cook-Deegan, director of Duke University's Center for Genome Ethics, Law and Policy. In addition, the way in which it advertised its tests directly to consumers also ran into controversy, he noted. The end result, Cook-Deegan said, was distrust and lower revenues for Myriad.
While Myriad did nothing legally wrong, Gold said, the firm's ultimate mistake was following the "old IP model, a decision that alienated it from the research community on the first hand, and from the institutions that pay for health services, particularly outside of the U.S."
Contrary to common belief, Gold maintained, "those researchers who patent more, partner less."
Gold said a "new IP era" is emerging that needs more and better partnerships.
"We need partnerships that avoid the duplication of early stage research, such as by encouraging the sharing of molecular libraries," he said. "We need partnerships that create exchanges of data and patents through which to turn the atoms of publicly funded discovery into molecules of innovation. We need partnerships through which communities help companies develop and design products that better reflect the real needs of those who use them, particularly in the developing world."
In addition, Gold said, collaborations also are needed to overcome concerns about high risk through joint public and private funding of promising avenues of research.
"And we need partnerships, such as through patent pools, that unblock the development, production and sale of medicines and technologies that the developing worlds needs to have a sustainable and secure economy," he said.
Gold pointed to the nonprofit Structural Genomics Consortium, which brings together governments, foundations and industry to determine the structure of proteins to better design medicines and places those discoveries in the public domain without restriction, as an example of a successful collaboration in the "new IP era."
UNITAID, which aims to provide the first sustainable effort to produce and distribute the formulations of the newest generations of antiretroviral medicines for HIV/AIDS to the developing world, and the University of California, Berkley's progressive licensing practices project also were among examples Gold cited as successful partnerships that benefit the world's health care needs.
"The biopharmaceutical industry can continue with the policies that failed in other technological areas," Gold said, "or they and government and universities can provide leadership in developing new business models that do rely on patents but in a new ways based on partnerships, information and risk sharing."
If patent holders fail to be more flexible, Cook-Deegan said, the government may intervene by using authorities already granted to regulators, such as so-called "march-in" rights.
The Biotechnology Industry Organization argued that a robust system for protecting IP rights is critical to establishing an environment in which biotechnology innovation can flourish. "The presence of patents and strong IP rights in no way precludes collaborations and partnerships with companies, governments, nongovernmental organizations or others," the trade group said in a statement. "Rather, it is precisely because of patents and strong IP rights that such collaborations and partnerships can, and do, take place at an ever-increasing rate." | 
