New models urgently required to replace outdated management of biotechnology IP

Seven-year study funded by SSHRC

The biotechnology industry must change its outdated approach to managing intellectual property (IP) or face increasing legal gridlock and decreasing financial returns, according to a new Canadian study released September 9. Headed by McGill Univ's Dr Richard Gold, the study calls for a new era for IP based on new models of collaboration and a greater measure of trust and communication amongst all players, from industry to universities, governments and non-governmental organizations.

In particular, it recommends the creation of a new entity to mediate patent disputes. Such a public-private partnership would also help to create trust amongst the various players, presumably leading to a greater number of innovation products to reach the marketplace and greater access to the fruits of biotechnology in low- and middle-income countries.

"Everyone is talking collaboration, especially for early-stage research where the stakes are very high and nobody wants to take the lead on it," says Gold, who is director of McGill's Centre for Intellectual Property Policy. "We need the government to play an active role in attracting industry and building these collaborative platforms and investing in it."

Entitled Toward a New Era of Intellectual Property: From Confrontation to Negotiation, the $3.5-million study was completed over a seven-year period by a 15-member international expert group. The report contains 20 recommendations within a framework that contains six themes: trust, communications, new models, scientific infrastructure, cross-cutting thinking and data and metrics. Nearly $3 million in funding was provided by the Social Sciences and Humanities Research Council, with the remainder contributed by the Canadian Institutes of Health Research.

industry attitudes are changing

When releasing the report in Ottawa last week, Gold cited recent comments of executives from two European pharmaceutical firms that support his contention that the current IP regime is broken and needs to be altered and updated. Sanofi Aventis president Francois Dehecq said late last year that the industry's IP model "has been dead for two years", while Pfizer's chief medical officer, Joe Feczko, was quoted as saying that new business models involving greater involvement with the public sector were needed. Even the latest Global Biotechnology Report for 2008 from Ernst & Young concluded that "pharma companies need to fundamentally reinvent their structures and incentives to improve the productivity of their innovation efforts". Despite the recognition of the need for change, Gold says many biotech and related industry associations have yet to catch on.

Another example of the change in mindset permeating the biotech sector is the Structural Genomics Consortium (SGC). Headquartered in Toronto, this international research initiative has attracted significant financial support from big pharma even though it places all protein structures it investigates in publicly accessible, free databases. The firms were attracted to SGC by being given the right to create wish lists of proteins to be investigated. Those lists are kept private.

"There's a huge difference between what you hear the lobby groups saying and the companies themselves. The companies are many years ahead of the big lobby groups," he says. "When I talk to people in industry … They recognize that the pools of innovation are diminishing. They want to change and they don't really know where to go."

Gold says many individuals within the federal bureaucracy acknowledge the need for changes to the IP system but lack of coordination and the current minority status of government have made it difficult — an environment reflected in the recent S&T Strategy.

"The S&T Strategy that came out in 2007 is still part of the old IP era. It doesn't concentrate on creating partnerships and it doesn't try and invest in these things," says Gold. "We need the government to play an active role in attracting industry and building these collaborative platforms. The bureaucrats that have been working on this, whether they're from Health Canada, Environment Canada or the agriculture department, they know all about this. .. I would also like to see more leadership from Industry Canada but I also acknowledge that they and the other departments are in a difficult situation … if they open their mouths they get attacked from all sides."

One concrete result stemming from the report is the creation of The Innovation Partnership, a non-profit consultancy specializing in IP use and management. Comprised of experts from developed and developing countries, it provides clients with advice, training and mediation and undertakes public consultation and dialogue.

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