Like many people interested in the tangled connections between health care progress and intellectual property rights, I avidly followed the Myriad Genetics case, decided by the Supreme Court this June 13. In sum, molecular diagnostics maker Myriad sought "the exclusive right to isolate an individual's BRCA1 and BRCA2 genes," but the Court, wisely I believe, made thoughtful distinctions about what is and is not patentable, deciding that, "A naturally occurring DNA segment is a product of nature and not patent eligible because it has been isolated…"
Of course, had the University of Utah not given Myriad an exclusive license to a discovery the university made in its own labs, there may have been no need for a conflict whatsoever. But among other things, the dispute resonates deeply with a call to action made by Eric Lander, President and Founding Director, The Eli and Edythe L. Broad Institute of Harvard and MIT, at November's Healing Ourselves Health Care Forum event. There, Lander made a potent case for creating a multi-corporate consortium that would openly share validated targets. Instead of stalling progress by withholding information on targets, he argued, they should open target data and compete on solutions—compounds and molecules addressing the targets.
I agree. If we're going to get the breakthrough products we want at a development cost we can afford, we have to figure out the best place to set the line between public and private interests, between the "intellectual commons" that benefits us all, and the intellectual property protection that encourages innovation and investment. What should be opened to the commons? What should be held by private interests?
“The majority of significant discoveries come from university labs and hospitals”
Given the stakes, these are more than academic questions. But I believe the academy can assert leadership on these issues. Let's face it: the majority of significant discoveries come from university labs and hospitals; their ownership of intellectual property gives them enormous influence over the distribution of knowledge. To date, they have been far too concerned with the size of their royalties, at the expense of public utility.
The fate of discoveries we all rely upon, and the intellectual property that results from them, rests in the hands of university technology licensing offices. Here's my proposal: I ask that the Association of University Technology Managers establish a set of standards, balancing public interests and private incentives, that would encourage the development of new chemical entities for reducing human suffering.
As Lander had suggested, anything having to do with genes, molecular pathways, and targets should be made openly available, or at least not subject to exclusive licensing. Instead, we should encourage competition around the development of molecules that interfere with or enhance activity in these pathways, rewarding the creators with the usual private incentives.
Can we agree to compete on therapeutic solutions, not on the underlying science we need to develop them? I'd like to hear your reflections on the matter: What should be in the commons, what should remain private? Where can we set the line to yield the most breakthrough drugs?