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Here are five steps to take immediately:

1. Create the World’s First “IP-Free Zone”

The publicly funded Human Genome Project began in 1988 as a grand scientific undertaking to decode all human genes and create a shared resource of knowledge that will be the foundation of 21st-century medicine. It’s time to codify that status in law by creating the world’s first intellectual-property sanctuary, or “IP-free zone.” Specifically, the U.S. government should mandate that the genome’s raw sequence data cannot be privately owned.

In a practical sense, we are already well on our way to this goal. Over the past several years, the Human Genome Project’s network of laboratories have published on the GenBank Web site a steady stream of decoded nucleotide base pairs within 24 hours of sequencing them. The policy insures that the genome data will be freely available to researchers around the world, and also discourages secrecy or proprietary claims over this valuable raw data.

With the Human Genome Project’s laudable commitment to open publication (thereby de facto disqualifying the raw data from patent claims), why bother writing a law? Because the formal establishment of an IP-free zone-a kind of “national park” of genome knowledge-will set a vital precedent that some kinds of precious information resources must be off-limits for private ownership.

As many are coming to realize as we move headlong into the knowledge-based economy, things work best when seminal information assets-particularly those needed by all players in a given high-tech sector to compete-are pooled and shared. This is the idea behind both open-source software and the hardware standards that have come to predominate in many high-tech sectors. These pieces of “infostructure” are what allow different engineers to design distinct machines that all plug into a single type of wall socket or send standardized software files over the Internet. Like public lands or public libraries, pooled knowledge assets must be made freely available and protected within a framework that preserves their integrity. Precisely because the raw sequence of the human genome-the actual string of DNA base pairs themselves-is already widely perceived as deserving of this special status as a category of knowledge, it makes an ideal candidate for the world’s first legally mandated IP-free zone.

2. Declare a Moratorium on Gene Patenting

The U.S. Patent and Trademark Office has clearly bungled the issue of gene patenting by years of equivocation and delay. We need a moratorium on gene patenting until we can all agree on sensible rules.

Patents have always represented a compact between an inventor and the public: The inventor gets a 20-year monopoly in order for the public to quickly get the benefit of the new innovation in the marketplace. Issuing broad patents that confer no such clear benefits can, as the Supreme Court noted in the key 1966 case Brenner v. Manson, create a “monopoly of knowledge…[that] may confer power to block off whole areas of scientific development, without compensating benefit to the public.”

The most urgent task is to clarify that before a gene can be patented, it must be shown capable of providing a benefit to the public-namely by bringing a new product or invention to the marketplace. Within our legal framework, this principle is defined as a patent’s “utility.”

In a hopeful sign, the director of the Patent Office, Q. Todd Dickinson, has proposed to raise the “utility” bar slightly by adding three words to its guidelines. To win a patent in the human genome field, applicants will have to describe a “substantial, specific and credible” use for their gene. While this represents an important step in the right direction, the Patent Office can and should do more. Although Dickinson may rightly argue that his is not a policymaking body, the Patent Office’s role on the front lines requires it to spot emerging problems and report them to Congress or otherwise work to redress them. To stem the continuing confusion in this area, Dickinson needs to take the lead, holding hearings that include all stakeholders and declaring a moratorium on gene patenting until acceptable rules are reached.

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Tagged: Biomedicine

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