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Introduction

The changes over the last twenty years in the dynamics of scientific progress generally, and in the biomedical arena in particular, have been as dramatic as the changes wrought upon a landscape by a river altering course, flooding some regions and carving others. Inexorably, the ground that had been solid crumbles, and new shores emerge. For those who have established the foundations of their research careers in the realm of pure academia, the new landscape lacks many of the familiar landmarks and paths. Though many people find such changes disturbing, confusing, or simply aggravating, the most successful researchers will have to learn to navigate the new terrain.

As is discussed in more detail in another chapter, one of the major forces precipitating the changes in the manner of scientific development occurred in the law of patents. First, in 1980, the Supreme Court ruled that life forms created through recombinant-DNA technology could be protected by patents. Second, in 1982, Congress created a special appeals court, the Federal Circuit Court of Appeals, to hear specific kinds of cases, including patent law. This court has clarified much of patent law, and made enforcing patents far more practical than it had been. Third, and most relevant to this chapter, Congress passed a series of laws in the early 1980s (with important, subsequent amendments) that enabled the transfer of some of the Government’s rights to inventions to non-Government parties. The combination of these events dramatically accelerated the development of the scientific field now called biotechnology, and started the legal field which today is broadly called "technology transfer," among other things. 2

"Technology Transfer," as the term is normally used, usually encompasses issues focused on acquiring and licensing patents, which are discussed in another chapter, in addition to the various research-related transactional agreements that are discussed in this chapter. Accordingly, to avoid confusion between the two topics, the tools discussed in this chapter will be grouped in subcategory, called "technology development."

People are largely unaware of all the various tools used to accomplish the transfer of technology. Ask people who have heard about technology transfer, and many will reply that it involves lawyers arranging for big corporations to license Government-owned patents. Ask them how technology transfer impacts their research, and they are likely to say, "not at all." But the river is still carving new territories, and more sooner than later, most of the pure researchers will be forced to navigate the new terrain. Research agreements, inventions, patent licenses, material transfers, confidentiality, software, copyrights, trademarks, and many other, perhaps even more unfamiliar things loom -- and pitfalls, deep enough to swallow a career or two, hide in between. To add another layer of confusion, the perspectives of for-profit industries, nonprofit/university groups, and Government about technology development are significantly different from each other.

In this chapter, to identify the new landmarks and map the terrain, a purely fictional scenario will be described, relating a series of hypothetical events. Then, using the scenario as a backdrop, some of the various tools will be examined in turn, with a focus on why, when, and how each is used appropriately. The causes of the more common snags will also be discussed, so that those problems caused by divergent perspectives may be avoided. Hopefully, at the conclusion, the features of the new landscape will appear as opportunities -- ways to enhance and enable research -- rather than as obstacles.

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Page Last Updated: 12-02-2008