Questions arise about the ownership of novel discoveries made at academic institutions while performing investigations that are based on proprietary information from industry. Blake (1994) has suggested that the clinical investigator who discovers a useful new effect of a drug studied under the manufacturer's sponsorship should have patent rights. Most companies believe that because they own the patent they should also own any use patents if the discovery occurred during the performance of a study. Universities could argue that the patent belongs to the inventor (or the inventor's institution) because it is a reward for the inventor's creative effort. Is the academic clinical investigator an employee of the sponsor—without intellectual property rights—or an independent scholar whose creative talents can benefit the sponsor's R&D program?
The matter of who should own the use patent if a clinical investigator discovers a new activity of the drug that the investigator is studying under manufacturer's sponsorship is a complex one. The ability of the investigator to make novel observations has been made possible by the company through its novel product and by support of the investigator's research. A company cannot be regarded in the same way as a publicly funded government agency. In drug development, investors have placed their money at risk in the hope that they will realize a return on their dollars. By the time the product is in clinical trials, tens of millions of dollars have already been invested by company shareholders. Many of these potential products fail at earlier stages, or even at the clinical trial stage. Industry will promote scholarship while commercializing products, but it is clearly in the context of shareholder risk. A company will not be willing to relinquish its rights to these discoveries. Regardless of the resolution of these issues, the public gains from the commercialization effort because it brings forth novel therapies that improve medical care.
Recently, growing concern has been voiced in many sectors regarding the exclusivity of scientific results stemming from federally supported research. Although academic institutions have the legal right to patent and license technologies derived from federally supported research, some of these arrangements call into question the inappropriate licensing of exclusive rights because of undisclosed conflicts of interest or other relationships (U.S. General Accounting Office, 1992). Particularly troublesome are arrangements that might stifle the release of important research results from research that has been underwritten by taxpayers for reasons of commercial or financial gain. Thus,