Medical Tourism in Developing Countries

144 ● Medical Tourism in Developing Countriesabroad. Yet even if the compound were a widely used one, the U.S. companycould still be liable under § 271(f )(1) if it were found to have beenactively encouraging foreign hospitals to use the compound in a test protectedby a U.S. patent.While the outsourcing of medical diagnostics under § 271(f ) has not yetbeen considered by the Federal Circuit or the Supreme Court, this issue is onethat will inevitably have to be addressed by the Courts or Congress. Judicialexpansion of § 271(f ) had been gradual but steady for some years. The FederalCircuit had recognized that the application of the statute will depend on theparticular industry and its practices. 8 Recent years have seen this judicial willingnessto accommodate § 271(f ) liability depending on industry norms andpolicy considerations. It was not unreasonable to imagine that the traditionalpolicy concern of protecting American inventors from foreign encroachment,coupled with the seeming support in the language of § 271(f ), could lead theFederal Circuit to an understanding of the component-process relationship thatfavors pharmaceutical patent holders. If those patent holders were protectedfrom diagnostic outsourcing by U.S. law, this would drastically curb the exportof tested materials abroad. However, the Supreme Court’s recent decision inMicrosoft v. AT& T, circumscribing the definition of a component, marks adeparture from the gradual broadening of the application of § 271(f ). 9 Itremains to be seen how Congress will respond to novel interpretations of§ 271 (f )’s scope in the light of new technology and scientific practices.As medical procedures shift eastward, clinical trials appear to be the nextendeavor that is outsourced to more economically viable locations. Producersof new medical devices struggle with strict regulations in the United States,while other countries, such as India are offering those manufacturers theopportunity to conduct clinical trials under laxer regulations (Apollo Hospitalsin India, for example, work with big pharmaceutical corporations abroad tocoordinate drug trials at home). In addition to less red tape, those conductingdevice trials in India can complete them more quickly, cheaply, and withmany more willing participants. It appears that some destination countriestend to be more open to new types of treatments that haven’t necessarily beenapproved in the United States. 10 But more importantly, these trials are cheaperto conduct and foreign regulators do not necessarily demand the same lengthand intensity of trials as some U.S. regulators have recently. Interestingly, theU.S. Food and Drug Administration has become more open about acceptingresearch on medical devices from other countries in its decision to approvefor domestic use. 11 The relative ease and efficiency of conducting these trialsabroad, coupled with the FDA’s increasing willingness to accept the results ofthose trials, makes the outsourcing of clinical trials a reality. That bodes wellfor the development of the medical tourism industry in LDCs.