Medical Tourism in Developing Countries

142 ● Medical Tourism in Developing Countriesany improvements it makes on an existing patent, thus circumventing any localprotection the U.S. patent holder might have originally had. The more up-todateand competitive foreign hospitals and research facilities become, the moreof a threat they could be to large U.S. pharmaceutical patent holders.Generally, U.S. patent law does not present an obstacle to the proliferationof medical tourism, yet there is an interesting trend emerging in medicaltreatment that warrants a closer look: pharmacogenomics, or personalizedmedicine. This is the practice of treating a medical problem with a moretargeted approach: a patient is tested for a particular genetic disposition,and then treated with a drug that helps only those with that particular disposition.A potential problem in the rapid expansion of pharmacogenomicsis the outsourcing of diagnostic testing or components of a test, for use byU.S. patients, to countries where it might be offered at significantly lowerprices. As the practice becomes more prevalent, but prices remain high, theexport of diagnostics or their components to a location where they mightbe performed at much lower cost becomes a reality.With medical tourism and outsourcing of other sectors on the rise, thereis no doubt this cutting-edge medical practice is similarly at risk for a moveoutside U.S. borders. But can the export of cancer cells or bodily fluids,sent abroad for the purpose of performing a diagnostic test, be considereda violation of U.S. patent law? Is it a violation to send code, which representsthe results of a test, abroad to be read and interpreted? Can a hospitaloverseas buy specific compounds from a company in the United States, ifthose compounds can be used to form a diagnostic test? An analysis of thepatent statute yields some potentially surprising results to these scenarios.U.S. patent law has historically been characterized by strict territoriallimitations—infringing activity occurring off U.S. soil could not be a violation.Yet this exclusion of extraterritorial infringing activity left the patentcode with a gaping loophole: manufacturers could create the componentsof an infringing product and simply assemble them abroad, thereby escapingliability. This issue came to a head in a Supreme Court decision of1972, Deepsouth v. Laitram, when the court held that such action did notconstitute direct infringement. 4 More than a decade later, Congress enacted35 U.S.C. § 271(f) as a direct response to the problem created in Deepsouth. 5Section 271(f) is an exception to the traditional patent limitation of territorialityin that it makes the offshore assembly of multiple components(exported from the United States) an actionable violation. 6Section 271(f) promises to have a growing role in patent litigation asthe globalization of trade and industry continues to develop. Because of itsextraterritorial reach, § 271(f) will have an impact on the global economy as