Thus, given the flexibility inherent in Article 39.3, and depending on the applicable legal system, national laws can follow different approaches for the approval of a second-entry marketing application. They may:
a) require the second-entrant to produce its own testing and other data or to obtain an authorization of use from the "originator" of the data;
b) allow the second-entrant to rely on the "originator's" data against payment of a compensation to the "originator" (when the "originator" has not given his consent for the use of the data);19
c) examine and rely upon the data submitted by the "originator" to evaluate the second-entrant application;
d) approve a second entry marketing application without examining or otherwise relying upon confidential information submitted by the originator.
19 This compulsory licence approach is the one applicable, under certain circumstances, in accordance with the U.S. FIFRA. See Annex I.
In all cases, the authorities will normally require that the second-entrant prove that his product is similar or "essentially similar" to the already registered product (in terms of its physical and chemical characteristics and attributes).20 Different types of bioequivalence studies are generally required for this purpose.21
20 See, e.g., article 4.8 (a)(ii) of the EC Directive 65/65/EEC.
21 In some countries, bio-availability studies are also required for the approval of generic versions of existing products.
In cases a) and b) the data receive specific protection, either on the basis of exclusivity or compensation. In case c) the second-entrant does not use the data; it is the authority who examines and relies on the data in its possession. In case d), finally, there is no "use" at all, since the authority does not use the testing and other data (which it may not even possess); it merely relies on public information and/or on the existence of a prior (domestic or foreign) marketing approval.
Neither in cases c) or d) is there a "commercial use" of the data. A contrary interpretation holds that even indirect reliance on data by a national authority constitutes a form of commercial use. Under this interpretation, the competent authority must be proscribed from "using" the data to support, clear or otherwise review second entrant applications for marketing approval for a set amount of time unless authorized by the "originator" (WHO, 2000, p. 39)
According to this interpretation, national authority reliance on the data submitted by the originator in order to assess a subsequent application constitutes "unfair commercial use", even when neither the authority nor the competitor actually "use" the data without the originator's authorization (for instance, when approval is given without any re-examination of the data). In the U.S. complaint against Australia, for instance, the USA argued that relying on the innovator's data allowed free-riding by generic drug companies on
"the innovator company's investment in developing the test data and thus puts the innovator company at a competitive disadvantage... The U.S. claims that Article 39 para.(3) means that generic companies are not allowed to derive commercial benefit from the innovator's test data" (Priapantja, 2000, p.6).
Under this view, the fact that a competitor obtains a commercial benefit or advantage constitutes an "unfair commercial use" of the data, notwithstanding that actual use may not occur and that the practice as such may not be "dishonest" or contrary to a country's prevailing values of morality or fairness in commercial activities.
This latter interpretation, however, clearly goes beyond what the provision mandates. It does introduce an obligation not negotiated during the Uruguay Round that, in practice, would limit legitimate competition and thereby erect barriers to the access to medicines.