2.6. El ‘diseño’ para la Ingeniería en Diseño
3.1.2. Oferta multidisciplinaria de Diseño a nivel nacional
A pertinent point to consider here is the likely implication of test data protection on the use of compulsory licensing. The potential problem that may arise is that even where a compulsory licence is issued, the generic manufacturer may still have to seek the approval of the patent holder to make use of the test data to obtain marketing approval.52 Thus, where a compulsory licence is issued in respect of a drug, data exclusivity may still present a significant hurdle by making marketing authorisation for the drug more difficult.53 This is because Article 39.3 establishes a quasi-proprietary, quasi-patent system that confers rights that are separate and distinct from a patent right.54 It is thus submitted that the grant of a compulsory licence to produce generics does not, on its own, waive the protection available under Article 39.3. The question that follows from this is whether a compulsory licensee may avoid gaining the data owner’s authorisation for marketing approval. A case could be made for arguing that use by government pursuant to the grant of a compulsory licence is not unfair and should not be treated as such. This is because the compulsory licensing regime under Article 31 of the TRIPS Agreement requires the payment of adequate remuneration where a compulsory licence is to be issued. It is therefore presumed that the compensation paid to a patent holder for the compulsory licence would have taken the data exclusivity right into account and such use of the information should therefore no longer be considered unfair.
In a similar vein, use by a third party pursuant to a compulsory licence will not, it is submitted, be inconsistent with the provision of Article 39.3 provided the third party is required to pay adequate compensation to the patent holder who will also be owner of the test data. Article 31(h) of the TRIPS Agreement provides that ‘the right holder shall be paid
adequate compensation in the circumstances of each case, taking into account the economic value of the authorization’. It is thus submitted that it will be an onerous burden indeed to expect a compulsory licensee to pay a separate remuneration for the patent right and
51
Pires de Carvalho, above n 18, 399.
52
Dwyer, above n 21, 843.
53
Clift, above n 2, 433.
54
94 anotherfor data exclusivity. Since Article 31(h) already requires the compensation paid to the right holder to take cognisance of the economic value of the authorisation, this will be enough to compensate for the use of test data as well.
3.3.1. Can Test Data be Compulsorily Licensed?
Another issue that is necessary to consider is whether the government can grant a compulsory licence in relation to a test data right, especially in cases where there is no need to get a compulsory patent licence. A brief examination of the negotiation history of the TRIPS Agreement may be pertinent here. The Anell’s draft (Chairman’s draft) of July 23, 1990 provided as follows on this point:
2A(a). Parties shall not discourage or impede voluntary licensing of undisclosed information by imposing excessive or discriminatory conditions on such licences or conditions which dilute the value of such information.
2A(b). There shall be no compulsory licensing of proprietary information.55
The Brussels Draft of December, 1990 did not have the equivalent of Article 2A(b) in the Anell’s draft but nonetheless provided thus:
3A. Parties shall not discourage or impede voluntary licensing of undisclosed information by imposing excessive or discriminatory conditions on such licences or conditions which dilute the value of such information.56
These provisions prohibiting or discouraging the compulsory licensing of proprietary information were not included in the final text of the TRIPS Agreement. Does this mean the TRIPS Agreement can now be interpreted as allowing the compulsory licensing of proprietary information? Pires de Carvalho argues that the fact that Article 39.3 does not mention compulsory licensing does not support the inference that it forbids it, as the Agreement does explicitly forbid compulsory licensing where such is deemed necessary. This is the case in respect oftrademarks under Article 23, which provides thus:
55Chairman’s Report to the GNG, Status of Work in the Negotiating Group, Negotiating Group on Trade-
Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, WTO Doc MTN.GNG/NG11/W/76, (23 July 1990).
56
Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations – Revision, GATT Doc MTN.TNC/W/35/Rev.1 (December 3 1990).
95
Parties may determine conditions on the licensing and assignment of trademarks, it being understood that the compulsory licensing of trademarks shall not be permitted and that the owner of a registered trademark shall have the right to assign his trademark with or without the transfer of the business to which the trademark belongs.
The argument therefore is that TRIPS has clearly and unequivocally made it known where compulsory licensing is not available, as in the case for trademarks, and in the absence of such express prohibition, it should be presumed that compulsory licensing will be available. While this argument is very compelling in principle, it is unlikely that compulsory licensing can be effectively pursued in practice under the provisions of Article 39.3 for a number of reasons. First, the earlier drafts of the Agreement shows there was a clear intention to prohibit compulsory licensing of undisclosed information,57 though the removal of the prohibition may also indicate an intention to allow it. Secondly, no compulsory licence can be granted under Article 39.3 save to the extent necessary to protect public interest or unless adequate steps are taken to prevent unfair competition. It would therefore appear that compulsory licensing may be available under Article 39.3 where it is used as a measure for taking advantage of the exceptions recognised under that provision. Any step taken in excess of that will be afoul of the TRIPS Agreement.