National laws may contain a provision relating to parallel imports on an international scale, as follows:
1. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder or with his consent.
2. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder, with his consent or in other legitimate manner.
3. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder or by an authorized party.
Option 1 provides for an exception relating to parallel imports originating in any country, subject to the condition that the product was marketed in such country by the patent owner or with his consent.
Option 2 broadens the exception, as it would also allow parallel imports in cases where the product was marketed in a foreign country in a legitimate manner, even without the authorization of the patent owner, such as where the product was not protected140 in the exporting country, or where it was sold under a compulsory license. This Option may be more vulnerable to challenge in the WTO than Option 1.
140 With the implementation of the TRIPs Agreement, pharmaceutical product patents will be recognized in all countries which are Members of the WTO. Therefore, the situation of lack of protection will become exceptional. It may still occur in cases where the inventor company decides not to apply for a patent in a given country, or where an application has been refused and, therefore, the respective product remains in the public domain.
A possible compromise between these two Options would be to limit the cases in which parallel imports without the consent of the patent owner are permitted, by requiring that the sale in the exporting country be made by an authorized party (Option 3). The authorization may be given by the patent owner or by a State authority under a compulsory license.