Yesterday the ECJ delivered its judgment in Case C-468/06 Lelos v GSK, a reference from the Greek competition authorities concerning a failure by GSK to fully meet orders submitted to it by Greek wholesales which GSK deemed to be well in excess of demand on the Greek market.
Although it is an abuse of a dominant position under Art.82 of the EC Treaty for an undertaking to refuse to supply wholesalers in order to put a stop to parallel importation, an undertaking can stop supplying if orders are placed which are out of all proportion to those previously sold by the same wholesalers to meet the needs of the market in that Member State. It is for Member States' courts to determine whether orders are not 'ordinary', i.e. if they are out of proportion to the needs of that Member State's market. The court stressed that such supplies can only be limited to protect the undertaking's economic interests. It is for the Member State's authorities, and not for pharma companies to crack down on parallel imports which are so extensive that the exporting market finds itself within sufficient supplies of the drug in question.
The IPKat notes that the ECJ wiggled out of commenting on a couple of issues of particular interest to IP lawyers:
- The argument was raised that consumers wouldn't ultimately benefit from parallel importation because any price differential between the importing country and the country of origin would be eaten up by parallel importers are resellers. No matter, said the ECJ - price competition would still result in the shape of 'financial benefits not only for the social health insurance funds, but equally for the patients concerned, for whom the proportion of the price of medicines for which they are responsible will be lower. At the same time... parallel trade in medicines from one Member State to another is likely to increase the choice available to entities in the latter Member State which obtain supplies of medicines by means of a public procurement procedure, in which the parallel importers can offer medicines at lower prices.' The IPKat says that this reasoning is limited to industries like pharma, where there is massive public procurement, backed by social funds. He also notes that this reasoning assumed that patients are responsible for a proportion of the cost, unlike the NHS, where a flat rate applies.
- The court felt it unnecessary to consider the argument that undertakings might need to limit parallel importation to recoup their R & D costs.
On the other hand, it should be recalled that, where a medicine is protected by a patent which confers a temporary monopoly on its holder, the price competition which may exist between a producer and its distributors, or between parallel traders and national distributors, is, until the expiry of that patent, the only form of competition which can be envisaged.