In January 2012, the Italian antitrust authority found Pfizer liable for abuse of dominant position in connection with the enforcement of its patent rights. Pfizer has been condemned to pay a fine of 10.6 mlo Euro.
Basically, in the authority's view, Pfizer was responsible for having illegitimately delayed the entry into the market of generic versions of its product Xalatan by abusing of its patent rights. The abuse consisted in the adoption of an excluding strategy including the following main elements:
1. the artificial extension of the Xalatan patent in Italy by means of: a) the application of a divisional patent; b) the validation of the divisional patent in Italy; c) the application for an SPC in Italy; d) the application for pediatric extension; and
2. the start of litigations aimed at discouraging or increasing the costs for the marketing of latanoprost generic products in Italy.
The decision has been appealed by Pfizer and there are very reasonable grounds to believe that it will be reversed.
Among such grounds, there is one that appears not to have been carefully considered by the authority: the European patent office found that the divisional patent application satisfied the patentability requirements. So the question is: can one be guilty of abusing rights in a valid patent? It should not be forgotten that the purpose of a patent is exactly that of excluding competitors from producing products incorporating the invention protected by the patent. In addition, Pfizer did not directly start legal actions against competitors but had been sued by those competitors that received sent cease and desist letters from Pfizer.
Whether the decision will be reversed remains to be seen. We will no doubt keep you updated.
In the meantime, however, consider antitrust when devising Pharma patent enforcement strategies in Italy.
I would be very much interested to hear your views on these issues. So feel free to contact me or send me questions at email@example.com.