On 12th February 2014, the Italian Supreme Administrative Court (“ISAC”) reversed the decision of the Court of first instance and confirmed the €10.6 million fine imposed on Pfizer S.r.l. (“Pfizer”) by the Italian Competition Authority (“ICA”) in 2012 for infringements of Article 102 TFEU, the prohibition against the abuse of dominance.
Pfizer is an Italian company operating in the pharmaceutical sector and was the right-holder of a patent for Xalatan, a drug used to treat glaucoma diseases and containing the active principlev Latanoprost.
Pfizer required and obtained Supplementary Protection Certificate (“SPC”) in many European Union (”EU”) Member States but not in Italy where the patent protection was set to expire in September 2009.
In January 2009, Pfizer obtained a patent for Latanoprost and, subsequently, Pfizer required and was granted a SPC which extended the patent protection for Xalatan in Italy until July 2011 as was it in other EU member states.
The abovementioned conduct was monitored by the ICA which, in 2012, sanctioned Pfizer for abuse of dominance as the ICA believed such behaviour was aimed to delay the entry of generic drugs on the market.
In particular the ICA and now the ISAC made the following allegations:
- Pfizer wanted to impede the marketing of generic drugs containing Latanoprost.
- After filing the patent request, Pfizer sent communications to generic companies warning them from marketing their products.
- Pfizer asked the Italian Medicines Agency not to issue authorisations for the marketing of generic drugs containing Latanoprost.
In essence, according to the ISAC, Pfizer misused its patent rights by trying to benefit from undue patent protection through a legitimate conduct (the request for the divisional patent and the SPC).
In EU case-law, the misuse of patents as an abuse of dominance was earlier condemned in the AstraZeneca case. However, the decision at issue seems quite different. Indeed, the EU decision held that AstraZeneca provided false information in order to obtain a divisional patent while Pfizer used the divisional patent as part of a wider strategy, aimed only to impede or at least delay the entry on the market of the generic drugs.
In our view, the ISAC’s decision is particularly welcome for the following reasons:
- It is stresses that antitrust authorities focus on the reasons underpinning the exercise of rights even if those rights have been lawfully obtained (the patent in the case at stake).
- It has been estimated that the above anti-competitive behaviour caused the Italian National Health Service to pay approximately 15 million Euros a year of additional costs.