European Commission Orders Italy To Drop Patent Linkage Delaying Generics

The European Commission has issued a formal request to Italy to remove linkage between patents and generic medicines authorisation that it says is causing delays in generics reaching the market.

The Commission issued the request for full compliance within two months with EU Directive 2001/83/EC, on the Community code for medicinal products for human use, which it said states that “the processing of marketing authorisation procedures can be carried out without being affected by the protection of industrial and commercial property interests.”

The Commission pointed out that the rules also state that “the authorisation holder of a generic drug is not allowed to place a product on the market before the patent on the reference product has expired.”

Italy has missed the timeline for changing its national law, which is resulting in long delays in the introduction of generics onto the market, at the expense of consumers.

“In particular,” in said, “in Italy, a law prevents manufacturers of generic products to submit their request for marketing authorisation prior to the penultimate year of the lifetime of a patent on a reference product. For example, if a patent on a reference product has a 10 year lifetime; manufacturers will need to wait at least 9 years before they are allowed to submit their request for marketing authorisation. As a result of this law, and of the lengthy procedure to secure the authorisation for marketing, manufacturers of generic products are placed at a disadvantage on the market.”

If Italy does not comply within two months the case could be referred to the European Court of Justice.

The European Generics Association and the Italian association for generic medicines (ASSOGENERICI) welcomed the announcement, saying that “as stated by the European Commission in the pharmaceutical sector inquiry report, linking the marketing authorisation process of generic medicines to intellectual property rights of the originator product (so called: “patent linkage”) is a clear abuse of the EU regulatory system.”

The generics groups said the action by the Italian government will result in increased competition in the market.

Commission announcement and infringement procedure are here.

EGA press release is here.