Italian Competition Authority investigates Pfizer’s effort to obstruct market access for a new generic drug for treating visual glaucoma

On 13 October 2010, the Italian Competition Authority (“ICA”) opened an investigation to ascertain whether Pfizer’s attempt to prolong the patent protection for its active ingredient latanaprost constitutes an abuse of its dominant position in the market for products for treating visual glaucoma in order to block or delay market access for generics.

The investigation was prompted by a complaint lodged by Ratiopharm, a generics producer. Ratiopharm highlighted a variety of Pfizer Italia’s conducts aimed at obstructing or postponing the introduction of generic drugs competing with Xalatan, Pfizer’s branded product for the treatment of visual glaucoma, into the Italian market.

In particular, Pfizer is accused of having allegedly abused the administrative procedure to obtain an extension of the patent protection until July 2011, without, however, launching any new product on the Italian market. In fact, the Complementary Patent Certificate obtained by Pfizer in Italy was based on a divisional patent (i.e. a type of patent application which contains matter from a previously filed application, i.e. the so-called parent application) that was recently declared invalid by the European Patent Office in Munich. Therefore, according to the ICA, the (unduly obtained) extended patent protection may have impaired the investments made by Pfizer’s competitors to market new generic drugs as of the date of the expiration of the patent protection, scheduled for September 2009.  While manufacturers of such generics drugs have recently been allowed to market their products, Pfizer has, however, undertaken legal actions based on counterfeiting claims. These actions would further increase the uncertainty for generics manufacturers if a court in Milan grants injunctions in Pfizer’s favor.

It is now for the ICA to determine whether Pfizer’s behavior constitutes an abuse of its dominant position in the market for products for treating visual glaucoma.

This is not the first case where the ICA investigates manufacturers of branded products that have taken steps to obstruct or delay generics market entry (see the twin cases Glaxo/Principi Attivi of 2006 and Merck-Principi Attivi of 2007).

The proceeding is scheduled to conclude on 15 October 2011. [Gabriele Accardo]