AGCM

PRESS RELEASE

PHARMACEUTICALS: ANTITRUST AUTHORITY LAUNCHES INVESTIGATION INTO PFIZER FOR POSSIBLE ABUSE OF DOMINANT POSITION

Proceedings to determine whether the company acted to prolong its patent protection for latanoprost (an active ingredient for treating visual glaucoma) by employing artful strategies to obstruct or delay the introduction of generic drugs

In a meeting on 13th October 2010, the Autorità Garante della Concorrenza e del Mercato decided to launch an investigation in order to determine whether Pfizer's behavior reflects a cunning effort to prolong its patent protection in Italy for the active ingredient latanoprost in order to block market access for a new generic drug.
The decision, which was communicated to the company during the course of multiple inspections that the Antitrust Authority officials conducted in collaboration with the Market Protection Unit of the Guardia di Finanza (Italian Tax Police), was adopted in response to a detailed complaint lodged by the company Ratiopharm. The complaint highlighted a variety of behaviors that Pfizer Italia S.r.l. had used to obstruct or postpone the introduction of generic drugs based on Xalatan - a medicine that Pfizer produces and markets for the treatment of visual glaucoma - into the Italian market. According to the documentation, Pfizer is alleged to have artfully requested and obtained a patent-coverage extension by first requesting a divisional patent and then requesting a complementary protection certificate (hereinafter CPC) to extend patent protection until 2011. The CPC, however, was based on a divisional patent that was recently declared invalid by the same European Patent Office in Munich.
The proceeding - which takes place in the wake of Pharmaceuticals Sector Inquiry concluded by the European Commission in 2009 - is setting out to determine whether Pfizer's behavior reflects an intentional effort to obstruct market access for a new generic drug, thus representing an abuse of Pfizer's dominant position in the market for products for treating visual glaucoma. With the expiration of patent protection scheduled for September 2009, generic drug producers had rightly identified an opportunity to begin marketing a new generic drug as of that date. Investments that were made in pursuit of this interest, however, were rendered fruitless by the extension of the patent protection period.
Pfizer adopted behaviors, including legal actions, that are alleged to have created an atmosphere of legal uncertainty about the possibility of marketing the new generic drug, acting intentionally to exacerbate market entry costs (in terms of planning and production) for the producers of generics.
The proceeding is scheduled to conclude on 15th October 2011.

Rome, 26th October 2010