[Ip-health] It: official press release on finasteride CL, (also mentions the two previous CL cases)

[James Packard Love]

*  The Merck group will be obliged to grant free licences to allow
the manufacture and sale in Italy of the active ingredient
Finasteride and related generic drugs two years before the 2009
expiration of the Complementary Protection Certificate. This was
decided by the Italian Competition Authority when, at its meeting on
21 March 2007, it accepted and made obligatory the commitment
presented by the multinational itself, thus bringing to a close
without penalty the proceeding relating to abuse of a dominant position.

*  The corporation's commitment to remove an obstacle to the
production in Italy of Finasteride and a generic version of related
pharmaceuticals, among the most important drugs used in the treatment
of hypertrophy of the prostate, will encourage greater competition in
this market and may lead to significant reductions in retail prices
and in costs for the National Health System in Italy and in other
European countries.

* In the pharmaceuticals sector in particular the Antitrust
Authority's initiative is aimed at encouraging more widespread use of
generic products, taking advantage of notifications from the Italian
Office of Patents and Trademarks within the Ministry of Economic
Development which are based on regulations governing patents in this
sector.

* In February 2006, the Antitrust Authority had already obtained the
opening up of licensing from another multinational, Glaxo, which
paved the way for the manufacture of generic forms of a powerful
migraine medicine, sumatriptan succinate. In this recently concluded
investigation,

* the Authority had also obliged the Merck group, by way of an
injunction, to grant licences for the manufacture of the active
ingredient imipenem cilastatina which is used in the treatment of
serious hospital infections.

http://www.agcm.it/agcm_eng/COSTAMPA/E_PRESS.NSF/
92e82eb9012a8bc6c125652a00287fbd/28653b373e56772ac12572ab003a4d68

Press releases
A364 - MERCK - ACTIVE INGREDIENTS (CONCLUSION OF INVESTIGATION)
number	19
date  03/26/2007

PRESS RELEASE
PHARMACEUTICALS: ANTITRUST AUTHORITY RULES MERCK MUST GRANT FREE
LICENCES FOR THE ACTIVE INGREDIENT FINASTERIDE
The Authority accepts and renders obligatory a commitment presented
by the companies Merck & Co. Inc. and Merck Sharp & Dohme (Italia) in
order to conclude the investigation launched in February 2005 into
possible abuse of a dominant position. Expected price reductions for
the drug to benefit consumers and the National Health System.

The Merck group will be obliged to grant free licences to allow the
manufacture and sale in Italy of the active ingredient Finasteride
and related generic drugs two years before the 2009 expiration of the
Complementary Protection Certificate. This was decided by the Italian
Competition Authority when, at its meeting on 21 March 2007, it
accepted and made obligatory the commitment presented by the
multinational itself, thus bringing to a close without penalty the
proceeding relating to abuse of a dominant position.

The corporation's commitment to remove an obstacle to the production
in Italy of Finasteride and a generic version of related
pharmaceuticals, among the most important drugs used in the treatment
of hypertrophy of the prostate, will encourage greater competition in
this market and may lead to significant reductions in retail prices
and in costs for the National Health System in Italy and in other
European countries.

This ruling needs to be seen in the wider context of the Authority's
efforts to encourage businesses to adopt commitments aimed at
improving market conditions, competition and consumer choice. In the
pharmaceuticals sector in particular the Antitrust Authority's
initiative is aimed at encouraging more widespread use of generic
products, taking advantage of notifications from the Italian Office
of Patents and Trademarks within the Ministry of Economic Development
which are based on regulations governing patents in this sector. In
February 2006, the Antitrust Authority had already obtained the
opening up of licensing from another multinational, Glaxo, which
paved the way for the manufacture of generic forms of a powerful
migraine medicine, sumatriptan succinate. In this recently concluded
investigation, the Authority had also obliged the Merck group, by way
of an injunction, to grant licences for the manufacture of the active
ingredient imipenem cilastatina which is used in the treatment of
serious hospital infections.

These were cases in which the Authority had to assess the abusive
nature of unjustified refusals to grant licences that were
indispensable for the production of active ingredients in quantities
sufficient to allow wide distribution of generic drugs, to the
benefit of competition and consequently of consumers.

Rome, 26 March 2007

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"