[Ip-health] More on the Italian compulsory license for finasteride

[James Packard Love]

Merck & Co., Inc.
FORM 10-K
As filed with the Securities and Exchange Commission on February 28,
2007

page 31

As previously disclosed, on February 23, 2004, the Italian Antitrust
Authority (=93ICA=94) adopted a measure commencing a formal investigation
of Merck Sharp&Dohme (Italia) S.p.A. (=93MSD Italy=94) and the Company
under Article 14 of the Italian Competition Law and Article 82 EC to
ascertain whether the Company and MSD Italy committed an abuse of a
dominant position by refusing to grant to ACS Dobfar S.p.A.
(=93Dobfar=94), an Italian company, a voluntary license under the
Company=92s Italian Supplementary Protection Certificate (=93SPC=94),
pursuant to domestic legislation passed in 2002, to permit Dobfar to
manufacture imipenem and cilastatin (=93I&C=94), the active ingredients
in Tienam, in Italy for sale outside Italy in countries where patent
protection had expired or never existed. A hearing before the ICAwas
held on May 2, 2005 and on June 17, 2005, the ICA found, on a
preliminary basis, that the Company=92s refusal to grant the license
was an abuse of a dominant position, and imposed interim measures
requiring the Company to grant a license to manufacture I&C in Italy
for stockpiling purposes only, until expiration of the SPC. On
November 16, 2005, the Italian Administrative court denied the
Company=92s appeal of the ICA=92s order. The Company=92s SPC expired in
January 2006. Proceedings before the ICA continued on the merits of
the Article 82 investigation and, in an effort to resolve the matter,
the Company offered a commitment to the ICA pursuant to which the
Company would grant non-exclusive licenses under its Italian SPC for
finasteride with respect to finasteride 5 mg for the treatment of
benign prostate hyperplasia. The deadline for the ICA to adopt its
final decision as to whether the Company=92s commitment warrants the
closure of the case is March 16, 2007.


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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"