Merck’s silence irrelevant as Sigma left gaspingMerck Canada Inc. holds a UK patent and a UK SPC covering the active ingredient in the asthma treatment Singulair. It started an action for infringement of these rights by Sigma Pharmaceuticals PLC, which was importing SPECIFIC MECHANISM
other states, e.g. Bulgaria and Romania.
“With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, the holder, or his beneficiary, of a patent or supplementary protection certificate state, the rights holder can prevent the for a pharmaceutical product filed such protection could not be obtained Member States for that product, may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the import and marketing of that product in the Member State or States where safety and efficacy. The authority grants the product in question enjoys patent a parallel import licence which allows the It is typically undertaken to exploit price protection or supplementary protection, importer to take advantage of an existing even if the product was put on the market in that new Member State for the first time by him or with his consent. and effective), and thus allows marketing Any person intending to import or covered by the above paragraph in a Member State where the product enjoys under the specific mechanism, the party patent or supplementary protection shall demonstrate to the competent product is additionally required to inform authorities in the application regarding the regulatory authority that it has given that import that one month’s prior one month’s notification to the rights into the accession treaty of these states: notification has been given to the holder holder in the country of import. or beneficiary of such protection.” Case backgroundSigma said that it notified Merck of its intention to import Polish Singulair into the UK, as required by the specific The parties’ argumentsSigma argued that it was not liable for damages in relation to its activities prior Sigma that the judge’s interpretation of the specific mechanism created a burden For more information, please contact: the patent position might be for a given Carpmaels & Ransford is a leading firm publically available registers, or at least correct Sigma company in the June 2009 their behalf, to determine the position.
letter. Merck also argued that its silence reference to notice by the rights holder
Carpmaels & Ransford is regulated by reference is to notice by the importer to
This Briefing Note was first published in the regulatory authority that notice has been importer’s notification under the specific IAM IP Newsletter. mechanism. In the present case, Merck’s silence did not imply consent, and Sigma Merck’s rights and Merck was entitled to Merck’s silence irrelevant as Sigma left gasping Copyright Carpmaels & Ransford 2012



GENDER MEDICINE/VOL. 7, NO. 4, 2010 Commentary Sex, Gender, and Pharmaceutical Politics: From Drug Development to Marketing Jill A. Fisher, PhD1; and Lorna M. Ronald, PhD2 1Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, Tennessee; and 2Interdisciplinary Studies Program, John Jay College (City University of New York), New York, New York Background

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