A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Tuesday 18 February 2014

"Mystery case" C-555/13: Singulair and generic montelukast

The SPC Blog thanks Manuel Durães Rocha (Trocado, Durães Rocha & Associados, Lisbon) for some further information concerning the "mystery case" from the Court of Justice of the European Union, Case C-555/13 Merck Canada (see earlier SPC Blog posts here and here).  Manuel explains:
This referral was requested by an arbitral court formed in Portugal on the basis of Portuguese Law nº 62/2011 to decide whether Merck´s Portuguese patent 92213 and its SPC 35 covering Singulair was or not infringed by generic medicines of montelukast put on the market by companies manufacturing montelukast generic medicines such as Alter, Accord Healthcare and Synthon. 
Although Merck´s patent elapsed on October 2, 2013, Merck owns SPC35 covering Singulair until August 18, 2014. Alter raised the question, arguing that SPC35 could not be effective until 18 August 2014 taking into consideration that Merck had already benefited from a 15 year market exclusivity counted from the date of the first MA granted for the European Community in August 25, 1997. Alter invoked recital 9 of EU Regulation 469/2009 to defend the proposition that the dates calculated through Article 13 of that regulation should match the objective of granting a 15 year market exclusivity and thus such SPC35 could not enter in force until August 18, 2014 because, if so, it would grant a market exclusivity to Merck of more than 15 years counted from the date of the first MA in the EU despite such SPC is valid until August 18, 2014.

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