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EFTA – MSD v. The Icelandic Patent Office / Negative term SPC

22 Dec 2017

MSD v. The Icelandic Patent Office, EFTA Court, 21 December 2017, Case no. E-5/17

“Merck Sharp & Dohme Corp. (“Merck”) filed an application for an SPC with the Icelandic Patent Office in September 2007. The period between the application date of Merck’s basic patent (July 2002) and the grant of the first marketing authorisation (March 2007) was less than five years. The Patent Office rejected the application because the SPC would then have a negative duration, which it found incompatible with, inter alia, the purpose of the SPC Regulation. In September 2015, the Board of Appeal for Industrial Intellectual Property Rights (Áfrýjunarnefnd hugverkaréttinda á sviði iðnaðar) upheld the Patent Office’s decision.

“Merck challenged this decision before the Icelandic courts. The question referred to the Court concerned whether the SPC Regulation permits the grant of an SPC of negative duration. In particular, the referring court pointed to the fact that Regulations (EC) Nos 1901/2006 and 469/2009, which provide for a six-month extension of certain SPCs, thereby giving a purpose to SPCs of negative duration, have not been incorporated into the EEA Agreement.

“The Court held that it follows from the SPC Regulation that where the application for an SPC meets the conditions listed, the competent authority shall grant the certificate. Nothing in the wording of the provisions of the SPC Regulation suggests that it precludes an SPC of negative duration. A positive duration is not listed among the conditions for obtaining a certificate, and a negative duration is not among the valid reasons for rejection The SPC Regulation thereby not only allows for the issuing of an SPC of negative duration, it requires the competent authorities in the EEA to issue an SPC where the conditions for granting the certificate are fulfilled.

“The grant of an SPC of negative duration is consequently permissible under the SPC Regulation and a competent authority cannot reject an application merely because an SPC’s duration is not positive.”

A full copy of the EFTA Court press release can be read here.
A copy of the decision (in various languages) can be read here.