Decision of the Austrian Supreme Court regarding SPC’s

The Austrian Supreme court recently decided about the duration of SPC’s based on “old” Austrian national patents, which patents had been filed prior to December 1, 1984. These patents had a duration of 18 years from the day of laying open to public inspection (and at least 20 years from the filing day, respectively).

A generic manufacturer challenged a granted SPC per declaratory request with respect to its duration in front of the Commercial Court of Vienna as first instance. The SPC was based on one of the old Austrian patents as mentioned above and was granted by the Austrian Patent Office with a duration until January 15, 2007. Filing date of the basic patent was April 12, 1979, laying open for public inspection was on January 15, 1984 with a duration until January 15, 2002. The medicament in question was subject of a first marketing authorization within the EEA issued on April 18, 1990.

According to Article 13 of the EU regulation 1768/92, the certificate shall take effect for a period equal to the period between the filing date of the basic patent and the issue date of the first marketing authorization within the EEA reduced by five years. Notwithstanding that, the duration of the certificate may not exceed five years from the date on which it takes effect.

However, according to the preamble of said EU regulation, the overall maximum period of exclusivity should not exceed fifteen years from the issue date of the first marketing authorization within the EEA.

As one can easily see from the above dates of the present case, the duration of the SPC was in line with Art. 13 of EU regulation 1768/92 (max. 5 years) but against the preamble (by providing more than 16 years of exclusivity).

The Supreme Court of Austria as the last instance now confirmed the decisions of the two prior instances and held in 4Ob 191/05z that the preamble of EU regulation 1768/92 and especially the maximum term of exclusivity mentioned therein has to be considered when calculating the term of a SPC (this is also in line with C-207/03 and C-252/03 of the ECJ). Therefore, a mere mathematical calculation of the term of a SPC strictly in line with Art. 13 is not applicable since it contradicts the intentions of EU regulation 1768/92.

01.09.2006