"In reality, there is nothing "new" about the rules the PTMO have used to calculate the expiry dates of SPCs, and there should have been no surprises but only very few minorachanges.Thanks so much, João, for this explanation -- which is sure to leave many readers even more puzzled than ever before!
However, this is not what really happened ...
It is interesting to note that, in that publication from the PTMO, the first two lines concern the "old starting date of the SPC " and the "new starting date of the SPC". It is quite intriguing and challenging to understand how a new formula to calculate an SPC's duration can have the result that all base patents that have SPC applications have reduced their duration by one day: the new starting date is (at least) one day before than the old starting date It is also interesting that this "rule" seems to apply only to patents which are extended by SPCs, while the expiry date of the other patents remain unchanged. Needless to say, the note posted by the PTMO is silent about this change ...
Taking into account all the data published by the PTMO, we can try to understand the PTMO's arithmetic:
* the expiry date of the patent is taken as 20 years, including the application date, meaning that a patent filed, for example, on January 2, 2000 would expire at 23:59:59 on January 1, 2020;Thus the two mistakes cancel each other out and the new expiry dates are, in general, correct, since the PTMO has reduced the duration of the patents by one day but has extended the duration of the SPC by... one day! This would not have been noticed, had the PTMO published only a list of the old and new expiry dates.
* the corresponding SPC would be in force from 00:00:00 of January 2, 2020;
* the expiry date was calculated by adding the difference between the Marketing Authorisation date and the application date to the first day the SPC is in force (and not to the last day of the patent) and then deducting five years.
Another quite interesting detail that has been revealed in this new publication is that corrections have been made previously (but not published) in the duration of some SPCs.
The affected SPCs (which in some cases have had their duration extended by years) relate to SPCs where the base patent was a national patent that was applied for before the entry into force of the IP Code of 1995 and granted after that IP Code came into force.
For these patents, the expiry date of the patent is calculated as the later date of (a) the date of application + 20 years (as stated for the first time in the 1995 IP Code) or (b) the date of grant + 15 years (the duration of patents according to the old IP Code of 1940).
This transitional provision of the 1995 IP Code resulted in patents that have more than 20 years of duration. For instance, a patent applied in 1990 and granted in 1999 will be valid until 2014, thus achieving 24 years from application date.
Now, the existence of these patents having a duration of more than 20 years from the application date has given rise to some problems regarding the calculation of the period covered by the base patent and the SPC. Regulations 469/2009 and 1610/96 and also the old Regulation 1768/92 do not take into consideration for the calculation of the duration of the SPC that in some situations a patent can have a duration of more than 20 years.
In the grant procedure for some of these SPCs, the Portuguese PTMO took into consideration recital (9) of Regulations 469/2009, which states that the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
That interpretation is exactly what has been corrected prior to the recalculation now published and had resulted in an extension on the duration of the SPCs.
The PTMO seems no longer to take this recital into account and we have now cases where the overall maximum of 15 years of exclusivity is largely exceeded, as is also the total 25 years of protection.
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