Holders of UK-issued supplementary protection certificates (“SPCs”) for patents covering products for which marketing authorisation was obtained through the centralised European procedure will be pleased by a recent decision of the UK Intellectual Property Office (“UK IPO”) which may extend their term.
Certain products (such as human medicinal products) require regulatory approval before they can be marketed. As this process takes a long time, a patents owner’s exclusivity under the patent covering such products will be reduced by the time taken to obtain authorisation. A SPC extends the exclusivity period granted by a patent (usually by around 5 years) to compensate for the time taken to obtain such regulatory approval.
SPCs come into force after the expiry of the patents on which they are based. The term of a SPC depends on when the marketing authorisation for the related patented product is granted in Europe. Products authorised to be marketed under the centralised European procedure have two dates associated with them: (A) the date of the European Commission’s decision to issue a marketing authorisation; and (B) the date of notification of that decision to the marketing authorisation applicant. Date (B) is usually 2 to 4 days later than date (A) but may be as much as 7 days later.
The UK IPO, along with other national patent offices in Europe, had traditionally favoured date A as the date of first marketing authorisation. However, in a decision in October 2013, the UK IPO announced that the correct date of first authorisation was in fact date B on the basis that a centralised marketing authorisation does not become effective until it is notified to the applicant. As a result, protection granted under many existing UK SPCs should be extended by an average of 2 to 4 days. While this timeframe does not seem impressive, the extra revenue generated during this period may be significant.
Holders of UK SPCs should review their term to see whether enforcing an extension is commercially interesting. However, holders should remain cautious as the UK IPO’s interpretation may not be valid in other member states and will likely require a ruling from the Court of Justice of the EU to confirm whether the UK IPO’s new practice is correct.