A word of warning to seek expert advice when paying renewal fees for UK Supplementary Protection Certificates (SPCs)
SPCs are a form of patent term extension in Europe that can provide up to 5 additional years of patent protection for medicinal and plant protection products that have gained regulatory approval. There is an additional 6 month extension also available for products subject to a paediatric investigation plan (PIP).
SPCs are national rights, so must be applied for nationally in Europe even if based on a European patent. Each country in Europe has different requirements for the payment of SPC renewal fees. In some countries, SPC renewal fees are payable annually. However, the UK is one exception to this where the renewal fees must be paid in a single, accumulated amount for the total period of protection required before the SPC comes into force.
The UK Patents Court issued a decision in March 2020 highlighting the importance of complying with the UK-IPO’s requirements for allowing an SPC to come into force once granted. The decision specifically highlights the differences between patent and SPC practice, and the consequences of not complying with the UK-IPO’s niche SPC requirements. This has a downstream impact on the ability to obtain the additional 6 month paediatric extension.
The Court found that if the maximum SPC term for a UK SPC is not taken and paid for in time (shortly before patent expiry), then it is also not possible to obtain a 6 month paediatric extension.
The requirements for obtaining an SPC are laid down in Article 3 of Regulation (EC) No. 469/2009 (termed “The SPC Regulation”), which lists four requirements for obtaining an SPC in all European Member States. However, whilst The SPC Regulation dictates the requirements for grant of an SPC in all Member States, there is no provision in The SPC Regulation that dictates the necessities for the SPC to come into force once granted. In particular, the requirement and method for paying annual fees is left for each European Member State to determine.
SPC term and annual fees in the UK
The term of an SPC is calculated by establishing the time period between the filing date of the patent and issuance of the first marketing authorisation and subtracting 5 years (with a maximum term of 5 years).
In the UK, once the SPC term has been established, the SPC holder is required to pay annual fees for the period of time that they wish the SPC to be in force for (up to the maximum term). Unlike patent practice where a fee is due annually, SPC annual fees must be paid as a cumulative, single payment before the SPC comes into effect, shortly before patent expiry.
The SPC holder can subsequently apply for a 6 month paediatric extension to their SPC term, bringing the maximum SPC term up to 5 years and 6 months. This requires, amongst other things, the provision of a further marketing authorisation containing studies showing that the product has been used in paediatric trials. The precise requirements concerning applying for a paediatric extension are listed in a further Regulation termed the “The Paediatric Extension (PE) Regulation”.
The SPC subject to Appeal – what went wrong?
Genentech applied for and were granted an SPC for their product ranibzumab (marketed as Lucentis®), which was approved for marketing throughout the EEA for the treatment of eye disorders.
The SPC was granted for a maximum term of 3 years, 9 months and 20 days using the above calculation. To obtain the maximum SPC term in the UK, the first-fourth year renewal fees should have been paid shortly before patent expiry.
Genentech instructed Master Data Centre (MDC) to pay the renewal fee amount that would allow the SPC to come into effect for the entire SPC term. However, MDC only paid the first and second annual fees resulting in the SPC expiring in April 2020 – effectively halving the requested SPC term. The SPC thus came into force with only the first and second annual fees having been paid.
The UK-IPO SPC examiner found that, under UK practice, it was not permitted to pay further annual fees after the SPC had come into force to effectively “top up” the SPC term to the maximum term granted. The examiner also found that correction of the error is also not possible.
Genentech also wanted to apply for the 6 month paediatric extension. However, the UK-IPO SPC examiner found that, under UK practice, a paediatric extension can only be granted where the patentee has availed themselves of the full SPC term, and so also refused their application for a paediatric extension.
The UK-IPO issued a decision that the SPC lapsed on 2 April 2020 because MDC only requested and paid for a 2-year SPC term.
Both Genentech and MDC appealed the decision to the Patents Court.
Both parties pursued the same line of argumentation as that used in the UKIPO hearing. Ultimately, the judge upheld all of the UK-IPO’s conclusions and dismissed both parties’ appeals.
Conclusions and practice notes
UK SPC annual fees must be paid (in full or in part) in the “prescribed period” and further payments after this period are inadmissible. If the maximum SPC term is not obtained, you cannot obtain a 6 month paediatric extension.
If you wish to obtain the paediatric extension, you must ensure that the full SPC term is paid for in the UK as an accumulated amount before the SPC comes into force. At Forresters, we have the necessary expertise to assist you with ensuring UK SPC renewal fees are paid correctly and on time to maximise your SPC term.
Please contact your usual Forresters attorney if you need further advice.