Out-Law News | 13 Mar 2020 | 12:03 pm | 2 min. read
The ruling is important for pharmaceutical companies and other businesses active in the UK's life sciences sector because it highlights how UK requirements around SPC fees are different to those of other countries in the EU, said life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.
The judgment is also highly relevant for biosimilar manufacturers shaping up to market rival products to Lucentis in the UK. Lucentis is the brand name under which Genentech sells ranibizumab, a product which is used to treat 'wet' age-related macular degeneration – an eye disease.
Genentech currently holds a monopoly in the UK market for ranibizumab as it holds an SPC for the product. That SPC is due to expire on 2 April.
Genentech and Master Data Center, a company Genentech had outsourced the administration of its SPC to, had asked the High Court to overturn an earlier decision by a hearing officer at the UK's Intellectual Property Office (IPO) regarding the SPC for ranibizumab.
The hearing officer had rejected the companies' bid to extend the term of the SPC after it was artificially shortened through an underpayment of fees.
When seeking to apply the SPC in the UK, Master Data Center submitted paperwork to the IPO which indicated that the SPC would last for a duration of two years only, instead of for its maximum possible term up to 23 January 2022. Master Data Center paid a fee reflecting the shorter duration.
Subsequently, Master Data Center asked the IPO to make a correction to ensure the SPC would apply for its maximum term. Genentech separately directly applied for a paediatric extension to the SPC and enclosed a form and annual fees which would extend the SPC to its maximum duration. It also later requested the original form that Master Data Center submitted and the associated fee sheet be corrected.
However, the IPO's hearing officer said that the corrections to the term of the SPC could not be granted in the case under UK patent rules, patent law or via a so-called paediatric extension, contrary to what Genentech and Master Data Center had argued. That decision has now been upheld by the High Court.
The High Court judgment featured a letter the IPO had sent to Genentech's patent agents in January 2018 which highlighted the administrative and fee requirements for registering an SPC in the UK.
The letter contained a warning, in capitalised and bold type, which read: "It is not possible for the applicant to opt to pay renewal fees annually on supplementary protection certificates in the United Kingdom. This is a request for a one-off payment of fees to cover the effective period chosen by the applicant for which he requires protection and cannot be extended. SPC practice is therefore different from that on patent renewals during the first 20 years of life of the patent and SPC annual renewal practice in other EC states such as France."
Patent law expert Jules Fabre of Pinsent Masons said: "In France, SPC holders have the option of either paying renewal fees annually – as for patents, except that for SPCs annual fees are not progressive – or paying all of the fees for the whole term up front, during the year prior to the SPC taking effect. There is also a six months grace period for late payments, subject to an additional fee."
05 Mar 2020