Admin error reduces term of pharma's SPC

Out-Law News | 05 Mar 2020 | 9:22 am | 2 min. read

A pharmaceutical company has had its bid to extend the term of a supplementary protection certificate (SPC) rejected after the term was artificially shortened through an underpayment of fees.

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law, said the case, ruled on by a hearing officer at the UK's Intellectual Property Office (IPO), "highlights a potentially expensive administrative mistake for Genentech".

As things stand Genentech’s SPC for ranibizumab in the UK is set to expire on 2 April 2020, though the company has raised an appeal.

"The error could however be confined to the UK. Despite the maximum term of the ranibizumab SPC being nearly four years from the date the SPC entered into force, annual fees were only paid to cover two of those years in the UK, but in both Ireland and France for example the SPC has the longer duration including a six month paediatric extension," she said.

In the case, the IPO's hearing officer rejected arguments from Genentech, along with those from a company it had entrusted with the administration of its SPC, that an extension could be granted in the case under UK patent rules, patent law or via a so-called paediatric extension.

Genentech's SPC took effect on 3 April 2018. 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. 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.

Hearing officer B Micklewright at the IPO held, however, that the Patent Rules 2007 do "not allow further annual fees to be paid in the situation where an application for a paediatric extension is made". They also confirmed that while a paediatric extension extends the maximum possible duration of an SPC, it cannot extend the artificially shortened duration of the SPC in this case.

The hearing officer further confirmed that corrections cannot be made to the SPC's paperwork to extend the duration of the SPC to its maximum term under the Patents Act 2007.

The hearing officer also determined that it was not open to them to exercise discretion in the case.

"There has been no irregularity of procedure, clerical error or mistake attributable, wholly or in part, to a default, omission or other error by the comptroller, an examiner or the Patent Office and therefore there is no basis upon which the comptroller may exercise his discretion under rule 107 to extend the period for paying further annual fees," Micklewright said.

"Ranibizumab is a hugely successful product for Genentech", said Sarah Taylor, patent expert at Pinsent Masons. "There are many biosimilar manufacturers waiting in the wings and it is important for them to have certainty around expiry dates so they can properly plan and minimise the risk around the launch of their products."