Out-Law / Your Daily Need-To-Know

SPC admin error could open market for ranibizumab in the UK

Out-Law News | 01 Apr 2020 | 9:07 am | 1 min. read

Genentech's supplementary protection certificate (SPC) for ranibizumab, which treats a form of eye disease, is due to expire in the UK tomorrow after the Court of Appeal in London rejected a late bid to extend the expiration date following an administrative error.

The unanimous ruling of the Court of Appeal judges on Tuesday afternoon, seen by Out-Law, upheld an earlier judgment by the High Court, which had in turn endorsed the views of a hearing officer at the Intellectual Property Office (IPO) who had considered the case.

The ruling is relevant to Genentech's monopoly in the market for its branded version of ranibizumab, Lucentis, which is prescribed as a treatment for 'wet' age-related macular degeneration.

Genentech's SPC took effect on 3 April 2018. When seeking to apply the SPC in the UK, the company's outsourcing provider 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. This meant that the SPC would expire on 2 April 2020 instead of 23 January 2022.

Master Data Center asked the IPO to make a correction to ensure the SPC would apply for its maximum term, while 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 an extension could not be granted under UK patent rules, patent law or via a so-called paediatric extension.

That view was also taken by the High Court after the companies raised an appeal, and their further bid for an extension to be applied before the Court of Appeal has now been rejected too.

In principle, the case could still be appealed to the Supreme Court.