Genentech Inc. v The Comptroller General of Patents

Under the UK supplementary protection certificate fee scheme, an applicant may choose a shorter period by paying the corresponding annual fees in advance. The certificate then lapses at the end of that period if further annual fees are not paid, and top-up fees cannot be paid after the certificate takes effect.

A paediatric extension adds six months to the maximum period calculated under the SPC Regulation. It does not permit unpaid annual fees to be added, prevent lapse, or create a separate certificate. The general power to correct errors under the Patents Act 1977 cannot be used to overcome the specific prohibition in rule 116(5). A procedural-extension discretion does not arise where no irregularity attributable to the Comptroller is established.

Two appeals concerned a supplementary protection certificate for ranibizumab. Genentech had instructed its agent, Master Data Center, Inc (MDC), to obtain the maximum term, expiring on 23 January 2022. MDC instead filed Form SP2 requesting a two-year term and paid £1,300. The certificate was therefore due to lapse on 2 April 2020.

A Hearing Officer refused applications seeking to correct or extend the certificate. The Patents Court dismissed both appeals: [2020] EWHC 572 (Pat). MDC argued that the Comptroller’s notice and form contained procedural irregularities. Genentech argued that rule 116(5) permitted top-up fees following a paediatric-extension application, that section 117 permitted correction of Form SP2, or that a paediatric extension could run from the lapse date. The common issue was the interaction between the EU SPC regime and the UK fee and correction provisions.

Both appeals were dismissed. Lord Justice Floyd gave the leading judgment, with which Lady Justice Nicola Davies and Lord Justice Arnold agreed.

1. MDC’s appeal. The UK scheme implements annual fees within Article 12 of the SPC Regulation. The fees remain annual fees even though they are paid in advance and in one amount. Their level increases according to the period selected. The Court of Appeal followed Tulane Education Fund’s Supplementary Protection Certificate [2013] EWCA Civ 890; [2014] RPC 10, in which the ability to elect a shorter period was an essential part of the reasoning.
2. An applicant may elect a shorter term by paying the corresponding prescribed fee. The applicant cannot later pay annual top-up fees. The certificate consequently lapses under Article 14(c) at the end of the selected period. The rule 116 notice and Form SP2 therefore correctly indicated that a shorter term could be selected, and the Comptroller was not required to state only the fee for the maximum term.
3. The Court applied the principle discussed in R (Kadhim) v Brent London Borough Council Housing Benefit Review Board [2001] QB 955. A prior ratio is not displaced merely because the point was not argued if the earlier judgment shows that it was considered and decided. Tulane had decided the relevant construction of rule 6, so departure was impermissible.
4. Genentech’s appeal. Rule 116(5), read against Article 13 and paragraph 5 of Schedule 4A to the Patents Act 1977, permits only payment of the fee for a paediatric extension after the certificate takes effect. A paediatric extension lengthens the Article 13 period by six months. It does not alter the prior election to let the certificate lapse for unpaid annual fees.
5. Section 117 is a general power to correct errors in documents. It cannot be construed to cure the separate failure to pay the annual fees prohibited by rule 116(5). Funds retained in MDC’s deposit account had not been paid to the UK Intellectual Property Office, and the payment history could not be rewritten.
6. A paediatric extension cannot begin from the lapse date of 2 April 2020. The EU regime contemplates only an extension of the maximum SPC period. Since no procedural irregularity attributable to the Comptroller was established, it was unnecessary to determine how the rule 107 discretion would otherwise have been exercised.

• Court of Appeal (Civil Division): dismissed both appeals: [2020] EWCA Civ 475.
• Patents Court: Mr Recorder Douglas Campbell QC dismissed Genentech’s and MDC’s appeals from the Hearing Officer’s decision: [2020] EWHC 572 (Pat).
• UK Intellectual Property Office: the Hearing Officer refused the applications seeking rectification, correction or extension of the supplementary protection certificate.