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A recent decision under UK legislation provides a timely example of the differences between Australian and UK patent term extensions (PTE).

Loss of a UK SPC

Earlier this year in Master Data Center, Inc (and Genentech Inc) v The Comptroller General of Patents [2020] EWHC 572 (Pat), Genentech, Inc. had the misfortune of losing a part of its patent coverage of ranibizumab in the United Kingdom, marketed under the trade name LUCENTIS, because of an error in paying prescribed annual fees.

LUCENTIS is a hugely successful anti-VEGF antibody used for treating various eye diseases. The patent in question was EP0973804, and the coverage was in the form of a supplementary protection certificate (SPC) SPC/GB07/012 granted on the patent.

SPCs serve a similar purpose to patent term extension (PTE) in other jurisdictions, including Australia. SPCs and PTEs each aim to compensate patentees for the delay between filing a patent application for a pharmaceutical substance and the pharmaceutical substance gaining regulatory (marketing) authorisation, during which time the patentee does not receive any return on investment.

Under UK legislation, despite being annual prescribed fees, SPC fees must be paid in a single lump sum prior to the SPC coming into effect. In the present case, Master Data Center, Inc (MDC), an annuity service provider, erroneously failed to pay the single lump sum covering the full duration of the SPC. Specifically, MDC only paid for a 2 year term, rather than the full 4 year term to which Genentech was entitled. Accordingly, Genentech’s SPC expired in early 2020, instead of early 2022. 

Hoping to pay the annual prescribed fees for the SPC’s third and fourth year, MDC argued that UKIPO’s letter regarding the annual prescribed fees was irregular in that it did not specify the requirement of a single lump sum. On that basis, MDC sought correction of the alleged irregularity under rule 107 of the Patents Rules 2007.

Genentech sought correction of the relevant form and payment of the annual prescribed fees for the third and fourth years of the SPC by relying on section 117 of the Patents Act 1977, which provides for correction of errors in patents and applications or any document filed in connection with a patent or application.

Unfortunately for Genentech, it was held that:

(i) there was no irregularity pursuant to rule 107; and

(ii) payment of the lump sum of the prescribed annual fees was a specific mandatory provision of the legislation that could not be circumvented by section 117.

Therefore, MDC’s appeal and Genentech’s appeal were both dismissed, and the SPC was not extended to its originally calculated expiration date.

Could the same occur for an Australia PTE? 

Patentees should rightly consider if any SPCs or PTEs are vulnerable to a similar error in other jurisdictions. However, under similar circumstances the outcome would not be the same in Australia.

First, Australian PTEs are subject to annual fees paid annually. That said, it is possible to pay annual fees for PTEs in one lump sum in advance. In fact, some patentees availed themselves of this option to avoid increased renewal fees that came into effect on 1 October 2020.

Second, regulation 13.6(1A) also extends the deadline for paying annual fees during the PTE to up to 6 months after each anniversary following the 20th anniversary, thereby providing a buffer for paying an annual fee.

Third, Australian patent legislation provides generous provisions for remedies where a relevant act is not done within a certain time because of an error or omission on the part of the patentee or its agent, or because of circumstances beyond control of the patentee. Although section 223 of the Patents Act 1990 is phrased similarly to that of section 117 of the UK legislation, the Australian provisions have been applied differently. As noted above, the UK court was concerned with “circumventing” specific mandatory provisions of the legislation. In contrast, section 223 has been applied beneficially in Australian jurisprudence. Furthermore, section 223 specifically contemplates lapse of a patent for failure to pay an annual fee. Accordingly, under a similar situation in which an annual fee was not paid in time by error, Australia’s remedial provisions would very likely have enabled the unpaid annual fees to be paid, thereby maintaining the PTE in force.

For further information on Australian PTEs or remedial provisions, please contact Dr Malcolm Lyons

 

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