Most people are aware that inadvertently lapsed registered intellectual property rights such as patents or patent applications can sometimes be restored. The good news for holders of a Supplementary Protection Certificate (SPC) is that the possibility of restoration or an equivalent remedy also exists in relation to the deadlines for filing and extending SPCs.
An SPC is a unique intellectual property right that can give up to 5 years additional protection for human medicinal, veterinary or plant protection products covered by a patent after the patent term has expired. It is intended to compensate the patent holder for the regulatory delay associated with obtaining marketing approval for such products.
SPCs for a human medicinal product can be extended by a further six months, as a reward for carrying out studies under an agreed Paediatric Investigation Plan (PIP).
Such an extension can provide additional patent protection at what is often the most valuable period in the lifetime of a patented pharmaceutical product – it is therefore the restoration of this particular right that is the subject of this article.
The process for requesting a paediatric SPC extension includes a definite deadline for filing the request – it must be filed no later than two years prior to the SPC’s expiry date.
What if the application for a paediatric extension was not filed in time?
Even if all other requirements have been satisfied by the SPC holder (the carrying out of studies under the agreed PIP, etc.), missing the deadline can still result in the inability to obtain a paediatric extension – the loss of this period of further exclusivity can have a hugely negative impact on the revenue stream for the pharmaceutical product that is protected by the SPC because the market entry of generic competitor products typically leads to a rapid price erosion.
Fortunately, filing an application for a paediatric SPC extension late isn’t necessarily the end of the world – under some circumstances even where the deadline for applying for the extension has been missed, the restoration or reinstatement of rights, or a similar remedy, is available. If obtained, restoration has the effect that the (late) application for the paediatric extension is deemed by the relevant intellectual property office to have been filed by the deadline of two years before the SPC’s expiry.
What are the requirements for a successful restoration?
Given that SPCs are national rights, any request to restore such inadvertently-lapsed rights must be filed at the national patent office in each of the countries of interest. The requirements to be satisfied at the various national patent offices in Europe are similar in many ways to those in relation to patent rights which have lapsed inadvertently.
In the UK, the route which needs to be taken is slightly different to that of restoration – an extension of time should be requested (the practicalities of which are further discussed in more detail in the next section). In order to be able to obtain such as a discretionary extension, it is necessary to show the UKIPO that the missing of the deadline was unintentional – i.e., it had always been the SPC holder’s intention to apply for the paediatric extension. The UKIPO will not restore rights where the SPC holder has simply changed its mind and has now decided it wishes to protect/maintain the rights in question.
For most of the other countries in Europe the standard which needs to be met for a restoration request to succeed is that the SPC holder must prove to the national patent office that the missed deadline and inadvertent loss of rights occurred in spite of all due care having been exercised by the SPC holder (and its representatives if relevant). This is a much higher standard to meet than the UK’s unintentional one, and the evidential burden of proving that all due care was indeed exercised by the parties is a heavy one. Nevertheless, it is still sometimes possible to rescue such rights, by submitting carefully structured detailed arguments and supporting evidence which show that there are very robust records, docketing and deadline management systems in place to ensure that patent office deadlines are met in a timely manner, but on this particular occasion something unusual happened, which interfered with established systems and caused the deadline to be missed.
The practicalities of requesting restoration and evidential requirements
At the UKIPO
If a deadline for filing a paediatric SPC extension application has been missed for a UK SPC, an extension of the deadline should be requested under Rule 108(1) of the Patents Rules 2007. It is at the Comptroller’s discretion to allow such an extension request, and in order to convince the UKIPO that discretion should be exercised in the applicant’s favour, the details of what led to the inadvertent missing of the deadline should be explained, including importantly the fact that this unfortunate event was unintentional and that the applicant had acted promptly to rectify the situation. This explanation should be in the form of a witness statement, including annexes setting out helpful supporting evidence such as screenshots, emails, etc. to show that it was the applicant’s intention to apply for the paediatric SPC extension – the UKIPO will not grant a discretionary extension in a situation, for example, where the applicant has simply changed its mind.
In addition, the required form and all of the necessary documentation for requesting a paediatric SPC extension should also be submitted (including a statement from the regulatory authority indicating compliance with an agreed PIP).
Restoration in other European countries – reinstatement
For most jurisdictions in Europe, in order for a restoration or reinstatement request to succeed, the applicant needs to show that the deadline was missed in spite of all due care having been exercised in the circumstances by the applicant (and their representative, if relevant).
The reinstatement request has to be filed within two months of removal of the “cause of non-compliance”, i.e., the date when the missed deadline was discovered. What is generally known as the “omitted act”, which is the filing of the request for a paediatric SPC extension and required documentation, must be completed at the same time as the reinstatement request, prior to the expiry of the two-month deadline.
Given the higher evidential burden in most jurisdictions in Europe, due to the requirement to satisfy all due care, typically more detailed evidence needs to be filed to support the restoration request as compared with a similar request in the UK. It is necessary to set out what occurred specifically in this instance which resulted in the inadvertently-missed deadline, and to demonstrate that it was a one-off mistake in an otherwise well-maintained and very reliable system. If possible, a particular, unusual circumstance or event should be identified which led to the established procedure failing this one time. Detailed information therefore needs to be provided to the various patent offices in Europe regarding the applicant’s internal monitoring systems for ensuring that deadlines are met, including prompts and cross-checks within the system, setting out the details of a perfectly functioning system that was in place at the time. The evidence which needs to be provided will have to show how the relevant records, docketing and deadline monitoring system works, illustrated by screen shots, etc. Again, this should be submitted to the relevant patent office in the form of a declaration or witness statement, with the supporting evidence included as annexes.
As the above illustrates, missing the deadline for filing an application for a paediatric SPC extension isn’t necessarily the end of the world. With carefully prepared and focussed arguments, and the subtle use of important supporting evidence, lost rights can sometimes still be rescued even during the most valuable period in a pharmaceutical product’s lifetime. This should come as a welcome relief to rights holders.