Supplementary Protection Certificates (SPCs) are vitally important to the pharmaceutical and agrochemical industries. Following the UK’s exit from the European Union (EU), we now have UK SPCs but with some important differences to the former arrangements.
Supplementary Protection Certificates (SPCs) are valuable national rights that partially extend patent protection for active ingredients in qualifying authorised medicines by up to five and a half years. SPCs exist to compensate innovative companies for the considerable time and resources spent in obtaining regulatory approval for medicinal and agrochemical products. This became necessary because all too often the patent term was expiring before companies had an opportunity to earn back their incurred costs in developing and obtaining regulatory approval for medicines. Since the introduction of the EU scheme, it is reported that over 20,000 SPCs have been granted by the national patent offices of the member states of the EU.
Whilst SPCs operate as national rights, they are derived from EU law, and are a political compromise because a simple patent term extension could not be agreed. The SPC regime was established in 1996, and the current EU Regulation is (EC) No 469/2009¹ for medicinal products, and (EC) No 1610/96² for agrochemical products. Under EU law, a six-month paediatric extension is also available to SPCs for medicinal products that have been evaluated in paediatric clinical trials in accordance with EU Regulation (EC) No 1901/2006³.
Granted SPCs and pending applications
With the UK no longer part of the EU, the UK has created an equivalent system of SPCs, and may in time diverge further from the EU’s SPC approach. For example, the UK could, in the future, consider adopting a simple patent term extension. For the present, the Patents (Amendment) (EU Exit) Regulations 2019 (as amended by the 2020 Regulations⁴) transposed all EU SPC law into UK national law. This maintains the current systems and processes so there is continuity for users. As a result, SPCs that were granted in the UK before the end of the transition period on 31 December 2020 remain in force. As EU law was transposed into UK law by the Withdrawal Agreement⁵, all SPC applications that were pending at the end of the transition period will be examined in accordance with EU law that would have been in force at the time the SPC application was made.
The UK SPC regime that has been put in place largely mirrors the EU system. Under the new regime, all new UK SPC applications will require an in force UK patent, and a UK marketing authorisation (MA) granted by the Medicines and Healthcare products Regulatory Agency (MHRA). All MAs for products authorised by the European Medicines Agency (EMA) before the end of the transition period have ‘grandfathered’ as UK MAs.
However, some important adjustments have been introduced to address the various forms of marketing authorisations in existence across the UK: For example as a result of the Northern Ireland Protocol⁶, there is a different approach for Northern Ireland. This is because Northern Ireland continues to be bound by the EU medicines regulatory framework, whilst Great Britain’s mainland of England, Scotland & Wales is not.
As a result of Northern Ireland’s continued post-Brexit regulatory alignment with the EU in this area, three different MA’s currently apply across the territories of the UK. The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020; Statutory Instrument (SI) 2020/1471) has been enacted to reflect these new categories of MA. These are:
- Pre-existing UK MAs valid across the EU ‘grandfathered’ as UK MAs;
- MAs for Northern Ireland granted as part of the European Medicines Agency (EMA) centralised procedure; and
- MAs granted by the MHRA for Great Britain only (i.e. England, Scotland, and Wales).
What this means in practice is that although there will not be separate SPCs, the scope of protection afforded by the grant of a new SPC will be determined by which UK MA is in place when the application is made. For example, an SPC granted on the basis of an MA for Northern Ireland will only extend protection in Northern Ireland. Similarly, an SPC granted for Great Britain (and not Northern Ireland) will only extend protection in Great Britain.
It is important to note that in our example above, it is possible to extend the SPC to cover the additional territory, provided that an MA is granted in that territory before the SPC takes effect. In order to receive the additional protection under such circumstances, applicants must notify the UKIPO within six months of the grant of the later MA and before the patent expires.
It is also important to remember that although the grant of a UK SPC is to be based on an MA valid in the UK, the duration of a UK SPC will be determined by date of the first MA in either the EEA or the UK. What this means in practice is that if the first MA was granted in the EEA before the UK, the period of protection will be calculated from the earlier EEA date, even though an SPC application cannot be made until the UK MA has been granted.
Other procedural differences
Despite the complications necessitated by the Northern Ireland Protocol, most other procedural aspects remain unchanged from a procedural perspective. For example, the timescales for applications to be considered by the UKIPO, fees, documentation, and enforcement in the UK Intellectual Property Office (IPO) and UK Courts all remain unchanged by the 2019 Regulations.
The process of applying for a six-month paediatric extension to SPCs for products tested in accordance with a paediatric investigation plan (PIP) remains the same. The paediatric extension is available based on equivalent provisions in the UK’s Human Medicines Regulations 2012. It is still necessary to file applications for the extension within two years of the SPC expiry date.
An important advantage for applicants under the UK scheme is that in contrast to the EU scheme, it is not necessary to have MAs across the entire EEA in order to benefit from the extension. This may present a new opportunity for companies who have yet to complete PIPs across all of the EEA states. Similar to the geographical protection afforded by UK SPCs, any extension will only apply to UK territories where the existing MA has been updated with a PIP. For example, if the PIP only applies to an MA valid for Great Britain (and not Northern Ireland), the extension will only extend SPC protection in Great Britain.
Does the SPC manufacturing waiver still apply?
In July 2019, an EU ‘manufacturing waiver’ came into force to support European generic manufacturing. The waiver enables generic and biosimilar companies to avoid infringement for activities whilst an applicable SPC is in force in two situations: (i) The manufacture and exportation to third countries of products covered by the SPC; and (ii) The manufacture and stockpiling of products within the last six months of validity of the SPC in order to prepare for a generic product launch within the EU upon expiry of the SPC.
The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 replicate the manufacturing waiver in the UK, with some subtle differences. In particular, under the EU waiver, the UK is considered a third country.
However, under the UK waiver the EU is not considered a third country for manufacturing purposes. As a result, the UK waiver is potentially less advantageous to generic manufacturers than the EU waiver, as illustrated by the following example:
Under the EU waiver, a company could manufacture and export to any third country, which would include the UK. In contrast, under the UK waiver manufactured products can only be exported to third countries outside the UK and the EU. It remains to be seen if generic manufacturers will restructure their operations to benefit from the difference between the UK and EU waivers.
Despite the EU not being a third country for the purposes of the UK waiver, the UK has chosen not to adopt the ‘EU Export’ logo, and instead only requires a ‘UK Export’ logo in an attempt to prevent products manufactured under the waiver being sold on the UK market.
To what extent will the UK diverge?
The significant body of existing case law of the Court of Justice of the European Union (CJEU) in relation to SPCs is retained in UK law. The UK Courts will continue to interpret retained EU law in accordance with past CJEU decisions, although the UK Courts are now able to depart from past CJEU decisions if they determine it right to do so. On the other hand, the interpretation of new UK SPC legislation will of course no longer be subject to the jurisprudence of the CJEU. The UK consulted on which courts may depart form EU law and concluded it is the Court of Appeal and Supreme Court, so most cases for some time to come will follow the EU law and not depart from it.
Although the status quo and alignment with the EU is mostly maintained for now, it seems probable (and perhaps inevitable) that divergence will occur in the medium to long term, either from changes to legislation or from case law, or both. The UK, for example, is keen to establish itself as an innovative economy and will look to see how the legal regime can encourage continued investment in research and development, and this may lead to review of the SPC regime at some stage.
From a legislative perspective, it is possible that the UK will decide to make changes to eligibility and the length of protection afforded by SPCs (either shorter or longer). For example, although the UK government has made it clear that it intends to support the innovative industry in the post-Brexit world, it may wish to incentivise the important area of biosimilars and certain other biotechnology-derived products. Divergence would also occur if the UK (or indeed the EU,) decides to extend the regime to other products, such as medical devices and drug/device combinations.
There is also opportunity in the future to address some of the frustrations with the SPC law, such as how combination therapies are dealt with and which MA should apply and its impact on term, and the problem of term expiration based on veterinary approval before human approval has been obtained. It is possible that with its new-found independence, the UK Courts will grasp the opportunity to finally clarify some of these and other difficulties that have plagued the EU SPC regime since its inception.
This is an important area and we will continue to monitor how it continues to evolve in the future. In the meantime, companies and their regulatory and IP teams should be alert to the procedures in place across the UK territories in order to ensure that available protections are not overlooked and lost. We look forward to providing further updates in due course.
The UKIPO’s guidance in relation to SPCs can be found here.
Efforts to extend the lifecycle of pharmaceutical and biotech products frequently involve innovations and improvements in product design, formulation, routes of administration and treatment indications. As competition between innovator (and generic) companies grows, coupled with an ever increasing regulatory environment, it is crucially important for stakeholders to consider lifecycle management strategies at an early stage of the R&D planning process. Understanding these issues is of course of equal importance to the generic sector considering generic product launches.
Patents, SPCs and regulatory exclusivities are the cornerstone incentives granting proprietary rights in pharmaceutical and biologics innovation. Whilst patents and SPCs provide monopoly rights, regulatory data exclusivity is an additional right that prevents a generic manufacturer from relying on certain pre-clinical and clinical data.
With pharmaceutical and biotech patent attorney specialists, and lawyers with prior in-house R&D experience, Venner Shipley is uniquely placed to advise you on all aspects of SPCs and regulatory issues. Click here to find out more!