Neil Lampert

UK SPC law in 2021

CIPA’s Life Sciences Committee provides a summary of proposed changes to UK SPC law with effect from 1 January 2021. Input from the CIPA Life Sciences SPC sub-committee has been taken into account in the drafting of the latest draft statutory instrument (SI) and changes have been made based on the sub-committee’s input. The committee has appreciated the opportunity to provide input and think that it has been beneficial.

Adraft statutory instrument (SI), ‘The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020’1 has been laid before the UK Parliament that, if approved, will come into effect on 1 January 2021. As explained in its accompanying explanatory memorandum,2 the SI amends UK legislation relating to SPCs and is warranted by changes to the regulation of medicines and agrochemicals once the Northern Ireland Protocol (NIP)3 comes into effect on 1 January 2021. Essentially, the instrument adjusts the current SPC regime to accommodate for future marketing authorisations that will cover only part of the UK (Great Britain or Northern Ireland).

The draft SI supplements other changes made to UK SPC law in the form of SI 2019/8014 and SI 2020/1050,5 both of which resolve inoperabilities arising from the retention of EU law. SI 2019/801 made various changes to ensure that the retained EU law6 on SPCs operated effectively following exit day, and SI 2020/1050 made further amendments to reflect that we are now in a transition period and to fix inoperabilities in the ‘manufacturing waiver’ legislation that was introduced by Regulation (EU) 2019/933. We will comment further on SI 2019/801 and SI 2020/1050 in a follow-up article in next month’s issue.

Background

SPCs take effect when a patent expires and can provide up to 5½ years extension7 for medicines and agrochemicals that have endured regulatory delays in getting to market. Under current EU law, an SPC can be granted in the UK for a product that is protected by a basic patent and which has a valid marketing authorisation (MA) to place the product on the market in the UK.

Until the end of the transitional period, the only MA valid in the UK is one which applies across the whole of the UK, approved by either the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). Following the transition period, under the NIP, Northern Ireland (NI) will still be bound by EU law for the authorisation of medicines and plant protection products, while Great Britain (GB; England, Wales and Scotland) will not. This means there will be separate MAs for NI and GB alongside UK MAs, which the SPC law will need to reflect.

The key changes to the Articles are outlined in the table below.

The upshot is that while SPCs will still remain a UK-wide right, their territorial extent of protection will extend only to the territory or territories where the MA or MAs allow the product to be sold. For example, an SPC based solely on a GB MA would provide protection only for GB, and so on. The territorial extent of protection is not, however, fixed at the point of applying for an SPC. The protection can be extended if an MA for the product has been granted covering a different part of the UK and the UK IPO is notified of it before the SPC comes into effect.

Transitional provisions

Regulation 7 of the draft SI provides the transitional provisions. SPC applications that are pending at the end of the transition period will be considered under the existing requirements – i.e. Regulation (EC) 1610/96 and Regulation (EC) 469/2009 as amended by SI 2019/801 and SI 2020/1050 – whereas SPC applications filed on or after 1 January 2021, including applications based on MAs that have been granted before that date, will be dealt with under the new provisions.

The transitional provisions also make it plain that if a UK MA underpinning an SPC is withdrawn after 1 January 2021 and replaced with a GB MA and a NI MA, the SPC will still continue to be valid.

Next steps

According to the explanatory memorandum accompanying the draft SI, the UK IPO is to publish informal consolidated texts of Regulation (EC) 1610/96 and Regulation (EC) 469/2009, which take into account all legislative changes for the end of the transition period.

Further guidance from the UK IPO to explain the changes is also expected to be available, subject to when the instrument is approved, at the end of November 2021. The new SP6 form will be made available on gov.uk for 1 January 2021.

Michael Pears, Joel Beevers and Stephanie Pilkington, on behalf of CIPA Life Sciences Committee

ARTICLE

2 – Scope

3 – Conditions for obtaining a certificate

4 – Subject matter of protection

5 – Effects of the certificate

7 – Application for a certificate

8 and 9 – Content and lodging of the application for a certificate PROPOSED CHANGES IN DRAFT SI

Any product that is the subject of a UK, GB or NI MA can be the subject of an SPC.

The MA upon which the SPC application is based can be a UK, GB or NI MA. The MA must be a valid MA to place the product on the market in the territory and must be the first MA to place the product on the market in that territory.

The SPC protects the product covered by any of the UK, GB and NI MAs associated with the SPC and further uses of the product as a medicinal product that are authorised in the UK before expiry of the SPC.

The protection conferred by the SPC will extend only to the territory within the UK where there is an MA that meets the requirements of Article 3 (i.e. a valid MA that is the first MA to place the product on the market in the territory) and which has been issued before the SPC takes effect.

The protection can cover an additional territory if an MA for the product which meets the requirements of Article 3 is granted in that territory after an application for an SPC is filed, but before the SPC takes effect. For example, if an SPC is originally based on an NI MA for the product, the protection conferred will initially extend to only NI, but if a GB MA is granted for the product before the SPC takes effect, it will be possible to extend the protection to also cover GB, and vice versa. The later MA must meet the requirements of Article 3 as of its date of grant. In the same way that SPC applications cannot be filed after patent expiry, the ability to extend the territorial protection of an SPC will also end at the point that the SPC takes effect (see also new Article 13A below).

An SPC application must be filed within six months of the grant date of the UK, GB or NI authorisation, and where there is more than one such MA granted, within six months of the earliest of such MAs. In other words, while the territorial protection of an SPC may extend to an additional territory if an MA for the product is granted in that territory after an application for an SPC is filed, the application must nevertheless be filed within six months of the earliest MA within the UK. It remains the case, however, that if the MA is granted before the basic patent is granted, the SPC application may be filed within six months of the date on which the patent is granted.

The number and date of the one or more UK, GB or NI MAs should be provided and published. For requests for paediatric extensions, there are requirements to provide and publish information on the territory in respect of which the statement indicating compliance with an agreed completed paediatric investigation plan (PIP) has been made.

ARTICLE

11 – Publication

13 – Duration of the certificate

[NEW] 13A – Authorisation granted after submission of an application for a certificate

[NEW] 13B – Extension of the duration of a certificate

14 – Expiry of the certificate

17 – Notification of lapse or invalidity PROPOSED CHANGES IN DRAFT SI – continued

Any MAs for the same product covering a different part of the UK that have been granted after the date of filing the SPC application but before the SPC takes effect, and that have been notified to the UK IPO before grant of the SPC, will be included in the notification of grant of the SPC.

A paediatric extension will only provide protection in the territory where a statement indicating compliance with an agreed PIP has been made. Thus, if only one MA associated with the SPC contains the necessary statement of compliance,8 the extension will only provide protection in the territory of that MA, even if the territorial extent of the SPC is wider. The article is also amended to clarify that a paediatric extension cannot provide protection in a part of the UK where the SPC does not.

Provides a mechanism for notifying the UK IPO of an additional MA that covers a different part of the UK to that of the original MA on which the SPC application is based. The UK IPO can be notified of this either during the pendency of the SPC application or once the SPC has been granted, but always within six months of the date of grant of the MA and before the expiry of the basic patent. Failure to meet this deadline will mean that the protection conferred by the SPC will not be extended to the territory covered by the additional MA. Such notifications are to made on Patents Form SP6 and will be published for the benefit of third parties.

Provides a mechanism by which a further request can be made for a paediatric extension to also provide protection in the territory of another MA associated with the SPC if the conditions for granting the extension have been met for that MA. Thus, an extension of the duration of an SPC in respect of a GB authorisation may be extended to include NI, and vice versa. Such requests should be filed before the normal deadline of no later than two years before expiry of the SPC.

The SPC will lapse following the withdrawal of all UK, GB and NI MAs for the product. If only a UK, GB or NI MA is withdrawn, but one or more such MAs remain valid, the protection conferred by the SPC will no longer extend to the territory covered by the withdrawn MA (as from its date of withdrawal), but shall continue in respect of the territory covered by any remaining MA.

Any limitation of the territorial extent of an SPC following a withdrawal under Article 14 will be published.

Notes and references

1. https://www.legislation.gov.uk/ukdsi/2020/9780348213645 2. https://www.legislation.gov.uk/ukdsi/2020/9780348213645/memorandum/contents 3. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840230/

Revised_Protocol_to_the_Withdrawal_Agreement.pdf 4. https://www.legislation.gov.uk/uksi/2019/801/made 5. https://www.legislation.gov.uk/uksi/2020/1050/introduction/made 6. Regulation (EC) 469/2009 concerning SPCs for medicinal products and Regulation (EC) 1610/96 concerning the creation of SPCs for plant protection products 7. SPC term beyond patent expiry is calculated as the period between the patent filing date and the date of notification of the first marketing authorisation (MA) in the area comprising the EEA and the UK, minus five years and to a maximum of five years. An additional six months’ protection can be granted as a paediatric extension of a medicinal product SPC, which must be applied for at each national office following update of the MA to reflect compliance with an agreed completed paediatric investigation plan. 8. This becomes possible under the amended legislation because requests for paediatric extensions filed in the UK after the transition period will no longer require evidence that the product has been authorised (with an updated MA indicating compliance) in all EU member states.