Patent Term Extension
23 June 2021
Patent Term Extension – Supplementary Protection Certificates
A Supplementary Protection Certificate (SPC) is a special extension to the period of protection provided by a patent. SPCs are only available for patents relating to active ingredients in medicinal, veterinary or plant protection products.
The purpose of an SPC is to compensate the patent holder for the loss of effective monopoly term resulting from the need to apply for regulatory approval for a product protected by the patent. SPCs protect the active ingredient for which regulatory approval has been obtained, as well as any use of the active ingredient in another pharmaceutical or plant protection product that has obtained such approval.
SPCs are national rights introduced by EU regulations. Specifically, Regulation (EC) No. 469/2009, which covers medical products, and Regulation (EC) No 1610/96, which covers plant protection products. SPCs can be obtained by applying to the national patent offices of countries in which a patent term extension is sought.
Countries in which SPCs are available
SPCs can be obtained in all EU member states, as well as in non-EU European states including the UK, Iceland, Liechtenstein, Norway, Switzerland, Albania, Bosnia & Herzegovina, Macedonia, and Serbia.
Many other countries around the world, including Australia, China, Japan, South Korea, and the United States have similar, SPC-type provisions in their law that allow for patent term extensions on certain pharmaceutical products.
In Europe, the maximum period of protection provided by an SPC is five years. However, an additional six-month extension can be obtained for medicinal products which have undergone a Paediatric Investigation Plan (PIP), as defined in Article 36 of Regulation (EC) No 1901/2006. PIPs are intended to support the authorisation of medicinal products in the paediatric population, although a PIP extension is not contingent on a marketing authorisation for paediatric use actually being granted.
The term of an SPC is calculated from the date of issuance of the first marketing authorisation (MA) within the European Economic Area (EEA) for the product, according to the equation:
Term = date of MA – patent filing date − 5 years
No SPC term is available if less than five years have elapsed between the patent filing date and the date of issuance of the first MA. Furthermore, if the first MA was issued more than ten years after the patent filing date, the SPC is given a term of 5 years.
The SPC application in a given country must be made within six months of the date of issuance of the MA for that country, unless the patent has not been granted, in which case the application must be made within six months of patent grant.
The applicant must have a patent in force in the country in which protection is sought and the patent must protect the active ingredient. A MA for a product containing the active ingredient must also have been obtained.
The SPC is granted to the proprietor of the patent and not to a licensee or manufacturer of the product.
The MA on which the SPC is based must be the first one granted for the active ingredient in the specific country. However, the length of allowable protection will be determined by the date of the first valid MA obtained in any EEA country, not necessarily the one on which the application is being made.
Regulation (EU) 2019/933 introduced a “manufacturing waiver”, which limits the effects of an SPC. The manufacturing waiver enables generic companies (“makers”) to produce products protected by an SPC within the EU during the term of an SPC, provided that the products are intended for export outside the EU. The waiver also permits manufacturing and stockpiling of medicinal products during the last six months of an SPC term for sale in the EU once the SPC term has expired.
The manufacturing waiver came into force on 1 July 2019, but does not apply to SPCs that were already in effect. For SPCs that were filed before this date but which only came into effect afterwards, the manufacturing waiver will become applicable from 2 July 2022.
The waiver provides generic pharmaceutical companies in the EU with an opportunity to commence manufacturing for export after the normal patent term expires, and to make preparations to enter the EU market immediately after expiration of the SPC. The manufacturing and stockpiling provision is particularly relevant for producers of biosimilars, who require considerable time to manufacture these complex products to the high specifications required. The waiver provides the time to do this and promotes the manufacture of this category of pharmaceuticals in the EU.
Brexit and SPCs
The UK formally left the EU on 31 January 2020 and EU law ceased to be applicable in the UK from 31 December 2020. However, the UK government has instituted measures to ensure that there is minimal change to the UK’s SPC legislation following Brexit.
In particular, the Patents (Amendment) (EU Exit) Regulations 2019, which came into force on 1 January 2021, bring current EU SPC legislation into UK law (as far as possible).
However, some aspects have changed. For example, marketing authorisations must now separately be obtained for Great Britain (England, Wales and Scotland) and Northern Ireland as a result of the Northern Ireland Protocol. Accordingly, SPC protection in the UK can now be obtained for either or both of these regions, depending on the type of MA obtained, and there are new regulations to account for this change. A similar change applies to paediatric extensions, which are now also limited to the region of the UK (GB and/or NI) in which the MA was obtained.
It should also be noted that an MA granted by a UK authority is now no longer considered to be a first authorisation to place the product on the EU market. However, the UK Medicines and Healthcare Products Regulatory Agency has agreed to convert authorisations granted by the European Medicines Agency before 1 January 2021 into equivalent UK authorisations.
Brexit and the Manufacturing Waiver
Manufacturing waivers are still obtainable for products protected by a UK SPC, as long as the products are for export outside the UK and EU, or are manufactured and stockpiled in the last 6 months of the SPC term for the purposes of placing the product on the market in the UK or EU once the term has expired.
However, since the UK is no longer an EU member state, it is considered a “third country” for the purposes of the EU’s SPC provisions. This means that a medicinal, veterinary or plant protection product that is protected by an SPC in the EU but not in the UK, can be manufactured in the EU and exported to the UK. The converse is not true. A product that is protected by an SPC in the UK may not be exported to an EU country, whether that product has SPC protection in the EU country or not.
As the UK is no longer subject to the decisions of the CJEU, it is possible that there may be some divergence in future in how SPC legislation is interpreted by the UK and other European courts. Given that some of the CJEU’s decisions relating to SPCs have been somewhat difficult to reconcile with established standards in patents case law, this may not be a bad thing for UK SPC holders. Time will tell whether any divergence makes a practical difference.
Life Sciences & Chemistry Group
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP June 2021