On 1 July 2019, a new SPC manufacturing waiver comes into force across the European Union. The new waiver affects both innovator and generic companies. A useful summary of what this new waiver involves is provided below.
In April 2019 the European Parliament adopted legislation amending Regulation (EC) 469/2009 (the SPC Regulation). The Council of the European Union followed in adopting the amendment in May 2019. As a result, from 1 July 2019 the amendment will be in force and will provide specific exemptions from SPC infringement for manufacturers of generic/biosimilar pharmaceutical products.
Firstly, the waiver will allow an EU-based company to manufacture an SPC protected medicine if the manufacture is done exclusively for export to a non-EU country.
Secondly, the waiver will allow an EU-based company to manufacture and stockpile an SPC protected product within the last six months of an SPC if done in order to place the manufactured/stockpiled product on the market in an EU country after the expiry of the SPC. This will allow companies to prepare for so called “day one entry”, where a generic product is placed on the market the day after an SPC expires.
Whilst the waiver provides clear advantages for European generics companies, the waiver will not apply equally to all SPCs. For example, the waiver will only apply fully to SPC applications made on/after 1 July 2019. If an SPC is pending or granted before 1 July 2019 and comes into effect on/after 1 July 2019, the waiver will apply but only from 1 July 2022 onwards (the so called transitional period). This may reduce/nullify the usefulness of the waiver depending on the duration of the SPC. For an SPC that is in force before 1 July 2019 the waiver will not apply.
If you are an SPC filer and wish to take advantage of the transitional period (for example if your product has patent protection due to expire before 1 July 2022 but is eligible for SPC protection), your SPC application will need to be filed before 1 July 2019. The waiver will apply fully to any SPC applications filed after this date.
If you are interested in filing an SPC application before the 1 July 2019 deadline please get in contact with our SPC team here as soon as possible.
In addition to the filing considerations noted above, there are requirements of companies wishing to make use of the waiver in order to manufacture SPC protected products.
Importantly, companies will need to notify the SPC holder (and the relevant authority) that they plan to manufacture the SPC protected product at least three months prior to acting and declare the EU state in which the actions will take place. SPC holders will of course be happy to receive such advance warning (increased from only 28 days in the original proposal). There are also further requirements regarding the marking of products that fall under the waiver.
The manufacturing waiver therefore provides an opportunity for European generics companies to compete more freely on the global stage whilst also allowing them to prepare for competition in Europe as soon as SPC protection expires. However, as noted by pharmaceutical companies worldwide, this opportunity comes at the expense of innovative companies as their current intellectual property rights are eroded.
If you are interested in filing SPC applications or would like further advice regarding the waiver, please contact our SPC team here.