UK experimental use exemptions: Part 4—the SPC manufacturing and stockpiling waiver

In the final article of a four-part series, Sophie Topham of Marks & Clerk discusses the supplementary protection certificate manufacturing waiver

Although not strictly speaking an experimental use exemption, there is one further means by which the production of medicinal products is exempted from infringement, namely, the Supplementary Protection Certificate (SPC) manufacturing waiver.

SPCs provide an extension to the period of exclusivity provided by a patent, of up to five years, for pharmaceutical products or plant protection products. They are intended to compensate the patent owner for the time required to obtain marketing authorisation for the product.

However, as of 1 July, 2019, certain acts no longer infringe SPCs (it should be noted, however, that this exemption does not have retrospective effect; does not apply to SPCs in force on 1 July, 2019; and from 2 July, 2022, only, will apply to certificates applied for before 1 July, 2019, and that take effect on or after that date).

In particular, the SPC manufacturing waiver provides that the manufacture of generic or biosimilar versions of the SPC-protected drug within the EU is not an infringing act if the manufacture is done exclusively for exporting the product out of the EU. This exemption from infringement applies for the lifetime of the SPC.

The waiver also exempts from infringement the manufacture of an SPC-protected product where the product will be stored within the EU, but this stockpiling exemption applies only within the last six months of the term of the SPC in question. This exemption is aimed at enabling generic and biosimilar manufacturers to launch the generic/biosimilar product as soon as possible after the day of expiry of the SPC, in order to improve patient access to medicines.

The SPC manufacturing waiver is based upon an EU Regulation, and there was, for a time, uncertainty as to whether the manufacturing waiver would continue in the UK after the Brexit transition period. However, the UK government decided to implement the manufacturing waiver in domestic law in largely the same form as it was introduced in July 2019, with only a change in the administrative requirements for benefitting from the exemption from infringement.

It should be noted that the SPC manufacturing waiver continues to apply where the SPC-protected product is being manufactured in the UK for exportation outside of the UK, Isle of Man and the EU, or where the SPC-protected products are stockpiled in the UK (in the last six months of life of the SPC) for selling in the UK, the Isle of Man or the EU once the SPC expires. However, for the purposes of the EU waiver, the UK is a third country, so companies can manufacture or stockpile under the EU waiver for export to the UK.

Summary

As discussed in this four-part series of articles, the various forms of the experimental use exemptions provide exemption from patent infringement in the UK for experiments having the purpose of discovering something new about the invention, for tests required to obtain abridged marketing authorisation for a generic drug, and for tests required for obtaining marketing authorisation for medicinal products or for providing information for determining the suitability of the product for use in healthcare.

In addition, depending on the specific circumstances, the manufacture of a patented product within the UK may not infringe an SPC where the manufacture is exclusively for exporting the product outside of the UK, the Isle of Man and the EU, or, in the final six months of life of an SPC, where the product is stockpiled within the UK ahead of sales in the UK, the Isle of Man or the EU. Thus, while Brexit has impacted the availability of some of the exemptions from infringement, there is still a range of exemptions available for the life sciences industry.

For more on this series, see  Part 1: the original,  Part 2—the Bolar exemption and  Part 3—the expanded exemption.

Sophie Topham is an associate at Marks & Clerk. She can be contacted at  stopham@marks-clerk.com