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.

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.