Patent linkage: tying regulatory approval to patent status

Patent linkage describes any mechanism by which a regulatory authority takes a reference product's patents into account when assessing or granting a generic marketing authorisation, as the United States does through Orange Book listings and the Hatch-Waxman stay. In the EU there is no such mechanism. Article 126 of Directive 2001/83/EC provides that a marketing authorisation may not be refused, suspended or revoked except on the grounds set out in the Directive, and patent status is not among them. The Commission's pharmaceutical sector inquiry of 2009 stated that linking regulatory approval, pricing or reimbursement decisions to patent status is unlawful under EU law, and the Commission has pursued Member States whose authorities nevertheless did so.

The same logic runs through the abridged application rules. Article 10 allows a generic to be filed once data exclusivity has expired, regardless of patents, and the Bolar exemption in Article 10(6) lets the applicant run the studies needed for that application during the patent term. The authority assesses quality, safety and efficacy, grants the authorisation, and leaves the question of whether marketing would infringe a patent or a supplementary protection certificate to the patent holder and the courts.

In practice this means that patent enforcement in Europe happens around launch rather than at approval. Originators monitor national and EU procedures, including published EMA agendas and CMDh statistics, to anticipate generic filings, and seek preliminary injunctions in national courts or, since 2023, in the Unified Patent Court for participating Member States. Generic companies decide whether to launch at risk, with a damages exposure if the patent is later upheld, or to wait, and the timing differs by country because patents and SPCs are national rights.

What goes wrong: a generic team assumes its approval signals freedom to operate, when the authority never looked at patents; an originator relies on a pricing or reimbursement body to block listing on patent grounds, which the Commission treats as unlawful linkage; launch dates are planned on one patent expiry date when SPC terms vary by Member State; and a company confuses regulatory data protection, which the authority does enforce, with patent protection, which it does not.