Patent cover, data exclusivity and market protection: three clocks, one product

Three different things

People say “the product is protected until 2031” as if there were one date. There are usually three, set by different laws, starting from different events, and ending in a different order from product to product.

• Patent cover (and the SPC that extends it) is a property right. It runs from the patent filing date and stops anyone making or selling what the patent claims. It can be challenged and revoked.
• Data exclusivity is a regulatory rule. For a fixed period after a new medicine is first authorised in the EU, no one may file a generic application that relies on the originator’s clinical data. It cannot be litigated away; it simply runs.
• Market protection follows data exclusivity: the generic may be filed and assessed, but may not be placed on the market until the protection ends.

The current EU rule: 8 + 2 (+1)

For products authorised under the current rules, data exclusivity lasts eight years from the first marketing authorisation in the EU, and market protection a further two years, so a generic can be filed at eight and sold at ten. One more year is added if, during the first eight, the originator obtains a new indication judged to bring a significant clinical benefit over existing therapies. Hence “8+2+1”, and a maximum of eleven years.

The clock starts at the first authorisation anywhere in the EU, by any route, and all later authorisations of the same product by the same holder share it; this is the “global marketing authorisation”. Whether two products are the “same” for this purpose is exactly what the Tecfidera litigation was about, and it is why the first-authorisation date is worth more than it looks.

Orphan medicines have a separate reward, ten years of market exclusivity, and new indications of old substances can earn one year of data protection for the new indication’s data.

The UK

The UK kept the same 8+2+1 structure when it left the EU, applied by the MHRA under UK law. The important difference is the start date: for a product first authorised in the UK, the UK clock starts from the UK authorisation; the EU clock, for the same product, starts from its first EU authorisation. Products authorised in the EU before 2021 carry their EU start date into the UK. As the two systems drift, the UK and EU clocks for the same product will increasingly end on different dates.

What the 2026 EU reform changes

The EU’s pharmaceutical package, politically agreed in December 2025, adopted by the Council in September 2026 and expected to apply to products filed from late 2028, keeps eight years of data exclusivity but cuts the baseline market protection to one year, and then lets originators earn it back: a year for addressing an unmet medical need, a year for comparative or multi-state trials with early EU filing, and a year for a new indication of significant benefit, with the extensions capped at two years in all (some summaries also list smaller developers as a ground). The model is “8+1(+1)(+1)”; the note on the new data and market exclusivity rules has the detail and the transitional rules. Supply conditions attach to the extensions. The package also widens the Bolar exemption so that generics can use a protected product for pricing, reimbursement, tender and health-technology work before expiry without infringing. The terms are subject to formal adoption and are tracked in the regulatory changes section.

How the clocks interact

The three clocks are independent, and any one of them can be the last to stop.

• A product authorised quickly after filing has a long patent life left and a five-year SPC; the regulatory clocks end first and are irrelevant to the launch date.
• A product authorised late, or whose patent was revoked, can be patent-free while data exclusivity still runs: a generic cannot even be filed. This is the Tecfidera situation.
• A product with a weak secondary patent and expired regulatory protection is where litigation decides the date, because nothing else does.

Parallel trade is different again. Regulatory protection stops generic copies, not the originator’s own product moving between member states; a parallel importer needs no reliance on the originator’s data. Patents and SPCs do bind parallel imports where the product was not put on the market by or with the consent of the patentee in the exporting state.

What to check

1. The first EU authorisation date of the product, and whether it shares a global authorisation with an older product.
2. The eight- and ten-year dates that follow, and whether a new indication added a year.
3. For the UK, the UK start date if it differs.
4. The patent and SPC position country by country, as a separate exercise.
5. The orphan status, which replaces the normal rule with a ten-year market exclusivity.

MPA Search holds the first EU authorisation dates alongside the patent and SPC data, so the three clocks can be read off one record.