Shidlovski /
8 February 2021EuropeJackie Mulryne

Second medical use: a regulatory perspective

As compound patents and regulatory data protection for medicinal products expire, pharmaceutical companies increasingly look to develop new uses for their products. This strategy usually involves filing second medical use patents to protect the invention and research investment.

As well as the complex patent landscape that surrounds such patents, and any extension to regulatory marketing protection that may be available, several regulatory and practical factors may impact how well second uses for existing products can be protected from immediate generic competition.

Regulatory background

When assessing a generic medicinal product, the competent authorities generally require the same information to appear in the summary of product characteristics (SmPC) and other product information of the generic medicine, as for the original, reference medicine.

However, a generic applicant is permitted, but not required, to remove from its SmPC any indications or dosage forms that are protected by patents so they can avoid infringing the rights attaching to the originator product. This is known as “skinny labelling” and allows the generic medicinal product to be placed on the market even if individual indications or dosage forms of the reference medicinal product are still patented.

The competent authorities in the EU have published guidance on how these carve-outs should be assessed. In particular, the competent authorities may include a statement on the packaging, on the SmPC, or in the patient information leaflet, to explain to patients and healthcare professionals why certain indications or dosage forms are lacking from the information available.

In addition, while it may be acceptable to omit certain indications and dosage forms from the generic label, it is unlikely to be possible to omit associated warnings or contraindications. All modifications are judged on a case-by-case basis and vary across the EU depending on the patent situation in each country.

The problem for patent holders

Healthcare professionals in Europe generally prescribe products based on experience with the product and their clinical judgement, and not a particular product’s authorised indications for use. In addition, prescriptions are often written using the generic, international non-proprietary name (INN) and the indication is rarely listed.

Therefore, if the product is otherwise considered to be the same as the originator product, a drug may be prescribed or dispensed cross-label in a way that may infringe a second medical use patent (ie, outside the authorised conditions of use of the generic product, and with reference to the full label of the originator product).

There are differences in prescribing and dispensing practices across the EU, as well as in the reimbursement rules for medicinal products. In practice, the strategies that may be used by patent holders to protect second uses, and the extent to which patents offer any protection for the product, depend on how medicines are prescribed and dispensed on a national basis.

As readers will be aware, there has been a lot of patent litigation across the EU, particularly in relation to pregabalin. This litigation has made the patent situation more complicated but has also considered the regulatory questions to a greater or lesser extent.

The regulatory regime and second medical use patents

As a starting point, it is generally accepted that generic product manufacturers cannot advertise a carved-out product for an indication that is not in its product label. It is a well-established principle of regulatory law that any advertising should be in line with the product’s SmPC.

In 2019, the Court of Justice of the European Union clarified that “carving-out” indications or dosage forms in the SmPC is a request to limit the marketing authorisation for the generic product, meaning competent authorities should not post the full label version of the SmPC, showing all indications associated with the (originator) product, on their website, instead of the carved-out (generic) version.

Beyond advertising, national healthcare systems have different approaches to second medical use patents, and the extent to which they should be taken into account by healthcare professionals.

Denmark is a good example of a system that seeks to protect second medical use patents: substitution groups are used, whereby pharmacies are required to offer the patient the cheapest medicinal product in the substitution group. However, the scheme was amended after the pregabalin litigation, so that products subject to a second medical use patent would not be included in a substitution group for the relevant indication. Instead, the healthcare professional must note the indication on the prescription, and if that indication is subject to patent protection, the pharmacy is not allowed to dispense the generic product.

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10 July 2020   The EU’s top court has ruled out extra exclusivity rewards to drug companies for products with a second medical use.

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10 July 2020   The EU’s top court has ruled out extra exclusivity rewards to drug companies for products with a second medical use.

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10 July 2020   The EU’s top court has ruled out extra exclusivity rewards to drug companies for products with a second medical use.