SPC protection for combinations

Many drugs, including vaccines, oncology therapies, anti-asthmatics and hypertensives, are administered as combinations of active ingredients. This is due to a number of different reasons ranging from policy to synergistic interaction. Combination drugs may also require substantial investment, even when one or both components have themselves been available as separate treatments for many years. In many circumstances, this has led those that manufacture and sell such drugs to seek supplementary protection certificates (SPCs) to preserve protection and thus protect the investment in the drug from generic competition.

The difficulty for these applicants is that it has proved very difficult to interpret the legislation governing SPCs — Council Regulation (EEC) No 1768/92 (SPC regulation) — as regards combination drugs. This is widely thought to be because the SPC regulation was only drafted to deal with those drugs comprising single, small-molecule active ingredients.

This problem primarily lies with Article 3, which deals with the qualifying criteria for SPC protection…

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