Agrochemical safeners deemed eligible for Supplementary Protection Certificates
1 August 2014
In good news for the agrochemical industry, the Court of Justice of the European Union (CJEU) has ruled that agrochemical safeners are eligible for Supplementary Protection Certificates (SPCs).
Regulatory authorisation is required before certain products, such as pharmaceuticals and agrochemicals, can be launched on the market. Authorisation can take several years, and so may significantly reduce the finite period of exclusive market rights offered by a related patent. SPC provisions exist to compensate for this, and provide a period of protection that can last for up to five years from formal expiry of the patent.
To be eligible for SPC protection, the law states that the patent and authorisation must relate to an ‘active substance’ or ‘active ingredient’. Principally this covers substances with a clear direct effect on a human, animal or plant, such as an active pharmaceutical ingredient or herbicide. However, questions have arisen over substances that have indirect effects, such as co-formulants and adjuvants.
In the pharmaceutical context the CJEU found that excipients and adjuvants do not qualify as being ‘active ingredients’ as they do not have therapeutic effects of their own (in decisions C-431/04 and C-210/13 respectively).
A recent decision by the CJEU in C-11/13 for Bayer Cropscience AG has delivered better news for agrochemical safeners.
Safeners are substances used to protect certain plants from the toxic effects of particular herbicides. Technically, the effect of a safener is only apparent if used in combination with the particular herbicide it is matched to. A German court referred a question to the CJEU, asking whether or not the SPC regulations should be interpreted to cover safeners. In its decision, the CJEU seems satisfied that as long as any “toxic, phytotoxic or plant protection action” of the safener is its own, it should qualify as an active substance.
Agrochemical companies can therefore now take comfort in the increased certainty of the eligibility of safeners for SPC protection. It will now be easier to ensure that the cost and effort of bringing safeners to market is offset by extended protection.
Life Sciences & Chemistry
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© Withers & Rogers LLP, August 2014