The importance of patents to the life sciences industry can hardly be overestimated. Patents are monopoly rights which protect research and new products. The ability to obtain a patent on a potential new drug candidate is likely to be key to decisions about investment and whether to proceed. Similarly, the loss of patent protection for a successful product, perhaps following an invalidity ruling, may result in very significant financial losses to the innovator company as the market opens up to the generics.
Patents for inventions
Patents may protect products, such as new drugs or medical devices, or processes such as a method of gene editing. They are applied for throughout the product development cycle. For example, in the case of a new drug, patents are typically obtained on the active ingredient itself and then further patents are added as new compounds and formulations are developed. This might include patents on second medical uses (repurposing) and sometimes even new dosage regimes if these are genuinely innovative.
SPCs – extended protection for some drugs
It can take 10 years or more and over £1bn to develop and obtain marketing authorisation to launch a new medicine. Patent protection normally lasts for 20 years. This means that if a patent is obtained early in the development process, the period of patent protection left in which to exploit the product in the market is severely reduced. In order to compensate life sciences patent owners for the time ‘lost’ in this way, extended patent protection of up to five years can be obtained in respect of some authorised medicines. The extension is known as a ‘Supplementary Protection Certificate’ (SPC) and can only be obtained for products that contain a new active ingredient – not, for example, for repurposed drugs or reformulations. This is a controversial issue. Many argue that in a time of financial pressure on health services, the financial incentive provided by the SPC should be available to repurposed drugs in particular, as they are potentially more cost effective than developing new active ingredients from scratch. On the other hand, health services also need cost-effective generic drugs. The SPC system was originally an EU system which the UK has retained post-Brexit, so it is now open to the UK to adjust these rules in the future if it wishes – so this is an area to watch.