Pharmaceutical innovations can be protected in many different ways. While some may be best kept as trade secrets, optimising protection generally involves reliance on data exclusivity and market protection, patents, supplementary protection certificates (SPCs), designs and trade marks, writes James Legg.
Periods of data exclusivity and market protection are generated by the first marketing authorisation for an innovative medicinal product (the ‘reference medicinal product’). In the European Union, a generic application, relying on the reference medicinal product’s data, cannot be submitted until eight years after the first marketing authorisation (a period of data exclusivity).
In addition, for a further two years, the generic medicinal product cannot be placed on the market (this is market protection). Furthermore, market protection may be extended by a year if the reference medicinal product is authorised for a new indication that brings “significant clinical benefit in comparison with existing therapies”. Taken together, this is commonly known as the ‘8+2(+1)’ approach.
A patent protects an invention; therefore, the protection provided by a patent is often much broader than the specific product or process that has, or is being, developed. A patent gives the patentee (the owner) the right to stop others exploiting the invention for a set period of time, usually 20 years from the application’s filing date.
A patent protects an invention; the protection provided by a patent is often much broader than the specific product or process
A patentable invention can relate to a product, a process, or even a new medical use for a known product. Patents are registered rights which are obtained by filing an application at an Intellectual Property Office (IPO) which then performs a search and examination. For a patent to be granted, the invention defined in the claims of the application must be new and not obvious compared to what has been made available to the public before the application’s filing date.
An SPC has the effect of extending for up to five years the term of a patent that covers a medicinal product for which a marketing authorisation has been obtained in the European Economic Area (EEA). However, the scope of an SPC is more limited than a patent as it covers only authorised uses of the medicinal product.
A design right protects the visual appearance of a product rather than its composition, for example the appearance of a medicinal product or its packaging. Registering a design with an IPO can provide protection for up to 25 years. Creating new designs can also lead to unregistered design rights.
A trade mark is a distinctive sign used to show a product or service’s unique origin. Trade marks are part of medicinal products and their packaging, taking the form of symbols, words, names, logos, and even smells or sounds. Trade marks can be registered with an IPO and, if this is done, must be renewed every 10 years to avoid expiry.
Trade marks may also be obtained through use without registration. Since a trade mark can be maintained indefinitely, this right provides a mechanism to maintain some protection long after the other forms of protection have expired.