Prophetic examples proliferate in biotech

Many patents in the field of “life sciences” contain fictitious examples, known as “prophetic”, of how the invention can be realised. Such imaginary examples enable applicants to increase the scope of their patents. This is a common practice that is now taking on significant proportions. At a time when multinationals are trying to obtain deregulation of their GMOs, an understanding of the broad outlines of this practice will give us a better grasp of the issues surrounding patents. The latest news on patents covering “biotechnological inventions”, particularly GMOs/NTGs, reminds us that these legal tools are above all long and complex texts. Yet the content of these texts determines the scope of these patents. In addition to a general description of the invention, including its industrial applications, a patent must describe one or more examples of how the invention can be put into practice. However, at the time the patent application is filed, these examples may or may not have actually been realised. When they are not real, they are said to be “prophetic”, “phantom”, “hypothetical” or “fictional”… Anglo-Saxons also speak of “paper examples”. This practice, which is authorised in several jurisdictions, including the United States and Europe (), nevertheless raises legal issues, particularly in the field of “biotechnological inventions”. A practice permitted subject to conditions The broader the scope of a patent, the greater its potential economic value. But in order to claim broad scope, it is necessary, among other things, to demonstrate that the invention can be made in different ways. For example, a patent claiming genetic sequences with a minimum percentage – 80%, 90% or 95% – of identity with the sequence actually “invented” is very broad. It would therefore take many examples of embodiments of the invention to show that it can be implemented over the entire scope of the claims. The number of examples required may be such that it is sometimes necessary to create fictitious ones. Providing a plurality of examples therefore helps to fulfil a fundamental requirement of patent law: an invention must be sufficiently described for “a person skilled in the art” – a biotechnology engineer, for example – to be able to reproduce it to its full extent using his or her general knowledge. The “biotech” sector is no exception to this requirement of sufficient description. The rapid development and strong competitiveness of this sector encourages its players to file numerous patent applications as soon as possible. This is the case even if, when the patent application is filed, the invention is not sufficiently supported by real examples. This is why applicants resort to “prophetic” examples. In the United States, since the early 1980s, (the US Patent and Trademark Office) has accepted such examples under certain conditions, in particular that they are not misleading and that they have a reasonable scientific basis. The USPTO also requires that they be distinguished from actual examples in the text of the patent. The EPO also allows prophetic examples, provided they are reproducible. But a 2021 survey shows that 75% of European patent applicants do not distinguish prophetic examples from real ones in their patent applications. Examples in granted patents are by default presumed to be valid. While an examiner may, in the course of the examination procedure, request certain additional experimental data, it is not assumed that he or she is required or able to test the embodiments of the invention. A person challenging the validity of a patent on the grounds of inadmissible prophetic examples will have the burden of proof.