“Prophetic Examples in Life Sciences Patents: Legal and Ethical Implications”

The Art of Patenting: The Role of Prophetic Examples in Life Sciences

Patents are the lifeblood of innovation, serving as a protective shield for inventors and their groundbreaking creations. However, within the realm of life sciences, a curious phenomenon has emerged. Many patents in this field contain what are known as “prophetic examples” – fictitious scenarios that illustrate how the invention could potentially be realized. This practice, while common, is now growing at an unprecedented rate, particularly as multinationals vie for deregulation of their Genetically Modified Organisms (GMOs). Understanding this practice is key to grasping the broader issues surrounding patents.

The Intricacies of Biotechnological Patents

Patents covering biotechnological inventions, particularly GMOs and New Genomic Techniques (NTGs), are complex and lengthy documents. The content of these texts determines the scope of the patents. 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 realized. When they are not real, they are referred to as “prophetic”, “phantom”, “hypothetical”, or “fictional”. This practice is authorized in several jurisdictions, including the United States and Europe (EPO – European Patent Office), but it does raise legal questions, especially in the field of biotechnological inventions.

The Conditions of Prophetic Practice

The broader the scope of a patent, the greater its potential economic value. To claim a broad scope, it is necessary to demonstrate that the invention can be made in different ways. Sometimes, it is necessary to create fictitious examples to show that the invention can be implemented over the entire scope of the claims. This practice is particularly prevalent in the rapidly developing and highly competitive biotech sector. In the United States, the USPTO (the US Patent and Trademark Office) has accepted such examples under certain conditions since the early 1980s. The EPO also allows prophetic examples, provided they are reproducible. However, a 2021 survey shows that 75% of European patent applicants do not distinguish prophetic examples from real ones in their patent applications.

The Impact of Fictional Examples

Patent offices may consider certain prophetic examples in a patent application to be purely speculative, without a solid scientific basis, or used to intentionally overestimate the scope of the invention. If this is the case, the patent will not be granted. If it were, however, by mistake, the patents could later be invalidated by the courts. The frequency of patents containing prophetic examples is far from anecdotal. Law professor Janet Freilich, of Fordham University, has conducted a study of more than 2 million US patent applications in biology and chemistry. She concludes that “at least 17% of the experiments in this population [of patents] are fictional”.

Legal and Ethical Implications of Prophetic Examples

Prophetic examples raise profound ethical issues, including the credibility of scientific research and the fairness of the patent system. They may favor large companies filing patents by enabling them to set up artificial legal barriers. On the other hand, they also run the risk of further damaging innovation by other, smaller players in the sector. Solutions, such as stricter guidelines for examining patent applications and greater transparency, should be put in place by national and regional systems to alleviate these problems.

The Questionable Strategy of Prophetic Examples

While the use of prophetic examples should in theory lead to stronger patents, this is in fact not the case overall. Janet Freilich speaks of a “surprisingly ambiguous – probably negative – correlation between the use of prophetic examples and the value of a patent”. She even concludes that, in the balance of benefits and costs, the latter prevail. The rush to file a patent application does not leave enough time to construct working examples. And in certain sectors, including biotech, the dynamic of patent applications is a trademark and serves the image of the company, which can highlight its portfolio of patents.

In conclusion, the practice of using prophetic examples in patent applications is a complex and controversial issue. While it can potentially increase the scope and value of a patent, it also raises significant legal and ethical concerns. As the world of patent law continues to evolve, it will be interesting to see how this practice is regulated and managed in the future.