Diverse and dense patent thicket
The number of biotech patents is increasing rapidly and continuously. In 2016, the total number of active patents exceeded 250,000, with China replacing the USA as the number 1 country of origin and Switzerland remaining in 11th place (figure below left).
It is worth noting that among the top 13 countries, the patents of Danish and of Swiss origin are located in the ‘sweet spot’ of the patent landscape (figure below right). This is due to their high Technology Relevance™ combined with a broad Market Coverage™, two parameters further explained in the note below the graphs.
The steady increase in the number of biotech patents results from growth in multiple dimensions: higher density in established fields, expansion to novel areas, and combination of technologies.
- The density of patents has become extremely high in established fields of biotechnology, such as health, chemistry, measurements, and agriculture. Nevertheless, emerging technologies, innovative combinations and improved, known features enable further developments and generate novel, patentable products and processes. Therefore, it is safe to assume that the patent density in the classical biotechnology fields will further increase in the future.
- Biotechnology continues to expand into novel, so far unexplored fields of application. As a result, the overall number of patents is increasing and alongside it, the diversity of the biotechnology patent landscape.
- The combination of biotech with other emerging technologies, for example digital technology or additive manufacturing, is bound to generate entirely novel product and process categories. Such combinations are prone to generate highly complex patents and involving multiple scientific disciplines.
Freedom-to-operate in biotechnology
The market launch of a new product initiates its commercial exploitation after a long period of product development and substantial investment. A worst-case scenario at this point is an unexpected infringement action filed by a competitor. Freedom-to-operate (FTO) analyses serve to avoid this scenario and to evaluate the risks of infringing existing or pending patents for a defined product or process in specified markets at a given time.
It is worth noting that the fact that a company owns patents protecting a new product, does not preclude the risk of infringing patents of third parties. Own patents may depend on earlier, broader patents owned by third parties, or they may not cover all relevant aspects of a given product. The objective of an FTO analysis is a near complete account of potentially infringed patents for a defined product or process. Thus, the effort needed to avoid infringement increases with the complexity of the investigated subject matter. FTO analyses relating to biotechnology are particularly intricate because several complexity factors coincide and multiply.
As outlined above, the increasingly dense and diverse biotechnology patent landscape represents a patent thicket, which is difficult to navigate. Patent thickets also exist in other domains, such as telecom, but in biotechnology, additional factors render the FTO task particularly challenging.
- The involvement of living organisms makes biotechnology patents inherently complex, in particular those involving biological processes. Even in its simplest forms, life comprises countless interconnected mechanisms and a high degree of redundancy and variability. As a result, the scope of protection of biotechnology patents is frequently fuzzy due to poorly defined or implicit features.
- Many technical terms used in life sciences are ambiguous or even controversial, and multiple synonyms describe the same subject. These linguistic hurdles impede the analysis of both patents and scientific literature, and they add one more layer of complexity.
- Many biotechnology products target a global market. Accordingly, FTO has to consider multiple countries, each with specific competitors, IP-legislations, and patent landscapes. For obvious reasons, this aspect broadens the scope of any FTO analysis.
Obtaining a realistic view of the FTO situation for a biotechnology product or process means managing the multiplied complexities involved. A systematic, stepwise approach helps to structure and focus the task, and support from IP professionals with specific knowledge of biotechnology is necessary.
Ideally, FTO accompanies the entire product development process, as an integral part of a comprehensive risk management. From early stages onwards, FTO aspects can significantly influence key decisions and help to prevent dead-end developments or costly redesigns at late stages.
Early on, the FTO may focus on a few key features of the envisaged product, and on a tightly defined core market. In parallel with the progress of the project and with increasingly precise product specifications, the FTO analysis can become progressively thorough by addressing more features and a broader market. This approach ensures a reliable, comprehensive FTO assessment up to and beyond market entry. In addition, the stepwise process can provide valuable insights into the dynamics of the technologies, players, and markets involved.
In summary, FTO analyses in biotechnology are a particular challenge due to multiplied complexities. FTO in biotechnology means having to address many difficult-to-define features within a dense, diverse, and highly dynamic patent landscape at a global level. However, the objective can be achieved by addressing FTO early on with an incremental approach and professional support, but most of all by ensuring a high IP-awareness of both scientists and decision makers in the industry.