The importance of freedom to operate
The potential impact of third party IP rights to the business of an enterprise is often underestimated, especially by start-ups and small- to mid-size firms. Conflicting third party patents may represent significant legal obstacles to the commercialization of a new product or technology and should be identified as early as possible during product development. One of the worst scenarios is a successful R&D project with a product that is ready to enter the market after years of development when suddenly a competitor’s blocking patent is found. We will assist you in preventing such critical business situation.  We are highly experienced in identifying and analysing third party rights that could pose potential threats to your business.

What must be done to establish FTO?
A well-defined strategy is needed for establishing freedom to operate (FTO), and it cannot be done in a week or two. A thorough FTO analysis forms an essential part of a long-term R&D project, especially in technology fields which are competitive and require significant R&D efforts such as in the pharmaceutical, biotechnology and life sciences sectors. It starts with a patent search that covers your future product as currently foreseen. As your product definition might - and in most cases will - change in the course of development, the search will have to be adapted and updated from time to time. Often, the search will retrieve patent applications filed by third parties that could potentially be relevant for your project. Such patent applications will have to be assessed and monitored with respect to their legal status and the changes that the applicant makes to the patent claims. In some cases, claims that are granted or likely to become granted can be circumvented in your product development. Alternatively, we might advise you to challenge the potentially conflicting IP right if there is sufficient evidence that its claims are invalid. In other cases, it may be most cost-effective to seek a license from the owner of the IP right.

The right timing
The right timing of the FTO activities is crucial. Performing a full-fledged FTO study already at the conceptual phase of an R&D project is certainly overdone, considering the cost of the analysis and the high likelihood of important changes to the target product features that will occur. At this stage, a preliminary patent landscape may be more useful. Vice versa, delaying a thorough FTO analysis until all major decisions on the new product profile have been made (or even until pivotal clinical studies are initiated) would involve an enormous risk that should be avoided by all means. So it's all about doing the right things at the right stage of your R&D project. We have been involved in numerous FTO studies and can advise you on the activities that are appropriate for your project at each stage.