38 LAWYER MONTHLY NOVEMBER 2024 What challenges do life sciences companies typically face when assessing freedom to operate, and how do you guide clients through this complex process? Freedom to operate (FTO) is the ability to make or use a product, service, or technology in a particular territory without infringing a third party’s IP right, such as a patent, trademark, or design. Having FTO is, therefore, critical for any company planning to launch a new product or service, particularly in highly competitive and patent-intensive sectors like life sciences. My advice to clients is to conduct a thorough FTO search and analysis early in the research phase, particularly as they begin to define their new product or service, to allow time to develop a strategy to deal with any blocking IP rights they may find. Their strategy may involve ‘designing around’ any patent claims, negotiating a licence, or even challenging the patent. A senior manager should be made accountable for leading the project team, which should ideally consist of a senior technologist and a patent attorney. ‘Designing around’ the patent claims involves modifying the product or service so that it would no longer infringe. A patent attorney should be involved in agreeing to the modification to ensure the new version would clearly fall outside the scope of the claims. Equally, any modification should retain the competitive features of the new product or service. If negotiating a licence is the favoured route, allow time to conduct internal due diligence and develop a licensing strategy before approaching the patent owner. In some situations, challenging the validity of the patent may be considered prudent. Typically, this would involve searching for new prior art documents that had never been considered in examination to attack the novelty or inventiveness of the patent claims. The prior art could
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