significantly influence both approval and marketability. Regulatory bodies typically evaluate products based on narrowly defined claims, and the language used in patent applications must reflect this precision. For example, when prosecuting combination products, careful consideration must be given to how we define the combination and its medical use. Inadequate or vague language could lead to misalignment between the patent claims and regulatory expectations, jeopardising both patent protection and the ability to gain regulatory approval. In practice, this means that my team and I work closely with clients to ensure that the definitions we use in patent applications align not only with scientific realities but also with regulatory requirements. For instance, if a diagnostic assay relies on a combination of biomarkers, it’s crucial to articulate this combination precisely in both the patent claims and the regulatory submission. A failure to do so could result in regulatory rejection or challenges in asserting patent rights later on. The introduction of “equivalents” in UK infringement proceedings adds another layer to this discussion. The concept of equivalents allows for some leeway in how patents are interpreted, acknowledging that innovations may not always replicate the patented invention in an identical manner but may still fall within its protective scope. This legal framework can both support innovation by providing a degree of flexibility and complicate the FTO landscape, as it may be unclear whether a new product or process is infringing upon existing patents. In practice, this means that when we innovate, we must do so with a keen awareness of existing patents and the potential for equivalents. Comprehensive FTO analyses are essential to identify existing patents that may pose risks. These analyses not only include searching granted patents but also examining pending applications and published literature. Understanding the competitive landscape allows us to navigate potential infringement risks proactively, ensuring that our clients can pursue 22 LAWYER MONTHLY NOVEMBER 2024 their innovations without fear of legal repercussions. Furthermore, fostering a culture of collaboration between regulatory affairs and patent teams can be invaluable. Regular communication ensures that both aspects are aligned and that innovations are not developed in a vacuum. For example, when working on green agrochemicals, where environmental regulations play a significant role, it’s crucial to consider both the patent strategy and the regulatory pathway simultaneously. This dual approach can streamline the process, minimising the risks of regulatory delays or challenges later on. Ultimately, achieving a balance between innovation and FTO requires a strategic, multifaceted approach. By understanding
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