data, and any amendments that have been made. In biotech, where the stakes often involve substantial investments and cutting-edge science, it’s crucial to ensure that the patent’s claims are clearly articulated and defensible. I also carefully examine opposition documents, focusing on the grounds for opposition and the prior art cited by the opponent. This step is foundational; a solid grasp of the material allows me to anticipate the opponent’s arguments and prepare counterarguments effectively. Next comes the crucial task of conducting a detailed prior art analysis. In biotech, this often means delving into complex scientific literature and assessing how the claimed invention stands in relation to existing patents. The aim is not only to validate the patent’s claims but also to identify potential weaknesses that the opposition may exploit. An additional layer of complexity arises when dealing with AI-based biotech inventions, particularly in relation to hearings before the Examining Divisions of the EPO. The intersection of AI and biotechnology poses novel challenges in patentability. In summary, my approach to preparing for EPO hearings is multifaceted and dynamic. Each case demands a tailored strategy that accounts for the intricacies of the technology involved, the arguments presented by the opposition, and the evolving landscape of patent law. By embracing a proactive mindset and remaining adaptable, I ensure that my clients are well-prepared to navigate the complexities of the hearing process, ultimately safeguarding their innovations and intellectual property in a fiercely competitive environment. Given your background in technologies like diagnostic assays and green agrochemicals, how do you balance innovation with ensuring freedom to operate for your clients, particularly in a highly competitive and regulated industry? Balancing innovation with freedom to operate in the fields of diagnostic assays and green agrochemicals is a nuanced and challenging endeavour. These are highly competitive and regulated industries, and it is essential to navigate both the patent landscape and the regulatory framework effectively. One of the first considerations is understanding that regulatory approval is often decoupled from the patent process. This distinction is particularly important when dealing with combination products, where the specific “active compound” presented in regulatory applications can WWW.LAWYER-MONTHLY.COM 21 One of the foremost challenges in biotech patent management is the timing of patent filings.
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