WWW.LAWYER-MONTHLY.COM 19 antibodies, and vaccines, presents a unique set of challenges that demand both technical expertise and strategic foresight. One of the foremost challenges in biotech patent management is the timing of patent filings. Many companies file patents at the earliest possible opportunity, often before sufficient supporting data have been generated. In the context of the European Patent Office (EPO), the ability to demonstrate the plausibility of a claimed clinical effect is crucial. When early data fail to substantiate claims, applicants may face rejections, particularly when close prior art exists that asserts similar effects. Although the EPO’s G2/21 decision has provided some guidance, demonstrating tailored strategies that align with the specific legal landscapes of each market. This complexity necessitates thorough preparation and foresight, enabling clients to secure their innovations across multiple jurisdictions effectively. Attorneys must keep up to date on developments in all key jurisdictions. For example, a decision such as the US Supreme Court decision in Mayo v Prometheus established a higher threshold for the patentability of methods involving natural phenomena. At a stroke, the decision wiped billions off the value of diagnostics IP estates, and patent attorneys were left scrambling for new approaches to protect their clients’ interests in those fields. Ensuring freedom to operate (FTO) is another critical aspect of biotech patent management. In crowded fields like antibodies and vaccines, overlapping patents can create significant infringement risks. Conducting comprehensive FTO analyses allows clients to navigate these complexities, identifying potential infringement issues before they arise. To maintain a competitive edge in this rapidly evolving landscape, several strategic approaches can be employed. Proactive patent filing, informed by a robust supporting data package, is essential. Aligning patent applications with Managing patent portfolios in the biotech sectors such as protein therapeutics, antibodies, and vaccines presents a unique set of challenges that demand both technical expertise and strategic foresight. distinctiveness remains a significant hurdle. The complexity inherent in biologics further complicates patentability assessments. Proteins and antibodies possess intricate structures and functions that necessitate detailed disclosures. To adequately capture the uniqueness of an invention, robust experimental data must be accompanied by clear explanations of the structure-function relationships. This complexity requires patent attorneys to possess a deep understanding of both the scientific and legal aspects of their clients’ innovations. Another persistent challenge lies in balancing broad and narrow claims during patent prosecution. Broad claims can offer extensive coverage and protection but are often more vulnerable to invalidation. Conversely, narrow claims may limit a client’s competitive advantage. Thus, striking the right balance becomes critical. Patent attorneys must draft claims that provide sufficient breadth while ensuring defensibility against potential challenges. Global patent strategies also pose unique challenges, as different jurisdictions have varying standards for patentability, particularly in the biotech sector. Navigating these differences requires
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