therapeutic applications, while in other cases, a narrowly defined product claim might leave a company vulnerable to competitors exploiting alternative uses. Next, I examine the remaining patent term of the granted patents. The lifespan of a patent can significantly influence its value. A patent nearing expiration may offer limited competitive advantages, while a robust patent with a substantial remaining term can provide significant market exclusivity. This factor becomes even more pertinent in the biotech field, where the development and approval processes can span years, making the remaining patent life critical for assessing the potential return on investment. The position of Supplementary Protection Certificates (SPCs) is another essential element in my due diligence process. SPCs can extend the protection of a patent by up to five years in the European Union, providing additional exclusivity for products that have undergone rigorous regulatory approval processes. Assessing whether an SPC has been granted or is likely to be granted for a particular patent can significantly enhance the overall value of a portfolio, making it an essential consideration during due diligence. In parallel, I analyse the competitive landscape, focusing on the number of major competitors in the field. Understanding who the key players are can inform our strategy and risk assessment. A crowded market with many competitors may signal potential challenges in gaining market share or maintaining pricing power. Conversely, a more consolidated market can suggest fewer threats to exclusivity, enhancing the value of the patent portfolio. Equally important is the number of competing products already in the market. Evaluating existing products helps gauge how saturated the market is and whether there are viable paths for commercialisation. If multiple competing products exist, it may indicate a highly competitive landscape where differentiation becomes crucial. This assessment provides insights into potential challenges the acquiring company may face post-acquisition, particularly in launching new products or securing market position. Combining these factors creates a comprehensive picture of the patent portfolio’s strength and viability. Throughout this process, collaboration with technical and regulatory teams is vital to ensure that all aspects are considered holistically. By integrating scientific and business perspectives, we can provide clients with a nuanced understanding of the potential value and risks associated with a patent portfolio. Ultimately, thorough patent due diligence not only helps identify potential pitfalls but also uncovers opportunities for growth and innovation. In the rapidly evolving biotech landscape, having a strong, defensible patent portfolio is crucial for securing a competitive edge, and my aim is to guide clients through this complex process, enabling informed strategic decisions that support their long-term success. WWW.LAWYER-MONTHLY.COM 23 the nuances of regulatory approvals and how they intersect with patent claims, and by staying vigilant about the patent landscape, we can position our clients for success. This proactive strategy not only protects their innovations but also ensures they can operate freely in a competitive marketplace. In the rapidly evolving sectors of diagnostic assays and green agrochemicals, this balance is essential for driving sustainable innovation while navigating complex legal and regulatory frameworks. Due diligence is crucial in patent acquisitions and mergers. How do you approach patent due diligence for biotech companies, and what factors do you prioritise when evaluating the strength of a patent portfolio? Conducting patent due diligence for biotech companies during acquisitions and mergers is a meticulous process that requires a keen understanding of both the technical aspects of the patents involved and the broader competitive landscape. My approach is holistic, encompassing several key factors that help evaluate the strength and viability of a patent portfolio. One of the first elements I assess is the type of granted claims within the patents. In the biotech sector, claims can be broadly categorised into product claims, medical use claims, and claims related to manufacturing processes. Each type serves a different strategic purpose and offers varying degrees of protection. For instance, product claims provide direct protection for a specific therapeutic compound, while medical use claims may cover a broader range of applications for that compound. Understanding the composition of these claims is crucial, as it impacts both the competitive landscape and potential infringement risks. In some cases, a strong medical use claim can enhance the overall value of a portfolio by allowing for broader Ensuring freedom to operate (FTO) is another critical aspect of biotech patent management.
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