40 LAWYER MONTHLY NOVEMBER 2024 teams to understand which are the most important patent families and markets, what stages of examination/ grant each family member is at, and if there are other patentable ideas in the pipeline. The filing strategy, particularly the international filing strategy, should be agreed upon to ensure the key commercial markets are covered. At this stage, it is important to give the leadership team a health check on their portfolio and agree on what actions are necessary to improve it. For example, it may be that securing early grant of a particular patent family member is a priority, perhaps to attract funding from investors. In this situation, you would recommend taking steps to accelerate the examination of the patent applications before the EPO, the UKIPO, and the USPTO. Other issues, such as FTO, may have been identified in reviewing the portfolio, and these should be highlighted to the leadership team together with any proposals to mitigate risk. IP policies and procedures, such as invention capture processes, invention review meetings, and inventor remuneration, are all areas where the SME may require support. What trends are you observing in the life sciences patent landscape, and how should SMEs position themselves to stay competitive in this field? Patenting activity in life sciences remains buoyant. There were more than 8,000 biotech patent applications filed with the EPO in 2023, representing a 6% increase compared to 2022, and a further 9,000 applications for pharmaceutical patents. Licensing deals are another indicator of patent activity and commercial interest. According to ‘JP Morgan’s Annual BioPharma Licensing and Venture Report 2023’, there were almost 500 R&D partnership in-licensing deals in 2023, involving $12.8 billion in upfront payments alone. Cancer was by far the therapy area of most interest, while biologics, such as antibodies, were the favoured modality, outstripping small molecule deals twofold. My advice to life sciences SMEs is simple: ensure they have an IP strategy in place that is fully resourced and actively managed by an IP manager who is accountable for implementing and delivering the strategy. ‘IP updates’ should be a fixed agenda item in the leadership team’s monthly meetings. Competitor intelligence, invention capture, patent filings, foreign filing strategy, portfolio reviews, FTO, trade secrets, IP training, and licensing are areas that require continual attention in maintaining a healthy portfolio and delivering the IP strategy. Ignore them at your peril! How can a robust freedom-to-operate analysis help SMEs mitigate risks and avoid costly litigation, particularly in the highly competitive life sciences sector? An FTO analysis is a risk mitigation tool aimed at avoiding time-consuming and costly litigation. Discovering a blocking patent just before launch or being served with a cease-and-desist letter from a litigious patent owner can be devastating for resource-constrained SMEs, especially in the litigious life sciences sector where exclusivity is key.
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