INTRODUCTION Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP
A Global Overview of Life Sciences & Pharma IP Litigation We are delighted to introduce the Life Sciences & Pharma IP Litigation 2025 edition of Cham - bers’ Global Practice Guides, which provides an overview of litigation in the life sciences and pharmaceutical sectors in a number of countries, and an update to the trends and developments expected in the coming year by leading lawyers in each jurisdiction. Litigation in the life sciences and pharmaceu - tical industries continues to be prolific across all jurisdictions. With increasing complexity of the technologies involved, innovators have ever more avenues to consider when protecting their inventions. However, the socio-political environ - ment companies are operating in is ever more challenging – governments in key manufac - turing jurisdictions, including China and India, have been taking steps to make their countries more attractive for innovators. If manufacturing countries become more patentee friendly, we could see changes in global life-cycle manage - ment and enforcement strategies and litigation dynamics in this sector, with an increased focus on enforcement against manufacturers of active pharmaceutical ingredients (API) and finished products in jurisdictions where enforcement of patent rights had previously been regarded as challenging. Biologics (and biosimilar versions of originator biologics) are now firmly established at the fore - front of pharmaceutical litigation, and comprise the vast majority of the current generation of blockbuster medicines. Whilst small molecule generic litigation continues, the rise of biolog - ics/biosimilars has had and continues to have an impact in terms of the dynamics of, and key regular players in, large-scale pharmaceutical patent litigation. Overall, the number of patent
disputes in the sector has remained steady but the disputes are increasingly complex and high- stakes and are often fought in parallel across multiple forums. Other industry trends include the continued rise in the frequency of “innova - tor-on-innovator” disputes. At the tail end of the year, the US Court of Appeals for the Federal Circuit released an opinion that Orange Book patents must claim at least the active ingredi - ent of a patent. It also addressed device pat - ents specifically, holding that patents which only claim device components do not meet the listing requirement. Parties in the pharmaceutical space will also have a particular eye out for develop - ments in the coming year regarding implications of the European Commission’s decision about the alleged misuse of divisional patents, where an innovator’s conduct of filing divisional patents to extend exclusivity on the market was found to be anti-competitive. This decision could have wide-ranging implications for life-cycle manage - ment throughout Europe. New technologies on the rise The focus on mRNA-based vaccines and treat - ment continues. The litigation related to the COVID-19 vaccines persists in some jurisdic - tions, while the parties have settled in others. Next generation technologies such as CRISPR gene editing and base editing remain on the forefront, and approvals of new CRISPR-based therapies are bound to lead to litigation in the area, including around licensing arrangements by the many players involved with the founda - tional CRISPR technology. With the rapid expan - sion of AI-based tools and technology, there has been continued focus on AI-based inventions. The UK courts continued to grapple with AI- based technology, and the UK Supreme Court is set to hear an appeal on the patentability of AI-based inventions in the coming year. The UK Court of Appeal had previously said obiter
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