James Warner

James has over 25 years of experience in the pharmaceutical sector, heading up our Pharma group for seven years, and “is well-known for handling multi-opponent oppositions, including rare cases with more than 10 opponents” (IAM1000). His practice focuses exclusively on medicinal chemistry inventions for pharmaceutical innovators, and he has acquired a reputation for his imaginative approaches to the legal and technical strategies on the most commercially important cases.

James is particularly sort after for conducting multi-opponent European Patent Office (EPO) opposition proceedings – he is one of only a handful of advocates to have extensive first chair experience of defending EPO oppositions with very large numbers of opponents, including over ten opposition defences of eight opponents or more, several of 15 opponents or more, and a recent record-breaking 20 opponent EPO opposition representing Janssen.

Individually recommended in numerous industry directories, James is particularly known for successfully prosecuting and defending NCE, combination, formulation, second medical use and dosage regimen patents on marketed products. In this sphere, he has advised on many of Novartis’ blockbuster products and has led many EPO opposition defences to generic challenges, most notably the multi-party oppositions against Novartis’ Entresto, Exforge, Glivec, Aclasta and Ultibro products. He is also a lead outside patent counsel for Gilead’s HIV and HBV portfolios, successfully defending Gilead’s TAF and cobicistat medicines, present in a variety of their blockbuster antiviral products, against multi-opponent oppositions. He represents Roche in EPO opposition and appeal proceedings and is a lead counsel in the small molecule space for several other pharma companies, including Janssen and Incyte. He brings practical experience of the interplay of patent, SPC and regulatory law to these commercial situations.

In his opposition work, commentators note that “James has a deep understanding of case law, the ability to navigate complex legal and technical intricacies, and can see the big picture alongside the small details to analyse each case effectively and develop the best possible strategy for success. James then makes complex arguments easy to understand and is highly skilled at picking up inconsistencies in the opponent’s arguments and uses them to strengthen his position. He is also experienced in the context of groundbreaking cases, where case law is yet to be established.” (IAM1000)

James’ EPO opposition work frequently brings him into contact with parallel national litigation, and he is particularly sought out to bring his EPO and technical experience to litigation strategies throughout Europe and the world. He has earned a particular reputation defending cases involving clinical trial disclosures and has represented patent proprietors in many of the leading cases in this space, particularly T239/16, T108/21, T1098/22 and T779/24.

James has also acquired a great deal of experience representing before the EPO’s Enlarged Board of Appeal, having prosecuted two petitions for review and successfully representing Novartis before the Enlarged Board of Appeal on the ground-breaking decisions regarding the transfer of priority rights, G1/22 and G2/22.