UK Trends and Developments Contributed by: Nicola Dagg, Jin Ooi, Ray Cheng and Nevyn Fournel, Kirkland & Ellis
The initial ruling resulted in a mixed outcome for both companies: Pfizer has been granted per- mission to appeal, while the High Court denied Moderna’s request. Consistently with trends in previous years, most of these cases resulted in the invalidation of the patents at issue (eg, Sandoz v Biogen ; Pfizer v GSK ; Samsung; Bioepis v JanssenBioNTech/ Pfizer v CureVac ; Abbott v DexCom ; Sandoz v Bayer ; Advanced Cell Diagnostics v Molecular Instruments ). However, there have also been several recent decisions which have bucked this trend in whole or in part ( Moderna v Pfizer/BioN - Tech; Accord/Sandoz/Teva v Astellas; Pfizer v UniQure ). These recent wins for patentees show that the English Courts are willing to uphold the validity of patents in appropriate cases. Unlike in previous years, the patent cases this year primarily involved the application of estab- lished legal principles to factual scenarios. How- ever, there have been a number of interesting practice-related developments, including: • a continued push for independent experts retained by a party to confer with each other and discuss the composition of the skilled team before finalising their reports ( Moderna v Pfizer/BioNTech ) (this issue has garnered con- siderable attention over the past few years, given that parties frequently prefer to isolate the evidence of their retained experts and it remains to be seen whether standard practice will shift in this manner); • a reminder that expert witnesses in the UK have a duty to independently assist the Court ( Pfizer v uniQure ); • the circumstances in which it is appropriate to grant an Arrow-style declaration ( Sandoz v Biogen ; Pfizer v GSK );
• the grant of a 9-10 day preliminary injunction pending judgment ( Bayer v Aspire ); and • a call by the Court of Appeal for those seek- ing patent revocation to clear the way as soon as possible and keep the English Courts properly and timeously informed of proposed launch dates ( Bayer v Sandoz ). Patent decisions on cutting-edge life sciences technology 2024 has seen the English Courts grapple with patents relating to inventions in a number of cut- ting-edge areas within the life sciences sector. In the second half of the year, we saw the first two UK patent decisions regarding COVID-19 mRNA technology in Moderna v Pfizer/BioNTech and BioNTech/Pfizer v CureVac . In Moderna v Pfizer/BioNTech ([2024] EWHC 1695 (Pat)) , the High Court (Meade J) upheld the validity of one of Moderna’s patents relating to modified mRNA but struck down another patent claiming betac- oronavirus mRNA vaccines comprising a spike protein in a lipid formulation for obviousness. In a separate trial ( [2024] EWHC 1648 (Pat) ), the High Court (Richards J) found that Moderna’s 2020 pledge not to enforce its COVID-19 patents gave Pfizer/BioNTech non-contractual consent to perform acts of patent infringement until the date Moderna withdrew its pledge. In BioNTech/ Pfizer v CureVac [2024] EWHC 2538 (Pat) , the High Court (Meade J) found two of CureVac’s patents relating to a split poly(a) tail in mRNA were invalid. Curevac acknowledged the invalid- ity of a third patent but plans to argue on appeal to the UK Supreme Court that the Supreme Court’s decision regarding insufficiency in the Warner-Lambert v Generics case was incorrect. In October 2024, we also saw one of the first English patent decisions relating to gene thera- py in Pfizer v uniQure [2024] EWHC 2672 (Pat) .
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