UK Trends and Developments Contributed by: Nicola Dagg, Jin Ooi, Ray Cheng and Nevyn Fournel, Kirkland & Ellis
The High Court (Hacon J) held that the claimed invention was not obvious in light of a published patent application as there was no reasonable expectation of success, relying heavily on sec- ondary evidence of inventiveness and finding that the prior art disclosure relied upon by Pfizer would have been viewed by the skilled team “as a scientifically meaningless bit of patent draft- ing”. Unlike in the EPO and other jurisdictions such as Australia, CRISPR patent litigation has yet to make its way to the UK. This is another exciting field within the life sciences sector, and it may see activity over the coming years. Biotech patent litigation continues to grow, but small molecule patent litigation remains active This year has been another big year for biotech patent litigation in the UK, which continues to grow in popularity as more and more biotechnol- ogy-related patent portfolios reach their expiry date. There has been impressive breadth in sub- ject matter, spanning biosimilars (eg, Sandoz v Biogen ; Samsung Bioepis v Janssen ; Amgen v Alexion ; Formycon v Regeneron ), rival biologi- cal vaccines ( Moderna v Pfizer/BioNTech ), DNA diagnostic methods ( Advanced Cell Diagnostics v Molecular Instruments ) as well as biotechnolo- gy-related entitlement disputes ( Hill v Touchlight ; Bionome Technology v Clearwater ) among other areas. However, traditional small molecule patent liti- gation remains active, with important decisions on blockbuster medicines such as rivaroxaban ( Sandoz v Bayer ) and enzalutamide ( Accord/ Sandoz/Teva v Astellas ). In Accord/Sandoz/ Teva v Astellas [2024] EWHC 2524 (Pat) , the High Court (Mellor J) held that a claim to the compound enzalutamide, used to treat pros-
tate cancer, was not obvious in light of prior art disclosing a structurally similar compound to enzalutamide. Mellor J held that the generics’ primary argument was tainted by hindsight and was not satisfied that their secondary argument had been trailed in evidence. Medical devices litigation continues apace Likewise, patents relating to medical devices continue to be litigated in the UK in 2024. The longstanding battle between Abbott and Dex- Com concerning continuous glucose monitor- ing devices, also active in the UPC, continues to rage on, with the High Court invalidating four of Abbott’s patents in January and in June finding that one of DexCom’s devices did not infringe the asserted patent, which in any event was invalid for obviousness. Several other cas- es between Abbott and DexCom are ongoing. There are also ongoing cases between Insulet and Menarini/EOFlow (insulin pumps) and Meril and Edwards (heart valves), whilst Abbott settled its UK dispute with SiBio this year in relation to its devices. Supplementary Protection Certificates (“SPC”) The UK also continues to develop its jurispru- dence in relation to supplementary protection certificates (“SPC”), with the Court of Appeal finding that a claim to an active ingredient A in combination with active ingredients B and C cannot be the subject of an SPC based on a marketing authorisation for A alone (Newron), and the High Court finding that a claim to an excipient which enhances the effect of an active ingredient falls outside the scope of SPC protec- tion (Halozyme). UPC Developments Only a year and a half following its opening, the UPC has been busy dealing with a variety
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