INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
at appeal level for the first time. Significant questions being considered have included claim construction, infringement (including under the doctrine of equiva ‑ lents and in relation to second medical-use patents), declarations of non-infringement, the requirements for granting preliminary injunctions, and various aspects of patent validity including two appeals in life scienc ‑ es disputes which have resulted in the UPC Court of Appeals’ latest decisions on inventive step (in which they adopted a “holistic” approach rather than the “problem–solution” approach, and emphasised that, for an inventive step attack to succeed, it had to be established that the skilled person would, not just could, have arrived at the claimed invention as the next step from the prior stage). Given the decentral ‑ ised nature of UPC first-instance decisions, some inconsistencies are still appearing between differ ‑ ent Local Divisions, with the associated risk of forum shopping by parties. Practitioners will be keen to fol ‑ low how these and other issues are ultimately resolved by the Court of Appeals. Further, the somewhat uncer ‑ tain extent of the UPC’s jurisdiction in relation to the European Patent Office (EPO) and national rights in both contracting and non-contracting states, remains an important consideration for parties developing and Following the decision of the Enlarged Board of Appeal of the EPO in G2/21 (handed down in March 2023), European jurisdictions have started to diverge some ‑ what in relation to the idea that a technical contribu ‑ tion should be plausible for there to be an inventive step as required for patentability. Several decisions over the past year have largely entrenched these dif ‑ ferences, with the UK Court of Appeal in the Dapa ‑ gliflozin proceedings following its own prior decision in the Apixaban proceedings which relied on the UK Supreme Court’s 2018 decision in Warner-Lambert . Thus, it appears that a technical contribution in the UK must be plausible ab initio, and post-filed evidence can be brought in only to confirm or reject an effect which is already rendered plausible by the patent. Meanwhile, several other European jurisdictions have followed the lead of the Dutch Court of Appeal in interpreting G2/21 to mean that a threshold closer to ab initio implausibility is correct. This lower threshold updating their product IP strategies. Diverging views on patent plausibility
for plausibility would make it easier for post-filed evi ‑ dence of a technical effect to be brought in. Meanwhile, the US approach continues to differ wide ‑ ly from both the UK and the rest of the EPC states. Rather than considering plausibility in relation to inventive step, the US primarily focuses on sufficiency in relation to enablement, as considered by the US Supreme Court more recently in Amgen . Though all agree that “armchair” inventions should be guarded against, these differing approaches emphasise the dif ‑ ficult balancing exercise for patent applicants when deciding whether to file early with limited data or wait for more evidence supporting an invention but with the risk of being scooped by keen competitors. It will be interesting to see to what extent these approaches will converge over the coming years. Product life cycle management and exclusivity While basic patents covering new products are incred ‑ ibly important, complementing them with a suite of other secondary patents and regulatory exclusivities is a critical element of every life cycle management strategy for an important and commercially successful product. Plenty of cases over recent years demon ‑ strate the powerful effect of a portfolio of patents con ‑ sisting of dosing, formulation, second medical use, and other additional patents in protecting originator medicines from generic or biosimilar entry. Likewise, additional rights such as supplementary protection certificates (SPCs) and regulatory data exclusivity are critical tools for innovators in life cycle manage ‑ ment. However, these additional protections are cur ‑ rently under the microscope in jurisdictions around the world, as governments increasingly seek to ensure that exclusivity periods are aligned with the invest ‑ ment required to develop innovative products, crack ‑ ing down on perceived abusive practices and exces ‑ sive exclusivity terms. Further, the approaches to exclusivity may vary across different jurisdictions, as seen in recent cases con ‑ sidering the SPC manufacturing waiver notice pro ‑ visions. While German courts have interpreted the requirements strictly, a more pragmatic approach has been taken in the Netherlands and the UK. This high ‑ lights that while the commercial value of exclusivity extensions can be immense, it is essential to consider
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