Mediation examples:

• disputes concerning marketing authorisations (MHRA), SmPC's and PIL, livery applications (Article 61 notifications, Directive 2001/83/EC); clinical trials;

• a dispute over funding of medical research involving various institutions;

• a dispute concerning the development of electronically controlled surgical equipment raising issues under the EU Medical Devices Directive;

• a dispute concerning the implementation of IT systems at a pharmaceutical research centre involving allegations concerning compliance with 'The rules governing medicinal products in the European Union' (EudraLex), Volume 4 - Good Manufacturing Practice, Annex 11 (Computerised Systems);

• a trade mark action between a generic manufacturer of a pharmaceutical product and a market leading brand;

• a patent infringement action in the medical devices field against numerous defendants, the claim being met with a defence of non-infringement (involving arguments on construction) and a counterclaim for invalidity based on lack of novelty (elements in the inventive concept contained in an earlier patent) and also lack of an inventive step (prior art at the time of filing combined with common knowledge suggesting obviousness), the dispute also involving arguments over commercial success and long felt want as secondary evidence of inventiveness;

• a dispute concerning a well-known medical product arising out of a deed of assignment of patents and an associated commercialisation agreement, a subsequent broader assignment of associated IP and the impact of expiry of patents on certain revenue sharing arrangements;

• a dispute in the pharmaceutical sector concerning distribution of various pharmaceutical products under a distribution agreement containing a 'take or pay' clause, the dispute concerning an alleged common assumption/common mistake made by the parties as to the size of the market (and potential for growth) and potential market share;

• a dispute between two medical technology companies concerning development of, and patent applications in relation to, various diagnostic devices, the dispute concerning ownership of various granted patents, future patents and alleged breaches of various collaboration and development agreements;

• a dispute between two pharmaceutical companies involving assertions of breaches of the guidelines for Good Distribution Practice (Commission Guidelines (2013/C 343/01));  Good Manufacturing Practice (Commission Directive 2003/94/EC - October 2003); and Good Pharmacovigilance Practice as published by the European Medicines Agency under various EU Regulations and associated Directives;

• a dispute between an academic institution and a pharmaceutical company over a patent licencing agreement and the scope of revenue to be included in the calculation of milestone payments due under the licence agreement at various stages of development of a novel pharmaceutical product e.g. FDA/European Commission approvals for particular indications, level of sales etc;

• a funding dispute between a medical practice and an Integrated Care Board following it assuming responsibilities from the relevant Clinical Commissioning Group following the termination of a Personal Medical Services Contract of a third party practice due to regulatory and safety concerns, and the entering into of an Alternative Provider Medical Services Contract to provide caretaking services on a temporary basis to patients of the third party practice;