In such a highly regulated industry, understanding the key challenges of negotiation and drafting an effective and watertight contract on an international level is a complex topic. It is vital that both legal counsel and commercial executives not only have the key skills and tactics to create a win:win scenario but also the knowledge to ensure any agreement is within the laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.
*Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
MODULE 1: INTELLECTUAL PROPERTY ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS
- Intellectual property terms in collaboration and licensing agreements
- SPC’s – Supplementary Protection Certificates- Securing the full commercial potential of your product
- When does R&D infringe patents? Understanding the experimental use and Bolar provisions
- Third party IP rights – ‘Freedom to Operate’ searches and implications for pharmaceutical industry agreements
MODULE 2: COMMERCIAL AND LEGAL ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS
- Key issues in contract manufacturing agreements
- Key issues in co-promotion, co-marketing and distribution agreements
- The EMA as a regulator for the pharmaceutical industry
Using regulatory processes to define contractual obligations
- Key issues in clinical trials and related agreements
MODULE 3: COMPETITION LAW WORKSHOP
- Introduction to relevant EU competition law rules
- Current competition law issues
MODULE 4: WORKSHOP ON COLLABORATION AND R&D AGREEMENTS
- Negotiation of collaboration and licence agreements concerning pharmaceutical product
MODULE 5: NEGOTIATION SKILLS IN THE PHARMA SECTOR
- The rise and rise of the negotiator
- Negotiate and succeed
- Structure for control
- Personal style and negotiation
- Practical exercise: Moving into engagement
- Influencing and persuasion
Susan Singleton is a solicitor with her own London solicitor’s firm, Singletons, which specialises in competition law, intellectual property and commercial law, both non-contentious and contentious. Until 2016 she was Vice Chairman of the Competition Law Association and author of 30 law books. She advises a wide range of UK and international clients including in the pharmaceutical sector. The 4th edition of her book on Commercial Agency Agreements was published in 2015. After working as a solicitor at London law firms Slaughter and May and Bristows, she founded her own law firm. She brought the first action for damages for breach of the competition rules to reach an English court (Arkin v Borchard Lines) and in 2015 was involved in litigation for clients in both the CJEU and UK in relation to challenges to EU and UK tobacco legislation. She advises lots of clients in particular about EU competition law and selective distribution agreements including in the pharma/ veterinary sectors, both for parallel importers and for brand owners. She is editor of the looseleaf Kluwer’s Comparative Law of Monopolies. In 2015-16 she was heavily involved in litigation before the English courts and CJEU in litigation relating to EU and UK legislation in the tobacco sector and in 2017 won damages for a client in trade infringement litigation (IPEC)
Stephen Reese is a partner at Clifford Chance and advises clients on both contentious and non-contentious intellectual property matters including patents, trade marks, trade secrets and copyright. Stephen represents and advises a broad range of clients in relation to the protection, exploitation and enforcement of their intellectual property rights. With significant experience representing clients within the life sciences and technology fields, Stephen has acted on some of the most significant licensing transactions in the life sciences industry. Since 2010, Stephen has been listed as one of IAM’s Top 250 Patent Licensing specialists.
Robert Maguire runs his own consultancy and his experience spans the full range of outsourcing and vendor management issues from determining what to outsource, through developing an appropriate contract strategy and building a performance dashboard to negotiation and conflict resolution to deal with the inevitable management issues that arise in any long-term relationship. Through his consulting, coaching, mentoring and skills development interactions, he helps major organisations in the public, private and not-for-profit sector transform their thinking and approach to their commercial relationships. Robert’s clients span a range of industries including pharma, consumer products, telecoms, transport and public sector both in the UK, the US and the Middle East. He is an accomplished line manager and consultant experienced in all aspects of purchasing and supplier management. Prior to establishing his own consultancy Rob was European Purchasing Manager for Reckitt & Colman plc where he established a European procurement function for the purchase of raw materials and sub-contracted products. He has worked as a consultant at Price Waterhouse and Ernst & Young and has worked with a number of pharma companies including Glaxo Welcome (GSK).
Tim Worden is a partner in the Intellectual Property Department of Taylor Wessing. He specialises in transactional, non-contentious and regulatory intellectual property in the life sciences, IT and hi-tech sectors. He advises on a range of IP, IT and commercial agreements, such as: technology and software licences, collaboration agreements, research and development agreements, clinical trials agreements and a range of services agreements; regulatory issues in the pharmaceutical industry – in particular in relation to the promotion of medicines in the UK – and in the medical devices sector; IP, IT and commercial issues arising out of mergers and acquisitions, venture capital investments and IPOs; IP and commercial contract disputes. Tim was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited, the UK subsidiary of the US pharmaceutical company. He has a degree in Natural Sciences (Chemistry and Biochemistry) from Cambridge University and a Diploma in Intellectual Property Law and Practice from Bristol University.
Laura Anderson is a Partner at Bristows in London. Since joining Bristows 16 years ago, Laura has specialised in commercial IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights across several industry sectors. In the life sciences sector, Laura advises on collaborations and licensing deals as well as downstream arrangements relating to clinical trials, manufacturing, marketing and supply.
Clive Douglas is a consulting life sciences lawyer and until recently he was General Counsel European Licensing & Transactions with Teva Pharmaceuticals, where he worked for 12 years. Clive handles a wide range of pharma-related commercial and corporate transactions, including IP, licensing, development, manufacturing, supply and distribution arrangements. Clive has previously held in-house commercial/corporate legal roles in telecommunications and property investment businesses and also has substantial law firm experience specialising in commercial, IT/telecoms and property law.
Catherine Drew is a partner at Pinsent Masons. She advises on all aspects within and on the border of the life sciences and healthcare sector. Catherine assists on both contentious and non-contentious matters, in particular advising on patent litigation and regulatory matters, whether in the life sciences sector or other related fields. Catherine also advises on patent litigation, in particular on a multi-jurisdictional basis and has experience in conducting patent litigation before all courts in the UK in a variety of sectors. Catherine has also spent time working in-house at one of the world’s largest pharmaceutical companies, with responsibility for coordinating all patent litigation in Europe. Given her technical background Catherine is able to provide support in creating persuasive written advocacy pieces directed to decision making bodies on matters such as medicine regulatory exclusivity, pricing and reimbursement and classification of products for the purposes of allocation of exclusivity rewards or value attribution. Catherine has also advised on regulatory issues arising in relation to borderline products and in related fields, such as the cosmetic sector, including consideration of the UK and European regulation of such products and compliance with the relevant advertising codes of practice. With her expertise Catherine is able to provide a ‘complete picture’ assisting clients in negotiating the various intellectual property and regulatory hurdles to bringing a regulated product such as a medicine to market in Europe.
Lucinda Osborne is a partner at Covington & Burling LLP. She is a member of the firm’s corporate and intellectual property practice groups and concentrates on transactional matters for pharmaceutical and biotech clients. She regularly advises clients in connection with their in and out-licensing activities, joint ventures, and collaborations and other strategic transactions, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. She has particular experience structuring and documenting global collaborations to reflect market practices and requirements in the United States.
Daniel Pavin is a partner in the Corporate Practice of Covington & Burling LLP’s London office. He has broad non-contentious and contentious experience, with an emphasis on advising companies for whom intellectual property rights are of paramount importance. In particular, Daniel advises life sciences clients on their licensing, partnering, collaboration and other strategic and commercial agreements, and on the IP aspects of mergers, acquisitions and strategic investments in the life sciences and technology sectors.
Sean is a qualified solicitor and Head of the Legal Team at Mewburn Ellis LLP. Once upon a time he was a scientist. He gained his BSc in microbiology from Imperial College, London and a PhD in the same subject from the University of Cambridge (Trinity Hall) where he focussed on the biochemistry of Pseudomonas sp. bacteria. On completing his PhD, however, he decided to apply his science to the legal profession and eventually trained as a solicitor at Slaughter and May. When he qualified Sean left the City to establish the technology transfer office at the London School of Hygiene & Tropical Medicine. Some years later the love of surfing sent him West and he joined the Bristol office of Osborne Clarke where he headed the transactional intellectual property team.
Sean advises his clients on technology transfer and the exploitation of intellectual property. This includes advising on strategy, conducting due diligence and preparing and negotiating transactional agreements (often in the context of corporate transactions). He also advises on life science/pharma regulatory issues.
Sean has particular experience in the life science, clean technology and defence/engineering sectors. In Chambers & Partners (2012) he was noted as “an expert on the non-contentious side, with a strong background in biotechnology that makes him extremely popular with clients”.
Lydia Torne, Managing Associate at Simmons & Simmons, has been involved on a range of contentious and non-contentious intellectual property matters, with a particular focus on transactional IP in the life sciences sector. Lydia regularly advises on a range of contractual issues including commercial licensing arrangements, research and development agreements, consortium agreements, material transfer agreements, manufacturing and distribution agreements, clinical trial agreements, monetisations and IP aspects of corporate transactions and financings. Lydia also advises on life sciences regulatory issues including the promotion of medicines and devices, borderline product classification and interactions with healthcare professionals.
Tom Carver is a partner at JA Kemp. He has broad experience in patent litigation (infringement and validity) in pharmaceuticals, medical and mechanical devices, and electronics, including advice concerning threats provisions. Tom co-ordinates and manages litigation in multiple jurisdictions, and has particular expertise in biotech patent litigation. Tom has a degree in genetics and worked on the first patent case in the UK relating to genetically modified organisms, Monsanto v Cargill, and the first patent case in the UK on DNA sequences, Eli Lilly v Human Genome Sciences. He has been involved in some of the most significant patent cases in the UK in recent years. Tom lived in China for three years, where he managed intellectual property enforcement for Western clients, including Dyson. His experience includes patent (design, utility and invention), trade secret, trade mark and copyright litigation against companies in provinces across China in sectors including capital and consumer goods, cosmetics and medical devices. He also has experience of non-judicial IPR enforcement in China at trade fairs, online and by Customs seizures.
Chris Milton is a partner at JA Kemp. He has experience of patent work in all aspects of chemistry, including pharmaceuticals, drug formulations, polymers and catalysts. He has particular expertise in the field of respiratory medicine. Chris works with a variety of clients, from universities and start-up companies to large multi-national corporations. He handles drafting of new patent applications, particularly in the pharmaceutical and polymer fields, and subsequent prosecution of patent applications at the United Kingdom Intellectual Property Office and the European Patent Office (EPO). Chris also has considerable experience of filing and prosecuting patent applications throughout the rest of the world, and consequently in advising clients in relation to the management of their patent portfolios. He has experience of EPO opposition and appeal work, including both defending and opposing patents in the pharmaceutical field, and has attended oral proceedings at Opposition Division and Board of Appeal levels. In some cases the opposition work has been just one aspect of global litigation, and so Chris has gained experience of working alongside teams of litigators throughout Europe and the rest of the world. Chris has also been involved in advising on freedom to operate and due diligence matters.
Ben Thomas is a Supervising Associate at Simmons & Simmons. He has experience of working across a range of contentious and non-contentious intellectual property matters, with a focus on patent and supplementary protection certificate litigation. Assisted by his strong technical background in biochemistry, Ben has a particular interest in the life sciences sector. He has acted for clients in a wide variety of industries, including pharmaceuticals, vaccines and medical devices, TMT and consumer goods (e.g. laundry detergents, vaping devices). He has acted for clients in disputes before the English Patents Court, the UK and European Union Intellectual Property Offices, and the General Court and Court of Justice of the European Union.
Niels Ersbøll, Partner, Arnold & Porter LLP, advises clients on EU competition law in relation to cartels and restrictive practices, merger control, abuse of dominance, and State aid. He is currently involved in several pending EU cartel investigations. He advises on merger control investigations by the European Commission and competition authorities worldwide for clients such as General Electric, Boston Scientific, Pfizer, and Sanyo. Where investigations (mergers or cartels) are run by several authorities in parallel, he assists with overall strategy and coordination. Niels also has significant experience helping clients with designing and implementing compliance measures and conducting internal investigations and audits.
Sarah Cowlishaw is an associate in the London Life Sciences group at Covington & Burling LLP. Her practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labelling and promotion. On the commercial side, she advises on the full range of agreements that span the product life-cycle in the life sciences sector. Sarah’s expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements and regulatory services agreements. She also regularly advises on regulatory aspects of corporate/commercial transactions, particularly regulatory due diligence.
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