In such a highly regulated industry and in these turbulent times, 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, especially with the complications of Brexit fast approaching.
MODULE 1: INTELLECTUAL PROPERTY ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS
- Practical workshop
- Intellectual property terms in collaboration and licensing agreements
- SPCs - Supplementary Protection Certificates - securing the full commercial potential of your product
- The Unitary Patent, the Unified Patent Court and Brexit
- When does R&D infringe patents? Understanding 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
- Medicines regulations using regulatory processes to define contractual obligations
- Key issues in clinical trials and related agreements
MODULE 3: WORKSHOP ON COLLABORATION AND R&D AGREEMENTS
- Negotiating and drafting collaboration and licence agreements
MODULE 4: COMPETITION LAW WORKSHOP
- Introduction to relevant EU competition law rules
- Practical workshop
- Current competition law issues
MODULE 5: NEGOTIATION SKILLS IN THE PHARMA SECTOR
- The rise and rise of the negotiator
- Practical exercise
- Negotiate and succeed
- Structure for control
- Personal style and negotiation
- Practical exercise
- Moving into engagement
- Influencing and persuasion
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 commercial and 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.
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.
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.
Sean Constable is an associate in the life sciences group at Mewburn Ellis LLP and is a European and Chartered Patent Attorney based in London. His work focusses on patent prosecution before the European Patent Office (EPO) and he has experience of both offensive and defensive opposition proceedings. He has experience filing and prosecuting patent applications on a broad variety of different technologies, with particular expertise in gene editing, protein engineering and antibody-based therapeutics. Sean also has experience working in-house at a biotechnology company in Cambridge, having been seconded there during his training and where he assisted the company with their patent portfolio and due diligence. He has a bachelor’s degree in Biochemistry from Imperial College London and a PhD in Neuroscience from University College London.
Mario Subramaniam, Senior Associate, Pinsent Masons, specialises in advising life science clients and other clients who rely heavily on intellectual property for their core business. He has negotiated strategic licensing, collaboration and other technology transfer arrangements, often with clients and partners in multiple countries. He has expertise drafting and negotiating agreements that span the product life-cycle from clinical trial agreements to complex licensing arrangements; from research and development agreements to manufacturing, supply, distribution and marketing agreements. Having previously worked as in-house counsel at a number of prominent life science companies, Mario has an intimate awareness of the challenges facing such clients and the need for clear and practical advice. Prior to qualifying as a solicitor in Australia and then in England and Wales, Mario worked as a research scientist in the fields of biochemistry and immunology at the University of Melbourne and Murdoch Children’s Research Institute (part of the Royal Children’s Hospital).
The Cavendish Hotel
81 Jermyn Street