In such a highly regulated industry and in these turbulent and uncertain times, understanding the key challenges of negotiating and drafting an effective and watertight contract on an international level are complex topics. They can be difficult for even the most well-equipped in-house lawyer and most often it is not the lawyer in the driving seat.
Commercial managers from all areas of the pharmaceutical industry are leading negotiations and drafting and managing key contracts on a daily basis. 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 current laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.
This programme will:
- Deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
- Focus on competition regulations pertinent to pharmaceutical industry agreements
- Analyse the commercial and legal issues affecting pharmaceutical industry agreements
- Examine collaboration and licensing agreements
This unique and highly interactive two-day programme looks at all stages of the contracting process and aims to deliver applied training through a balanced blend of practical learning. The presenters will use a mixture of practical exercises and cases from the pharmaceutical industry to ensure you leave the seminar with the knowledge and skills to perfect all stages of the contracting process.
Benefits of attending
By attending this seminar, you will:
- Update your practical skills when drafting effective licensing and collaboration agreements
- Explore the current issues relating to IP including the Unitary Patent and Unified Patent Court
- Understand the key intellectual property issues affecting pharmaceutical industry agreements
- Explore the implications of SPCs for pharmaceutical industry agreements
- Learn how to draft contracts to avoid anti-trust infringement
- Familiarise yourself with the key commercial and legal issues that affect pharmaceutical industry agreements
- Gain knowledge of the key issues in clinical trial agreements, contract manufacturing agreements and co-promotion, co-marketing and distribution agreements, and material transfer agreements
- Get to grips with competition law relevant to doing deals in the pharmaceutical industry and best practice tactics to use
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Course Provider
Mr Ben Thomas,
Supervising Associate ,
Simmons & SimmonsBen 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.
Fred Nicolle,
Simmons & SimmonsFred Nicolle is a UK and European qualified patent attorney (CPA, EPA) at Simmons & Simmons. He has over 15 years experience specialising in patent prosecution and contentious matters for the life sciences sector. He has particular expertise in pharmaceuticals, medical devices, consumer health products, cosmetics, foods and health supplements. He graduated from the University of Cambridge with a Master of Natural Sciences degree with a final year research project in synthetic organic chemistry.
Fred has extensive experience of contentious patent proceedings in opposition at the European Patent Office and in national litigation, having defended patents for numerous commercially important products. Notable examples include the defence of patents for Noctiva™ (desmopressin acetate nasal spray), Bendeka® (bendamustine HCl injection), Revlimid® (lenalidomide), Xeplion®/Invega Sustenna® (paliperidone palmitate), wound dressings, and contact lenses.
Fred is featured in The Legal 500 and IAM Patent 1000 as a recommended patent attorney.
Jonathan Dack,
Arnold and PorterJonathan Dack is a member of the Life Sciences group, advising on a wide range of commercial transactions involving intellectual property, technology and data. With over ten years working in law firms and pharmaceutical companies, his experience includes drafting patent licenses and research collaboration agreements, supply and distribution agreements, clinical trial agreements, and advising on IP commercialization strategy. Jonathan also represents clients in private company M&A (both domestic and cross-border) and manages integration exercises that involve complex IP and technology issues. Jonathan holds an MSc in Regenerative Medicine alongside his legal qualifications. He acts as a Non-Executive Director and Trustee for the UK Stem Cell Foundation.
Mario Subramaniam,
Pinsent MasonsMario Subramaniam is a Legal Director in the Life Sciences Transactions team at Pinsent Masons. As a former research scientist, he has a passion for the life sciences and has expertise in advising clients on intellectual property, commercial and regulatory aspects of the pharma, biotech, medtech and digital health sectors. He has advised on agreements that span the product life cycle, including strategic licensing and research collaboration arrangements, clinical trials, manufacturing, supply and distribution agreements. Having previously been in-house counsel at a number of prominent life science companies, Mario has a deep understanding of clients’ needs in this sector and is renowned for his clear and practical advice.
Mr Tom Carver,
Partner ,
JA KempTom 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.
Mr Niels Ersbøll,
Partner ,
Arnold & Porter LLPNiels 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.
James Agnew,
Simmons & SimmonsJames Agnew is a supervising associate at Simmons & Simmons. He has worked on a range of contentious and non-contentious intellectual property matters including commercial licensing, collaboration agreements, software protection, settlement proceedings and the intellectual property aspects of corporate transactions, financings and commercial arrangements. James also advises on life sciences regulatory issues including the promotion of medicines and devices and interactions with healthcare professionals. He has experience in a wide range of industries, including life sciences, TMT, finance, Fintech, energy and defence, with a focus on transactions involving intellectual property.
Mr Stephen Reese ,
Partner ,
Clifford ChanceStephen 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.
Peter Rudd-Clarke,
Osborne ClarkePeter specialises in helping businesses navigate regulatory challenges and liability risks, particularly in the life sciences, healthcare and consumer products sectors.
Peter advises a range of businesses including medical device companies, software producers, pharmaceutical manufacturers, service providers and producers of lifestyle products.
His regulatory experience includes advising on the regulation of medical devices and consumer products, as well as CE/UKCA marking, clinical trials, regulatory investigations, the application of industry codes and ongoing compliance matters.
The litigation and risk management side to Peter’s practice involves defending manufacturers of complex products against liability claims, often across multiple jurisdictions; as well as advising clients on product recalls and corrective actions.Peter is ranked in the Legal 500.
Mr Ewan Townsend,
Counsel ,
Arnold & Porters Food, Drug and Medical Device practiceEwan Townsend is Counsel in Arnold & Porter’s London office and assists clients in the life sciences sector on regulatory and commercial matters. He has experience with a broad range of regulatory issues that arise throughout the medicinal product and medical device life cycle, including research and development, clinical trials, marketing authorisations, manufacturing, distribution, advertising, pricing and reimbursement. Ewan’s work also includes drafting and negotiating commercial agreements for his life sciences clients, such as licence agreements, manufacturing, distribution and supply agreements, clinical trial agreements and service agreements, and advising on the intellectual property and regulatory issues that arise in the context of those transactions.
Who Should Attend
Personnel from R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing functions, including:
- In-house counsel
- Commercial and contract managers
- Business development managers
- Purchasing and procurement personnel
- Heads of legal departments
- Legal advisers
- Patent, IP, trade marks or licensing counsel
