Course overview
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 training 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 training course 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 course with the knowledge and skills to perfect all stages of the contracting process.
Benefits of attending
By attending this training course, 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
CPD Hours: 12
Course Content
- Day 1
- Understanding licensing and collaboration agreements
- Workshop: Understanding licensing and collaboration agreements
- The Unitary Patent and the UPC One Year On
- Third-party IP rights - freedom-to-operate searches and implications for pharmaceutical industry agreements
- Supplementary protection certificates (SPCs) - securing the full commercial potential of your product
- Understanding and drafting R&D agreements
- Day 2
- Medicines regulations using regulatory processes to define contractual obligations
- Key issues in clinical trials and related agreements
- Key issues in contract manufacturing agreements
- Key issues in co-promotion, co-marketing and distribution agreements
- Key issues in material transfer agreements
- Introduction to relevant EU competition law rules
- Practical workshop: Current competition law issues
Speakers
Mario Subramaniam
Mario is a partner at Bird & Bird and an IP and transactions specialist with extensive experience in the Life Sciences. He advises global Life Science clients on strategic IP licensing, collaboration and partnering transactions. He also supports those clients with M&A, joint ventures, asset acquisitions and disposals, strategic manufacturing, supply and outsourcing arrangements. Prior to qualifying as a solicitor, Mario worked as a research scientist in the fields of tumour immunology and molecular biology. Having spent a significant period of his career in-house advising Life Science clients, Mario brings a wealth of experience and a unique perspective to clients contemplating strategic transactions and partnerships. His experience and approach also brings great synergy to Bird & Bird's outstanding Life Sciences offerings, allowing an unrivalled opportunity to support clients with their most pressing challenges.
Tom Carver
Tom Carver is a partner at White & Black Legal. 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.
James Agnew
James 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.
Fred Nicolle
Fred 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.
Stephen Reese
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.
Peter Rudd-Clarke
Peter Rudd-Clarke 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.
Ewan Townsend
Ewan Townsend is a Partner at 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.
Niels Ersbøll
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.
Sharmela Kalmer
Sharmela Kalmer is a Partner at Gowling WLG (UK) LLP. Sharmela is a trusted advisor to a number of emerging and established innovative technology and life sciences companies operating in a range of sectors, including biotech and medtech. With a wealth of industry experience, Sharmela's sector knowledge gives her a solid understanding of the opportunities and issues faced by clients and how to navigate these issues to access new market opportunities.
