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 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. She is 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 is a regular speaker at about 30 conferences a year in the UK and abroad. 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.
Stephen is a partner at Olswang 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.
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 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 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, Supervising 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.
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 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.
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