Our specialist multi-disciplinary LIFE SCIENCES team advises businesses at all stages of the medicines supply chain
Our multi-disciplinary life sciences team advises a wide range of clients in the life sciences sector including some of the world’s largest pharmaceutical companies, biotech companies, healthcare providers and medical devices manufacturers.
We advise life sciences companies at all stages of the medicines supply chain on the full range of legal issues affecting them including competition, regulatory and compliance, intellectual property including patents and trade marks, product life cycle, clinical trial agreements, collaboration, licensing and other commercial transactions.
We also have extensive experience of advising on acquisitions in the life sciences area and in advising banks and financial institutions with an interest in this space.
Intellectual property rights are of vital importance to companies in the life sciences sector and are often the most valuable assets of the business. We can help companies in the life sciences and healthcare space to effectively and efficiently protect and exploit their intellectual property rights.
We have extensive experience of handling litigation at all levels of the UK courts, as well as managing multi-jurisdiction disputes and working with leading IP practitioners in the overseas territories in which our clients are active. However, an equally important aspect of our work is advising on the effective protection, use and licensing of IP rights to maximise our clients’ commercial advantage and prevent disputes arising. Our team advises on the full range of contentious and non-contentious intellectual property including patent litigation and licensing, and trade secrets litigation.
Our Commercial team has extensive experience and in-house expertise of the legal issues that affect life sciences and healthcare companies on a daily basis.
Our experience extends to generics, animal health, eye care, innovators, manufacturers, vaccines, medical devices as well as biotech and delivery systems. In particular, we work closely with in-house life science and pharmaceutical teams and regularly assist with the drafting, negotiation and termination of commercial agreements. These include NDAs, clinical trials, joint working agreements and collaboration arrangements, sales or purchase terms, rebates, sales of marketing authorisations. We also advise on manufacturing and supply contracts, warehousing and logistics, standard template agreements, appointment of field sales teams, outsourcing and procurement and licensing and marketing contracts.
Competition and EU law
Ensuring compliance with competition law should be a key priority of any life sciences and healthcare business. Because of the importance of the sector to the global economy, and the dynamic nature of life sciences markets, the sector is, and will continue to be, a high priority for enforcement. Competition law can also provide an opportunity for businesses to ensure that competitors play fair, and can result in substantial damages being awarded for infringements.
Our competition team is hugely experienced in the life sciences sector. We have many years’ experience of working with regulators and companies in this area. Experience includes advisory work, implementing compliance training, acting in relation to government investigations and dawn raids and carrying out litigation including judicial review of government policy.
Pharmaceutical and biotechnology businesses are subject to a huge range of regulations. In addition to general regulations (e.g. anti-bribery and corruption, competition law and data privacy), life sciences businesses are required to comply with a range of sector specific regulations and voluntary schemes.
We have experience of advising on both general and sector specific regulations impacting life sciences businesses. We have provided compliance training and have assisted businesses on issues as they arise. These include government investigations, including dawn raids, issues arising in the context of commercial and corporate transactions and day to day issues facing businesses.
We have considerable experience of handling disputes arising for clients in the life sciences sector over many years. We often work closely with the client’s in-house team and have developed a detailed understanding of the sector and what is important for their businesses.
Our work involves advice on issues as they emerge, mediation, litigation and arbitration. Where urgent situations arise we have considerable experience of seeking injunctive relief to prevent damage or loss.
In addition to disputes arising under licensing, supply and development agreements, we also deal with other issues such as product recall and claims arising. We also act for life sciences clients in relation to construction and engineering disputes.
Examples of our experience include:
- Successfully representing a multinational pharmaceutical company relating to a multi-million pound cross-border fraud to obtain freezing and seizure orders
- Acting for pharmaceutical clients in relation to dawn raids by the SFO on their UK offices
- Acted for an international life sciences company in an ICC arbitration against a foreign life sciences company
Corporate and Banking
We have experience of advising both buyers and sellers of companies and businesses in the pharmaceutical, life sciences and healthcare sectors. This includes management teams on leveraged transactions.
We have advised on equity fundraisings including private equity and development capital transactions and debt transactions including traditional senior bank debt but also warrants and other forms of finance.
Data protection issues are now high profile and often come under the spotlight. We act for organisations looking to resist Freedom of Information requests or dealing with Data Protection or data licensing issues. The arrival of the General Data Protection Regulations means that we are helping many organisations to prepare for its impact. Our team is well versed in data protection issues and has in-house experience for a worldwide major pharmaceutical company on data protection issues.
Our advice covers data licensing, dealing with sensitive personal data, data breaches, appointment of data processors in outsourced IT and services, transfers of personal data outside the EEA, making and resisting data subject access requests and freedom of information requests. We draft privacy and cookies notices, advise on notifications to the Information Commissioner’s office and assist in the preparation of policies and standard operating procedures including for surveillance and interception of emails and privacy impact assessments.
We work closely with our international colleagues on trans-border transactions and provide advice on implementation of the General Data Protection Regulations.
- Advising the UK stakeholders responsible for UK’s overall implementation of the Falsified Medicines Directive
- Advising an international pharmaceutical company on complex patent, regulatory and data protection issues
- Assisting a global pharmaceutical company on successful Judicial Review of Home Office policy