Whether you are raising capital, incentivising your staff, entering into a licence, protecting your intellectual property or preparing to sell your life sciences business, we can help you navigate the relevant legal and other risks.
We understand the challenges that early stage, growth and more established life sciences (including medical devices) companies and their investors face in this highly regulated area and in this difficult environment.
We use our industry insight to deliver pragmatic advice on fundraisings, investments, mergers & acquisitions, other transactions, commercial disputes and compliance obligations in the industry. We can also support with patent drafting, filing, prosecution and where necessary litigation. We have particular experience in relation to patents for medical devices.
Life sciences businesses face a range of commercial and legal opportunities and challenges:
- The expiry of patents for many blockbuster and other drugs - the so-called “patent cliff”, the increasing scope this creates for the marketing of generic drugs and the growing take-up of biosimilar medicines is driving consolidation in the market, including through mergers, acquisitions and joint ventures, and creating opportunities for start-ups and growth companies.
- Smaller companies require strategic or financial investment. Even the smallest companies in this market need to have a clear business plan and supportive investors, and be able to demonstrate they have protected their intellectual property and complied with data protection and other laws and regulations.
- Companies in this space usually require ongoing protection of their trade marks, copyright, databases and other intellectual property rights, as well as their patents. Our Intellectual Property and Trademarks teams can deliver solutions that are sensitive to your goals, budgets and strategy and are complemented by advice on contractual, employment law, tax and insurance considerations.
- Data, data protection and information security are crucial areas of focus in this space, notably in respect of clinical trials. Regulators like the Information Commissioner’s Office are likely to take any breaches of data protection obligations by life sciences businesses very seriously.
- Manufacturers of medical devices will need to consider the more stringent obligations introduced under the EU Medical Device Regulation.
- Any transactions in this area are likely to involve detailed legal due diligence, warranties and negotiation of how risks should be allocated.
We have experience advising on all these matters for life sciences businesses and their investors, helping our clients to pre-empt and find solutions to the commercial and legal challenges that they face.
Our life sciences experience
- Advising Iksuda Therapeutics - an antibody drug conjugation platform, on its Series A $47m funding round, led by Mirae Asset.
- Acting for US global leader in the distribution of pharmaceutical supplies on the construction and fit out of its UK facility to comply with the requirements of the Medicines and Health Care Products Regulatory Agency.
- Advising a private equity-owned consumer healthcare company on the acquisition of over-the-counter brands from a pharma company and on a bid for some further brands being sold through an auction process.
- Acting for BGF as lead investor on the £33m Series B investment round of biopharmaceutical company Phoremost.