Our specialist life sciences lawyers, including several who have degrees and doctorates in relevant disciplines have extensive knowledge of the sector and first-hand experience working in the pharmaceutical industry.
Our lawyers have led complex, multi-jurisdictional life sciences patent and SPC litigation, acting both for brand owners and generic drug manufacturers. They have experience co-ordinating cross-border patent litigations, advising on freedom to operate and clearing the way, helping clients with market access as well as market protection.
We have practical experience in the highly regulated field of drug development, expertise that includes registration, regulatory and compliance regimes and pharmacovigilance along with pre-clinical development and phase I-IV clinical trials.
We understand the full scope of legal agreements that underpin the development stage of new products, including evaluation, pipeline, co-development and out-licensing or in-licensing arrangements. We can advise on the range of options and legal positions in these agreements which represent business critical factors for life sciences’ clients, and our IP lawyers excel in this area.
As more and more pharmaceutical clients move into digital health, we have specialist knowledge and experience in the team to advise also on issues in technology and on the risks and opportunities in connected health, as well as wider Medtech experience.
Our lawyers advise on a broad spectrum of issues including:
- IP transactions, licensing and development agreements
- patent and SPC litigation
- manufacturing and supply agreements
- regulatory issues
- brands and marketing
- strategic advice for corporate transactions
- funding and state aid
- development, commercialisation and regulatory compliance strategies
We have handled transactions and disputes across a range of life sciences disciplines including pharmaceuticals, biotech products (including antibodies) and medical devices.
Team members’ experience includes:
- acting for multinational company focusing on generic products in an action successfully to revoke the SPC for a dual combination product for the treatment of HIV, under Article 3(a) of the SPC Regulation and other grounds
- advising and negotiating a multi-million pound complex agreement for a client which includes licensing of a patent application, co-development work, milestone payments and assignment of the patent application on the successful outcome of the clinical trials
- advising MiRNA Diagnostics on a patent licence and assignment for its novel traumatic brain injury medical device
- acting for a major pharmaceutical drug manufacturer and brand owner in a precedent-setting patent case, successfully defending an action to revoke the client’s patent/SPC for its blockbuster drug
- advising MidTech (the NHS Innovation Hub for the West Midlands) on a patent assignment and revenue sharing agreement for a bespoke new COPD (Chronic Obstructive Pulmonary Disease) App for interactive COPD self-management and remote monitoring of key metrics
- advising a connected health medtech company on a number of important aspects of the commercial sale of one of its medical devices in accordance with the EU Medical Device Regulations, including its marketing campaign and the structure of payments to healthcare professionals to ensure compliance with the EU Medical Device Regulations and the relevant code of practice for the healthcare professionals was not breached
- acting for a pioneering epigenetics testing company on its first seed investment round. Including assistance with the due diligence activities required for the investment which required an understanding of the science behind epigenetic factors affecting welfare and chronic disease and also the issues for personalized healthcare
Other life sciences clients include:
- Profile Pharma
- AMR Centre
Life sciences is part of Shoosmiths’ wider intellectual property offering. If you would like help finding the right team or lawyer please contact us on +44 (0)3700 863 000 or contact us by email to [email protected].