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Life sciences IP

Our Life Sciences Group is a highly recommended, multi-disciplinary legal team with extensive experience of the issues faced by the different sectors of the pharmaceutical, biosciences and medical devices industries. Lawyers across the Group have extensive experience of the issues faced by the international biomedical industry with patent lawyers across the world providing cutting-edge advice to the life sciences sector. Our Life Sciences Group is highly integrated and are able to advise you in multiple jurisdictions.

We understand the challenges facing your industry and combine our scientific knowledge with legal experience to understand your operational needs and to provide commercially-focused advice. We also have an

understanding of the regulatory issues within the healthcare sector and can advise you on how to maximise business opportunities whilst operating within this framework.

You will benefit from lawyers who understand your business, who can look beyond individual deals to the business and industry drivers and provide guidance that is as commercially smart as it is legally correct.

In the Life Sciences arena, our team provides a comprehensive service across Commercial Contracting including Intellectual Property transactions such as licensing and on complex product and business acquisitions and disposals including the transfer of marketing authorisations and brands. The wider team also covers Corporate Transactions such as M&A, as well more niche areas such as Competition, Data Protection, and Product Liability. Through our Munich office we can also assist with patent prosecution and maintenance.

We act for a range of clients such as Alere, Angel Biotechnology, AstraZeneca, Catalent Pharma Solutions, Cochlear, Edwards Lifesciences, IDIS, Roche, Shire Pharmaceuticals, Smiths Medical, Teleflex, United Drug and Vertex Pharmaceuticals, as well as smaller companies and advise on a range of matters.

Life sciences IP experience

IP experience

We deal with a full range of services including strategic advice on IP rights, prosecution of patent, utility model, trade mark and design rights applications at European and national offices, opposition proceedings at European and national offices, IP portfolio management (patents and trade marks) drafting expert opinions, due diligence support and dealing with infringement actions.

We provide a full range of advice on intellectual property issues, including:

  • brand selection and clearance, advising on the INN system and on pharmaceutical trade mark registration programmes
  • prosecution of patent, supplementary protection certificates, utility model and design rights applications at European and national offices
  • opposition proceedings at European and national offices; IP portfolio management (patents and trade marks)
  • helping clients to structure clinical trials to take advantage of the Bolar exemption and experimental use exemption to minimize the risk of patent infringement
  • advising on complex technology licences and partnering arrangements in the pharmaceutical and biotech sectors

In the court room, our work includes advising on pharmaceutical and biotech patent disputes, including infringement actions, applications for urgent relief and obtaining freedom to operate for clients by clearing the path with revocation actions or applications for declarations of non-infringement. We also advise on parallel import disputes, including developing coherent and effective policies to address repackaging, co-branding and de-branding. Counterfeiting is an increasing problem in the pharmaceutical sector, and we can also help clients implement a vigorous anti-counterfeiting strategy.

Our work includes advising on pharmaceutical and biotech patent disputes, including infringement actions, applications for urgent relief and obtaining freedom to operate for clients by clearing the path with revocation actions or applications for declarations of non-infringement. We also advise clients on parallel import disputes, helping them to navigate the detailed case law developed by the courts in the EU in this area and to develop coherent and effective policies to address repackaging, co-branding and debranding strategies.

Counterfeiting is an increasing problem in the pharmaceutical sector, and we can also help you implement an anti-counterfeiting strategy suitable to your key products and routes to market.

  • Global pharma company - on the implications of co-ownership of patents for a new chemical entity in six jurisdictions in the EU, and associated issues of exhaustion of patent rights and compulsory licensing.
  • U.S. biopharma company - on data exclusivity, market exclusivity and SPC issues arising put of the orphan designation of treprostinil sodium in the EU for the treatment of pulmonary arterial hypertension.
  • Global pharma company - on the impact of the EU Paediatric Regulation and its orphan drug status in the EU on marketing authorization pathways, intellectual property protection and data/market exclusivity.
  • Cochlear - on a Technology Development and License Agreement with GN Resound, a large conventional hearing aid manufacturer.
  • Oxyrane - in relation to a complex transaction for the in licensing of IP over chiral epoxide production technology and subsequent in licensing deals with a French research institution for upstream activators sequences and recombinant promoters sequences functional in Yarrowia.

Regulatory experience

We deal with many regulatory issues as part of our advisory and transactional work, whether it be from advising on Bolar exemptions to Marketing Authorisation transfers. We guide clients through the complex interaction between the systems of marketing authorization, data exclusivity and availability, scope and duration of supplementary protection certificates; due diligence support in relation to product acquisitions. This can related to both active ingredients authorized centrally by the European Medicines Agency and by national authorities via the decentralized procedure, orphan drug market exclusivity and issues arising under the EU Paediatric Regulation.

  • Advising on the reclassification of a drug from prescription only to over the counter (pharmacy only).
  • RMS Innovations -on the regulation of its kits and services relating to autologous tissue implants, and preparing a standard contract for the supply of kits and services.
  • Advising on the sale of an unlicensed pharmaceutical in the UK for compassionate use.
  • C.B. Fleet Inc. - prepared a EU Pharmacovigilance Agreement for use by it with its EU distributors.

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Eversheds Sutherland is the name and brand under which the members of Eversheds Sutherland Limited (Eversheds Sutherland (International) LLP and Eversheds Sutherland (US) LLP) and their respective controlled, managed and affiliated firms and the members of Eversheds Sutherland (Europe) Limited (each an "Eversheds Sutherland Entity" and together the "Eversheds Sutherland Entities") provide legal or other services to clients around the world. Eversheds Sutherland Entities are constituted and regulated in accordance with relevant local regulatory and legal requirements and operate in accordance with their locally registered names. The use of the name Eversheds Sutherland, is for description purposes only and does not imply that the Eversheds Sutherland Entities are in a partnership or are part of a global LLP. The responsibility for the provision of services to the client is defined in the terms of engagement between the instructed firm and the client.