By Peter J Pliszka of Fasken Martineau DuMoulin
During the relatively short history of class proceedings in Canada, developers and manufacturers of medical devices and pharmaceuticals (medical products) have found themselves at the receiving end of a significant number of class action claims. To date, the main battleground in respect of these claims has been the certification motion, a preliminary step in which the court assesses whether or not a given claim should proceed as a class action.
Medical devices manufacturers are braced for the overhaul of the EU Medical Devices Directives. New Regulations, which are closer to final adoption than ever (although not quite there yet), are expected to clarify the regulation of medical devices in Europe – at least once the delegated and implementing acts have been put in place.
The eighth edition of this ever-expanding publication features over 1,200 listings from 417 law firms across four distinct areas of research: patent litigation, regulatory, product liability defence and transactional.
In this analysis of the life sciences legal market, the following individuals and law firms stand out as the most highly regarded in our research process.
The life sciences industry is continuing to evolve in a time of economic uncertainty, demographic transformation and technological innovation. Governments are moving towards stricter regulatory regimes, and more austere pricing and reimbursement policies. The spiralling cost of R&D, along with technological innovations, continue to push life sciences companies into partnering transactions, as well as driving M&A deal activity. Meanwhile, the burgeoning biopharmaceutical industry is now faced with the emergence of game-changing biosimilars. It is a challenging time for life sciences companies and legal teams alike.
This edition features the world’s leading life sciences practitioners divided into four discrete practice areas, comprising 360 patent litigators, 226 product liability defence experts, 229 regulatory specialists and 176 transactional lawyers from a total of 363 firms across 45 countries.
Hogan Lovells takes top spot in our research this year with an unprecedented level of recognition in our life sciences research. Following closely behind, Sidley Austin offers comprehensive global advice and excels in the regulatory side of the field. Bird & Bird has a dominant pan-European offering, especially with regard to patent litigation. Covington & Burling is also an instantly recognisable name in life sciences and a leading player in the regulatory and transactional fields on a global scale. Meanwhile, Arnold & Porter impresses, in particular, with its transatlantic regulatory advice. Firms also excel domestically, including Hyman Phelps & McNamara in the US, Bristows in the UK and Uría Menéndez in Spain.
We also select the five most highly regarded individuals from each of our patent litigation, product liability defence, regulatory and transactional chapters.
The life sciences industry has always faced a complex system of legal and structural challenges. Nowadays, however, pharmaceuticals, biotechnology and medical device companies face tougher regulatory enforcement, a stronger plaintiff bar, greater competition over patents and product pipeline issues – as well as an uncertain economic environment. This has led to profound changes in the legal marketplace in recent years.
In this edition Who's Who Legal singles out the world's leading individuals and firms in the field of life sciences law in four distinct areas: patent litigation; product liability defence; regulatory and transactional work. Once again international heavyweight Bird & Bird leads our research with more listings than any other firm across the four sections, with patent litigation a particular area of strength. Hogan Lovells follows close behind, with the firm garnering the most inclusions in the product liability defence sphere and Sidley Austin demonstrates particularly impressive regulatory expertise. Other standout firms include Covington & Burling, Arnold & Porter and Simmons & Simmons.
We also pick out the most highly regarded individuals in the world in patent litigation, product liability defence, regulatory and transactional life sciences law.
In this edition we divide our research into four distinct sections. No single practitioner earns recognition in all of the IP, product liability, transactional and regulatory sections, which demonstrates the diverse nature of the work in this sector.
For the first time in this edition we have focused our research on four distinct categories of life science-related work, with the aim of identifying the leading practitioners for each discipline. Through interviews with clients, lawyers and industry contacts we have picked out the foremost lawyers for related intellectual property disputes and counselling, regulatory matters, product liability defence work and transactional deals in the sector.
Bird & Bird leads our research with 31 individuals selected overall, followed by Hogan Lovells which fields 26 lawyers from nine different countries. Both Covington & Burling LLP and Sidley Austin LLP have 20 practitioners recognised, demonstrating the strength of their life sciences practice groups.
With the benefit of over 15 years of research and thousands of nominations from clients and private practitioners worldwide, Who’s Who Legal takes a closer look at developing trends in the legal market worldwide. In this edition we divide our research into four distinct sections. No single practitioner earns recognition in all of the IP, product liability, transactional and regulatory sections, a fact which demonstrates the diverse nature of the work in this sector.
This edition features more lawyers in a greater number of jurisdictions than its predecessors. The expansion attests to the continuing leaps in sophistication and geographical spread the discipline has undergone in the past year, despite the travails of the global economy in general and life sciences companies in particular.
In this section we analyse the findings of our research in greater depth to identify the firms and practitioners who stand out worldwide.
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Nominees have been selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Only specialists who have met independent international research criteria are listed.