Intellectual property in Ireland
A&L Goodbody's intellectual property team handles a variety of complex matters in all areas of IP law, including representing clients before the General Court of the European Union. The firm specialises in the technology area, but beyond this it also advises on work involving media, retail, and financial services sector clients. The team is led by John Whelan, while the 'practical, responsive and solution-focused' Claire Morrissey advised the Bank of Ireland on its digital transformation programme, involving IP issues related to software licensing. John Cahir is experienced in both contentious and non-contentious work, and advises large multinational organisations.
‘The firm impresses with their strength and depth and manages to blend this well with accessibility and commerciality. They take time to understand things from a business and a legal perspective. Advice is always practical, clear and solution-focused.’
‘I work closely with Claire Morrissey and her team. Claire is always available, practical, responsive and solution focused. She ensures, that as her client, we are kept closely involved in the deal process. She takes the time to ensure all stakeholders are fully engaged.’
Amgen Technology (Ireland)
Boston Scientific Corporation
Accord Healthcare Ltd
Commodores Entertainment Corporation
Bank of Ireland
- Defended Boston Scientific Corporation in patent proceedings brought by Edwards Lifesciences PVT.
- Advised Commodores Entertainment Corporation in a dispute with Fifth Avenue Entertainment LLC, in a case before the General Court of the European Union.
- Acting as lead adviser to Bank of Ireland on the Bank’s digital transformation programme Core Banking Systems, including advising on the licensing of business critical software.
Mason Hayes & Curran LLP has a prominent practice in the area of contentious IP law. Practice head Gerard Kelly has acted in some of the most prominent IP law cases of 2019. The firm's expertise in contentious matters was demonstrated by its representation of Teva Pharmaceuticals in a high-profile dispute over its launch of a generic retroviral HIV drug. The firm also handles brand portfolios for a number of companies. Brian McElligott specialises in non-contentious work, and led on managing Boyne Valley Group's trade mark portfolio. Richard Woulfe retired from the practice in 2019.
Boyne Valley Group
Fresenius Kabi Deutschland
Irish Educational Publishers
- Representing Teva Pharmaceuticals in a patent infringement and invalidity action concerning an anti-retroviral HIV drug.
- Represented Fresenius Kabi Deutschland in patent infringement proceedings concerning a biosimilar used in the treatment of inflammatory diseases.
- Acted for Facebook Ireland in the defence of trade mark infringement proceedings issued by Allianz.
Led by the 'very knowledgable' Deirdre Kilroy, Matheson's IP practice provides 'pragmatic, commercial advice' and advises on trade marks, copyrights, and patents. The IP team forms a part of its broader technology and innovation team. In addition to its non-contentious advisory work, the firm also handles contentious matters for multinational clients, including Irish proceedings relating to a high-profile copyright infringement case against Sony Music Entertainment, involving the band One Direction.
‘I used Matheson for a cross-border deal involving certain complex intellectual property issues and contractual rights. They were down-to-earth pragmatic and came up with a number of potential solutions to solve the issue.’
‘My experience with them is in the trademark area. They have absolute command of the substance of the trademark laws and also important insights on how Brexit will affect certain Ireland-related trademark matters.’
‘They provide pragmatic, commercial advice that is specific to our sector.’
‘Deirdre Kilroy — very knowledgeable, sound commercial judgement, responsive to clients and effective in handling difficult opposing counsel.’
‘Chris Bollard is a leader in data protection and IT. He is the “go-to” guy on GDPR. His approach is without fail focused yet flexible. Chris always provides pragmatic, commercially and legally sound advice on GDPR.’
Norwegian x NBA
Sony Music Entertainment
- Assisted airline Norwegian with negotiating the contract for its sponsorship of the 2019 NBA London game.
- Ongoing advice to Irish Music Rights Organisation.
- Prepared a legal agreement between Guaranteed Irish and its member companies in respect of use of the GI trade mark.
Offering clients 'a strong depth of skills' in intellectual property law, McCann FitzGerald handles contentious and non-contentious matters for public and private sector clients. The practice works on all areas of IP law, including patent, copyright and trade mark infringement. The practice is headed by Fiona O’Beirne, whose approach is 'dedicated, resolute, thorough and forensic' , and Paul Lavery, 'a go-to expert in this area'. Recently promoted partner Douglas McMahon is 'excellent' and specialises in advisory work, and Adam Finlay is also highly praised by clients.
Fiona O’Beirne; Paul Lavery
‘They have a strong depth of skills in this area and the overall service delivered by the firm in the handling of IP issues has been top class.’
‘What stands out is the team’s legal expertise coupled with their extensive knowledge across a wide range of industries and commercial application. They also have a great ability to quickly understand your needs as a client, McCann FitzGerald has been our external lawyers for 15 years or more and we wouldn’t think of going somewhere else given the quality and consistency of service they provide, along with their deep understanding of our sector and our firm.’
‘We have been working together with Fiona O’Beirne and Shane O’Brien for the past year or so. It has been a pleasure working with them and I have been really impressed. Compared with other Irish counsel I have worked with in the past they have been much more involved in the details of the technical (scientific) aspects of the case. They have immersed themselves in the technical details and made a really valuable contribution in that regard. I have been particularly impressed by the clarity of their drafting and the fact that they have been prepared to “come off the fence” and give direct advice. They are extremely “user friendly” and it has been great working alongside them.’
‘We used Fiona O’Beirne to coordinate Court proceedings (including choice of appropriate barristers to plead in Court) to be brought in the Dublin High Court. The entire team has been exceptionally professional, supportive and helpful in moving onwards and coordinating the Irish matter with other Court proceedings pending abroad.’
‘Over the years I have worked (as a client) with most of the large legal firms in Ireland. Thus far McCann is the best. We have dedicated partners assigned and where their expertise is lacking in a particular area we are quickly moved to another partner. Our key contact and key advisor is Adam Findlay (a partner in the Technology & Innovation Group) who has been excellent both in terms of advice and in terms of dealing/meeting with my clients and collaborators (creating of research agreements, licences and dealing with investors).’
‘Doug McMahon and Adam Finlay are the two partners we most closely work with in relation to IP matters. Their qualities are the ability to quickly understand our particular issue and requirements, their excellent response times, the occasions they will go the extra mile and work late or during the weekend, and the fact that you feel you are their only client.’
‘Paul Lavery is the go-to expert in the area. He is our go-to person and is a pleasure to work with. Doug McMahon is excellent in this area and is developing really well as a partner in the team.’
‘In relation to intellectual property, the main partner involved was Fiona O’Beirne who provided excellent analysis and insight in relation to a difficult litigation case, delivering an approach that was dedicated, resolute, thorough and forensic. Senior Associate Mark Ellis also worked with us on IP issues and delivered an assured, professional service of a high calibre.’
Transport Infrastructure Ireland
National Transport Authority
- Acting for Vodafone in a number of proceedings related to patent and copyright issues.
- Representing Gilead in Commercial Court litigation against Mylan and Teva relating to its supplementary protection certificate for HIV medicine Truvada.
- Advising Transport Infrastructure Ireland on all intellectual property issues (including trade mark licensing, ownership, branding and brand guidelines issues) arising in connection with the outsourcing of the operation of free flow tolling on the M50, the motorway around Dublin city.
Specialising in the life sciences and pharmaceutical sectors, Whitney Moore has handled some of the most high-profile contentious cases in the space in recent years. A particular highlight was its work defending Merck and Mylan in a dispute relating to pharmaceutical patents. Beyond life sciences, the firm has also acted on cases involving trade secrets and passing off, demonstrating the breadth of its experience. The practice is jointly headed by Aoife Murphy, whose 'thorough knowledge of IP' is valued by clients, and Robin Hayes, who 'provides careful strategic input and detailed knowledge of the law'.
Aoife Murphy; Robin Hayes
‘Highly knowledgeable IP section with two top notch partners who are helpful, hard working and practical. Aoife Murphy has a thorough knowledge of IP and works incredibly hard to bring cases together. Robin Hayes provides careful strategic input and detailed knowledge of the law and science.’
Merck, Sharp & Dohme Corp.
EISAI R&D Management Co.
Edwards Life Sciences PVT
F. Hoffman La-Roche
- Acting for Merck, Sharp & Dohme Corp. in patent infringement proceedings against Clonmel Healthcare, concerning Merck’s supplementary protection certificate for a cholesterol drug.
- Representing Edwards Lifesciences in proceedings before the Commercial Court against Boston Scientific, alleging infringement of Edwards’ patent in respect of transcatheter heart valves.
- Acting for Epsilion in High Court proceedings seeking damages and injunctive relief for breach of confidence (trade secrets).
William Fry's sizeable IP team handles work across the full gamut of IP matters, including contentious and non-contentious work. David Cullen heads the non-contentious IP team; his work includes advising multinationals including Diageo and Valeo Foods Group on their brand portfolios. Head of contentious IP Laura Scott is 'highly experienced' and very active in contentious IP litigation. Other team members include Colette Brady, who has extensive experience in trade mark litigation, and Leo Moore, who 'always finds practical and commercially oriented solutions to solve the client's issues'. Additionally, consultant Carol Plunkett handles a number of contentious matters, including working alongside Scott and Moore to represent GlaxoSmithKline in a trade mark invalidity and passing off action.
Laura Scott; David Cullen
‘The team is very strong in technology, food & beverage and pharma but is a full service team. The team is very responsive, cost efficient and always finds practical and commercially oriented solutions to solve even the most complex cases in favour of the client.’
‘I have worked with William Fry for many years. Laura Scott has now taken up the role as lead and is highly experienced and expert in all areas of IP. Colette Brady also works on that team and is excellent. Aside from her subject expertise she works extremely hard and ensures that all issues are thoroughly prepared. I have worked with Carol Plunkett, Laura and Colette on a number of cases in the last 12 months ranging from SPC validity proceedings to copyright. We are awaiting judgment in one case where I expected we would lose at the proofs stage but now believe that we will likely win because of the work put in by the team. On the IP side I would rate Fry as the leading firm in Ireland.’
‘I work closely with Leo Moore. Leo is a well known/leading practitioner in the Irish market and someone whom I met on the IP conference circuit. I like to work with people I know and in the case of international work, those that are highly regarded in their own country. Leo is very personable and as a lawyer, he is very responsive, cost efficient and always finds practical and commercially oriented solutions to solve the client’s issues.’
‘I rate both Laura Scott and Carol Plunkett highly in terms of competence, experience, knowledge and judgement.’
‘William Fry is the standout firm in Ireland for intellectual property litigation and patent litigation in particular.‘
Bord Gáis Energy
Royal Dublin Society
- Advising X-Celeprint on complex multi-jurisdictional patent licensing arrangements and research and development agreements relating to its market-leading micro-transfer printing technology.
- Acting for both Diageo and Valeo Foods Group on all aspects related to managing their brand portfolios.
- Advising on the successful conclusion of highly complex negotiations in relation to the naming rights for the stadium in Dublin owned by the RDS, which is the home ground for the current Pro14 champions, Leinster Rugby.
Founded in 2016, Acuatus handles contentious and non-contentious IP matters for multinational corporations. Recent work includes successfully representing Mylan in a high-profile case regarding a generic HIV drug. Practice head Alistair Payne is 'very reliable and extremely accurate', while the firm's 'excellent network with international partners' is demonstrated by its work alongside local firms, including representing Rondo in trade mark disputes in Ireland and the US, and Athlone in a patent infringement case in Germany. Additionally, the firm manages Groupe Danone's trade mark portfolio in Ireland.
‘They are very competent and give good strategic advice, and have an excellent network with international partners.’
‘Alistair Payne is very reliable in everyday cooperation and extremely accurate.’
Rondo Foods GmBH
Ogalas Unlimited (trading as Home Store & More)
Awas Ireland Ltd (Dubai Aerospace Group)
Athlone Extrusions Limited
- Successfully represented Mylan in a case against Gilead, involving Mylan’s planned launch of a generic HIV drug.
- Acted for Rondo, a pet food company, in the High Court in a trade mark infringement action brought by Mars, and also acted for Rondo in instructing US counsel in a separate claim brought by Mars in the US.
- Represented Athlone, in conjunction with CMS Hasche Sigle and Eisenfuhr Speiser, in a German patent infringement case brought by Senoplast.
Arthur Cox‘s intellectual property team recently widened its scope and relaunched its trade mark filling practice, while it also continues to be well known for handling IP advisory and disputes matters and assisting with tax-efficient IP structures. The team is led by Rob Corbet and newly promoted partner Olivia Mullooly, who is valued by clients for her 'great negotiation and communication skills'. Gavin Woods is an experienced litigator, who recently acted for Coolmore Stud in an action to prevent the publication of a book by a former employee. Isabel Foley is another key contact; she represented Dunnes Stores before the Supreme Court in a novel case related to comparative advertising.
Olivia Mullooly; Rob Corbet
‘I work with Olivia Mullooly on any trade mark issues of my clients in Ireland. Olivia has great negotiation and communication skills. Olivia provides the same high standard that you expect when you work with the gold and silver circle firms in London.’
Trinity College Dublin
Origin Enterprises plc
Foundry Innovation and Research 1
Johnson & Johnson
- Acting for Facebook in defamation proceedings brought by Miriam O’Callaghan regarding alleged fake advertisements using her name and image.
- Representing Enbio in an appeal against a decision of the Controller of Patents, Designs and Trade Marks removing the name of one of the co-inventors of a patent owned by the client from the Irish Patent Register.
- Defending Dunnes Stores, one of Ireland’s largest retail chains, in proceedings initiated by Aldi, where Aldi alleges that a 2013 Dunnes Stores in-store comparative advertising campaign breached comparative advertising regulations and therefore infringed Aldi’s trade marks.
Led by Patricia McGovern, DFMG Solicitors advises on a range of intellectual property work, including patents, trade marks, and copyright. In addition to advising on the management of IP portfolios for clients including Phillip Morris, BMW, and Gilead, the firm is also active in contentious matters. A particular highlight in this area was its representation of Rowex in its passing off dispute with GSK. McGovern is a member and former Chairman of the Intellectual Property and Data Protection Committee of the Law Society of Ireland, and is also a member of several international IP law associations.
Millstreet Horse Show
Northern & Shell
- Managing Gilead Sciences’ trade mark portfolio in Ireland, including the prosecution of applications and dealing with oppositions.
- Handling contentious matters for BMW in Ireland.
- Acting for certain Sandoz companies and Rowex in the ongoing passing off dispute with GSK.
The technology and intellectual property team at Beauchamps, which manages IP portfolios for Irish and international companies, is 'responsive, knowledgeable, and friendly'. In addition to its advisory work, the firm acts for large multinationals in copyright infringement proceedings. The team is led by Maureen Daly, who is 'intelligent, articulate and thorough' and advises on all aspects of intellectual property. Daly is also a former chair of the Intellectual Property and Data Protection Law Committee of the Law Society of Ireland.
‘Very competent IP professionals. Responsive, knowledgeable and friendly.’
‘I’ve found that working with Beauchamps is easy. The solicitors I’ve worked with have made themselves available when needed, turned things around quickly and delivered excellent work. They are fully dedicated, working long hours and pulling out the stops when needed.’
‘Maureen Daly goes above and beyond and is very diligent, pragmatic and helpful.’
‘I’ve worked with Maureen Daly for years now. Maureen is intelligent, articulate and thorough in her work, she is extremely dedicated and doesn’t miss a beat.’
AIB Development Capital
Ordnance Survey Ireland
Vanguard Healthcare Solutions
- Advising Epona, an Irish equine healthcare company, on all legal issues including intellectual property matters.
- Acted for AIB Development Capital on IP issues related to its investment in Fulfil Nutrition.
- Advise the Irish Society for the Prevention of Cruelty to Children on all legal matters, including IP issues.
Byrne Wallace handles contentious and non-contentious IP issues, offering 'a very good spread of capabilities'. The practice is particularly active for clients in the public sector, with its recent highlights including representing a national public health body in a high-profile case involving the misuse of copyrights in pregnancy counselling services. The firm also handles significant life sciences work, where Colin Sainsbury, who has 'excellent life sciences knowledge and experience', is the key name. Sainsbury, Darren Daly and experienced litigator Jon Legorburu are the practice heads.
Darren Daly; Colin Sainsbury; Jon Legorburu
‘They have a very good spread of capabilities. A “one stop shop” for all of our legal requirements.’
‘Relaxed manner combined with professionalism. Willing to go the extra mile.’
‘They are simply fantastic to work with. There is never a fuss. The work is completed efficiently and without delay.’
‘Neil Keenan is a consummate professional who gets the job done, with a minimum of fuss. Always there when you need him. Associate Catherine Dowling has a fantastic ability with an excellent “can do” manner. Nothing too much trouble. A rising star. Colin Sainsbury is considered and effective.’
‘Colin Sainsbury has excellent sectoral (life sciences) knowledge and experience. Creative and thorough in finding solutions.’
‘Darren Daly, Jon Legorboru and Colin Sainsbury are simply at the top of the league in IP in Dublin.’
Q3 Medical Devices
National Library of Ireland
- Acted for a national public health body in high-profile passing-off proceedings, securing an injunction against a defendant who was using the client’s copyright to mislead the public into believing that they were offering objective pregnancy counselling services.
- Advised Latch Medical on a seed investment and licence agreement from University College Dublin.
- Advised Q3 Medical Devices and its subsidiaries in Germany, the US, and China on a broad range of life sciences sectoral specific agreements, including commercial and clinical trial agreements.
'Commercial, knowledgable, and fun to work with', Eugene F. Collins advises on all areas of IP. A particular highlight was its work for BSkyB in copyright enforcement proceedings related to sports broadcasting, which related to unauthorised streaming, a complex and novel area of copyright law. Additionally, the team manage trade mark portfolios for clients including Johnson & Johnson and The Juice+ Plus Company. The practice is headed by David Hackett who brings a 'positive, problem solving outlook', and works alongside the firm's corporate and property law teams.
‘They are commercial, knowledgeable and fun to work with.’
‘Attention to detail, speed of response and commercial awareness give them a substantial edge over competitors.’
‘I have known David Hackett for many years – especially for his IP work and he brings a positive, problem solving outlook whilst being a pleasure to deal with. He doesn’t make a drama out of a crisis and is good value for money in a market that is often very expensive.’
Johnson & Johnson
Harvey Norman Trading
Kylemore Abbey Trust
Marks & Spencer
British Sky Broadcasting Group
- Advised Tifco, the leading hotel management group in Ireland, on a number of recent hotel acquisitions, which have involved significant rebranding challenges.
- Acted for BSkyB in enforcing its copyright of commercial sports broadcasts, including issuing court proceedings and obtaining injunctions.
- Managed the Irish trade mark portfolio of Johnson & Johnson, including advising on the registration and availability of trade marks, submitting applications, and preparing submissions to overcome any objections.
Eversheds Sutherland's intellectual property practice advises a range of clients, from domestic Irish companies to large multinationals, on issues related to patents, copyrights, and trade marks. Its position as a part of an international network of firms enables it to assist with multi-jurisdictional matters; its work as lead adviser to Banach Technologies, where it acted on IP issues in Ireland, Australia, and the UK, demonstrates this global reach. The practice, which is led by the 'personable' Marie McGinley, was recently bolstered by the arrival of senior associate Neasa Ní Ghráda from A&L Goodbody.
‘Maria McGinley has a personable style and approach which has been well-received by internal clients.’
Independent News and Media plc
Goffs Bloodstocks Sales
- Advised Iarnród Éireann/Irish Rail on a significant outsourcing of its payroll services and the IP issues that arose in respect of the licensing of the current Irish Rail legacy system.
- Assisted Busy Bees, a childcare provider, with its acquisition of the Giraffe Childcare Group by handling all trade mark and copyright elements of the deal.
- Advised Independent News and Media plc on the assignment of copyright in bespoke database software that was developed by an external consultant.
Hayes Solicitors' 'strong collection of skilled lawyers' specialise in advisory work on intellectual property matters, working with large multinationals and domestic Irish companies. While it is particularly active in the media sector, with clients including The Irish Times and Noel Kelly Management, it is active for clients in a variety of sectors including advertising and software. David Phelan heads the practice and Laura Fannin provides 'very professional and meaningful legal support and advice'. Jeremy Erwin advises clients on commercial and business law matters, including IP, and is another name to note. Other clients include Primark, Publicis and Ogilvy.
‘Hayes solicitors always make you feel like you’re their only customer, giving expert advice on complex issues from GDPR to contract negotiations.’
‘All advice is clear, understandable and provided in a friendly format’
‘A strong collection of skilled lawyers who are able to address most of our legal requirements. There is also a personal touch and a willingness to listen to our input.’
‘They listen, reflect and then advise. They take the time to get to know the problem and you feel you are genuinely getting the appropriate advice after due consideration. I would particularly note in this case Breda O’Malley and Matthew Austin.’
‘Worthy of particular note are Matthew Austin, Laura Fannin and Mary Gavin. What separates Hayes from other firms in my view is the integrity of all the team and the ethical approach they employ in all advice and opinions.’
‘Laura Fannin from Hayes works with us and she is always willing to go the extra mile for us. Laura takes the time to fully understand the commercial challenges or issues we may be dealing with and this helps Laura give us very professional and meaningful legal support and advice.’
The Irish Times
Society of the Irish Motor Industry
The Irish Fairy Door Company
- Advised Way2Pay on the negotiation of a nationwide SaaS agreement to license use of its processing system with its primary customer, Three.
- Assist Primark with intellectual property issues.
- Advised ISQua (International Society for Quality in Healthcare) on two cross-jurisdictional agreements to license its health and safety training IP in China and South America.
Led by the 'technically excellent' Peter Bolger, LK Shields Solicitors' intellectual property team handles contentious and non-contentious work. The firm is particularly strong in the media sector, but the diversity of its practice is evidenced in its work for Mars in a patent case related to pet food products and its management of Starbucks' trade mark portfolio. Ciaran Markey is particularly specialised in contentious matters, while Jeanne Kelly is 'sharp' and is particularly active for clients in the media sector.
‘The team is very proactive, commercial, and easy to deal with. They are responsive and have good strength in depth.’
‘Good IP lawyers who know their stuff, are friendly and charge a fair and reasonable price.’
‘Technically outstanding. Our ‘go to’ in Ireland.’
‘Peter Bolger is technically excellent, commercial, astute, and a thoroughly nice person to work with.’
‘Peter Bolger is very user friendly. Easy to talk with, happy to help and knows his stuff.’
‘Peter Bolger is always on the button! Jeanne Kelly is great fun to work with, bright and sharp.’
Digital Marketing Institute
Dublin County Board
Carzone / Auto Trader
- Represented FremantleMedia in Commercial Court proceedings related to its ‘Got Talent’ brand.
- Represented Mars in high-value trade mark infringement proceedings related to the 3D shape of its pet food product.
- Managing Starbucks’ trade mark portfolio in Ireland.
Specialising in IP matters related to collaborative research arrangements between universities and the private sector, Ronan Daly Jermyn also handles work in other sectors including publishing and advises on trade mark matters for corporate clients. The firm is currently advising universities including University College Dublin, the Royal College of Surgeons in Ireland, and the University of Limerick on IP matters related to their research work. The practice is led by experienced litigator Darryl Broderick and the 'professional and friendly' Diarmaid Gavin, a specialist in non-contentious matters. JP Gilmartin advised the Galway Cultural Development & Activity Company on IP issues related to Galway's designation as a European Capital of Culture for 2020.
Diarmaid Gavin; Darryl Broderick
‘Vast experience, in-depth knowledge and understanding, quantity and quality of specialists.’
‘Intellectual property management is at the heart of our business model. The RDJ team offer a broader perspective in the fields of IP strategy, IP exploitation, IP enforcement, and how these link back to Share Subscription and Shareholder Agreements. Critically for us, RDJ having a presence in Galway and Dublin provides us with feet on the ground in the locations where we predominantly operate.’
‘Quick turnaround of work and very engaging. Nothing is a problem to them.’
‘Highly knowledgeable, experts in their areas, they take the time to understand our concerns/objectives, and take the time to explain the rationale behind their advice. Diarmaid Gavin and Associate Elena Vassileva are excellent to work with.’
‘Diarmaid Gavin is professional and friendly. Helpful and responsive. Supportive. Brings experience in the field to bear. Realistic and pragmatic – which is something I look for in a legal advisor’
‘We value Diarmaid Gavin for the depth and breadth of his commercial experience with SSSA, contracts with academic institutes, and dealing with international litigation matters. John Cuddigan gives us help, advice and perspective on setting up complex matters in Ireland’
University of Limerick
University College Cork
Knowledge Transfer Ireland
Clinical Research Development Ireland
University College Dublin
Royal College of Surgeons in Ireland
- Advising University College Dublin on contractual arrangements for the third phase of the Enterprise Ireland-funded Food Health Ireland technology centre.
- Assisting the Royal College of Surgeons in Ireland with clinical research agreements.
- Advised Clinical Research Development Ireland on developing template agreements for the conduct of clinical trials, medical device studies and non-interventional investigations.