Industry focus: Healthcare and life sciences in Belgium
At Bird & Bird, the life sciences and healthcare department handles a range of contentious and non-contentious matters, ranging from data exclusivity litigation and biotech development advice to IP licensing and clinical trial contracts. Practice and international industry group head Marc Martens is a regulatory specialist who often assists clients producing new medicines and medical devices, with support from counsel and pharmaceuticals expert Nicolas Carbonnelle. The team also has experience in e-health issues and public procurement legislation applied to hospitals, particularly during the Covid-19 pandemic. Jean-Christophe Troussel handles patent and trade mark issues, while Paul Hermant advises on corporate transactions.
Other key lawyers:
Nicolas Carbonnelle; Jean-Christophe Troussel; Paul Hermant
Polpharma, Hexal (Sandoz), Cipla, Almirall
Celyad, Immunxperts, Novadip, Janssen Pharmaceutica, MaSTherCell SA, Tissuegene Inc, Celgene, Adaptimmune, Bonetherapeutics
Precision for Medicine Group, the Swiss-based European Respiratory Society, the Belgian Grand Hôpital de Charleroi, Osivax, Sobi, European Molecular Biology Laboratory
IGV (Sony and Daiwa Securities)
Promethera Biosciences SA
Ablynx (Sanofi), VUB
Dental Labo Vanderbeken
- Assisted Promethera Biosciences following the cancellation of its planned IPO and a subsequent round E financing, as well as a joint venture with Hao Tian Development Group for the development and commercialisation of its products in South-East Asia and China.
- Assisting in several high-profile disputes concerning data exclusivity for Polpharma and Hexal (Sandoz), two before the General Court of the European Union and two pending before the French Administrative Court.
Covington & Burling LLP
The European life sciences team at Covington & Burling LLP has a multidisciplinary and cross-border set-up which integrates the firm’s competition, corporate, data privacy, IP and trade law expertise. Its recent caseload includes GDPR and Brexit-oriented import advice for pharmaceutical and medical device manufacturers, as well as Covid-19 related assistance for clients guiding vaccine development, supplying medicines and seeking emergency authorisations. Practice head Peter Bogaert handles EU and regulatory mandates, with Adem Koyuncu – who splits his time between Brussels and Frankfurt – and recently promoted partner Bart Van Vooren, a biodiversity compliance specialist, the other main players.
Other key lawyers:
Adem Koyuncu; Bart Van Vooren
Bristol-Myers Squibb (BMS)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Merck Sharp & Dohme
'Extremely experienced in all regulatory issues', the Crowell & Moring team is 'very pragmatic and very thorough', with extensive knowledge of pharmaceuticals and life sciences. Known predominantly for handling IP and regulatory matters, its caseload includes acting in patent, SPC and trade mark disputes and negotiating product and other contractual agreements. Litigation expert Kristof Roox leads a team consisting of senior counsel Gunther Meyer, who specialises in medical devices and licensing, along with counsel Jurgen Figys, a trained biomedical scientist able to provide strategic advice to healthcare companies on clinical trials and treatments.
Other key lawyers:
Gunther Meyer; Jurgen Figys
‘I have had the pleasure of working with Jurgen Figys. I have come to know the team as responsive, knowledgeable and nevertheless flexible and able to provide practical advice. I would absolutely reach out to Crowell for their expertise in the field of pharmaceutical regulation and data protection in the future.’
‘The team is extremely experienced in all regulatory issues.’
‘Kristof Roox stands out.’
‘They are very pragmatic, very thorough and, at the same time, know the business.’
Alcon Research Ltd
Medicines for Europe
Insud Pharma (formely Chemo Group)
Gear Up Medical
MS Data Alliance
- Representing a large US clinical stage gene therapy company with respect to various licensing agreements.
- Representing Mylan and Synthon in patent and SPC disputes with originator pharmaceutical companies.
- Advised Medicines for Europe on obtaining a comfort letter from the European Commission to deal with shortages during the Covid 19-crisis.
HOYNG ROKH MONEGIER
Clients appreciate the 'highly specialised patent practitioners' at IP boutique HOYNG ROKH MONEGIER, which also handles a range of trade mark and regulatory matters in the life sciences sector alongside various cross-border disputes. Brussels managing partner Liesbeth Weynants heads the team and specialises in cases relating to unfair competition, privacy and data protection law, with support from litigators Benoît Strowel – also the firm's managing partner – and Steven Cattoor. Other areas of expertise include new medical device and product qualifications and registrations, as well as distribution and parallel import issues.
Other key lawyers:
Benoît Strowel; Steven Cattoor
‘A network of highly specialised patent practitioners covering a number of jurisdictions.’
St. Jude Medical
Teva Pharmaceutical Industries Ltd.
Teva Pharma Belgium
Yeda Research and Development Company Ltd. (Innovative)
At Van Bael & Bellis, the life sciences department provides pan-European advice on regulatory, marketing, IP and product liability cases, including litigation. Catherine Longeval and pharmaceuticals specialist Peter L’Ecluse co-head the team, with Longeval praised for offering 'incredible depth and breadth of regulatory knowledge' – particularly during the Covid-19 pandemic, with an influx of new matters concerning clinical trials, supply chain issues, medicine shortages and the imports of non-CE marked PPE. Other key names include David Hull, recognised for his 'top-range competition expertise', and Michael Clancy, who made partner in February 2020.
Catherine Longeval; Peter L’Ecluse
Other key lawyers:
David Hull; Michael Clancy
‘They are in a class of their own: Catherine Longeval has incredible depth and breadth of regulatory knowledge, which is combined with David Hull’s top-range competition expertise and a unique ability to solve complex issues quickly and efficiently.’
‘Catherine Longeval for life sciences regulatory matters and David Hull for life sciences competition work are both extremely accessible and responsive – they always respond within minutes/hours – and straight-talkers. There is very little need to translate their advice to business colleagues.’
‘Experience in healthcare and pharmaceuticals. The environment is changing and Van Bael & Bellis adapt quickly.’
‘Easy connection with the lawyers and quick reactions on preliminary questions. Quickly understand the client’s needs and provide good advice. Peter L’Ecluse (and his team) are very reliable.’
‘Extremely knowledgeable firm on specific life sciences questions, especially pharmaceutical matters such as IP, market access, pricing and reimbursement, and competition.’
‘Flexibility and rapidity of response. Pragmatic approach. Working with Catherine Longeval and Peter L’Ecluse is always a very enjoyable experience.’
Belgian Federal Government
- Represented Horus Pharma in proceedings before the Council of State brought by a competitor, Théa Pharma, against the Federal Agency for Medicines and Health Products, concerning the scope and use of the various authorisation procedures for new medicinal products.
- Representing a young girl suffering from a serious and rare disease in litigation against the producer of a medicinal product that is not (yet) reimbursed in Belgium, and in negotiations with the Ministry of Public Health and the Federal Agency for Medicines and Health Products, resulting in a court order for BioMarin to continue the free supply of the medicine.
- Representing Xellia and Zoetis in the landmark Lundbeck case, which concerns “reverse-payment” patent settlements in the pharmaceutical sector, on appeal before the EU Court of Justice.
Allen & Overy LLP
Allen & Overy LLP's multidisciplinary life sciences team draws on the expertise of the IP, IT, corporate, public law, antitrust and employment practices, with experience in both contentious and non-contentious matters. Brussels-based senior counsel Geert Glas handles the negotiation of agreements and transactions, alongside acting in patent litigation, while Antwerp-based Filip Van Elsen specialises in digital medicine and connected health issues. Counsel Eveline Van Keymeulen – who splits her time between Brussels and Paris – typically advises on strategic product regulation and is considered a go-to authority on medicinal cannabis or hemp usage.
Geert Glas; Filip Van Elsen; Eveline Van Keymeulen
ALTIUS predominantly specialises in patents work for pharmaceuticals clients, with other instructions on healthcare-oriented regulatory and more general IP-related matters. Litigation specialist Christophe Ronse heads the practice and handles much of this work, with close support from Phillippe de Jong, whose experience advising on plant variety rights and parallel import issues is invaluable. During the Covid-19 pandemic, the team has also assisted clients with market access and import restrictions.
Other key lawyers:
Philippe de Jong
French National Institute of Origin and Quality
Agricultural Industries Confederation Ltd
- Representing Eli Lilly & Co. in patent litigation against Fresenius concerning its patent on the second medical use of the active ingredient pemetrexed, in combination with vitamin B12, for the treatment of certain cancers.
Clients appreciate the 'excellent understanding of EU regulatory law' found in Jones Day's cross-practice healthcare and life sciences department, with Cristiana Spontoni as both a domestic and global head. Her recent work includes acting for BioMarin in a case against the Belgian state, as well as handling regulatory, M&A, competition and compliance matters from the pharmaceuticals, medical devices and diagnostics, food and cosmetic products sectors. The wider team is also instructed on cross-border matters, and benefits significantly from the ability to work alongside the firm's international network.
‘The practice in Brussels has an excellent understanding of EU regulatory law and how the legislative processes work within the European Commission.’
BioMarin Pharmaceutical Inc.
E 172 Consortium
Pharmaceutical Product Development (PPD)
PPTA (Plasma Protein Therapeutics Association)
The Procter & Gamble Company
Sumitomo Dainippon Pharma
- Acting for BioMarin in a wide variety of regulatory, legal and litigation matters.
- Acting for PPTA in a broad range of regulatory and legal matters, including advising on the EU regulatory framework for blood and plasma products.
- Advised Evidera, a business unit of Pharmaceutical Product Development LLC, on its acquisition of Medimix International.
Loyens & Loeff's healthcare and life sciences group benefits from its firm-wide multidisciplinary approach to assist clients with corporate, employment, tax and public law matters. Ongoing cases involve the negotiation of contractual agreements and revisions – concerning recent PPE procurement and employer/employee-side rights in light of the Covid-19 pandemic – as well as large-scale transactional management and pharmaceutical-related acquisitions. Restructuring and benefits specialist Filip Saelens heads the team alongside counsel Stéphanie De Smedt, who was promoted in January 2021; Valentijn De Boe is another key contact for public-private partnership and administrative issues.
Filip Saelens; Stéphanie De Smedt
Other key lawyers:
Valentijn De Boe
Arseus Medical NV
GHO Capital Partners LLP
Carestream Health Inc.
Agilent Technologies Inc.
Bristol Myers Squibb
Stop Darmkanker VZW
Cinven / Bain Capital
Bristol Myers Squibb Belgium
- Advised Medicom on its winning tender for the EU-wide joint procurement for the supply of personal protective equipment (PPE).
- Acted as Belgian and Dutch counsel to GHO Capital Partners, a European specialist investor in healthcare, in the context of the acquisition of the Ardena Group.
- Intervened on behalf of Avrox SA in summary proceedings before the Belgian Council of State regarding requests for the suspension of the award of a framework contract to Avrox for the supply of millions of reusable face masks for the Belgian population.
NautaDutilh's multidisciplinary life sciences team offers a range of advisory, transactional and disputes services covering licensing and research contracts; clinical trial, market access, distribution and compliance regulations; IP issues; and data protection and product liability concerns. Jointly led by Florence Verhoestraete, who typically acts on transactional and contentious patent, trade mark and unfair competition matters, alongside corporate specialist Elke Janssens, the department has a client roster including start-ups, scale-ups, global institutions and research centres. Philippe Remels handles large M&A transactions in this space.
Florence Verhoestraete; Elke Janssens
Other key lawyers:
Bausch Health companies Inc.
Cliniques Universitaires Saint-Luc
Johnson & Johnson
VIB (Flemish Institute for Biotechnology)
- Assisted the underwriters in the $862.5m (including over-allotment option) fundraising by argenx.
- Advised Invitae on the acquisition of 100% of the shares of Orbicule, a software developer for the diagnosis of rare diseases.
- Assisted Nyxoah with its €25m private financing round.
Considered as a 'one-stop firm in Belgium for healthcare matters', Quinz's life sciences and technology practice is co-headed by the 'smart, business-minded and solution-driven' Olivier Van Obberghen and Pieter Wyckmans, who is recognised as 'top notch in healthcare regulatory matters'. The team's workload typically includes the drafting and negotiation of licensing contracts, assisting on antitrust and data privacy compliance matters, and advising on clinical development, market access, pricing and reimbursement distribution. Senior associate Marion Lapage 'is a very gifted transactional lawyer'.
Olivier Van Obberghen; Pieter Wyckmans
Other key lawyers:
‘In my view, Quinz is the one-stop firm in Belgium for healthcare matters. I have worked with many other healthcare specialists in the past, but Quinz are personalised, highly knowledgeable, and efficient in handling my various assignments, which is unequalled in the Belgian market.’
‘Olivier Van Obberghen is a very smart, business-minded and solution-driven lawyer. Pieter Wyckmans is top notch in healthcare regulatory matters.’
‘Associate Marion Lapage is a very gifted transactional lawyer.’
‘The team has very extensive expertise in drafting contracts with biotech and pharma companies. The team is well aware of regulatory issues and also the legal demands of large and medium-sized companies.’
‘Pieter Wyckmans is very knowledgeable, open and to-the-point. Pieter has vast expertise and comes up with solutions which are acceptable for all the contract parties. Marion Lapage is very knowledgeable and will do everything to meet the client’s timelines ASAP.’
‘The team is very reactive in addressing our contracting needs and provides high-quality work in short time frames.’
‘Pieter Wyckmans and Marion Lapage know and understand our business and our needs, and are ready to provide help within short periods of time.’
‘Quinz is, in my view, the only Belgian life sciences boutique that excels in all relevant areas of expertise required to serve life sciences clients (regulatory, pricing and reimbursement, compliance, transactional matters and competition law). The fact that most lawyers within their team have in-house experience is definitely also one of their greatest assets. They are extremely pragmatic, client-friendly and their level of responsiveness is flawless.’
Johnson & Johnson/Janssen Pharmaceutical
Sarepta Therapeutics Inc
Grünenthal Pharma GmbH &Co. KG
Federal Knowledge Centre
- Assisting Johnson & Johnson, on a worldwide basis, in setting up the supply chain network for its Covid-19 vaccine under development, entailing assistance in technology transfers, capacity arrangements, manufacturing and supply agreements, and licensing set-ups.
- Assisting Arvelle Therapeutics with the setting up of its global compliance policies in view of the anticipated launch within the EU of the anti-epileptic blockbuster cenobamate.
- Assisting listed company Hyloris in the co-development and in-licensing of several products for commercialisation in the US market.
Simmons & Simmons
Clients appreciate Simmons & Simmons' ‘ability to listen and adapt’ when advising on regulatory, compliance and transactional IP instructions from both a contentious and non-contentious standpoint. Practice head Olivier Mignolet specialises in commercial law and related disputes, with a particular emphasis on pharmaceutical legislation, while counsel Annabelle Bruyndonckx is an expert on medical device matters. The team is expanding its working breadth, with an increasing focus on the development of digital health tools, launching online services and healthcare marketing, where ‘highly recommended’ associate Vladimir Murovec is particularly active.
Other key lawyers:
Annabelle Bruyndonckx; Vladimir Murovec
‘Ability to listen and adapt.’
‘Highly competent and remain available and able to deliver advice in classical terms, not just legal jargon.’
‘Vladimir Murovec combines unique expertise in both pharma as well as medical device regulatory matters with a broad knowledge of most other legal domains that are of interest to our industry. He coordinates all of our cases with the upmost diligence and professionalism; he involves experts where needed and streamlines communication. A highly recommended young lawyer with potential.’
‘The team is extremely competent in this field of law and greatly committed so we feel perfectly comfortable whenever we interact, as we perceive that our issues are handled with the highest level of professionalism.’
At Stibbe, the IP and life sciences practice is 'smart, forward-thinking and commercially minded', to the benefit of its pharmaceuticals, medical device and healthcare company clients. Headed by Ignace Vernimme, who 'sees the bigger picture and commands a strong team' alongside the 'very responsive' Philippe Campolini, it leverages a full-service approach to provide advice on regulatory and contentious matters spanning corporate, employment, public and competition law, among others. Medicinal products expert Vernimme and patent litigator Campolini are supported by of counsel Manuel Campolini to complete the core team.
Ignace Vernimme; Philippe Campolini
Other key lawyers:
‘Smart, forward-thinking and commercially minded. Combines experience with context to deliver great outcomes.’
‘Ignace Vernimme sees the bigger picture and commands a strong team. He has a knack for knowing when to step in and thinks on his feet.’
‘High level of availability, very professional, fast answers, good communication, and listen to the customer.’
‘Philippe Campolini offers clear communication, availability and engagement. He stands out for his quality of work and efficiency.’
‘Philippe Campolini from Stibbe is very responsive and works well with our other European attorneys to support our overall strategy while fine-tuning the arguments to the vagaries of the Belgian legal system.’
‘Great competence and expertise, with fantastic creative thinking and a forward-looking approach, which is essential in the pharma sector. The fact that they have a wide variety of clients makes them open minded and increases their level of expertise.’
ANMI (Advanced Nuclear Medicine Ingredients)
ORA (Optimized Radiochemical Application)
Perrigo (Omega Pharma)
- Obtaining a pan-European injunction for R.G.C.C. Holdings, a Swiss-based group active in the development of private blood tests for cancer, in a trade mark case against Belgian biotech company OncoDNA.
- Acted for Mundipharma in summary proceedings before the Brussels courts against Roche, Genentech and BioWin, which failed in their attempt to obtain an injunctive order against the launch of the biosimilar Truxima on the Belgian market.
- Assisting the Biostrand group in the development of an entirely new licensing model for bioinformatics and the setting up of a joint venture with Globachem.
Baker McKenzie CVBA/SCRL
Baker McKenzie CVBA/SCRL's multi-practice healthcare and life sciences group combines its corporate and antitrust expertise to assist domestic and global pharmaceutical, biotech, medical device and healthcare services companies. Matters typically involve acting for bidders looking to acquire existing groups or new products, as well as advising on clinical research, product registration and other market access issues. Biotech and finance expert Roel Meers heads the team along with counsel and regulatory specialist Els Janssens.
Els Janssens; Roel Meers
- Acted as lead counsel to Galapagos, a Belgian clinical-stage biotech company, on its $5.4bn collaboration with Gilead Sciences Inc., a US global research-based biopharmaceutical company.
- Advised Calliditas Therapeutics, a specialty pharmaceuticals company based in Sweden, on the regulatory aspects of its IPO on the Nasdaq Global Select Market in the US.
- Advised Mithra Pharmaceuticals on its $295m licence and supply agreement with Mayne Pharma for an exclusive licence to commercialise Estelle® (a novel combined oral contraceptive product candidate) in the US.
At CMS, the healthcare and life sciences practice is most notable for public procurement work, and often provides assistance to hospitals, healthcare providers and biotech companies. Virginie Dor co-leads the team alongside technology specialist Tom De Cordier and senior associate Bruno Fonteyn; the practice also handles regulatory matters relating to new medicines, medical devices, clinical trials, and the production and supply of PPE following the Covid-19 pandemic.
Bruno Fonteyn; Virginie Dor; Tom De Cordier
European Commission – Euriphi
Cliniques Universitaires Saint-Luc
Hospital of Charleroi
- Acting as the legal team of a consortium led by MedTech Europe in the framework of the EU-funded pan-European Euriphi project.
- Assisting one of the biggest university hospitals in Belgium in its reconstruction project by drafting the specifications and contracts, conducting the competition procedures for project phase awards, and assisting with the management of strategic decisions and negotiations.
- Assisting Getinge with the drafting, preparation and submission of its bid for the EU tender launched by the EU Commission for a project value of €1bn.
The Deloitte Legal life sciences and healthcare practice leverages its multi-disciplinary expertise in corporate, commercial and data protection cases, with a particular venture capital and EU regulatory focus. Christel Brion and Christoph Michiels co-head the team; Brion advises pharmaceutical clients on clinical studies, market compliance and IP litigation, while Michiels assists biotech and medtech start-ups and scale-ups through the course of various financial issues and equity investment rounds.
Christel Brion; Christoph Michiels
ProDigest, MRM Health, MRM Technologies
DLA Piper's healthcare and life sciences department provides advice on domestic and EU regulatory issues, antitrust, M&A, data privacy and product liability-related matters. Its main players are competition partner Bertold Bär-Bouyssière, employment and restructuring specialist Eddy Lievens, and corporate duo Erwin Simons and Caroline Daout. The firm's multidisciplinary and cross-border approach also allows the practice to combine elements of international experience.
Bertold Bär-Bouyssière; Eddy Lievens; Erwin Simons; Caroline Daout
Istar Medical SA
Global Health Investment Fund
- Representing Merck KGaA in an investigation by the European Commission and by the UK Competition and Markets Authority into “reverse patent settlements”, also labelled “pay for delay”.
- Advising iStar Medical SA on a regular basis on various commercial agreements and clinical tests process documents, including NDAs.
Osborne Clarke's multidisciplinary group advises predominantly on corporate and commercial transactions, as well as handling any arising disputes. Practice head David Haex is well experienced in M&A, equity capital markets and fundraisings from across the life sciences and medical devices sectors, while Hadrien Chef advises on various large-scale transactions, joint ventures and investment schemes. Marie Canivet is another name of note for distribution agreement-related litigation.
Other key lawyers:
Hadrien Chef; Marie Canivet
- Advised Bone Therapeutics on concluding a €15m fundraising composed of bridge loans, new equity, convertible bonds and subordinated bonds.
- Assisting OncoDNA in the context of the filing of its friendly takeover bid to acquire all the outstanding shares of French company IntegraGen.
- Assisting Wolfgang Dorfner as guarantor with the sale, assignment and transfer of the assets and the contracts relating to the Alpha Foods business by Alpha Foods LLC to Alpha Foods BV.