Bird & Bird houses a deep bench which handles the full spectrum of issues for its lucrative client base of pharma, medical device, and biotech companies. The group regularly advises on marketing authorisations and EU regulations concerning the use of human tissue and allocation of biological material, with the practice experiencing growth on the digital health front. Practice head Marc Martens is known for his expansive regulatory expertise, with particular emphasis on clinical trials and biobanking; Martens regularly appears before the European Court of Justice in disputes concerning data exclusivity, in addition to advising on the lifecycle of biotech products and advanced therapies. Jean-Christophe Troussel has vast knowledge of both contentious and non-contentious IP and technology related matters, with a strong focus on the monetisation of innovation, research and development (R&D) deals, and enforcement strategies. Paul Hermant exhibits broad experience in handling venture capital financings, securities offerings, and M&A within the life sciences space.
Industry focus: Healthcare and life sciences in Belgium
Bird & Bird
Practice head(s):
Marc Martens
Other key lawyers:
Jean-Christophe Troussel; Paul Hermant; Nicolas Carbonnelle; Kevin Munungu
Testimonials
‘Very knowledgeable, responsive, professional.’
‘Very accessible and reply quickly.’
Key clients
Polpharma Pharmaceutical Works
Nueraxpharma
Teva Pharma
Kaneka Eurogentec
PDC*Line Pharma SA
Terumo Europe
Op2Lysis SAS
CooperVision
Essencia (bio.be)
Novadip
MaSTherCell SA (Catalent)
EMBL
Vital Strategies
UCB
European Commission: SMART-BEAR project
EG (formerly Eurogenerics)
Covington & Burling LLP
Peter Bogaert and Bart Van Vooren jointly lead the practice at Covington & Burling LLP, which leverages its international presence to act for a varied client base of trade associations and companies in the cosmetic and food, pharmaceuticals, and diagnostic spaces. The group is well versed in advising on reimbursement procedures, novel IVD regulations, and global pathogen sharing rules. Bogaert is known for his longstanding expertise in domestic and EU regulatory systems, frequently advising medical device and biotechnology companies on policy assignments. Van Vooren regularly appears before the General Court (EGC) and the Court of Justice of the European Union (CJEU), representing both human and veterinary pharmaceutical, and medical device companies.
Practice head(s):
Peter Bogaert; Bart Van Vooren
Key clients
AbbVie
AstraZeneca
BioNTech SE
Bristol-Myers Squibb
GlaxoSmithKline
Eli Lilly
The European Confederation of PharmaceuticalEntrepreneurs (EUCOPE)
Johnson & Johnson Group
MedTech Europe
Royal Canin
Aloe Vera of Europe
Roche
International Federation of Pharmaceutical Manufacturersand Associations (IFPMA)
Takeda Pharmaceutical Company
Work highlights
- Representing Aloe Vera of Europe in litigation before the EU General Court, including a request for suspension, against a Commission Regulation banning HADs, a substance that is found naturally in most plants, for an infringement of the precautionary principle.
- Advising the vaccines working group of the IFPMA on matters involving seasonal influenza, as well as the Pandemic Influenza Preparedness Framework (PIP) under the umbrella of the WHO.
Crowell & Moring
Praised for its ‘fierce‘ intelligence, the team at Crowell & Moring stands out for handling a myriad of issues relating to generics, with particular emphasis on off-label uses, parallel imports, and data exclusivity. Practice head Kristof Roox has deep expertise in handling patent disputes concerning trade marks and copyright with ‘gravitas and charisma‘, in addition to advising on a myriad of regulatory and commercial matters concerning medical devices and pricing. Senior counsel Jurgen Figys is known for advising European industry associations and biotech companies on advertising issues, clinical trials, and market authorisations, while recently promoted counsel Matteo Mariano is adept at advising technology and life sciences clients on patent enforcement and questions surrounding ownership of data. Associate Wietse Vanpoucke joined the team from Quinz, contributing his expansive knowledge of EU regulatory issues, including the EU pharmaceutical package and CE markings.
Practice head(s):
Kristof Roox
Other key lawyers:
Jurgen Figys; Matteo Mariano; Wietse Vanpoucke; Christopher Dumont
Testimonials
‘They act as real partners and think along with us, which is great as they can convert our message into decent law.’
‘Creative thinking, innovative legal proposals. Excellent availability, excellent support to customer, and practical point of view.’
‘Kristof Roox and Christopher Dumont are able to deliver within tight deadlines. They bring innovative ways to help customers, excellent collaboration within a group of customers. Clear when conveying information and summaries.’
Key clients
Sandoz
Viatris (formerly Mylan)
Synthon
Zentiva
Novartis
Medicines for Europe
Honeywell
Fresenius Medical Care
Polpharma
Neuraxpharm
Work highlights
- Assisting multiple pharmaceutical companies (Sandoz, Mylan, Neuraxpharm, Zentiva, Polpharma) which market generic DMF products (with active substance dimethylfumerate (DMF)) in a case relating to the blockbuster drug Tecfidera in which regulatory data exclusivity is at the core of the dispute. The team is representing Neuraxpharm, which is marketing a generic DMF product, in a pan-European patent invalidity and infringement dispute against the patent proprietor before the Belgian courts.
- Assisted a major pharmaceutical company with a variety of regulatory issues such as data exclusivity, patent linkage, skinny labelling and the regulatory aspects of parallel imports.
- Assisting Sandoz with the launch of rivaroxaban by initiating a revocation action against a secondary patent that could postpone generic market entry.
HOYNG ROKH MONEGIER
Pan-European IP boutique HOYNG ROKH MONEGIER houses a broad team which advises on a variety of matters, including filing interventions with regulatory entities, patent infringement proceedings, and discriminatory market access related disputes. Liesbeth Weynants heads up the practice, maintaining both a patent litigation and regulatory focused practice. Weynants regularly assists with compliance training and drafting agreements concerning pricing and reimbursement, data protection, and supply chain management. Benoît Strowel stands out for his vast expertise in multi-jurisdictional patent disputes across Europe, and is supported by Tim Robrechts, who regularly acts for international clients within the life sciences and software industries. Charlotte Behets Wydemans and Ine Letten joined the team in December 2022 and April 2023 respectively.
Practice head(s):
Liesbeth Weynants
Other key lawyers:
Steven Cattoor; Benoît Strowel; Tim Robrechts; Charlotte Behets Wydemans; Ine Letten
Testimonials
‘The HRM Belgian team is part of a global IP team at HRM that we work very closely with. Given that we are involved in patent litigation on a global scale, one of the things that makes HRM unique suited to meet our needs is its global reach and expertise.’
‘Liesbeth Weynants and Steven Cattoor are stand-out partners on our HRM Belgian team. They grasp complex issues very quickly and effectively communicate, convey, and advocate the client’s positions.’
Key clients
Abbvie
Biocodex
Biogen
BioNTech
Novartis
OncoDNA
Teva
Quinz
With an 'unsurpassed level of excellence', the team at Quinz is hailed by clients as the 'finest life sciences and healthcare practice in Belgium', dispensing advice to international consortiums and biotech companies on both domestic and international projects. Practice co-head Olivier Van Obberghen stands out for his 'visionary passion' for strategic transactions, including supply chain and spin-off projects, in addition to pharma compliance work. Co-head Pieter Wyckmans is noted for his 'unequalled' regulatory knowledge surrounding clinical development, pricing and reimbursement, and market access issues. Michiel D'herde is particularly adept at advising on international research collaborations, while Marion Lapage is known for handling a broad range of issues arising throughout product life cycles, such as logistics services, licensings, and R&D outsourcing projects.
Practice head(s):
Olivier Van Obberghen; Pieter Wyckmans
Other key lawyers:
Michiel D’herde; Marion Lapage; Amber Cockx; Pauline Meskens
Testimonials
‘Quinz is our go-to firm for life sciences matters. The team is able to handle complex cases in a pragmatic way. Their advice is always spot-on, and they always put great effort in understanding the context in which we operate. Every member of the team exudes that ambition to always offer added value in every service. ’
‘Pieter Wyckmans and Olivier Van Obberghen bring a breath of fresh air to the legal profession. Their down-to-earth mentality, the passion they put into their work and firm and their mutual respect are simply exceptional. It is always a pleasure to work with them. Amber Cockx and Pauline Meskens are definitely associates to watch.’
‘Quinz’s life sciences department clearly has the finest life sciences and healthcare practice in Belgium. Their support has always been flawless, on point and tailored to my needs. The breadth, depth and cohesion of the Quinz life sciences team is impressive, as well as the dedication for the life sciences sector that each individual team member clearly radiates.’
‘Olivier Van Obberghen and Pieter Wyckmans – Their symbiotic and complementary passion for the life sciences sector has become a brand on its own. Pieter has an unequalled knowledge of the Belgian pricing and reimbursement landscape and is a brilliant and creative negotiator. Olivier is definitely the go-to person for healthcare compliance in Belgium and is a gifted and inspirational speaker on this subject.’
‘It is striking to see how genuine companionship and dedication for the life sciences sector of Olivier Van Obberghen and Pieter Wyckmans has elevated their team to an unsurpassed level of excellence in Belgium. Pieter exudes a visionary passion for biotech and digital health and is a gifted negotiator. Olivier truly excels in understanding the pharma regulatory and compliance landscape, and his recommendations are always spot-on and pragmatic. Senior associates Marion Lapage and Michiel d’Herde are definitely individuals to watch. ’
‘Excellent life sciences transactional practice, including complex supply chain agreements. Quinz provides very focused and efficient support and works well with in-house clients.’
‘Quinz is undoubtedly the go-to firm in Belgium for life sciences and healthcare. They have the best and the largest team in the market. I was flabbergasted by the level of excellence and pragmatism of the team. What I like most is that you immediately feel that the life sciences department comes as a team – you can just feel their passion for the sector and how much they enjoy working together on complex matters.’
‘Olivier Van Obberghen is truly the star in the sector. His knowledge of the regulatory landscape is simply stunning, and he understands the needs of biotech players like no other. He is one of the most gifted negotiators I know: charming but tough, charismatic but humble, and unyielding when it comes to getting the best possible outcome in very difficult situations.’
Key clients
Johnson & Johnson
UCB Pharma
Takeda
Galapagos
Telix Pharmaceuticals
Vertex
Bayer
ExeVir
Abscint
Priothera
IPOPI
Sciensano
Precirix
Incyte
Gates Ventures
SunshineSmile (PlusDental)
ATB Therapeutics
Novo Nordisk
Merck KGaA
Biogazelle
Hyloris
Febelco
BlueBirdBio
Grünenthal Pharma GmbH &Co. KG
ISA Pharmaceuticals
Federal Knowledge Center
BVI (PhysIOL)
Recordati
ObsEva
Avroxa
Pharma.be
CleanBiologics
Roche
Eli Lilly
Novartis
SOBI
Syndesi Therapeutics
Seuss+
Clinops
TwoBridge Pharma
EISAI Pharma
Materialise
Vaccinopolis
Cell Matters
Ardena
Amyl Therapeutics
Pharvaris
Optimapharm
Croma-Pharma GmbH
Dokteronline
Kenvue
Galderma
MedTech Europe
NanoBay
NCardia
Owkin
E-health Ventures
Gimv
European Vaccine Initiative
TB Alliance
Astrivax
Terumo
Sarepta
Vifor Pharma
Work highlights
- Advised Astrivax and its lead investors on setting up a large Belgian biotech seed financing round in recent history (€30m) and securing the rights on KU Leuven’s vaccine technology. The firm advises Astrivax on all regulatory challenges to progress the lead candidate into clinical stage.
- Assisted ISA Therapeutics with the valorisation of its IP portfolio, including the out-licensing arrangement with Regeneron. The firm supports the entirety of ISA’s clinical trials in Europe.
- Assisting Novo Nordisk with the setting-up of an EU-funded consortium under the IHI Project, iCARE4CVD (with a budget of €22m), with the aim to build predictive models, algorithms and tools able to reliably predict complications of cardiovascular disease.
Van Bael & Bellis
Van Bael & Bellis houses a broad practice which advises a lucrative client base, which notably includes Amgen, Eli Lily, and Gilead. The group is proficient in handling product liability issues, parallel import disputes, and distribution strategies. Catherine Longeval co-heads the team alongside Peter L’Ecluse. Dispute resolution specialist Longeval has a great deal of knowledge spanning medicines, cosmetics, and biotech products, while L'Ecluse is noted for handling a broad range of issues, including pricing and reimbursement mandates, and advertising matters, regularly appearing before the Council of State to challenge reimbursement decisions. Michael Clancy is known for his competition law expertise, particularly in relation to promotional activities, R&D collaborations, and pricing strategies.
Practice head(s):
Catherine Longeval; Peter L’Ecluse
Other key lawyers:
Michael Clancy; Thibaut D’hulst
Key clients
AbbVie
Amgen
AstraZeneca
Baxter
Bayer
Belgian Federal Government
CSL Behring
Eisai
Eli Lilly
ForHerCare
Gedeon Richter
Gilead
GlaxoSmithKline
Horus Pharma
Mylan
Novo Nordisk
Patient Centrics
pharma.be
PTC Therapeutics
Schwabe Pharma
Takeda
UCB
Vertex
Zoetis
Work highlights
- Advising Novo Nordisk on a range of regulatory matters, including sponsorship projects, advertising of medicines, and the use of clinical trial data.
A&O Shearman
Co-headed by Filip Van Elsen and Tine Carmeliet, the practice at A&O Shearman is known for advising a diverse client base on a broad range of mandates, including product approvals, and licensing and collaboration agreements. The group assists numerous sell-side targets and private equity investors, in addition to domestic scale-up companies and global pharmaceutical giants. In Antwerp, Van Elsen maintains a digital transformation-focused practice, often handling digital medicine-related technology transactions and outsourcing issues; while Carmeliet, based in Brussels, stands out for her deep knowledge of regulatory exclusivities, transparency regulations, and digital health solutions. Brussels’ Geert Glas retired at the end of 2023.
Practice head(s):
Filip Van Elsen; Tine Carmeliet
Testimonials
‘I love working with the Allen & Overy LLP healthcare and life sciences practice. Its a multidisciplinary team that understands all aspects of life sciences transactions and the team members often read my mind about what I want, and when they identify issues, they always have multiple solutions ready to mitigate those issues.’
ALTIUS
Housing a team which is praised by clients for its 'unmatched' quality, ALTIUS dispenses expert advice to a varied client base of pharmaceutical, biotech, and software developers. The practice handles a broad range of issues, including pricing and reimbursement work, data related license agreements, and hospital tenders. Christophe Ronse leads the team alongside Philippe de Jong. Ronse is noted for his expertise in acting for domestic and international healthcare clients in both national and international patent disputes, while de Jong handles a broad range of IP issues concerning parallel imports and plant variety rights. Promoted to partner in September 2023, the 'hands-on' Kirian Claeyé contributes his deep regulatory knowledge of marketing strategies, clinical trials, and life cycle management.
Practice head(s):
Christophe Ronse; Philippe de Jong
Other key lawyers:
Kirian Claeyé; Bart Junior Bollen
Testimonials
‘Kirian Claeyé is a hands-on lawyer who combines practical knowledge with a deep understanding of the Belgian life sciences regulations.’
‘Extensive knowledge of the Belgian HC environment, high levels of collaboration and availability.’
Key clients
AbbVie
Hologic
P3Lab
Hipra
Organon
Applied Medical
Azelis
Beiersdorf
VWR-Avantor
VMD – Inovet
Anicura
Gilead
Bayer Pharma
Novartis
Biogen
Ferring
Merck (MSD)
Work highlights
- Representing Novartis in proceedings before the Council of State and Belgian civil courts in relation to pricing and reimbursement decisions.
- Advised Merck Sharp & Dohme (MSD) on managed entry agreements with the Belgian reimbursement authorities.
- Advised Beiersdorf on the promotion and advertising of medicinal products, medical devices and cosmetics.
Jones Day
The team at Jones Day handles the full gamut of issues for a varied client roster of pharmaceutical companies, research institutes, and medical device manufacturers. Leveraging its network across the European Union, the firm advises on numerous digital health matters, pre-market clinical trials, and post-market studies. Practice head Cristiana Spontoni is known for acting on a variety of matters concerning product regulation, in addition to both pre and post-market issues relating to product liability, distribution, and data privacy. Ursula Schliessner maintains a health and safety focused practice, while Jörg Hladjk focuses on privacy and cybersecurity mandates, regularly advising research centers and medical device companies.
Practice head(s):
Cristiana Spontoni
Other key lawyers:
Ursula Schliessner; Jörg Hladjk
Key clients
Arsenal Capital
Astellas Pharma Inc.
BioMarin Pharmaceutical Inc.
Cellectis SA
Institut Pasteur
International PNH Interest Group
Lipton Teas and Infusions
MedTech Europe
Pharmaceutical Product Development
Shiseido
Sumitomo Dainippon Pharma
Work highlights
- Representing BioMarin, a company involved in developing and commercialising innovative biopharmaceuticals for rare diseases driven by genetic causes, in a wide array of regulatory, legal, and litigation matters.
- Advising Sumitomo Dainippon Pharma on a wide variety of ongoing regulatory and legal matters on a pan-European and global basis.
- Advising Institut Pasteur on an array of EU-wide and global regulatory and legal matters.
NautaDutilh
'Top-class IP litigator' Florence Verhoestraete and Philippe Remels jointly lead the team at NautaDutilh, which is praised by clients for its 'very creative' approach to IP litigation. The group appears before courts across the EU in product liability disputes, in addition to advising on IPOs and competition issues concerning unfair business practices. Verhoestraete is noted for her longstanding expertise in transactional IP issues, including research collaborations and IP assignments, often acting for research centres, start-ups, and large international life sciences companies. Remels has notable knowledge surrounding transactional issues, and is known for handling an array of private financing rounds and general corporate matters.
Practice head(s):
Florence Verhoestraete; Philippe Remels
Other key lawyers:
Sien Vandezande; Tanguy de Haan
Testimonials
‘The Nauta team has great experience in the field of IP litigation, especially for healthcare and life sciences. Their approach is very creative, but based on thorough research about the laws, precedents and recent tendency of the relevant courts. Also, the team has an excellent network with many specialists. With these assets, the Nauta team provides wonderful service to clients.’
‘Florence Verhoestraete is an experienced, top-class IP litigator, forming a team and collaborating. Her view is based on vast and deep experience in IP litigation and she can bridge legal analysis and commercial interests for clients in a creative manner.’
‘Florence Verhoestraete and Tanguy de Haan make a brilliant team and complement each other’s skillsets very well. Great knowledge of the life sciences industry and some of its most complex IP matters.’
Key clients
Abacus Medicine
Allergan
Azalea Vision
Bausch Health companies Inc.
Cliniques Universitaires Saint-Luc
GSK
Johnson & Johnson
Mediq
Morrow
Nyxoah
Onward Medical
S-Biomedic
Suazio
VIB
Vico Therapeutics International
Work highlights
- Assisting S-Biomedic’s shareholders and Co-Founders with the sale of shares to Beiersdorf.
- Assisting the underwriters in the $1.27bn capital raise of argenx.
- Advising Nyxoah on its $50m at-the-market offering program and on a $15m private placement of new shares, and a $3m sale of new shares under its ATM program.
Simmons & Simmons
Exhibiting 'outstanding' proficiency in handling regulatory matters concerning medical devices and biopharmaceutical products, Simmons & Simmons is noted for advising a notable client base which includes GlaxoSmithKline, Haleon, and Sanofi. The 'very balanced and effective' Olivier Mignolet and Annabelle Bruyndonckx lead the team. Mignolet has vast knowledge of regulatory issues and commercial litigation, while Bruyndonckx maintains a medtech and digital healthcare-focused practice, often advising global biotech and pharmaceutical companies on qualification, product liability, and marketing authorisation issues, supported by Nele Jonckers, who has a great deal of knowledge in handling cross-border compliance matters. Alexander Wenzel joined the practice from Cooley LLP, contributing his deep experience in advising biotech manufacturers.
Practice head(s):
Olivier Mignolet; Annabelle Bruyndonckx
Other key lawyers:
Nele Jonckers; Alexander Wenzel
Testimonials
‘The team is unique, with expert knowledge. The Belgium team often proposes innovative approaches.’
‘Very committed, very smart, extensive knowledge.’
‘Olivier Mignolet and Annabelle Bruyndonckx form a very balanced and effective duo. They have a perfect knowledge of their field of expertise; they are proactive and extremely reliable.’
‘Annabelle Bruyndonckx is directly involved with the public health authorities and has a superb network. ’
‘The life sciences team is service minded, responsive and willing to help.’
‘Annabelle Bruyndonckx has an extensive knowledge of the legislation and the sector. Her understanding of the reality of the business is impressive and she has an excellent capacity to identify the essence of the issue and how to resolve it in a pragmatic way.’
‘Simmons and Simmons offer a unique understanding of the needs of healthcare companies. Their knowledge of the regulatory system is outstanding, as are their connections to deliver the correct document to the right hands. They are service-oriented; you can count on their expertise, ethics, and commitment.’
‘Know-how, availability, creativity, knowledge of the issues, and reliability. Annabelle Bruyndonckx is the lawyer you want onboard in any complex legal regulatory situation; Nele Jonckers is the perfect complement to support her work.’
Key clients
Alcon
Align Technology
AlloVir
Alnylam
Andocor
Becton Dickinson
beMedTech
Coloplast
Danone
Depharm
Exphar
GlaxoSmithKline
Haleon
Medista
Noventure
Octapharma
The Oncidium Foundation
Oncosil
Rhythm Pharmaceuticals
Roche Diagnostics
Samsung Bioepis
Sanofi
Seagen
Servier
Snitem
Stallergenes Greer
Terumo
Trasis
Xilloc
Vitaflo
Zimmer Biomet
Stibbe
The team at Stibbe handles the full gamut of regulatory issues relating to hospitals, EU co-promotion agreements, and cases concerning public procurement contracts. Practice co-head Ignace Vernimme is known for his longstanding experience of representing clients before regulatory authorities, including the Belgian Medicine Agency and the Belgian Pharmaceutical Association, while co-head Philippe Campolini primarily focuses on patent litigation and joint research agreements. Louis Bidaine has a great deal of experience in handling multinational patent disputes, in addition to a wide array of non-contentious matters, including rebates, marketing strategies, and promotional practices.
Practice head(s):
Ignace Vernimme; Philippe Campolini
Other key lawyers:
Louis Bidaine
Testimonials
‘Very responsive, quickly able to grasp complex matters.’
‘Ignace Vernimme is great in keeping the overview of things while still paying attention at all the details. Can quickly cover the essentials. Very knowledgeable.’
Work highlights
- Acting for Mylan in proceedings before the Court of Justice of the EU against the European Commission in relation to an exemption granted to one of its competitors on the market exclusivity of its product Tobi Podhaler as an orphan medicinal product.
- Assisted Out& Out with obtaining a descriptive seizure order, which allowed Out&Out to have an independent expert search for evidence of infringement at the competitor’s headquarters. The firm is preparing infringement proceedings to obtain an injunction against the competitor.
Baker McKenzie CVBA/SCRL
The ‘diplomatic‘ and ‘passionate‘ team at Baker McKenzie CVBA/SCRL leverages the firm’s international network to assist its broad client base with disputes concerning tenders, corporate financing issues, and competition issues involving pricing. Els Janssens and Roel Meers jointly lead the team. Janssens advises numerous clients in the medical device, pharmaceutical, and health services industries, primarily focusing on assisting industry associations with EU policy. Meers is noted for his transactional experience within the Benelux biotech and healthtech markets, where he often advises clients on corporate finance and capital markets transactions. Elisabeth Dehareng maintains a technology and IP focused practice, with particular emphasis on data protection and privacy in the healthcare sector.
Practice head(s):
Els Janssens; Roel Meers
Other key lawyers:
Elisabeth Dehareng; Olha Sviatenka
Testimonials
‘Great knowledge of the specificities of the pharmaceutical industry.’
‘Roel Meers is always available, pragmatic, he is business minded and has a solution oriented approach.’
‘Els Janssens stands out for her regulatory expertise.’
Key clients
Abbott
Abbvie
Acorda Therapeutics
Agomab Therapeutics
Astellas
Baxter
Becton Dickinson
BVI Medical
Cochlear
CSL Behring
EFPIA
Embecta
Engrail Therapeutics
European Medicines Verification Organization EMVO
Ferring
Galapagos
GSK
Hyland
ICU Medical
Inari Medical
Intuitive Surgical
Johnson & Johnson
Karl Storz
MDxHealth SA
Menarini Operations Luxembourg SA
Phardiag Ltd
Laboratorios Menarini SA
Menarini France SA
Merit Medical
Microport
Mithra Pharmaceuticals
MSD
Neurocrine Bioscience
Octa Pharma
Opentrons
PTC Therapeutics
Regeneron
Sequana Medical NV
Seqirus
Siemens Healthcare
Tecan
Vaccines Europe
Xenon Pharmaceuticals
Unilabs
Work highlights
- Advised Mithra Pharmaceuticals on its senior secured convertible facilities agreement with funds managed by Highbridge Capital Management, LLC and funds managed by Whitebox Advisors LLC, for a three year term, in an amount of up to €100m.
- Advised Biocartis Group on its comprehensive recapitalisation.
- Advised MDxHealth on its $100m acquisition of the Oncotype DX®GPS (Genomic Prostate Score®) test from Genomic Health, Inc., a subsidiary of Exact Sciences Corporation, and the financing of the acquisition through an up to $70m loan and security agreement with an affiliate of Innovatus Capital Partners, LLC.
CMS
Jointly led by Bruno Fonteyn and Virginie Dor, the team at CMS acts for a varied client base of hospitals and pharma companies. Dor has a great deal of expertise in public procurement policy, regularly advising clients on the tendering and execution of public projects, while Fonteyn frequently represents pharma companies and healthcare providers before public authorities and national courts. Fonteyn is also noted for his regulatory knowledge surrounding medical devices, biocides, and the ethics of clinical trial assessments and medical experiments.
Practice head(s):
Bruno Fonteyn; Virginie Dor
Key clients
Medtech Europe
Group Lagarrigue
Synlab
Cliniques Universitaires Saint-Luc
Medi-Market
Hospital of Charleroi
CHR de Verviers
BioGen
Pharma.be
Work highlights
- Advising MedTech Europe on procurement and competition related issues.
- Assisting Group Lagarrigue with the acquisition (through its Belgian subsidiary Finicoma) of different Belgian targets active in the orthopaedic business.
- Advising Synlabin on the acquisition by the German private equity fund BC partners (through Synlab HoldingGmbH) of Belgian Laboratoire Dr. Collard.
Deloitte Legal
Primarily based in Brussels, the team at Deloitte Legal exhibits ‘clear, in-depth‘ expertise across a broad range of areas, with particular emphasis on medtech regulatory matters. Practice head Christoph Michiels has ample expertise in venture capital and private equity transactions, regularly assisting investor syndicates and management teams with early stage spin off projects. Jean-Christophe Top acts for numerous pharma, digital health, and medtech clients in matters concerning ethics compliance and the commercialisation of novel therapies, while Matthias Vierstraete maintains an IP and IT focused practice in Ghent.
Practice head(s):
Christoph Michiels
Other key lawyers:
Matthias Vierstraete; Jean-Christophe Top
Testimonials
‘The team is very diverse, so we have easy access to a lot of different profiles when addressing different challenges.’
‘Jean-Christophe Top is our principal contact, he reacts rapidly and very efficiently to our different requests. Matthias Vierstraete is experienced and provides valuable advice.’
‘Up-to-date knowledge of applicable legislation, fluid communication, and timely service.’
‘Clear, in-depth individual expertise in each field.’
‘I am satisfied with the services of the firm. Their professionalism and expertise are good and they deliver their services with thoroughness and sufficient quality. What really sets them apart is their expertise in the complex world of CE marking for medical applications; they have a thorough understanding of the regulations and their guidance was helpful when navigating the complicated requirements.’
‘The team goes to great lengths, digging into regulations as well as recent and longer-standing caselaw to prepare a case to perfection.’
‘The staff assumes their own knowledge, but tests it against our knowledge and experience to arrive at a match. There is true cooperation with mutual respect.’
Key clients
Nipro Medical Europe
Nipro Digital Technologies Europe
The Akkermansia Company
QLEVR
S-Biomedic
Indigo Diabetes
VIPUN Medical
D-Tek
eTheRNA Immunotherapies
UC-Leuven Limburg (UCLL)
European Cystic Fybrosis Society
Belgian State, FPS Public Health
IBSA
Agomab Therapeutics
Amber Technologies
Aphea
Apitope International
Augustine Therapeutics
Bioqube Ventures
Complix
Deuteroncology
Dualyx
FOx Biosystems
Inbiose
Minoryx Therapeutics BE
MRM Technologies
MRM Health
Prodigest
Protealis
Rewind Therapeutics
S-biomedic
Vipun Medical
Work highlights
- Advising Nipro Medical Europe on regulatory life sciences, and IP and IT matters. The firm is advising on the client’s MDR and Brexit transition, and continues to assist the company with agreements, complaints/notifications from notified bodies and authorities alike, medical device borderline cases, transition towards an eQMS, ethical and sunshine act considerations.
- Assisted FPS Public Health with setting up the Belgian Health Data Agency (HDA).
- Assisted Aphea.Bio with its Series C investment round of approx. €70m (including assistance with negotiations and the drafting of the shareholders and subscription agreement, stock option plan) and closing of the first tranche capital increase of approximately €25m.
DLA Piper
DLA Piper leverages its international network to assist its clients with EU marketing authorisations, data transparency, and mandates concerning the public procurement of medicines. Dividing his time between Brussels and Rome, Marco de Morpurgo leads the team, regularly advising on sector specific behavioural and compliance related matters; he is also known for his extensive knowledge of national and EU regulations governing the pharma and biotech industries.
Practice head(s):
Marco de Morpurgo
Key clients
Medtronic
Sanofi
Syneos Health
Bristol Myers Squibb
ResMed
Takeda
Incyte
Philip Morris International
GlaxoSmithKline
Novartis
Ipsen
Gilead
WuXi Apptec
Medica Group
argenx
Sarepta Therapeutics
Amgen
Work highlights
- Assisted argenx BV with setting up a global distribution network for its autoimmune disease products. This involved reviewing distribution agreements in over 25 jurisdictions, and ensuring compliance with EU competition law.
- Advising Iovance Biotherapeutics on its acquisition of worldwide rights to Proleukin from Clinigen LImited, with a £166.7m upfront payment and potential milestone payments and royalties.
- Assisted Reata Pharmaceuticals with the preparation for the launch of a pipeline medicinal product in the EU and the UK. The team advised on market access, pricing, and reimbursement, contract drafting, supply chain management, compliance with Key Opinion Leaders, MSLs, and healthcare professionals, along with corporate and employment matters.
Loyens & Loeff
Loyens & Loeff houses an experienced team which is known for acting in a wide variety of mandates, including tax structuring issues, actions against the European Commission (EC), and public procurement tenders for healthcare providers. Notable clients include AstraZeneca, Galapagos, and Demant. Stéphanie De Smedt leads the team with her deep knowledge of both GDPR and the Clinical Trials Regulation, often advising on the negotiation and drafting of collaboration agreements. Valentijn De Boe has a great deal of experience in public procurement contracts, and regularly assists hospitals and healthcare institutions.
Practice head(s):
Stéphanie De Smedt
Other key lawyers:
Valentijn De Boe; Filip Saelens
Key clients
AstraZeneca
Demant A/S
Galapagos
B. Braun Medical
Gamma Biosciences Holdco Limited
Criteria Bio Ventures SICC S.A.
GBA Group
Work highlights
- Advised Galapagos on Belgian and Dutch tax in relation to the post-acquisition restructuring of Cellpoint BV.
- Acted for AstraZeneca in high-profile litigation before the Belgian courts regarding the execution of its vaccine delivery contract with the European Commission and EU Member States.
- Assisted Demant with the acquisition of the audiology branch of Goed Hulpmiddelen.
Osborne Clarke
Rated by clients for the regulatory capabilities across the team, Osborne Clarke acts for a broad client base which notably includes Coopervision, OncoDNA, and Medi-market. The ‘excellent‘ Hadrien Chef leads the team and has vast corporate expertise, regularly assisting medical diagnostic, medtech, and biotech companies with financings and reorganisations. Praised for his ‘sharp edge‘, Vladimir Murovec is known for his deep regulatory knowledge, particularly in relation to digital health, pharma, and medical device issues.
Practice head(s):
Hadrien Chef
Other key lawyers:
Vladimir Murovec; Marie Canivet
Testimonials
‘They consistently work as an integrated team, involving the right people at the right time. The practice got a solid boost with the arrival of Vladimir Murovec and are now a fully-fledged medtech and pharma practice with top-notch regulatory capabilities. It is good to see their practice flourish from a local Belgian provider to a truly international service offering with standout EU regulatory competence.’
‘Hadrien Chef stands out as an excellent lawyer.’
‘Vladimir Murovec is able to admirably handle both domestic mandates with a purely local element and global EU projects. Vladimir is quite sharp, but keeps it casual with the team and is always happy to brainstorm about potential projects, which is nice and refreshing; he’s become a reference in Regulatory and Compliance in the EU Life sciences space.’
‘Vladimir Murovec is very committed, provides to-the-point information and high quality output. ’
‘Hadrien Chef has a global overview and understanding, providing preventative advice. He is highly flexible and available.’
‘What sets OC Brussels apart is their knack for seamless teamwork. In recent years, they’ve become a go-to provider for multiple global pharmaceutical businesses with top regulatory capabilities.’
‘I truly appreciate Vladimir Murovec’s versatility, he navigates local and global assignments with ease, whether it’s handling national investigations or diving into global-scale projects connected to EMA procedures or European Commission approvals.’
‘Vladimir Murovec has that sharp edge when it comes to regulatory and compliance in the EU Life Sciences arena. He keeps things laid-back and is easy to approach which sets him apart as a go-to lawyer in the field.’
Key clients
Afflelou Group
Alnylam Pharmaceuticals
Bepharbel Manufacturing
Bone Therapeutics (BioSenic)
Coopervision
Epstein, Becker & Green
Medi-Market
Novo Nordisk
OncoDNA
Sunrise
Work highlights
- Advised BioSenic on its reverse merger with French Company Medsenic, in addition to advising on the client’s IP, commercial and overall ECM needs.
- Advised Sunrise on its recent €17m fundraising, led by Kurma Partners and the EIC fund, its subsequent acquisition of strategic assets in France and the US from French company Dreem SAS, and its partnerships, distribution and regulatory strategy to support the roll out of its sleep apnoea test in Europe and the American market.
- Advised a global pharmaceutical company on its dealings with a local biobank for the storage and shipment of plasma-derived products across the European Union.
Simont Braun
The team at Simont Braun exhibits expertise across a variety of areas, including disputes concerning the corporate branding of generic medicines, and trade mark cases. Practice co-head Eric De Gryse is particularly knowledgeable in international patent cases concerning the market entry of biosimilars and medical devices, while co-head Rafaël Jafferali handles a broad range of class actions and arbitrations before the Belgian Supreme Court. Axel Maeterlinck is noted for his longstanding expertise in corporate governance and M&A work.
Practice head(s):
Eric De Gryse; Rafaël Jafferali; Axel Maeterlinck
Key clients
Eurofins
Work highlights
- Represented the European Commission and the 27 Member States against AstraZeneca for its delays of delivery of millions of doses of Covid-19 vaccines to the EU. After a judicial victory for the EC in summary proceedings, the parties found an amicable settlement.
- Representing Samsung Bioepis against Novartis in a revocation action that was brought before the Brussels Business Court in February 2023. In these proceedings the nullity of the Belgian portion of three European patents owned by Novartis is invoked. The three patents are divisionals of a same European patent that has been revoked earlier in opposition proceedings before the EPO.
- Acting for EG, a producer and distributor of generic medicines, in matters of advertising law related to medicines (market practices and specific regulatory rules).
Taylor Wessing
Jointly led by Christian Dekoninck and Patricia Cappuyns, the team at Taylor Wessing is proficient in advising on the full spectrum of IP-related issues, including UPC matters, SPC litigation, and data exclusivity questions. Dekoninck has a great deal of knowledge surrounding patent litigation, while Cappuyns focuses on European Commission investigations involving both competition and patent law aspects. Marie Keup is noted for her expansive expertise in trade marks and design rights within life sciences.
Practice head(s):
Christian Dekoninck; Patricia Cappuyns
Other key lawyers:
Marie Keup
Testimonials
‘The team is relatively compact in size but experienced in IP cases including patent litigation. One of the strengths of the team is its ability to understand complicated technical issues. The team has rich experience in litigation, and performs excellently in the court room.’
‘I have been working with two attorneys, Christian Dekoninck and Marie Keup in multi-lateral patent litigation. Christian is a good organiser of the team, his writing skill makes him one of the best among many attorneys I have worked with.’
‘Marie Keup is very smart.’
Key clients
Viatris
Dana-Farber Cancer Institute
Pfizer
NIPRO
Johnson & Johnson
Teva
Work highlights
- Represented Pfizer in its patent litigation against Moderna involving the Covid-19 vaccines.
- Represented Dana-Farber Cancer Institute (linked to Harvard Medical School) in SPC litigation against the Belgian State.
- Successfully defended NIPRO against patent infringement claim by Fresenius, relating to filters used in dialysis treatments.