Industry focus: Healthcare and life sciences in Belgium

Bird & Bird

Bird & Bird has a preeminent reputation in healthcare and life sciences globally and its Brussels practice is equally adept in contentious and non-contentious mandates. The team is especially active in the hospital sector, advising on a mix of pricing, reimbursements, e-health issues and public procurement. Practice head Marc Martens‘s deep regulatory expertise notably encompasses areas including biobanking, advanced therapies and clinical trials, working with a deep roster of regional, national, and European organisations. Jean-Christophe Troussel and Paul Hermant are noted for their focus on IP-based and transactional mandates, respectively. Nicolas Carbonnelle continues to work with a number of high-profile clients on medical biotechnology and pharmaceutical instructions, often in a cross-border capacity.

Practice head(s):

Marc Martens

Other key lawyers:

Jean-Christophe Troussel; Paul Hermant; Nicolas Carbonnelle

Key clients

Polpharma

Terumo

Teva

European Respiratory Society

Astellas Pharma

European Commission

Promethera Biosciences

Mithra

Amgen

Reckitt Benckiser

Univercells

Work highlights

  • Representing Polpharma in an EU General Court case in regulatory data protection.
  • Instructed by European Respiratory Society to review the IP provisions in a draft collaboration agreement with a leading pharmaceutical company in the framework of the Clinical Research Collaboration “European Respiratory Network for Data-sharing in COVID-19″.
  • Served as transaction counsel for the partnership between listed company Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) and Purna Female Healthcare (PFH) – a spin-off founded by Purna Pharmaceuticals NV (a Belgian manufacturer of pharmaceutical products) and Creafund NV (a Belgian private equity fund) – to develop and commercialise an innovative combination therapy for the treatment of severe and recurrent vulvovaginal candidiasis (rVVC).

Covington & Burling LLP

A stellar roster of blue-chip pharmaceutical companies, medical device manufacturers, and European associations turn to the 'dedicated' and 'highly skilled' group at Covington & Burling LLP for its multi-jurisdictional capabilities in the full gamut of contentious and non-contentious issues. The team is experienced in a wealth of pan-European regulatory and policy-based matters and high-value disputes, appearing regularly before the European Commission as well as the national and European courts. Practice head Peter Bogaert is widely praised by clients for his 'unmatched expertise and experience' advising on EU regulatory frameworks governing the full scope of the life sciences sector. Bart Van Vooren is chiefly focused on pharmaceuticals, food, and cosmetics, with impressive credentials as both an academic and an EU litigator. Robin Blaney is also noted.

Practice head(s):

Peter Bogaert

Other key lawyers:

Bart Van Vooren; Robin Blaney

Testimonials

‘Expert people, collaborative spirit, punctual, and take ownership.’

‘Both partners and associates are very professional and knowledgeable. They go the extra mile in the light of our interests. Very flexible, meet deadlines, explain complex legal matters and give excellent advice and support.’

‘Dedicated team of highly skilled regulatory lawyers that master the ability to work in the different product and chemical rules (medicines, devices, cosmetics, biocides, etc.), allowing also to leverage learnings and insights from one field to the other.’

‘Unique regulatory legal expertise in pharmaceuticals, and more generally, life science matters. Ability to tackle multi-jurisdictional issues.’

‘Peter Bogaert has unmatched expertise and experience in the field, and one of the sharpest minds. He has built a robust team of individuals to support the practice, including Bart Van Vooren who is following closely in his footsteps.

‘I enjoy working with Robin Blaney for his expertise and pragmatism. He is a great asset to any dossier and provides clear and actionable advice to the legal team and the business.’

‘Multiple individuals with excellent life science expertise. Pragmatic and client friendly approach.’

‘Both Peter Bogaert and Robin Blaney are excellent in their field, with extensive expertise across different life science issues and a pragmatic approach.’

Key clients

AbbVie

AstraZeneca

BioNTech SE

Bristol-Myers Squibb (BMS)

GlaxoSmithKline (GSK)

Eli Lilly

European Federation of Pharmaceutical Industries and Associations (EFPIA)

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Johnson & Johnson Group

MedTech Europe

Merck Sharpe & Dohme

PTC Therapeutics

Roche

Spadel

Takeda Pharmaceutical Company

Work highlights

  • Represent 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.
  • Represent Sanofi in three proceedings before the EU General Court regarding complex regulatory questions around the use and protection of clinical trial data, and “New Active Substance” status of two products Jevtana and Aubagio.
  • Advising AbbVie on a range of EU regulatory matters pertaining to centralised authorisations before the EMA, as well as EU and national member state rules on interactions with healthcare professionals.

Crowell & Moring

Led by renowned patent litigator Kristof Roox, the pharmaceutical and life sciences group at Crowell & Moring is highly regarded by clients for its capabilities in cross-border patent disputes, and regulatory and legislative reviews, both at the Belgian and EU level. The team is noted for its interdisciplinary approach to instructions and frequent collaboration with the firm’s IP, competition and privacy departments. Jurgen Figys , who benefits from a background in biomedical science, is routinely sought out by a host of companies for his expertise in regulatory issues, SPC litigation and digital transformation in the healthcare sector. Matteo Mariano is noted for his knowledge of pharmaceutical IP. Since publication, Judith Bussé left the firm.

Practice head(s):

Kristof Roox

Other key lawyers:

Jurgen Figys; Matteo Mariano

Key clients

Viatris (formerly Mylan)

Sandoz

Novartis

Medicines for Europe

Gear Up Medical

Pharma Patent

Honeywell

Fresenius Medical Care

Apotex

Alcon

Synthon

Zentiva

Aurobindo

Stada

Work highlights

  • Defended Sandoz in summary proceedings brought by Bayer and prevented the launch of Sorafenib Sandoz being blocked until December 2022.
  • Acted for a leading international pharmaceutical company in two disputes regarding a rival company’s promotional materials.
  • Advised a leading vaccine manufacturer through its outside counsel on how to prevent potential injurious actions based on alleged patent infringement.

HOYNG ROKH MONEGIER

A wealth of market-leading names from the worlds of pharmaceuticals and life sciences regularly instruct HOYNG ROKH MONEGIER on a host of mandates. The team is highly regarded for its patent portfolio management and European-level patent litigation capabilities, while also having considerable expertise in regulatory frameworks and data exclusivity law – advising clients on major, cross-border product developments, registrations and pricing issues. Practice head Liesbeth Weynants is praised for her 'wealth of experience' in European regulatory matters, including MA procedures, clinical trials and pharmacovigilance. Managing partner Benoît Strowel is an experienced multi-jurisdictional patent litigator who represents various biopharmaceutical heavyweights. Pharmaceutical science is a cornerstone of Steven Cattoor's patent and trade secret litigation practice, while Delphine Borgniet is noted for her experience of medicinal market access strategy and administrative proceedings regarding parallel import authorisation.

Practice head(s):

Liesbeth Weynants

Other key lawyers:

Benoît Strowel; Steven Cattoor; Delphine Borgniet

Testimonials

‘Very practical advice on the cross-over between regulatory and IP law. Responsive and easy to work with. Really know their stuff.’

‘Liesbeth Weynants is very easy to work with and gives user friendly and practical advice.’

‘The team has a great depth of experience in patent litigation. Very responsive. Sound advice. Always a pleasure to collaborate with them in executing the client’s litigation strategy.’

‘Steven Catoor brings a high level of experience and a great deal of common sense in his advice. Always a pleasure to collaborate with him on patent litigation matters, he responds in a timely fashion and with well thought through arguments.

‘Liesbeth Waynents is an excellent lawyer with a thorough knowledge of the sector.’

‘Benoit Strowel is a legend in his own right.’

‘Steven Cattoor has been impressive and great at project management.’

‘Lisebeth Weynants is excellent for European regulatory advice with her wealth of experience.’

Key clients

Biocodex

Biogen

Boehringer Ingelheim

Ceva Santé Animale

Solvay NV

Teva Pharmaceutical industries Ltd.

Van Bael & Bellis

The market-leading life sciences practice at Van Bael & Bellis fields a strong and sizeable team able to advise on a host of contentious and non-contentious mandates across the sector. The team is highly regarded by public and private sector clients, ranging from multinational pharmaceutical giants to pan-European associations and sovereign states. Praised by clients as an 'exceptional legal advisor', Catherine Longeval routinely represents various heavyweight clients in high-profile litigation and CEPANI-governed arbitral tribunals. Peter L’Ecluse's life sciences expertise is concentrated in patent licensing, registration, and pricing reimbursement, representing entities in various administrative proceedings. Also noted for his EU competition expertise, Michael Clancy's recent disputes-based instructions include appearances before the Court of Justice appealing patent settlement verdicts. Koen T’Syen and Thibaut D’hulst are other names to note.

Practice head(s):

Catherine Longeval; Peter L’Ecluse

Other key lawyers:

Michael Clancy; Koen T’Syen; Thibaut D’hulst

Testimonials

‘Van Bael & Bellis continues to provide outstanding services to our company in a wide range of competition and regulatory matters. The partners in charge are very accessible and the response time and quality of the advice are second to none.’

‘Catherine Longeval is very knowledgeable and responsive. Her no-nonsense style works very well with my business clients. David Hull and Mike Clancy are clear experts in the life sciences sector which make them an obvious choice for all types of anti-trust support.’

‘The collaboration with the team always goes well. They are ready and available to help with any issue. The team delivers great work and within time. In meetings, documents, reports, you understand what the team means and what they put on paper is readable and understandable. This is not always the case with other law firms.’

‘Koen T’Syen and Thibaut D’hulst are great lawyers to work with. They are available, ready to help and they know what they are talking about. Both lawyers try to understand how the company works and what strategy or solution could work best in the particular situation. No meeting or call is too much for them and they are always well on time in delivering advice.’

‘Approachable and diverse team.’

‘Highly experienced, and available, with detailed knowledge of the policy context.’

‘Catherine Longeval and her team are extremely knowledgeable on the pharma sector and provide outstanding service in all legal domains (from litigation to regulatory advice). The team works very efficiently and the legal advice is crystal clear.’

‘Catherine Longeval is an exceptional legal advisor and manager. She immediately grabs the case, sets up a team of lawyers and succeeds in providing clear and pragmatic legal advice.’

Key clients

AbbVie

Amgen

AstraZeneca

Baxter

Bayer

Belgian Federal Government

CSL Behring

Eisai

Eli Lilly

Gedeon Richter

Gilead

GlaxoSmithKline

Horus Pharma

Intercept

Mylan

Pfizer

Pharma.be

Schwabe Pharma

Takeda

UCB

Vertex

Zoetis

Work highlights

  • Representing a young girl suffering from a serious and rare disease in litigation against the producer of a medicinal product (Biomarin) that is not (yet) reimbursed in Belgium.
  • Represented Xellia and Zoetis in Lundbeck, the landmark case on appeal before the EU Court of Justice involving “reverse-payment” patent settlements in the pharmaceutical sector.
  • Advising Zoetis on a range of regulatory matters, including: (1) distribution and GDP, (2) sponsorship of HCPs, and (3) interactions with veterinary clinics, among others.

Allen & Overy LLP

Allen & Overy LLP’s Belgian life sciences team consistently handles an array of multi-jurisdictional mandates, advising on regulatory, transactional, and contentious matters for a formidable roster of clients. The practice is jointly led by two partners working across multiple sites: Geert Glas, a Brussels-based adviser to major pharmaceutical and biotech companies on litigation and licensing projects, and Antwerp-based Filip Van Elsen, an expert in digital health and telehealth. Tine Carmeliet regularly assists various pharmaceutical and biotech clients with respect to regulatory frameworks and data protection issues.

Practice head(s):

Geert Glas; Filip Van Elsen

Other key lawyers:

Tine Carmeliet

Key clients

Fund+

Inbiose

Johnson & Johnson

reMynd

Syngenta

V-Bio Ventures

Zimmer Biomet

Work highlights

  • Advised Syngenta on its digitalisation initiatives, and with regard to the company’s European trademark strategy.
  • Advising Fund+, a Belgian investment fund that makes long-term equity investments in innovative life sciences companies, on the intellectual property, commercial, licensing and data appreciation issues arising out of its targets in Belgium.

ALTIUS

Led by patent litigation specialist Christophe Ronse and agri-food expert Philippe de Jong, ALTIUS‘ multidisciplinary team acts for a number of transnational pharmaceutical conglomerates, medical device manufacturers, biotech companies, and foreign governments on cross-border disputes and proceedings before the domestic and European courts. The team also has niche expertise in the application of EU-wide compliance regulations and patent enforcement actions. The ‘genius’ Kirian Claeyé is a key contact within the team for parallel import/distribution support and IP portfolio management across the life sciences sector.

Other key lawyers:

Kirian Claeyé

Testimonials

‘Christophe Ronse is very professional, hard working and creative, and he helps us to establish a bridge between us and our transaction party.’

‘Altius has saved us a great amount of money and they are worth every cent. The level of service was outstanding with the whole team and especially with the key contact person.’

‘If I could, I’d give a 5 star rating to Kirian Claye who has proven to be a genius. We are working together a bit more than two years and time after time he solved our issues in a simple and eloquent way. Fast and clear communication and a complete risk analysis of the chosen strategy. For me, Kirian Claye has the charisma needed to guide you in each step and makes the legal aspect of our business fun, comprehensible and exciting.’

‘Excellent quality of legal advice rendered in time at a reasonable cost. What else can a company wish for?’

Key clients

Merck Sharp & Dohme (MSD)

Gilead

Eli Lilly

Biogen

Novartis

Euroseeds

SES Vanderhave

Bayer Cropscience

DSM

Mitsui Agriscience

Work highlights

  • Represented Eli Lilly & Co. in patent litigation in respect of its patent on the second medical use of the active ingredient pemetrexed (of its blockbuster medicine Alimta®) in combination with vitamin B12 for the treatment of certain cancers.
  • Represents SES Vanderhave before the CJEU in the context of a preliminary reference made by the Belgian Council of State in annulment proceedings against a Belgian regulatory act temporarily allowing the use of certain neonicotinoids on sugar beet crops.
  • Representing the Islamic Republic of Pakistan in opposition proceedings against India’s application to be granted protection for the name ‘Basmati’ under the EU geographical indication quality scheme.

Jones Day

Jones Day handles the full spectrum of healthcare and life sciences work, including in the cutting-edge fields of diagnostics, digital health, virtual clinical trials and app-based care. In recent work, the team advised on high-profile advance pricing agreements, EU regulatory reviews, and major cross-border investments, divestments and acquisitions. Practice head Cristiana Spontoni is praised for her 'very extensive' knowledge and capabilities, working with a myriad of companies on the full lifecycle of new products, including regulatory enforcements and post-recall crisis management. Luca Salernitano is also noted.

Practice head(s):

Cristiana Spontoni

Other key lawyers:

Luca Salernitano

Testimonials

‘Very good industry knowledge and expertise regarding relevant statutory law, case law and industry practices.’

‘Cristiana Spontoni is one of the best in this field, very extensive knowledge and experience, always very good to work with. Very efficient.’

Key clients

AbbVie Inc

Arsenal Capital

BioMarin Pharmaceutical

Institut Pasteur

Pharmaceutical Product Development

Shiseido

Sumitomo Dainippon Pharma

Loyens & Loeff

Fielding a cross-office Benelux group that works collaboratively on a litany of multi-jurisdictional mandates, the team at Loyens & Loeff is ideally positioned to assist an array of key life sciences companies with major transactions and disputes. The team is jointly led by IP and data protection expert Stéphanie De Smedt and public procurement specialist Valentijn De Boe, who works with various public hospitals, pharmaceutical companies, and financial institutions on high-value developments. Wannes Buelens is noted for his broad knowledge of health law, encompassing medical devices, clinical trials and patient rights.

Other key lawyers:

Wannes Buelens

Testimonials

‘Able to respond to niche life sciences questions well.’

‘Quick responses, with no need for clarifications.’

Key clients

Juvisé

Melisana

AstraZeneca

Softhale NV

Redmile – AgomAb Therapeutics NV

Arseus Medical NV

GHO Capital Partners LLP

Agilent Technologies Inc.

Bristol Myers Squibb

Mylan

SERB

Eurogenerics (Cinven / Bain Capital)

Arthrex

Medicom

PharmaBelgium-Belmedis

Work highlights

  • Acting for AstraZeneca in its dispute with the European Commission regarding the execution of the COVID-19 vaccine delivery agreement and alleged delays in deliveries of the vaccine to the EU market.
  • Acting as Belgian counsel to Softhale NV and its existing shareholders (the sellers) with the acquisition by Sino Biopharmaceutical Limited of Softhale NV.
  • Assisting California-based private equity investor Redmile Group on its Series B investment in AgomAb Therapeutics.

NautaDutilh

Well regarded by clients for its capabilities in high-value, cross-border deals, NautaDutilh is regularly engaged by blue-chip multinationals and leading Belgian companies active across the life sciences sector. The team's transactional pedigree sees it advising on biotech IPOs, equity capital markets acquisitions, and financing rounds for high-tech medical ventures. Florence Verhoestraete is a highly experienced IP and life sciences practitioner with key expertise in licence work, collaboration agreements, and consortia agreements for research funding. Philippe Remels regularly takes the lead on healthcare transactions, acting for publicly-listed companies as well as investors and underwriters.

Practice head(s):

Florence Verhoestraete

Other key lawyers:

Philippe Remels

Testimonials

‘The team at NautaDutilh is very well-versed and capable in complex cross-border transactions in the Life Sciences field. From our perspective, they are a leading firm in Belgium in this field and have an experienced team, comprised of professionals with different specialisations.’

‘Philippe Remels is very experienced with transactional matters and an excellent partner to work with on cross-border mandates. I greatly appreciate his friendly and collaborative approach.’

Key clients

Abacus Medicine

Allergan

arGEN-X

ASIT Biotech

Azalea Vision

Bausch Health companies Inc.

Chiesi

Cliniques Universitaires Saint-Luc

ImmuPharma PLC

Invitae

Johnson & Johnson

Nyxoah

Servier

Teva Pharma

Univercells

VIB (Flemish Institute for Biotechnology)

Vico Therapeutics

Work highlights

  • Assisted the underwriters with a $1.15bn (approx. €995m) fundraising by argenx.
  • Assisted Nyxoah with its IPO on Euronext Brussels and on Nasdaq.
  • Advising ASIT Biotech on a potential business combination whereby the French group DMS will contribute its imaging activities to ASIT Biotech in exchange for newly issued shares.

Quinz

The life sciences and technology team at Quinz works with a host of market-leading companies on high-value transactions, distribution agreements, regulatory matters and compliance questions. Cross-border licensing structures, strategic partnerships, and representation in competition authority investigations are further core competencies. Pharmaceutical compliance expert Olivier Van Obberghen and pharmaceutical regulatory specialist Pieter Wyckmans are both highly regarded for their 'intelligence and exceptional industry knowledge'. Marion Lapage is experienced in every element of the product lifecycle, ranging from R&D to supply chain establishment.

Practice head(s):

Olivier Van Obberghen; Pieter Wyckmans

Other key lawyers:

Marion Lapage

Testimonials

‘We appreciate the direct contact with the different partners, their knowledge, open-minded, quick response and the time they take to help you and to solve the problems.’

‘The team is pragmatic and approachable. They are committed to act as your partner, thinking along with the in-house lawyers and supporting them towards the business where needed.’

‘Olivier Van Obberghen and Pieter Wyckmans are trustworthy, intelligent and they have exceptional industry knowledge.’

‘Each member of Quinz’s large life sciences team breathes a passion for life sciences. Quinz’s life sciences department is more than just a group of individuals, they really come as a team. Assignments are always allocated to the right individual or expert group.’

‘The two team leaders Olivier Van Obberghen and Pieter Wyckmans are both truly bright lawyers. It’s always a pleasure for me to see how much both respect, value and complement each other and this clearly inspires their team. Olivier Van Obberghen is the authority in pharma compliance and patient involvement and his level of pragmatism is truly stunning – his legal advice is always spot-on.’

‘Pieter Wyckmans has developed an unequalled expertise in regulatory and pricing and reimbursement matters and is one of the most creative lawyers I know – he is also a very gifted and poised negotiator.’

‘Olivier Van Obberghen is a very bright and creative lawyer. I never stop being impressed by his ability to immediately grasp and dissect the complexity of a problem, highlight its weaknesses and come up with an ingenious solution on the spot. He is available around the clock and is extremely congenial.’

‘Quinz’s main expertise is in contract negotiations in the area of biotechnology, pharma and in the life sciences, and it especially understands the challenges that small and medium sized companies are facing in this sector. No need for us to explain in detail the scientific background of the project as most of the Quinz employees have a profound scientific knowledge.’

Key clients

Priothera

Gates Ventures – EPND

ObsEva SA

Telix Pharmaceuticals Ltd

UCB Pharma SA

ISA Pharmaceuticals

ExeVir

Abscint

Sciensano

SunshineSmile ()

Octimet

Johnson & Johnson

Takeda

Argenx

Galapagos

Vertex

Arvelle

Bayer

IPOPI

Precirix

ATB Therapeutics

Novo Nordisk

Merck KGaA

Biogazelle

BlueBirdBio

Grünenthal Pharma GmbH &Co. KG

Federal Knowledge Center

PhysIOL

Recordati

Yesse Technologies

Obseva

Avroxa

Pharma.be

CellPointBio

CleanBiologics

Roche

Eli Lily

Modis

Novartis

Oxyrane

Phonak

SOBI

Syndesi Therapeutics

Sinox

Zeussplus

Clinops

TwoBridge Pharma

EISAI Pharma

Materialise

Aimovig

Avroxa

F. Hoffman – La Roche AG

Work highlights

  • Appointed by ObsEva as its exclusive partner for overseeing and giving advice on all marketing materials that will be elaborated in the framework of the launch, and to ensure compliance with the regulatory framework applicable within the EU.
  • Assisted Sciensano with the drafting of the consortium agreement of the BelCoVac Consortium, which set out the overarching terms and conditions applicable to the research projects (including clinical trials and follow-up research).
  • Assisted Octimet in out-licensing of its core compound under development to DeuterOncology and its investor Newton Biocapital.

Simmons & Simmons

Simmons & Simmons‘ team stands out for its a deep interest in sector digitalisation, where it works closely with various companies, regulators and industry associations on a host of cutting-edge mandates. Notable focus areas for the team include in vitro diagnostic device regulation, digital health regulation, data protection and global healthcare compliance projects. Public procurement regulation and disputes are further key workflows. The practice is headed up by Olivier Mignolet, an experienced arbitrator and litigator with niche expertise in life sciences regulation. Annabelle Bruyndonckx is highly regarded for her focus on medtech and the digitisation of consumer healthcare.

Practice head(s):

Olivier Mignolet

Other key lawyers:

Annabelle Bruyndonckx

Testimonials

‘The Simmons & Simmons team combines high quality, which I’d define as excellent analytical skills, knowledge of the market, understanding of the business and clarity, with an approachable and informal style. They are truly capable of working with in-house counsels as if they were members of the team.’

‘Annabelle Bruydonckx is an experienced and very knowledgeable lawyer, and supported us on a number of critical matters.’

‘Articulate, lucid, and always available.’

‘Great team: professional, positive, and client-focused.’

‘Collaborative, competent, committed.’

Key clients

Align Technology

BeMedTech

Octapharma

Sanofi

GlaxoSmithKline

Stibbe

Highly reputed for its IP capabilities, Stibbe's cross-practice team also works with a host of renowned public and private sector clients on numerous compliance issues and contentious proceedings, as well as an array of registration and regulatory issues. Ignace Vernimme has significant experience of health products and healthcare services, handling high-stakes litigation and proceedings before various Belgian regulatory authorities. Philippe Campolini works with numerous clients in the life sciences and medical device industries, while Manuel Campolini is noted for his deep knowledge of domestic and EU-wide pharmaceutical regulatory frameworks.

Practice head(s):

Ignace Vernimme; Philippe Campolini

Other key lawyers:

Manuel Campolini

Testimonials

‘A good team with solid practitioners, experienced in all areas.’

‘Ignace Vernimme is a safe pair of hands. Smart, focussed and charming with clients.’

Key clients

Accord Healthcare

AG Insurance

ANMI (Advanced Nuclear Medicine Ingredients)

AXA

AZ Delta Roeselare

AZ Maria Middelares

Biostrand

Brussels Medical Devices Center (BMDC)

Corden Pharma

CSL Behring

Genomic Health

Getinge

Ghelamco

Hospital Waregem

Mundipharma

Mylan

ORA (Optimized Radiochemical Application)

Perrigo (Omega Pharma)

Peters Surgical

R.G.C.C. Holdings

Relu Dental Imaging

S.A.M. Promedical

S.E.R.P.

Sipcam Oxon

Taizhou Bailly Chemicals co

Teonia

Télé-Secours

Toxikon

Victrix

UZ Leuven

Work highlights

  • Advised CSL Behring on several major matters: (i) regarding the possibility to establish payments by instalment for an ATMP, (ii) in a matter regarding off-label reimbursements and (iii) regarding Belgian legislation on blood products.
  • Successfully representing Mundipharma in summary proceedings before the Brussels courts against Roche, Genentech and Biowin who failed in their attempt to obtain an injunctive order against the launch of the biosimilar Truxima on the Belgian market by Mundipharma.
  • Acting for Sipcam Oxon and Taizhou Bailly in a patent and regulatory litigation against Syngenta.

Baker McKenzie CVBA/SCRL

Drawing on the firm's considerable international network, Baker McKenzie CVBA/SCRL's healthcare and life sciences practice regularly works with a host of domestic and international companies and industry associations on multinational procurements, clinical research contracts, and other market access mandates. The team works closely with its corporate department on a host of high-value pharmaceutical sector deals, with recent highlight including big-ticket IPOs and convertible bond offerings. The team is jointly led by Roel Meers, a specialist in biotech sector corporate financing, and Els Janssens, a healthcare regulatory expert who advices on drug approval and oversight procedures at a Belgian and EU level. Fiona Carlin is noted for her expertise in pharmaceutical distribution networks and competition issues.

Practice head(s):

Els Janssens; Roel Meers

Other key lawyers:

Fiona Carlin

Key clients

Galapagos

Calliditas Therapeutics

Mithra Pharmaceuticals SA

Sequana Medical NV

MDxHealth SA

MRM Technologies

CureVac

Work highlights

  • Advised CureVac N.V. on the frame of its request to participate in and negotiation of a public procurement procedure launched by the EU Commission, this under utmost urgency, in August 2020, regarding the provision of the COVID vaccine for all European countries.
  • Advised Galapagos on the amendment of its existing collaboration and licence agreement with Gilead Sciences.
  • Advised Mithra Pharmaceuticals, which is listed on Euronext Brussels, on its debut €125m convertible bond offering.

CMS

CMS' cross-practice collaboration and multilingual capabilities make it a popular choice for a varied roster of pharmaceutical heavyweights, industry associations and hospital groups. The team is especially renowned for its public procurement capabilities, working with some of the largest Europe-wide governing bodies on high-profile, cross-border projects. Joint practice heads Bruno Fonteyn and Virginie Dor are noted for their expertise in health sector regulation and EU-wide health and social care procurement mandates, respectively.

Practice head(s):

Bruno Fonteyn; Virginie Dor

Testimonials

‘Very hands-on knowledge and ability to provide very practical examples to the business. Feedback received was really what we needed, being very hands on, easy to understand feedback to specific practical questions.’

‘I don’t know that many lawyers that are able to provide such practical advice (no theory but really a precise and clear answer to specific business cases) as well as Virginie Dor.’

Key clients

Moderna

Biogroup

French Group Lagarrigue

Synlab

European Commission – Euriphi

MedTech Europe

Cliniques Universitaires Saint-Luc

Medi-Market

Getinge

Hospital of Charleroi

CHWAPI (one of the largest hospital groups situated in Belgium (Tournai)

OraSure

SOFIPOLE

Work highlights

  • Assisted Moderna with the submission of its tender for the Covid-19 vaccines’ tender launched by the EU Commission on behalf of the Member States and the negotiations on the advanced purchase agreement (APA) between Moderna and the EU Commission.
  • Assisted Biogroup, the French largest lab group, in connection with the acquisition of the Belgian clinical lab Group CMA-Medina, the leading player in medical lab testing in Belgium.
  • Assisted French group Lagarrique with the acquisition of Belgian group Aqtor!, specialised in the fitting, manufacturing and delivery of products of prosthetics, orthotics, bandage, mobility aids and orthopaedic shoes.

Deloitte Legal

Deloitte Legal's life sciences and healthcare practice is experienced in the full spectrum of corporate and venture capital work for clients in the biotech, medtech, and clean tech sectors. Distribution agreements, IP rights enforcement, and EU regulatory reviews are further core workflows for the team. A number of biotech and medtech start-ups and scale-ups routinely turn to Christoph Michiels for assistance throughout the development process. Benoît Féron and Kathleen De hornois are other names to note.

Practice head(s):

Christoph Michiels

Other key lawyers:

Benoît Féron; Kathleen De hornois

Key clients

A-MANSIA BIOTECH SA

S-Biomedic NV

Indigo Diabetes NV

VIPUN Medical NV

MRM Health NV

Miracor Medical NV

Aphea NV

AgomAb Therapeutics NV

Softhale

DLA Piper

DLA Piper's sizeable practice regularly assists various leading pharmaceutical and life sciences companies in high-value, multi-jurisdictional matters. The team is noted for its EU and Belgian regulatory coverage, most notably in relation to market authorisation, pricing and reimbursement issues, clinical trials, and public procurement. Eddy Lievens is routinely instructed by Pfizer to assist with a litany of employment and social security law matters. Caroline Daout advises various pharmaceutical companies on strategic transactions.

Practice head(s):

Eddy Lievens; Erwin Simons; Caroline Daout; Richard Sterneberg; Kristof De Vulder

Key clients

Pfizer Inc.

Argenx

UCB

Global Blood Therapeutics

iStar Medical SA

Global Health Investment Fund, a US investment fund structured by JPMorgan Chase & Co. and the Bill & Melinda Gates Foundation

CorMedix GmbH

Takeda Pharmaceuticals International AG

Ontex (Healthcare Division)

Buddy Technologies Limited

Dexcom

Medtronic

AmerisourceBergen

Teleflex

Incyte

ElmediX NV

Nexuzhealth

BASF Antwerpen NV

Baxter

Vertex

Lonza

Shire Pharmaceuticals

Gates Corporation

NJOY

GE Healtcare

Filorga Manufacturing SA

Hyunda International

Work highlights

  • Advised Pfizer Inc. on the divestment of its Upjohn business in to Viatris Inc.
  • Advised Pfizer Service Company BV on the transfer of its External Supply Planning department to Bucharest, Romania, with a closure of the department as a consequence.
  • Advised Pfizer Inc on the closing of a EUR 21,301,150.00 equity investment in Imcyse SA, a Belgian company active in the field of active specific immunotherapy.

Osborne Clarke

Osborne Clarke‘s life sciences and healthcare experience encompasses a range of corporate and commercial concerns, including cross-border VC and M&A transactions, tax matters, and pharmaceutical sector employment law. Data protection and IP rights advice are further key competencies. David Haex is an experienced transactional lawyer with many years of experience assisting biotech, medtech and pharmaceutical companies. Since publication, Vladimir Murovec joined the firm.

Practice head(s):

David Haex

Other key lawyers:

Vladimir Murovec

Testimonials

‘Osborne Clarke is very attentive to its customers. The firm is able to understand and manage very specific innovation issues. They are very easy to work with and are able to work well with different law firms as a team.’

Key clients

Bone Therapeutics

Delphi Genetics

The Adecco Group

Acutus Medical

OncoDNA

Wolfgang Dorfner

ImmunXperts

Novo Nordisk

Bepharbel Manufacturing

Nausicaa Ventures

Work highlights

  • Advising Bone Therapeutics on numerous matters including its €16m loan financing from the European Investment Bank, its €10m private placement, set-up of two stock options plans and the update of its corporate governance charter in light of the BCCA and the new Belgian Code on Corporate Governance.
  • Assisted Delphi Genetics SA with the sale of 100% of its shares through an auction process coordinated by the US-based investment bank Achelous Partners.
  • Representing an association dedicated to the design and development of gene therapy treatments for rare diseases in an important litigation concerning the performance of a patent licence agreement.