Firms To Watch: Industry focus: Healthcare and life sciences

Led by Magali Feys, the practice at AContrario.Law handles the full gamut of healthcare data protection and security matters. The group is particularly adept at advising on large projects and digital transformations.
The team at King & Spalding LLP is well equipped to handle a broad variety of EU regulatory issues affecting international pharmaceutical companies, including product launches, and paediatric investigation plans.

Industry focus: Healthcare and life sciences in Belgium

Bird & Bird

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.

Praxisleiter:

Marc Martens


Weitere Kernanwälte:

Jean-Christophe Troussel; Paul Hermant; Nicolas Carbonnelle; Kevin Munungu


Referenzen

‘Very knowledgeable, responsive, professional.’

‘Very accessible and reply quickly.’

Kernmandanten

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.

Praxisleiter:

Peter Bogaert; Bart Van Vooren


Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Kristof Roox


Weitere Kernanwälte:

Jurgen Figys; Matteo Mariano; Wietse Vanpoucke; Christopher Dumont


Referenzen

‘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.’

Kernmandanten

Sandoz


Viatris (formerly Mylan)


Synthon


Zentiva


Novartis


Medicines for Europe


Honeywell


Fresenius Medical Care


Polpharma


Neuraxpharm


Highlight-Mandate


  • 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.

Praxisleiter:

Liesbeth Weynants


Weitere Kernanwälte:

Steven Cattoor; Benoît Strowel; Tim Robrechts; Charlotte Behets Wydemans; Ine Letten


Referenzen

‘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.’

Kernmandanten

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.

Praxisleiter:

Olivier Van Obberghen; Pieter Wyckmans


Weitere Kernanwälte:

Michiel D’herde; Marion Lapage; Amber Cockx; Pauline Meskens


Referenzen

‘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.’

Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Catherine Longeval; Peter L’Ecluse


Weitere Kernanwälte:

Michael Clancy; Thibaut D’hulst


Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Filip Van Elsen; Tine Carmeliet


Referenzen

‘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.

Praxisleiter:

Christophe Ronse; Philippe de Jong


Weitere Kernanwälte:

Kirian Claeyé; Bart Junior Bollen


Referenzen

‘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.’

Kernmandanten

AbbVie


Hologic


P3Lab


Hipra


Organon


Applied Medical


Azelis


Beiersdorf


VWR-Avantor


VMD – Inovet


Anicura


Gilead


Bayer Pharma


Novartis


Biogen


Ferring


Merck (MSD)


Highlight-Mandate


  • 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.

Praxisleiter:

Cristiana Spontoni


Weitere Kernanwälte:

Ursula Schliessner; Jörg Hladjk


Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Florence Verhoestraete; Philippe Remels


Weitere Kernanwälte:

Sien Vandezande; Tanguy de Haan


Referenzen

‘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.’

Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Olivier Mignolet; Annabelle Bruyndonckx


Weitere Kernanwälte:

Nele Jonckers; Alexander Wenzel


Referenzen

‘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.’

Kernmandanten

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.

Praxisleiter:

Ignace Vernimme; Philippe Campolini


Weitere Kernanwälte:

Louis Bidaine


Referenzen

‘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.’

Highlight-Mandate


  • 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.

Praxisleiter:

Els Janssens; Roel Meers


Weitere Kernanwälte:

Elisabeth Dehareng; Olha Sviatenka


Referenzen

‘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.’

Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Bruno Fonteyn; Virginie Dor


Kernmandanten

Medtech Europe


Group Lagarrigue


Synlab


Cliniques Universitaires Saint-Luc


Medi-Market


Hospital of Charleroi


CHR de Verviers


BioGen


Pharma.be


Highlight-Mandate


  • 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.

Praxisleiter:

Christoph Michiels


Weitere Kernanwälte:

Matthias Vierstraete; Jean-Christophe Top


Referenzen

‘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.’

Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Marco de Morpurgo


Kernmandanten

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


Highlight-Mandate


  • 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.

Praxisleiter:

Stéphanie De Smedt


Weitere Kernanwälte:

Valentijn De Boe; Filip Saelens


Kernmandanten

AstraZeneca


Demant A/S


Galapagos


B. Braun Medical


Gamma Biosciences Holdco Limited


Criteria Bio Ventures SICC S.A.


GBA Group


Highlight-Mandate


  • 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 ‘excellentHadrien 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.

Praxisleiter:

Hadrien Chef


Weitere Kernanwälte:

Vladimir Murovec; Marie Canivet


Referenzen

‘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.’

Kernmandanten

Afflelou Group


Alnylam Pharmaceuticals


Bepharbel Manufacturing


Bone Therapeutics (BioSenic)


Coopervision


Epstein, Becker & Green


Medi-Market


Novo Nordisk


OncoDNA


Sunrise


Highlight-Mandate


  • 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.

Praxisleiter:

Eric De Gryse; Rafaël Jafferali; Axel Maeterlinck


Kernmandanten

Eurofins


Highlight-Mandate


  • 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.

Praxisleiter:

Christian Dekoninck; Patricia Cappuyns


Weitere Kernanwälte:

Marie Keup


Referenzen

‘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.’

Kernmandanten

Viatris


Dana-Farber Cancer Institute


Pfizer


NIPRO


Johnson & Johnson


Teva


Highlight-Mandate


  • 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.