Industry focus: Healthcare and life sciences in Italy

Bird & Bird

Jointly led by Giovanni Galimberti and Massimiliano Mostardini, the team at Bird & Bird is well-known for its strong focus on pharma and life sciences-related patent and regulatory litigation. Galimberti is particularly adept at coordinating pan-European litigation for international healthcare clients, in addition to advising on trade marks and unfair competition issues, while Mostardini is recommended for his vast knowledge of clinical trials and licensing. Antonella De Gregori is a key contact for clients in the pharma and chemical sectors, and Claudia Ricciardi often advises on collaborative and sponsored research agreements. Evelina Marchesoni is well-known for her expertise in biotech patents and supplementary protection certificates, while Mauro Turrini‘s workload consists of pricing and reimbursement, and pharmacovigilance compliance issues. Simone Cadeddu stands out due to his exceptional knowledge of public procurement.

Practice head(s):

Giovanni Galimberti; Massimiliano Mostardini


Other key lawyers:

Antonella De Gregori; Claudia Ricciardi; Evelina Marchesoni; Mauro Turrini; Edoardo Bàrbera; Simone Cadeddu


Testimonials

‘Excellent knowledge of local practice and laws, wide arrays of areas of activity, excellent connection with foreign affiliates.’

‘Edoardo Bàrbera and Evelina Marchesoni. Outstanding knowledge of practice and of local pharma and patent law.’

Key clients

Alcon Italia


Astellas Pharma


Benefis


Dexcom


DOC Generici


Doctolib


Edwards Lifesciences


Fisher & Paykel


Gruppo San Donato


Heska Corporation


INCIPIT


Istituto Europeo di Oncologia


ISchema View


Kyowa Kirin Italia


Multimedica Clinical & Research Campus


Permedica


Polpharma group


San Donato Group


San Raffaele Hospital


Swiss Pharma International


Telethon Foundation


Work highlights


  • Assisted Fisher & Paykel Healthcare in preliminary injunction proceedings on the basis of a European patent related to a breathing tube.
  • Assisting DOC Generici with signing the agreement for the acquisition of the rights for manufacturing and marketing Muscoril® – a medicine with a myorelaxant action, currently commercialised by Sanofi – for Italy, Portugal and the Czech Republic.
  • Successfully assisted Amgen with defending the award of a contract for the supply of the drugs based on the active ingredient known as Eculizumab to the hospitals of the Apulia Region.

BonelliErede

BonelliErede houses a broad team which handles a wide variety of issues, including the data protection aspects of clinical trials, major transactions within the healthcare space, and complex regulatory disputes. Andrea Carta Mantiglia heads the practice and is recommended for his vast knowledge of international tenders and M&A within the life sciences sector. Monica Fantino is a key name for both Italian and cross-border M&A mandates, often advising on joint-promotion agreements and R&D contracts, while Elettra Gaspari is noted for her vast corporate and EU law expertise. Ivan Rotunno joined the team from Orrick, Herrington & Sutcliffe in February 2024, bringing his deep knowledge of cybersecurity. Daria Ghidoni also joined in February 2024 from an in-house position in a major pharma company, contributing her broad experience in cross-border M&A and licensing, in addition to pharma regulation.

Practice head(s):

Andrea Carta Mantiglia


Other key lawyers:

Giovanni Guglielmetti; Monica Fantino; Elettra Gaspari; Ivan Rotunno; Daria Ghidoni


Testimonials

‘The BonelliErede team is always competent, supportive and proactive. They are reliable and able to give advice.’

‘Open, proactive, communicative, competent, very concrete, they understand specific needs of the customer.’

‘Very efficient, responsive and well organized. Fully engaged and business oriented.’

Key clients

Chiesi Farmaceutici S.p.A.


Menarini


Ferring Pharmaceuticals


Luxottica S.p.A.


Humanitas S.p.A.


Bausch & Lomb – lom S.p.A.


Dompé Farmaceutici S.p.A.


Zambon S.p.A.


Pfizer Italia S.r.l.


Recordati industria Chimica e Farmaceutica S.p.A.


Roche S.p.A.


Gruppo San Donato


Novocure Italy S.r.l.


Fisiopharma S.r.l.


Segesta S.p.A.


Work highlights


  • Advised Gruppo Ospedaliero San Donato and GKSD in the acquisition of a majority stake in American Heart of Poland SA.
  • Assisting Fisiopharma with the review and negotiation of its commercial contracts.

DLA Piper

DLA Piper’s broad offering regularly handles cross-border joint ventures, private equity investment mandates, and clinical trial agreements for its lucrative, global client base of pharma and biotech companies. Practice head Roberto Valenti is well-equipped to assist clients with the full range of soft IP disputes and commercial issues surrounding medical devices. Marco de Morpurgo divides his time between Rome and Brussels, with his primary area of expertise being EU and Italian regulation of biotech, medical devices, and pharma products. Raffaella Quintana stands out due to her longstanding expertise in internal investigations and commercial fraud matters within the life sciences space, often representing pharma companies, while regulatory expert Nicola Landolfi is known for his vast knowledge of both EU and Italian law governing the licensing of products and clinical trials.

Practice head(s):

Roberto Valenti


Other key lawyers:

Marco de Morpurgo; Raffaella Quintana; Gualtiero Dragotti; Nicola Landolfi


Testimonials

‘Very well-prepared and skilled.’

‘Roberto Valenti is very prepared and talented in understanding issues and favouring solutions.’

‘Competence, professionalism, punctuality, preparation, and in-depth knowledge of the subject matter are all aspects that distinguish DLA Piper from others.’

‘People are always available and prepared.’

Key clients

Pfizer Italia S.r.l.


Pfizer S.r.l.


Wyeth Lederle S.r.l.


Eli Lilly


Iovance Biotherapeutics


Vertex Pharmaceuticals


MD Italy


Sifi


Menarini Group


Medtronic


Reckitt Benkiser


GE Healthcare


Work highlights


  • Assisted the Pfizer Group in relation to all aspects of Italian law relating to the integration of Seagen’s Italian business into Pfizer’s Italian business, completed by means of the merger by incorporation of Seagen Italy S.r.l. with and into Pfizer S.r.l.
  • Assisting Sifi S.p.A. with respect to the licence agreement with Affamed and to the entrance and establishment of the joint venture in the Chinese market, including the shareholder agreement.

Herbert Smith Freehills LLP

Herbert Smith Freehills LLP‘s practice is recommended for its strength in IP disputes, including infringement actions against generic drug manufacturers. The team is also noted for its experience in mandates involving the rules governing commercial relationships with hospitals and healthcare practitioners (HCP). Practice head Laura Orlando often appears before the Unified Patent Court (UPC) on behalf of global pharma companies; Orlando is well-known for her expertise in patent lifecycle management and data exclusivity. Sara Balice is a seasoned litigator with vast knowledge of cross-border SPC and patent cases, often assisting originator companies in cases against generic companies, while Enrico Maria Mancuso leads the firm’s corporate crime team, often advising on bid-rigging and internal investigations. Frederico Bracalente is a key name for white-collar and corporate crime work, with a strong focus on corruption and tax-related crime, and Martina Maffei is well-versed in both contentious and non-contentious IP work within the life sciences sector, often advising on marketing issues.

Practice head(s):

Laura Orlando


Other key lawyers:

Sara Balice; Enrico Mancuso; Frederico Bracalente; Martina Maffei


Testimonials

‘I recommend this firm for the preparation and kindness, and the prompt availability of its members.’

‘Laura Orlando. Really competent and prepared.’

‘The team is incredibly available and the members cooperate with each other in order to give you advice.’

‘Always try to find the best solution for your problems, taking into consideration the characteristics of the client.’

Key clients

Abbvie


Biogen


Eli Lilly


CSL Behring


Gilead


Janssen


Lionhealth


Lundbeck


Millennium Pharmaceuticals


Otsuka Pharmaceutical Co.


Roche


Sanofi


Veterna


Santen Pharmaceutical Co


Elekta S.p.A.


Philips S.p.A.


Abbott S.r.l.


Abbott Medical Italia S.r.l.


Abbott Rapid Diagnostics S.r.l.


Zambon S.p.A.


Work highlights


  • Assisting Elekta S.p.A., the Italian subsidiary of a global innovator of equipment and software for radiotherapy, charged with criminal association allegedly aimed at committing several bid-rigging offences in criminal proceedings pending before the Court of Monza.
  • Assisting Sanofi with filing 4 infringement actions related to its patent EP2493466, which protects a new antitumor use of the active ingredient cabazitaxel for the treatment of prostate cancer.
  • Representing Millennium and Janssen in two proceedings before the Court of Milan on the same patents protecting Velcade against three other generic companies, namely Dr. Reddy’s, Zentiva and Hikma

Hogan Lovells International LLP

The ‘very knowledgeable‘ team at Hogan Lovells International LLP often acts in civil proceedings involving product liability allegations, in addition to handling the full range of transactional issues and patent infringement cases. Christian Di Mauro leads the team with his ‘unique‘ expertise in product liability, often handling disputes and product safety mandates. Regulatory expert Giuseppe Aminzade has ‘outstanding‘ experience in handling the full spectrum of compliance work, while Chiara Perolari is well-equipped to assist with clinical trial agreements and compliance programs. Giovanni Ghirardi stands out due to his vast knowledge of unfair competition and trade mark work, in addition to handling cross-border patent disputes. Francesca Rolla is a key contact for investigation and compliance work within the healthcare and life sciences sectors.

Practice head(s):

Christian Di Mauro


Other key lawyers:

Giuseppe Aminzade; Chiara Perolari; Giovanni Ghirardi; Francesca Rolla; Elisa Rossi; Angelo Forte


Testimonials

‘Giuseppe Aminzade is very professional in providing the right level of support when dealing with the authorities and external communication channels.’

‘Expertise and experience within the practice, business acumen, capability to meet client needs and interaction with different levels of employees within organisations.’

‘Giuseppe Aminzade – great leader, outstanding experience in the practice and with different companies.’

‘Excellent knowledge of life science and excellent litigation skills.’

‘Very knowledgeable team and very good support on product liability litigation.’

‘Christian di Mauro is a very good lawyer who is willing to help. He is very organised and very knowledgeable of the sector. He has unique expertise in life sciences.’

Key clients

Angelini Holding


Baxter


Beckton Dickinson


Bracco Imaging


Calibre Scientific International


Chiesi


CHR Hansen Italia


Elanco


Elfie


Eli Lilly


Farmacosmo


Fidia Farmaceutici


Formula Pharmaceuticals


GE Healthcare


Grünenthal


Idorsia


Immunogen


Innate


Livanova


Luxottica


Madrigal


Masimo


Merz Therapeutics


Moleculin


MorphoSys


Novartis


Orthofix


Qiagen Marseille


Recordati


SilkBio


Sorin Group


Takeda Shire


Waldemar Link


Zhermack


Zoll


Work highlights


  • Represented Farmacosmo S.p.A. in relation to the sale to G&Ph Holding of a stake representing 67% of the share capital of Innovation Pharma and on the simultaneous sale by Innovation Pharma to Farmacosmo of a stake representing 67% of the share capital of Farmacia De Leo. The transaction aims to optimise Farmacosmo’s investments in the store pharmacy segment which is in line with the strategic plan approved by the issuer.
  • Representing Meril Life Sciences PVT. Ltd. in relation to a patent infringement and unfair competition litigation brought by Edwards Life Sciences in Italy (before the Court of Milan, Turin, and Naples) against the same Meril Life Sciences PVT. Ltd. and its distributors. Edwards Lifesciences Corporation claims that the marketing and distribution of Meril’s Myval device and the Navigator device would infringe a number of patents, including several divisional patents, owned by Edwards Lifesciences Corporation and constitutes unfair competition.
  • Assisting Zhermack S.p.A. with solving an impasse that had arisen following a clash between the client’s business goals and the registration requirements for medical device manufacturers in the EUDAMED database, according to the MDR. The issue causing the impasse concerned a complex interplay of regulations on the use of trade names by the company, medical device labelling and the requirements for registration in EUDAMED. This led to a stoppage by the Italian regulatory authority, which rejected the client’s proposal of registration in EUDAMED.

Portolano Cavallo

Luca Gambini and ‘outstanding regulatory lawyer’ Elisa Stefanini jointly lead the team at Portolano Cavallo. The group’s workload consists of a wide variety of mandates arising at the intersection between tech and life sciences, in addition to handling a broad array of IP issues. The team regularly assists health tech, medical device, and pharma clients. Stefanini is well-known for her expertise in pricing and reimbursement, advertising, and market access issues relating to medical devices and medicines, while Gambini is recommended for his broad knowledge spanning the full range of transactional issues within the life sciences sector. Ilaria Curti is a key contact for internal investigations, often with cross-border elements, in addition to advising on whistleblowing. Claudio Todisco is noted for his strong specialism in the regulatory framework governing pharmaceuticals and medical devices.

Practice head(s):

Luca Gambini; Elisa Stefanini


Other key lawyers:

Ilaria Curti; Claudio Todisco


Testimonials

‘The drafting of the documents took place extremely quickly and punctually. The team is cohesive and well-prepared. Always available for a discussion.’

‘The whole team proved to be very attentive to the practical and business aspects of the operation, distinguishing itself from competitors who are instead too focused on theoretical aspects.’

‘Impressive regulatory practice with expert life sciences sector knowledge. Responsive and flexible.’

‘Elisa Stefanini and Claudio Todisco impress with their regulatory expertise, commercial approach and sector understanding.’

‘Elisa Stefanini is the stand-out lawyer. She is an outstanding regulatory lawyer, with wide experience and a deep knowledge of the industry and the relevant regulations. She has a very pragmatic and business-oriented approach and is able to coordinate complex and cutting-edge projects.’

‘The team is very close-knit and collaborative. They work as a sole professional and, thanks to that, they are really able to offer multidisciplinary advice, which is particularly important in the management of complex projects. This is quite unique in the Italian legal market and it makes the difference.’

Work highlights


ADVANT Nctm

ADVANT Nctm‘s offering is noted for its broad experience, spanning joint ventures and M&A, to supply agreements and allegations of bid rigging. The team is also well-equipped to assist with a wide variety of data protection issues, particularly in relation to the processing of personal data. Practice co-head Lorena Possagno is a key contact for corporate and commercial matters within the life sciences sector, often advising major pharma companies. Co-head Paolo Gallarati is well-versed in M&A and often handles compliance work.

Practice head(s):

Lorena Possagno; Paolo Gallarati


Other key lawyers:

Giulio Uras; Francesca Bonino


Key clients

Fresenius Group


AstraZeneca


Uriach Italy


Endomagnetics Ltd


Aboca


Doc Generici


Genetic S.p.A.


Colisée Italia


Apoteca Natura


Curium Italy S.r.l.


Work highlights


  • Advising Uriach Italy in relation to on-going M&A activities.
  • Advised Endomagnetics in relation to the assessment of corruption/bribery risks potentially related to business relationships with Italian counterparties in the context of training/educational events for healthcare professionals.

Studio Professionale Associato a Baker & McKenzie

The team at Studio Professionale Associato a Baker & McKenzie handles a range of disputes relating to payback claims, spin-offs and commercial issues. Hailed by clients as ‘one of the top professionals in the pharma industry‘, practice head Roberto Cursano utilises his prior experience in the Italian Ministry of Health to assist with pricing and reimbursement issues, and clinical trial agreements. Public law expert Mario Cigno often advises on matters involving product recalls and public tenders, while Riccardo Ovidi is well-known for his compliance expertise, particularly in relation to the marketing and distribution of medical devices and medicines. Francesca Baratta is a key name for pharma and biomedical clients seeking advice on internal investigations.

Practice head(s):

Roberto Cursano


Other key lawyers:

Mario Cigno; Riccardo Ovidi; Francesca Barratta


Testimonials

‘Overall very good team on compliance and corporate matters. Always available and their advice is effective with a practical approach.’

‘In-depth knowledge of laws, rules and regulations – the ability to offer precise and effective advice – multidisciplinary and international approach.’

‘Competence and professionalism – Availability, adaptability, flexibility – Problem-solving – Excellent communication skills.’

Key clients

Integra Lifesciences


Baxter International Inc.


Regeneron Italy


ICU Medical Group


Abbott S.r.l.


Servier


Nuova Farmec


Hartmann Group


Intervet


Crossmed


PerkinElmer


Vyaire


Meridian Bioscience


Illumina


Applied Medical


Work highlights


  • Assistance to several med-tech companies, amongst which, ICU Medical Group, Hartmann Group, Crossmed S.p.A., Integra Lifesciences, Vyaire, Meridian Bioscience, Bio-rad Laboratories, Illumina and Applied Medical in the context of a public law litigation before the Rome Administrative Court and the Italian Constitutional Court, for an overall value of more than 50 million Euros, to challenge payment orders issued by Italian authorities pursuant to the Italian legislation on clawback for medical devices.
  • Assisted Baxter with all the regulatory and corporate aspects necessary to complete the integration upon completion of two complex intra-group transactions.
  • Assisted Regeneron with wide range of regulatory, corporate and commercial matters following the incorporation of the new legal entity in Italy.

Chiomenti

Chiomenti houses a ‘highly seasoned‘ team which stands out due to its strong corporate and commercial and public procurement expertise. Luca Liistro leads the team and utilises his ‘outstanding market insight‘ to assist both domestic and overseas clients on M&A and business restructurings. Filippo Brunetti stands out due to his extensive expertise in compliance, the establishment of cooperation groups, and public health policy issues, with a strong focus on medical device and pharma product reimbursement.

Practice head(s):

Luca Liistro


Other key lawyers:

Filippo Brunetti


Testimonials

‘Overall, very dedicated and hard-working team, offering full support and advice.’

‘Luca Listro has a very strong healthcare practice and outstanding market insight into this sector.’

‘The team consists of lawyers specialised in M&A and commercial contracts who all appear to be very dedicated.’

Very high efficiency. Responsive under pressure. The team has very good business acumen.’

‘They combine professionalism and pragmatism with an attitude that makes it a real pleasure working with them.’

‘Highly seasoned in the health sector – deal oriented/deal maker team.’

‘Luca Listro’s responsiveness and market/sector knowledge marks him out from other lawyers carrying out M&A in this sector.’

Key clients

Abbott S.p.A.


Air Liquide Sanità Service


Albis International


Alfasigma


Amplifon


Artsana


BioNTech


BioVelocITA


Carestream Dental Italy


Coloplast


Columbus Education Association


Enterprise Therapeutics


Fidia Farmaceutici S.p.A.


Forest Laboratories


Gilead Sciences


Groupe Simago SAS


Khiron


Hantech


Laboratoires Expanscience


Menarini Group


Moderna Inc.


Neuraxpharm


Recordati


Roche S.p.A.


Sumitomo Chemical Italia


Surmodics


Techwald Holding


Viatris


Xvivo Perfusion


Zambon Group


Zobele


Work highlights


  • Advising Alfasigma in the acquisition of Intercept Pharmaceutical Inc., traded on the NASDAQ exchange and focused on the development of novel synthetic bile acid analogs to treat chronic liver diseases. The transaction contemplated a public tender offer and a subsequent cash merger.
  • Advising Viatris on the sale of its OTC business to Cooper Consumer Health.
  • Advising Novo Holdings that through a merger agreement has acquired Catalent, Inc. in a transaction that values Catalent at $16.5 billion on an enterprise value basis.

Dentons

Dentons‘ offering has ‘outstanding expertise‘, advising a lucrative client base which notably includes FUJIFILM. Praised by clients for being ‘trustworthy and very knowledgeable‘, practice head Luca Pocobelli is well-equipped to advise on corporate reorganisations, joint venture agreements, and M&A within the life sciences sector. The ‘excellentIlaria Gobbato specialises in public procurement, advising both private and public entities on public tender procedures.

Practice head(s):

Luca Pocobelli


Other key lawyers:

Ilaria Gobbato; Sara Biglieri; Federico Fusco


Testimonials

‘The team is really strong and always available to help and assist the client in a very proactive way.’

‘The team is focused on our needs. always ready to respond to our requests with professionalism and competence, bringing innovation and growth to our sector.’

‘The team is always focused on trying to find a solution fitted to the clients’ needs.’

Key clients

Johnson & Johnson


FUJIFILM


Cerba Healthcare


White Lab


PureLabs


Ortho-Clinical Diagnostic Italy


NeoApotek


Lifescan


Alliance Medical


Archimed


Newron Pharmaceuticals


Work highlights


  • Advising FUJIFILM Group on the structuring of the corporate reorganization of its Italian companies.
  • Advising White Lab on the acquisition of several companies.
  • Advising PureLabs on the acquisition of a majority stake in L.A.M, the VivoLab network, and in Centro Sa.Na.

Gitti and Partners

Gitti and Partners houses a broad practice known for handling the full range of commercial transactions, reorganisations, and anti-corruption mandates. The ‘smart, diligent and meticulousPaola Sangiovanni leads the team and is well-versed in anti-corruption issues, in addition to advising on joint venture and license agreements. Flavio Monfrini frequently assists clients with M&A within the tech and life sciences spaces, while Francesco Stelio Clerici focuses on data and regulatory work. Leonardo Maria Moscati joined the team in February 2024, contributing his vast knowledge of corporate and commercial law, and his experience in advising on regulatory issues within the life sciences industry.

Practice head(s):

Paola Sangiovanni


Other key lawyers:

Flavio Monfrini; Francesco Stelio Clerici; Leonardo Maria Moscati


Testimonials

‘Paola Sangiovanni’s advice is always clear and practical, and her availability and engagement is thoroughly appreciated.’

‘Very good specialised knowledge of regulations of the life science sector, but also a good understanding of the business, so they provide practical and value-added legal advice. Able to work in complex cases and be involved in multijurisdictional matters. Good team resources. They are up-to-date with changes in regulation and provide good updates to clients. Very dedicated and professional.’

‘Paola Sangiovanni is a quick thinker with a great overall sense of policy and what theoretical solutions are realistic to try. She is also a joy to work with due to her never-ending positive energy. Flavio Montfrini can solve any puzzle and is the guy you want on complex contracts.’

Key clients

Medtronic Inc.


Mozarc Medical


Arcaplanet


Work highlights


  • Assisted Mozarc Medical with the sale of a portion of its business and with tackling complex issues in the areas of public procurement, corporate, insolvency and labour.
  • Advised Arcaplanet in the acquisition of several veterinarian clinic chains.

Orrick, Herrington & Sutcliffe

Jean-Paule Castagno and Attilio Mazzilli co-lead the team at Orrick, Herrington & Sutcliffe, which is recommended for handling the full range of transactional mandates, from series financings to M&A. The team also handles data privacy and protection work. Castagno is noted for his longstanding experience in corporate investigations and white-collar crime work, while Mazzilli stands out due to his strong focus on the tech sector, and his extensive knowledge of M&A and venture capital work.

Practice head(s):

Jean-Paule Castagno; Attilio Mazzilli


Testimonials

‘They deal with our files with as much care as if it were their own business.’

Key clients

Medical Microinstruments


GAPMED


KCK MedTech,


Supernova Invest


Panakes


Bianalisi S.p.A.


Eurosirel S.p.A.


Work highlights


  • Advised Medical Microinstruments on its US$100 million Series C financing.
  • Advised Gapmed on an appeal against Resolution no. 1514 of the Lombardy Region, which prevented the authorisation of new contracts for the outsourcing of core healthcare services (e.g. emergency room services, anaesthesia, paediatrics, etc.).
  • Advised Indaco Venture Partners on its investment in the US$38 million Series A financing of Freya Biosciences.

Osborne Clarke

Handling a vast range of disputes, the team at Osborne Clarke is also well-equipped to advise on distribution and manufacturing agreements, and consultancy agreements with HCPs. Maria Grazia Medici heads the practice with her longstanding regulatory expertise, often assisting clients with market authorisation issues. Giulia Verusio is well-versed in corporate and commercial matters within the life sciences and healthcare sector, in addition to having broad expertise in compliance with data protection and privacy rules. IP specialist Federico Ferrara is a key name for major disputes and non-contentious work involving licensing and counterfeiting.

Practice head(s):

Maria Grazia Medici


Other key lawyers:

Giulia Verusio; Federico Ferrara


Key clients

Actavis Italy S.p.A.


Dentsply Sirona Italia S.r.l.


Euroapi Italy S.r.l


Grifols Italia S.p.A.


Havas Group


Health Italia S.p.A.


SDM Società Dietetica Medica S.r.l.


Sic. Or. S.r.l. – Sicor Societa’ Italiana Corticosteroidi S.r.l.


Teva Italia S.r.l.


Wellspect S.r.l.


Zhermack S.p.A.


Work highlights


  • Represented Teva Italia S.r.l. before the Council of State in the first dispute concerning the inclusion in the Transparency List and thus the automatic substitution at pharmacy level of the originator drug produced by biological synthesis with Teva’s equivalent Teriparatide drug produced by chemical synthesis.
  • Advised Grifols Italia S.p.A. on high-value legal proceedings related to the fractioning of plasma within Italy’s ‘payback’ system, successfully suspending a €122 million tender notice and participating in a preliminary market consultation for a forthcoming €100 million tender.
  • Advised SDM Società Dietetica Medica S.r.l. on regulatory, contractual, and intellectual property matters following its acquisition by Nestlé Health Science, ensuring compliance with advertising rules and managing intellectual property effectively.

Pavia e Ansaldo

Pavia e Ansaldo’s caseload primarily consists of clear-the-way litigation and payback disputes. In Milan, practice head Gian Paolo Di Santo has longstanding IP litigation expertise, in addition to advising on acquisitions. Filippo Fioretti leads the firm’s antitrust and competition team from Rome, while Gabriele Girardello is well-versed in a broad range of IP matters, including fee negotiations and strategy design work.

Practice head(s):

Gian Paolo Di Santo


Other key lawyers:

Filippo Fioretti; Gabriele Girardello


Work highlights


Trevisan & Cuonzo

Trevisan & Cuonzo houses a broad team of ‘true subject matter experts‘ known for handling the full range of trade mark and patent work, with a strong emphasis on opposition and pharma clearance. Gabriel Cuonzo acts as the firm’s managing partner, and ‘real star and total expertDaniela Ampollini has longstanding experience in assisting with the exploitation and protection of IP rights, and commercial agreements. Donatella Capelli is a seasoned litigator who regularly appears before both Italian and EU courts on behalf of pharma companies in cases concerning patent and SPC rights enforcement, areas in which Luca Pellicciari is also an expert. Federica Bocedi is an integral member of the team on the IP side.

Practice head(s):

Gabriel Cuonzo; Donatella Capelli; Daniela Ampollini; Luca Pellicciari


Other key lawyers:

Federica Bocedi


Testimonials

‘Leading some of the most important pharmaceutical patent cases in Italy, T&C are able to translate the developing case law into practical advice for clients, and indicate clear steps to navigate this fast-paced and ever-changing environment.’

‘Donatella Capelli is an experienced professional, with a genuine desire to do the right thing for her clients. She is very responsive and humble, open to hearing her clients’ views and works extremely well with all foreign counsel in multijurisdictional litigation.’

‘True subject matter experts.’

‘Daniela Ampollini – a real star and total expert in her field. I would not want to work with anyone else. Total confidence in Daniela’s legal assessment, analysis and advice.’

Work highlights


Gianni & Origoni

The offering at Gianni & Origoni is well-equipped to assist clients with abuse of dominance investigations and reimbursement disputes within the medical devices space. The team is recommended for its strong focus on administrative disputes and non-contentious IP work involving licensing. Rosario Zaccà leads the team and is experienced in the full range of corporate issues, including M&A and joint ventures. Antonio Lirosi is well-equipped to assist clients with public procurement issues, while administrative law expert Cinzia Guglielmello is a key contact for issues surrounding tenders.

Practice head(s):

Rosario Zaccà


Other key lawyers:

Antonio Lirosi; Cinzia Guglielmello


Key clients

Alchimia Sgr


ArchiMed S.a.S


Aspen


Biofarma Group


Owner of Istituto Dermopatico dell’Immacolata


GE Medical System Italia


Herbalife Italia


Hippocrates Holding


Isagro


Leadiant Group


Livanova


medac GmbH


MSD


Novartis AG


Novo Nordisk


Orthofix


Pentaferte


Polygon


Sanofi Aventis


Takeda Italia


Sharon Laboratories


Zambon Group


Work highlights


LCA Studio Legale

Agostino Migone de Amicis, Andrea Carreri, and Alberto Mocchi all jointly lead the team at LCA Studio Legale, which stands out for handling the full range of issues relating to administrative disputes concerning regional budgets, marketing and reimbursement. The team is also well-equipped to handle supply chain issues and clinical trial agreements. Migone de Amicis is noted for his longstanding experience in the full spectrum of matters concerning clinical trials, while Mocchi is recommended for his strong focus on commercial agreements relating to the licensing, supply, and distribution of pharma products. Leonardo De Vecchi is a key name for regulatory work and public tenders for the supply of medicinal products.

Practice head(s):

Agostino Migone de Amicis; Andrea Carreri; Alberto Mocchi


Other key lawyers:

Leonardo De Vecchi; Nicola Maffioletti


Testimonials

‘The team is largely experienced in the industry of healthcare and life science, both from the regulatory, litigation and administrative perspectives.’

‘Alberto Mocchi is an experienced lawyer and has a large panel of references over the healthcare and life science sector.’

‘Very experienced in clinical research and regulatory matters.’

‘I have the pleasure to work with Agostino Migone de Amicis, Very knowledgeable and experienced ’

‘It’s an interactive practice, you can see the various departments have a strong collaboration and this results in a full service for the client that may take advantage of the different profiles and expertise that provide support.’

‘Alberto Mocchi combines a solid knowledge of the industries of his clients, with a can-do approach, at the same time supportive and challenging, provides consultancy offering clear identification of legal requirements, risks, and how to manage business in respect to the applicable legislation.’

‘LCA’s people are great experts in the Life Sciences sector. They propose brilliant and clear strategies for problem-solving, even on complex topics. They work side by side with the client. Their approach is creative and sincere, providing in a short time all the information and all the best suggestions necessary. The results of their work have been enormously satisfactory.’

‘Leonardo De Vecchi is an outstanding litigator before the Administrative Courts and has a deep knowledge of Italian public procurement regulation.’

Key clients

APT S.r.l.


Bausch & Lomb-IOM S.p.a.


Dealfa S.r.l.


Didofà S.r.l.


Extractum Pharma Zrt


Garofalo Health Care S.p.A.


GSK Vaccines S.r.l.


Habilita S.p.A.


Incyte Biosciences Italy S.r.l.


Instrumentation Laboratory S.p.A.


Janssen-Cilag S.p.A.


Med Consulting S.r.l.


Suanfarma S.A.


Novartis Farma S.p.A.


Zentiva Italia S.r.l.


Work highlights


  • Advised shareholders of Aesculapius Farmaceutici S.r.l. on the sale of 100% of the corporate capital to AMNOL Chimica Biologica S.r.l. (part of the CERES Pharma group).
  • Assisted Cab Polidiagnostico S.r.l. in the sale of a 40% stake in Cab S.r.l. to Lifenet S.r.l.
  • Representing Casa di Cura Habilita S.p.A. before the Administrative Court of Piedmont to appeal against the regional budget dedicated to private hospitals and clinics for the healthcare assistance provided to local citizens

LS CUBE Studio Legale

The ‘high calibre’ team at LS CUBE Studio Legale is noted for its strength in work involving the marketing of pharma and medical device products. Paolo Ricci is a corporate and commercial specialist who handles major transactions. Regulatory expert Paola La Licata has longstanding experience in marketing authorisation mandates and CE marking procedures. ‘Champion’ Rosanna Sovani is a key contact for biotech clients seeking advice on market access and public affairs issues, while Massimiliano Marinozzi handles the full range of disputes, including mass claims and antitrust proceedings.

Practice head(s):

Paolo Ricci; Paola La Licata; Massimiliano Marinozzi; Rosanna Sovani


Testimonials

‘Boutique firm which combines high calibre individuals and a collaborative approach with a personal engagement on projects. The firm also provides government relations and public policy advice on issues related to health products.’

‘Paolo Ricci, Paola La Licata and Rosanna Sovani are focused and passionate about health-related matters (ranging from market access to product licensing and regulatory compliance). Their creative and yet rigorous mindset is a critical part of their professional success.’

‘Paola La Licata does a very good job.’

Key clients

Actial Farmaceutici


Advanz


Agave


Arkopharma


Bristol Myers Squibb


Celgene


Covington&Burling LLP


Daiichi Sankyo


Diasorin


Ely Lilly


Exact Sciences


Gilead


Grant Thorton


HRA


IBSA Farmaceutici


Kyowa Kirin


Manni Oil


Novartis


Oncopeptides


Ospedale Bambin Gesù


PharmaExtracta


Pfizer


Promelav


Red Smeeth


Roche


San Raffaele IRCSS


Schwabe


Stallergenes


TrasMedics


UPSA


Vertex Pharmaceuticals


Work highlights


  • Assisted the client with the drafting and implementation, including relevant training of SOPS to manage bid and tenders procedures, price & reimbursement and commercial practices.
  • Advised on the funding of the National Oncologic Plan with specific funding of the Cancer Regional Network (Reti Oncologiche Regionali) and the provision of an innovative regional resource allocation mechanism based on the achievement of certain goals.

PedersoliGattai

In addition to handling the full range of transactional issues within the life sciences and healthcare space, the team at PedersoliGattai often acts in administrative proceedings concerning tenders. Luca Saraceni utilises his broad commercial expertise to advise on cross-border M&A, and Sergio Fienga is well-placed to assist with public procurement issues and administrative issues. Licia Garotti has ample experience in handling patent and trade mark disputes, advising both pharma and biotech clients.

Other key lawyers:

Luca Saraceni; Sergio Fienga; Licia Garotti


Key clients

Affidea


Advanced Sterilization Products Italia


H.I.G. Capital and Polygon S.p.A.


General Medical Merate S.p.A.


Hollycon Italy


NTP Nano Tech Projects


NMS Group


Fondazione EBRI


Neo Apotek S.p.A.


Skinlabo S.r.l.


Work highlights


  • Assistance to H.I.G. Capital and subsequently its portfolio company, Polygon, with several transactions that resulted in a total investment of approx. EUR 400 million in the biomedical technology sector and that were carried out through acquisitions of Polygon, first, and, then, Sincronis.
  • Assisting General Medical Merate S.p.A. (and its subsidiaries) with AI-driven projects, including distribution agreements, research and development agreements and software development agreements.

Simmons & Simmons

Praised for its ‘unique’ industry experience, Simmons & Simmons excels in assisting with the full gamut of IP work within the sector, in addition to product liability and marketing issues. Jointly leading the team, the ‘outstanding’ Stefania Bergia is recommended for her broad knowledge of patent, trade mark, and trade secret matters, and Giulio Enrico Sironi primarily handles cross-border IP disputes. Having joined the group from BonelliErede in March 2024, practice co-head Vincenzo Salvatore and Giuseppe Ragucci contribute their vast regulatory expertise.

Practice head(s):

Stefania Bergia; Giulio Enrico Sironi; Vincenzo Salvatore


Other key lawyers:

Giuseppe Ragucci; Mauro Teresi


Testimonials

‘Competence, professionalism, timeliness and attention to the needs of the corporate customer.’

‘Stefania Bergia is an outstanding lawyer, she is able to provide excellent legal advice, which helps to master even very complex situations. She is a brilliant teacher and is able to explain the legal framework of the presented case in a way that makes said situation immediately comprehensible even for non-experts in the field.’

‘A very strong team with excellent knowledge of the local market.’

‘Mauro Teresi brings deep knowledge and experience to matters, trustable and dependable.’

‘What makes S&S unique is the excellent teamwork, their dedication and commitment to client success. This collaborative spirit fosters a supportive and efficient environment that is evident in the quality of service delivered. They maintain open and honest communication with the client and provide clear and concise legal advice.’

‘They are client-oriented, show a willingness to negotiate economically, and do not compromise on the quality of the service they offer. ’

‘The team consists of professionals with unique experience in the pharma industry with an ability to not only respond quickly to the needs of society but also provide valuable support’

‘Vincenzo Salvatore is a professional with a unique profile in the field of law firms. His great experience and availability make him a key partner for the firm, which finds in him a valuable interlocutor.’

Work highlights


Franzosi Dal Negro Setti

Franzosi Dal Negro Setti‘s team of ‘competent and expert professionals‘ is well-placed to assist clients with marketing and market access issues, and is experienced in handling contractual matters. Stefano Giberti is active across the pharma, biotech, and medical device industries, and co-leads the team alongside Francesco Setti. Francesca Libanori left the firm in December 2023.

Practice head(s):

Stefano Giberti; Francesco Setti


Testimonials

‘Competent and expert professionals in the field of life science.’

‘Quick and ready responses for review, especially in clinical trial and regulatory matters.’

Work highlights


Legance - Avvocati Associati

Giovanni Nardulli leads the ‘brilliant and highly qualified’ team at Legance - Avvocati Associati, which is well-equipped to assist clients with joint ventures and M&A, spin-offs, and data protection issues. Pietro Merlino is well-known for his expertise in both EU and Italian competition law, often handling matters involving licensing and distribution issues, in addition to investigations into restrictive practices. Lorenzo Gentiloni Silveri is a key contact for pharma companies, healthcare facilities, and medical device clients. Filippo Pacciani and Monica Riva are both key figures within the team.

Practice head(s):

Giovanni Nardulli


Other key lawyers:

Pietro Merlino; Lorenzo Gentiloni Silveri; Filippo Pacciani; Monica Riva; Ada Esposito


Testimonials

‘Brilliant and highly qualified team of professionals. They are capable of handling complex issues with a very high degree of efficiency and quality and with a deep knowledge of the healthcare industry. ’

‘Lorenzo Gentiloni Silveri is a true leader in the field and a great professional. His dedication and attention to the client are incomparable. ’

‘The lawyers are very competent and capable of understanding clients’ needs. They have a unique capability of finding an excellent way to solve each problem. Every task is done on time. If you have an urgent question, they will be there for you because there is a lawyer for you in all areas of law.’

‘Lorenzo Gentiloni and the healthcare team are unique in terms of organisation. The healthcare team can work with in-house counsel with respect and competence and achieve remarkable results.’

‘This practice is well consolidated and integrated within a firm which can provide 360° support.’

‘Pietro Merlino knows the pharma industry very well and has real passion for it.’

‘Working in the healthcare and life science sector is very difficult because it needs a strong general preparation plus many specific aspects. What characterises Legance is its very strong preparation in all fields of law.’

‘Avv. Gentiloni is an outstanding lawyer, complete in his preparation, curious about new challenges.’

Key clients

A. Menarini Industrie Farmaceutiche Riunite


AbbVie


Agilent Technologies


Allergy Therapeutics


Amplifon


Bracco


Casa di Cura La Madonnina


C.O.T. Cure Ortopediche Traumatologiche


Eusphera


Farmindustria


Fidera


Genera – Centri di Procreazione Medicalmente Assistita YesGenuina Pet Food Italia


GB Pharma


GKSD


GKSD ProCure


Gruppo San Donato


Gruppo San Donato East Europe


Gruppo Villa Maria


GSD Healthcare


GSD Sistemi e Servizi NoHippocrates NoItalsalute


TS Alessandro Volta Foundation


LIRH Foundation


Kolinpharma


KOS Group


Medipass


Metall Zug AG


MSD Italia


Nuvasive Italia


Ospedale Galeazzi IRCCS


Ospedale San Raffaele IRCCS


Policlinico San Donato IRCCS


RiverForce Partners


Roche


Serenis Health


Smart Clinic


Sphera Encapsulation


Stryker European Operations Limited


Teva Italia


U.G.A. Nutraceuticals


Università Vita-Salute San Raffaele


Villa Chiara


Villa Erbosa


Istituti Clinici Zucchi


Istituti Ospedalieri Bresciani


Istituto Clinico Villa Aprica


Work highlights


  • Assisted Gruppo San Donato in a joint venture agreement with Generali Italia to establish Smart Clinic, a joint venture aiming at the creation of a healthcare facilities network throughout Italy and based on an integrated private healthcare-insurance ecosystem
  • Assistance to Metall Zug AG on Italian law aspects related to the creation of a new joint venture in the infection control and life science domain with Miele & Cie. KG.
  • Assistance in the establishment of Gruppo San Donato East Europe, a Romanian-registered company controlled by Policlinico San Donato that will carry out medical activities in Romania, with a focus on the field of cardiac surgery.

Masotti Cassella

Luca Masotti and Carlo Piatti jointly lead the group at Masotti Cassella, which regularly advises on the drafting of commercial agreements, payback litigation, and disputes concerning public tender procedures. Masotti is noted for assisting medical device manufacturers with M&A, private equity transactions, and commercial disputes. Piatti is a key name for banking and public law issues.

Practice head(s):

Luca Masotti; Carlo Piatti


Key clients

Ab Medica S.p.A.


Glenmark Pharmaceuticals


Ab Medica France


Società Italiana di Farmacologia


Officine Ortopediche Rizzoli


Studio Pacinotti


Era Endoscopy


Work highlights


  • Advised Ab Medica Holding SpA on the sale of Officine Ortopediche Rizzoli. The sale was partly funded by a vendor loan structured through the subscription by Ab Medica of bonds issued by Barbieri SpA.
  • Advising Glenmark on the acquisition of 100% shares in Sintesy Pharma SRL.
  • Representing a client in a complex series of procedures challenging a decision of the Italian Government which was based on a law recently issued in Italy, that has already raised a large number of litigations started by medical device companies, as well as several debates on a national level.