Industry focus: Healthcare and life sciences in Italy

Bird & Bird

Capable of advising on ‘every aspect of the business cycle of a product or service’, the life sciences and healthcare group at Bird & Bird benefits from a wealth of experience working with pharmaceutical companies and regulators.  Led by practice heads Giovanni Galimberti and Massimiliano Mostardini, all lawyers in the team hold a degree in a scientific field and spent a significant proportion of their career in the industry prior to joining the team in Milan. The team has been very active during the Covid-19 crisis and has been finding innovative ways to help clients navigate this ever-changing landscape; its regulatory legislation tracker is a good example of this. Afra Casiraghi and Claudia Ricciardi were recently promoted to the partnership. Antonella De Gregori and counsel Mauro Turrini are also noted.

Practice head(s):

Giovanni Galimberti; Massimiliano Mostardini

Other key lawyers:

Afra Casiraghi; Claudia Ricciardi; Antonella De Gregori

Key clients

Asoltech

Bbraun

Biofer Spa

Bionap

Chemo Group (now Insud Pharma)

Curium Group

Dompé

Edwards Lifesciences

Fondazione Telethon

Gruppo San Donato

INCIPIT

Medical Microinstruments

Ospedale San Raffaele

WinMedical

Work highlights

  • Acted for Mylan in regulatory litigation relating to the appeal of several decisions regarding refunds on medicinal products based on fixed combinations of active principles.
  • Advised Gruppo San Donato on the negotiation, drafting and execution of a strategic alliance with EY for business transformation following the Covid-19 emergency.
  • Assisted both Ospedale San Raffaele and Fondazione Telethon (which co-manage HSR-Tiget Institute, one of the world’s leading cell and gene therapy research institutes) with IP transactional assistance.

BonelliErede

The healthcare and life sciences practice at BonelliErede is made up of a large, multidisciplinary team. Led by Vincenzo Salvatore it provides regulatory assistance to multinational pharmaceutical companies as well as support on cross-border M&A deals. This year the firm created a dedicated Task Force to help clients through the management of any legal aspects arising from the pandemic as well as assisting companies outside of the healthcare sector in facilitating the production of PPE. One example being providing regulatory assistance pro bono for Solvay Solexis on the marketing of medical gowns. Francesco Mastroianni joined the firm from the Italian Medicines Agency as senior counsel. Monica Fantino is also noted.

Practice head(s):

Vincenzo Salvatore

Other key lawyers:

Francesco Mastroianni; Sara Lembo; Monica Fantino

Testimonials

‘ Great attention to the issue by the studio’

‘ Sara Lembo knows the sector and the most critical issues very well’

Key clients

Chiesi farmaceutici

Dompé

Pharmacielo

Zambon

Bluebird Bio

Gilead

Kedrion

Roche

Work highlights

  • Advised Pikdare on access to documents concerning the auditing of blood centres.
  • Provided regulatory assistance to Kedrion concerning the marketing of finger prick blood tests.

DLA Piper

Led by Roberto Valenti, the practice at DLA Piper assists key players in the healthcare and life sciences sector with regulatory work, M&A and dispute resolution. In addition to setting up a legal task force to assist clients during the Covid-19 emergency, the firm also started the Up Again programme aimed at helping businesses recover in the aftermath. Highlights included advising Abbott Medical on complex, multidisciplinary matters as well as assisting GSK vaccines and R&D teams with a variety of different topics, including in the ultra-rare disease space, Marco de Morpurgo has led on this.

Practice head(s):

Roberto Valenti

Other key lawyers:

Marco de Morpurgo

Testimonials

‘In the Life Science area, Roberto is endowed with great competence and knowledge of the subject, as demonstrated by the 10 years of leadership at the Life Science Working Group of the American Chamber of Commerce’

‘Roberto Valenti has always shown great attention to the dynamics of the sector, great capacity for listening and synthesis, and great professionalism in dealing with complex topics in a simple way.’

‘The strength of the DLA Life Science Team is customer orientation: in their legal advice, the team consultants do not stop to give a mere opinion on the question submitted, but also help the customer to evaluate possible alternatives.’

‘The team’s professionals are very knowledgeable and helpful. What sets them apart from other law firms is their flexibility. We happened to have to ask for urgent advice and they always found an availability to support us.’

Key clients

Pfizer

Abbott Medical

GlaxoSmithKline

Iovance Biotherapeutics

Vertex Pharmaceuticals

Essity

Serres Oy

Menarini

Allergan

Reckitt Benkiser

Work highlights

  • Advised Abbott on complex multidisciplinary matters.
  • Advised Pfizer on complex multidisciplinary matters.
  • Advised GlaxoSmithKline’s vaccines and R&D teams on various topics, including some areas of unchartered territory in the ultra-rare disease space as well as in the growing cell and gene therapy space in Europe.

Hogan Lovells International LLP

The team at Hogan Lovells International LLP is active across the complete spectrum of work in the healthcare and life sciences sector. Highlights included assisting Recordati with a headline M&A deal involving an Italian pharmaceutical group and acting for an American biotech company in a regulatory dispute against an Italian pharmaceutical company. Christian Di Mauro heads the team.

Practice head(s):

Christian Di Mauro

Other key lawyers:

Francesca Rolla

Testimonials

‘The ability to understand the customer’s needs with professionalism.’

‘The deep knowledge and experience in the sector as well as the ability to grasp the changes underway in the reference areas and enhance them.’

‘Great knowledge of the subject, relevant professionalism, excellent ability to work in a team.’

‘Particular mention for Avv. Christian Di Mauro’

‘Experience in drug law and product liability litigation’

‘Francesca Rolla is very experienced in product liability matters, fast response time’

‘The high professionalism and competence in customer management which is reflected in the accurate and prompt assistance’

‘Sympathy, availability, preparation, reliability’

‘Well-coordinated team made up of helpful and well-trained people’

‘The team has a particular knowledge of the pharma business. Both in the M&A / commercial field and in the regulatory field’

‘Outstanding team of experienced and sophisticated practitioners. They’re very responsive and offer client friendly advice.’

Key clients

Baxter AG, Baxter S.p.A and Baxalta S.p.A..

GE Healthcare

Eli Lilly

CHR Hansen Italia

Fidia Farmaceutici S.p.A.

Formula Pharmaceuticals Inc.

Recordati S.p.A.

Sorin Group – LivaNova

Qiagen Marseille

Grünenthal

Takeda Shire

Work highlights

  • Assisted Recordati with the asset purchase with Novartis to acquire the worldwide rights to Signifor® and Signifor® LAR®.
  • Successfully acted for Eli Lilly in the urgent DNI (declaration of non-infringement) proceedings started by a generic company, Fresenius Kabi.
  • Assisted Sorin Group Italia and LivaNova Deutschlands facing serious issues worldwide in connection with one of their devices, allegedly contributing to causing serious injuries (and often, death) to patients.

Pavia e Ansaldo

Gian Paolo Di Santo heads the team at Pavia e Ansaldo , which represented Ethypharm in the first 'clear the way' action for a generic product in Italy as well as assisting key players in the pharmaceutical market with a variety of matters. The team lost Agostino Migone de Amicis who joined LCA Studio Legale in January 2021.

Practice head(s):

Gian Paolo Di Santo

Key clients

Actavis Italy S.p.A.

Accord/Intas

Novartis Services

Ethypharm

Istituto Clinico Humanitas

Fondazione MBBM (Monza e Brianza per la Mamma e il suo Bambino)

Bio-Techne Corporation

Almirall

Fondazione Roche

Aristo Pharma Group

FADOI Committee for the 2018 Report

Health Commission of FEDERMANAGER

Techdow

Work highlights

  • Advised Fondazione MBBM on the establishment of a ground-breaking Europe-wide public/private initiative to develop synergies in the treatment of leukaemia, lymphomas and solid tumours in children.
  • Acted for Genentech in a first-of-its-kind IP action by Eli Lilly concerning clearance for a €300m drug.
  • Represented Ethypharm in the first “clear the way” action for a generic product in Italy against an originator.

Portolano Cavallo

The 'responsive and very attentive' practice at Portolano Cavallo  provides a full range of services to clients within the life sciences industry including transactional, regulatory and contentious issues. Clients include multinational pharmaceutical companies, healthcare providers and manufacturers of medical devices. M&A specialist Luca Gambini and regulatory expert Elisa Stefanini head the practice.

Practice head(s):

Luca Gambini; Elisa Stefanini

Testimonials

‘Specialist skills, in-depth study of every aspect underlying the issues dealt with, constant updating’

‘Rapidity in finding requests with completeness of information’

‘The studio has assisted us on important operations, especially in the digital field, always identifying valid solutions in areas where the interpretation of the regulatory data is extremely complex. The ability to follow innovation always suggesting a solution (legally viable path) is certainly the strength of the studio. To it are added punctuality, availability, patience, as well as high professionalism.’

‘The lawyer Elisa Stefanini (and her staff) certainly deserves to be mentioned for the high coordination capacity of the work team and the always guaranteed telephone availability.’

‘Great availability and attention to customer needs, rapid response while maintaining an excellent quality standard’

‘I had the pleasure of collaborating with Elisa Stefanini and I appreciated her competence in the sector, her maximum availability and the ability to involve the most appropriate people in her team for the various issues submitted’

‘Portolano life science practice is very reliable, acute, agile, mixing all legal practices to assist players, including regulations, data privacy, AI, corporate M&A, IP, competition, etc. They are offering a high level service with a good team size (not too big) which make them stay dynamic’

‘Luca Gambini and Elisa Stefanini are both experts and pragmatic persons, easy to access, get to the point and very well understand client’s needs. They understand and can evolve in an increasingly digitalised landscape They are international in their practice.’

‘This firm is highly respected. Their Life Sciences team is impressive.’

‘I have had the pleasure of working with Elisa Stefanini and Luca Gambini. Elisa advised my company on healthcare matters. Her advice was specific and targeted. She demonstrated a high degree of knowledge and a masterful command of the intricacies of the local laws and how they apply to healthcare businesses. I highly recommend her and her firm. ’

‘The team is a professional team, responds very accurately and quickly showing a lot of attention to the customer.’

‘High competence of professionals in the areas of expertise of the firm, high specialisation in particular in pharmaceuticals, in-depth knowledge of risk areas and the ability to develop practical solutions that meet the needs of the client’

‘Practicality in the opinions provided, quick response, willingness to provide support and assistance even at short notice’

‘The team were responsive and knowledgeable. ’

‘Portolano is by far (one of) the most pragmatic top firms in Italy. Their service is fast, their advice is always hands-on but thorough. ’

‘I mainly work with Elisa Stefanini. Elisa is extremely knowledgeable in life sciences. Her responsiveness is supersonically fast (which is often a must for us) and she is most notably a very agreeable person to work with. ’

‘Professionality, competences, knowledge, problem solving’

‘The Portolano Cavallo law firm is very responsive and very attentive to every request that is addressed to it. The quality of the answers also distinguishes it from other companies.’

‘Luca Gambini and Elisa Stefanini are very helpful. They are also very efficient in their field.’

‘ The ability to understand needs and to be pragmatic but rigorous in proposing a solution’

‘Respect, kindness and transparency’

Studio Professionale Associato a Baker & McKenzie

Known for its 'reliability', the team at Studio Professionale Associato a Baker & McKenzie is focused mainly on M&A transactions and regulatory work within the healthcare and life sciences sector, working for both Italian and multinational pharmaceutical and medical devices companies. Pierfrancesco Federici and Roberto Cursano co-head the department. Associate Mario Cigno is also noted.

Practice head(s):

Pierfrancesco Federici; Roberto Cursano

Testimonials

‘Continuous updating, proximity to the customer and flexibility towards his needs.’

‘Professionalism.’

‘Reliability and preparation are certainly guaranteed by the professionals of this studio.’

‘Roberto Cursano has an in-depth knowledge of the sector and can provide timely and efficient advice tailored to the client’s requirements. His knowledge of the market can be compared to that of in house counsels of pharma companies. He has an overview of all relevant regulatory, compliance and legal issues of the sector.’

‘Roberto Cursano is an excellent advisor. Always available and provides timely and efficient advice. Very few advisors on the Italian market can boast this knowledge and sensibility for the life science sector.’

Key clients

AbbVie Inc.

Takeda Pharmaceutical

Bristol-Myers Squibb

Stryker EU

Abbott Laboratories

EUSA Pharma

Beaver-Visitec International

Biogen Idec

Exact Sciences International

Grupo Ferrer Internacional, S.A.

MSD Italy

Eli Lilly

ICU Medical

Waters

Applied Medical

Bio-rad

AMO Italy

Lifescan

Work highlights

  • Advised AbbVie on an acquisition of Allergan (global value $63bn).
  • Advised Takeda Pharmaceutical on the acquisition of Shire Plc. (global value $62bn).
  • Advised Bristol-Myers Squibb on the acquisition of Celgene (global value $74bn).

Dentons

Led by Luca Pocobelli, a partner in the firm's Rome office, the team at Dentons advises Italian and international clients on a wide spectrum of transactions within the healthcare and life sciences sector. Experienced litigator Sara Biglieri is a partner in the Milan office and 'is very knowledgeable on the substance of the law, and has excellent judgement.' In this sector she handles complex tort and product liability litigations; clients include multinational medical devices and pharmaceutical companies. Ilaria Gobbato, who was promoted to the partnership in 2021, has a focus on public procurement matters; she assists with contentious and non-contentious matters for Italian and international clients.

Practice head(s):

Luca Pocobelli

Other key lawyers:

Sara Biglieri

Testimonials

‘Ilaria Gobato is very professional, responsive and to the point. She has hands-on knowledge of the Italian health care sectoral regulation and is excellent at advising in particular on relationships with health authorities.’

‘Great availability of the whole team: some of them are always reachable and able to give the necessary support’

‘Traditional approach but much appreciated the ability to map also new solutions (cloud, remote meetings, etc.)’

‘Great availability and ability to propose clear solutions supported by usual reasons’

‘I use Dentons lawyers in Milan – specifically Sara Biglieri and her team. They have exceptional knowledge of the courts in Italy. They provide wise counsel and consistently deliver excellent results on our matters.’

‘Sara Biglieri is excellent. She promptly responds to all inquiries and keeps us well-apprised of the developments in our cases. More importantly, she provides wise counsel, is very knowledgeable on the substance of the law, and has excellent judgement.’

Key clients

Johnson & Johnson

ArchiMed SAS

Lifebrain

Ortho-Clinical Diagnostic Italy S.r.l.

Friulchem

Shedir Pharma

Fondazione Opera San Camillo

Work highlights

  • Advised Friulchem on the acquisition of 13% of the shares in Pharmabbie .
  • Assisted Ortho-Clinical Diagnostic Italy with several commercial, corporate, litigation, banking and regulatory matters.

Herbert Smith Freehills

The practice at Herbert Smith Freehills is jointly headed by 'one of the leading experts in the life sciences sector,' Laura Orlando, and Sebastian Moore. The firm represents clients in significant patent disputes and advises pharmaceutical companies on regulatory issues surrounding the development of vaccines and the distribution of medicinal products and medical devices.

Practice head(s):

Laura Orlando; Sebastian Moore

Other key lawyers:

Sara Balice; Martina Maffei; Spartak Kodra

Testimonials

‘In a few years they have been able to create a team that is a reference point in the Life Sciences sector’

‘Laura Orlando is a lawyer with a strong focus on IP Life Sciences (litigation and otherwise). Sara Balice stands out in the team’

‘The studio has a very customer-oriented approach and is able to adapt to requests. This makes it possible to achieve the expected result while also paying attention to the costs of consulting.’

‘Laura Orlando is one of the leading experts in the Life Science sector and assists the largest Italian and foreign pharmaceutical groups. The focus is on intellectual property law and regulatory issues’

‘The firm’s professionals are highly qualified in the legal field and are able to offer an excellent level of assistance to clients trying to satisfy their respective needs and expectations as much as possible. Professionals also react to individual requests with extreme punctuality.’

‘The professionals I worked with (lawyer Laura Orlando and Sara Balice) immediately acquired the basic technical knowledge specific to the case to better face their work and therefore offer the best possible advice. They are extremely prepared from a legal point of view and try to reach the objective of interest for the client as quickly as possible.’

‘They are really unique. They are a large team, they are highly sophisticated in terms of strategic approach, incredibly responsive, with an international and business-like mindset.’

‘Laura Orlando is nowadays the best and most famous life sciences lawyer in Italy. She has won all the existing life sciences awards in a row in recent years. Everyone knows her in the life sciences market. She is not only the best practitioner and strategist but also an opinion leader. Sara Balice and Martina Maffei and are also very good, they do advise on IP but also regulatory. I also worked with Spartak Kodra on a small matter. The entire team is excellent.’

Key clients

Gilead Sciences, Inc.

Achilles Vaccines

MiRNA Green

Eli Lilly

Millennium Pharmaceuticals

GlaxoSmithKline

Elanco (animal health division of Eli Lilly)

Dompé

Lundbeck

Federfarma.CO

Clerical Medical

Roche

Zambon

Orrick, Herrington & Sutcliffe

The team at Orrick, Herrington & Sutcliffe assists with a full range of matters within the healthcare and life sciences sector including antitrust and competition litigation, clinical misconduct, M&A, white-collar criminal law as well as corporate and regulatory work. The practice is led by experienced criminal litigator Jean-Paule Castagno; antitrust and competition specialist Pietro Merlino; corporate lawyer Marco Nicolini and litigation and arbitration expert Riccardo Troiano.

Practice head(s):

Jean-Paule Castagno; Pietro Merlino; Marco Nicolini; Riccardo Troiano

Other key lawyers:

Marco Dell’Antonia; Riccardo Caselle

Testimonials

‘Customer focus, professionalism’

‘Marco Nicolini, always available, prepared and professional’

‘Orrick, Herrington & Sutcliffe LLP assists us in numerous operations, always ensuring maximum availability and professionalism. Strengths: high skills, quick feedback, ability to deal with practices with a transversal vision and proactive approach. Coordination with other law firms is excellent.’

‘Attorneys Marco Nicolini, Marco Dell’Antonia and Riccardo Caselle distinguished themselves for their skills, punctuality, constant availability and problem solving skills. In general, all the professionals of Orrick, Herrington & Sutcliffe LLP have proven to be absolutely up to the tasks they have been assigned.’

Work highlights

  • Represented F. Hoffmann-La Roche in the appeal proceedings brought before the Council of State (CoS), the Italian Supreme Court of Cassation and the European Court of Human Rights against the Council of State’s July 2019 judgment concerning the alleged anti-competitive arrangement between the Roche and Novartis groups concerning the use of pharmaceutical products Lucentis and Avastin for the treatment of certain ocular conditions, which, in 2014, had led the Italian Competition Authority (ICA) to impose hefty fines upon the investigated companies.
  • Assisted Healthware Group in the acquisition of pharmaphorum connect.
  • Advised Bianalisi on its acquisition of Liguria Radiologia and its subsidiary Omnia Medica., as well as Laboratorio Analisi Cliniche Forcina.

Chiomenti

The healthcare and life sciences practice at Chiomenti covers a variety of complex transactions. The firm has continued with its work advising on long-term research and development projects as well as providing regulatory advice on how to increase testing capacity for Covid-19 in Italy. Led by Luca Liistro, the practice has also worked on large, industry-specific M&A deals. The group also benefits from the administrative expertise of Filippo Brunetti.

Practice head(s):

Luca Liistro

Other key lawyers:

Filippo Brunetti

Testimonials

‘Great attention to the issue by the firm’

‘Strong sector expertise, both from a strictly legal / regulatory point of view, and from an operational and commercial point of view. Important relationships with industry players and knowledge of the dynamics in place. Visibility on the M&A activity of the reference sector.’

‘Senior partner always personally involved. Great customer support, in all phases of the projects, with the ability to staff additional staff with very little notice. In general, the ability to work with the client as a single team.’

‘Partner Luca Liistro – Negotiating skills combined with an understanding of issues, even purely financial / numerical. Ability to manage difficult counter-parties, including through  “intelligent mediation”. Direct involvement in all phases of a project. Courtesy and competence much appreciated also by the counterpart.’

Key clients

Abbott S.p.A.

Air Liquide Sanità Service

Albis International

Alfa Sigma

Artsana

Carestream Dental Italy

Becton Dickinson

Forest Laboratories

Genoma Group S.r.l.

Gilead Sciences

Khiron

Laboratoires Expanscience

Lifebrain Group

Life Care Capital

Menarini Group

Merck Sharp & Dohme (Italia)

Molmed Molecular Medicine

Neuraxpharm

Roche S.p.A.

SoBi Pharma

Zambon Group

Work highlights

  • Advised Life Care Capital on the reverse take-over transaction pursuant to Article 14 of the AIM Italia Rules (Regolamento Emittenti), to be completed through the sale by the majority shareholders to Life Care Capital of a certain amount of shares representing, in aggregate, about 32% of the corporate capital of Biogenera S.p.A. and the subsequent merger for incorporation of Life Care Capital S.p.A. into Biogenera S.p.A and the simultaneous listing of the financial instruments of the company resulting from the merger on the AIM Italia.
  • Advised in the context of a complex internal corporate reorganisation of Becton Dickinson Italia S.p.A. and Bard S.r.l. , two Italian subsidiaries of Becton, Dickinson and Co., through the acquisition by BD Italy from C. R. BARD GMBH of the entire corporate capital of Bard S.r.l. with consideration to be paid by way of promissory notes.
  • Advised Molecular Medicine in connection with Fininvest undertaking to adhere in the context of a voluntary tender offer launched by AGC Inc on the shares of Molmed S.p.A..

Gianni & Origoni

The practice at Gianni & Origoni handles M&A transactions and patent disputes within the healthcare and life sciences industry. Clients include pharmaceutical, healthcare and biotechnology companies. Led by Rosario Zaccà, the firm assisted Novartis with a significant antitrust case. Antonio Lirosi handles the firm's administrative litigation.

Practice head(s):

Rosario Zaccà

Other key lawyers:

Antonio Lirosi; Eva Cruellas Sada

Testimonials

‘Understanding of our business, our risk tolerance and our management team’

‘Rosario Zaccà is an expert in almost everything, very calm, pragmatic and a true ‘deal maker ”

‘Excellent skills in administrative and corporate law, a partner or senior always speaks with the clients, but there are also good associates available for secondment periods, with a certain flexibility in defining agreements in terms of time and presence.’

‘Availability and attention to customer culture and customer compliance systems.’

LS CUBE Studio Legale

Led by Paolo Ricci, the life sciences team at LS CUBE Studio Legale provides regulatory advice as well as assistance with commercial and corporate transactions on both a national and international basis. The team has also advised on numerous legal public affairs and data protection matters. Paola La Licata is an expert in regulatory matters related to marketing and advertising procedures, pricing and commercial agreements, clinical trials, observation studies and compliance. Rosanna Sovani brings her public affairs experience to assist with policy strategy, advocacy and market access advice to multinational clients in the biotech space.

Practice head(s):

Paolo Ricci

Other key lawyers:

Paola Li Licata; Rosanna Sovani

Testimonials

‘We found in this study a technical knowledge of regulatory issues and pharmaceutical legislation that is not common to be found in law firms.’

 ‘I have worked on several occasions with Paola La Licata. I appreciate her availability and reliability and, above all, the extremely technical skills on regulatory and pharmaceutical law issues that make the difference compared to other firms, which also operate in the life science sector’

‘Strong collaboration – different expertise’

‘Availability, strong focus on results and respect of timelines. Good communication’

‘The team is professional, flexible and service oriented’

‘Paolo Ricci has been very dedicated to the client and the deal, always looked for efficient solutions taking care of the client’s interest.’

‘In comparison with other firms, LS Cube is faster and with more experience. We did some commercial work with them and the experience was overall more than positive. Their legal knowledge is big, but also combined with actual experience and practice. They take into account all the circumstances when approaching a particular matter, not only legal, but business.’

Key clients

Actial Farmaceutici S.r.l.

Amgen

Arkopharma

Bluebird bio

Brystol Myers Squibb

Daichi Sankyo S.r.l.

Federsalus

HRA Pharma

Kyowa Kirin S.r.l.

Omeopiacenza S.r.l.

Ospedale Bambino Gesù

OTI S.r.l.

Schwabe Italia S.r.l.

Stallergenes

Texsus

Vifor Fresenius Medical Care Renal Pharma Italia S.r.l.

Vifor Pharma

OMAR

OSSFOR

Myriad

Gilead

Novartis

Celgene

Sarepta

Work highlights

  • Advised Gilead, Novartis , Celgene, Bluebird bio, Sarepta on the establishment of a Group of Interest named #VITA (Value and Innovation of Advanced Therapies), which has the aim to make advanced therapies more affordable.
  • Assisted Grant Thornton with a number of M&A deals, particularly in the life sciences area, both cross-border and national.
  • Assisted UPSA with the reorganisation of the Italian entity after the acquisition by Taisho Pharmaceutical Co of Japan, including advice on regulatory issues.

Masotti Cassella

Led by Luca Masotti, the team at Masotti Cassella acts for medical device, biotechnology and pharmaceutical companies in disputes as well as on corporate and regulatory matters. Recent work includes assisting ab medica with a regulatory and compliance matter concerning a recall of products and the subsequent litigation.

Practice head(s):

Luca Masotti

Key clients

ab medica

Genomnia

Telbios

Era Edoscopy

Officine Ortopediche Rizzoli

Biomat

Abex (Spain)

ab medica France

ab salud (Spain)

Excelencia Robotica (Portugal)

Ab Renting

Rentalmed (Spain)

Medical Labs

Work highlights

  • Advisng ad medica on all aspects of its corporate, commercial, regulatory, procurement and litigation matters.
  • Assisting Officine Ortopediche Rizzoli with creating a network of franchisees in the Italian territory to commercialise its products, and with negotiating an exclusive distribution agreement to introduce in the Italian market the revolutionary Keego exoskeleton manufactured by Canadian company B-Temia
  • Assisted Biomat with its internationalisation and in the research of possible industrial and equity partners.

Nctm Studio Legale

The 'astute' team at Nctm Studio Legale assists clients in the life sciences sector with commercial and corporate matters. Highlights included advising pharmaceutical companies such as AstraZenca and Gilead on corporate, compliance and data protection matters. The practice heads are Lorena Possagno  and Paolo Gallarati. Healthcare and health services specialist Vito Bisceglie was a new arrival from DLA Piper.

Practice head(s):

Lorena Possagno; Paolo Gallarati

Other key lawyers:

Vito Bisceglie

Testimonials

‘Nctm Studio Legale has assisted us in numerous operations, distinguishing itself for professionalism and availability. The team has proven to be able to respond perfectly to the needs presented to it, matching the feedback deadlines and always offering excellent solutions.’

‘The professionals of Nctm Studio Legale are always ready and attentive to the requests submitted to them. The quality of the service provided is always high.’

‘The ability to advise businesses as if they were an in-house lawyer.’

‘Their ability to explain things in clear and simple ways is also very impressive. The team are kind and astute and their speed of service is great.’

‘Preparation, speed of reaction, knowledge of the sector’

‘Professionalism and competence’

‘Very competent, professional and reserved’

Key clients

Aboca S.p.A.

Assogenerici

Astrazeneca S.p.A.

Fresenius / NephroCare Group

Crinos

Doc Generici Srl

Gilead Group

Dilafor AB

Johnson & Johnson

Mediolanum Farmaceutici Group

Opocrin S.p.A.

Uriach / Laborest Group

Work highlights

  • Assisted all Italian companies of Fresenius Group / NephroCare Group with corporate, commercial and M&A requirements as well as in compliance, privacy, administrative and data protection issues.
  • Assisted Opocrin in the second financing round in Dilafor AB.
  • Advised Astrazeneca on compliance and data protection matters.

Osborne Clarke

The practice at Osborne Clarke handles the negotiation of commercial contracts, product liability and patent litigation as well as regulatory work. In addition, the firm represents blue-chip clients in novel competition matters and public procurement disputes in the Supreme Court. The team has recently been engaged to assist various companies with converting their business to make PPE or donating medical equipment to hospitals in an effort to combat the Covid-19 crisis. The team is led by Maria Grazia Medici; Federico Ferrara is also noted for his IP expertise.

Practice head(s):

Maria Grazia Medici

Other key lawyers:

Federico Ferrara; Giulia Verusio

Testimonials

‘Accuracy and professionalism as well as the ability to always respond adequately to the needs of society.’

‘Punctuality and speed of response to the problems submitted’

‘Extensive knowledge of the pharmaceutical sector, with particular regard to administrative litigation, especially litigation with the Medicines Agency, price and reimbursement negotiations, administrative litigation in general.’

‘The differentiating element is the extreme flexibility in timetables and the maximum availability in managing emergencies in a timely manner.’

Key clients

Grifols Italia S.p.A

Teva Italia S.r.l

Sciterion S.r.l

SDM Società Dietetica Medica S.r.l (Pronokal Group)

Valedo S.r.l

Health Italia S.p.A

Actavis Italy S.p.A.

Sicor Societa’ Italiana Corticosteroidi S.r.l.

Work highlights

  • Represented Grifols Italia in a significant procurement dispute with two competitors, CSL Behring and Baxter Manufacturing, following the award to the client (in a temporary joint venture with Kedrion) of a tender organised on behalf of a group of Italian regions for the industrial processing of plasma.
  • Advised SDM Società Dietetica Medica on contracts for sponsoring a series of CME events and clinical trials on the effect of the ketogenic diet.
  • Represented Valedo, an innovative digital business that brings together pharmaceutical companies, distributors and advertisers and negotiates bartering agreements in which OTC drugs are bartered for advertising space, in the sale of a majority stake to IPE.

Pedersoli Studio Legale

Pedersoli Studio Legale has a specialist healthcare and life sciences practice - covering issues ranging from white-collar criminal defence to M&A to regulatory and compliance issues. The team is experienced in the pharmaceutical, biotechnology and medical devices sectors and has been particularly active in the field of competition law. The firm is coordinating the healthcare committee of the American Chamber of Commerce's efforts to advance a move from operational to strategic public procurement in Italy. Enrico Maria Mancuso, Sergio Fienga and Luca Saraceni head the practice.

Practice head(s):

Enrico Maria Mancuso; Sergio Fienga; Luca Saraceni

Testimonials

‘The firm boasts solid experience in the life science sector especially for criminal litigation. In recent years, the firm has assisted the main Italian and foreign companies in disputes relating to compliance issues.’

‘The firm has a significant number of young partners and this allows it to adapt to the needs of younger internal legal departments.’

‘The lawyer Enrico Maria Mancuso is one of the leading experts in Italy in the criminal field and in recent years has assisted the most important Italian and international companies in criminal investigations and disputes regarding 231 compliance.’

‘Availability, attention to the customer, speed in execution, strategic vision of the pharma sector’

‘Our experience with the Pedersoli legal practice has been optimal. Although the Pedersoli firm assisted only us, they were effectively leading the negotiation on behalf of both partners, due to their obvious leadership, expertise and insights in the life science sector. All documents were written and exchanged in English and they proved absolutely efficient in this.’

‘They are an all-round and one-stop firm and our relationship with them will certainly grow. I consider the Pedersoli legal firm a key asset in our strategic planning and growth.’

Work highlights

  • Acted for a client in criminal proceedings pending before the Court of Appeal of Bologna, in relation to several episodes of bribery and fraud
  • Assisted Plurima with the acquisition of 90% of Log-Os, a company specialising in medical logistics.
  • Assisted Advanced Sterilization Products Italia in relation to an administrative proceeding concerning a tender launched by the local health authority in Bari, Apulia region.

Trevisan & Cuonzo

The 'small but dedicated' team at Trevisan & Cuonzo assists multinational pharmaceutical and biotechnology companies with copyright and patent disputes. The co-heads of practice are founding partners and experienced IP lawyers Gabriel Cuonzo and Luca TrevisanDaniela Ampollini and Donatella Capelli are also highly regarded patent litigators. A key name at associate level is Luca Pellicciari who has been praised for his 'attention to detail and ability and eagerness to engage with the technical aspects of the case.'

Practice head(s):

Gabriel Cuonzo; Luca Trevisan

Other key lawyers:

Daniela Ampollini; Donatella Capelli; Luca Pellicciari

Testimonials

‘This team has an impressive grasp of the legal and regulatory interface in the pharmaceutical space. They are experienced pharma litigators and exclusively work for innovators.’

‘Gabriel Cuonzo is a named partner. He knows everyone and has tremendous hands on experience. He is also easy to work with and very kind. Donatella Capelli is a very good partner and operates as Gabriel’s second in command for our team. She is a superb advocate and is impressively quick to grasp complex scientific issues..’

‘The best patent litigation firm in Italy. Decades of experience in this very specialist area make this the go-to firm for serious companies, giving the team an enviable client list and experience to match.’

‘Gabriel Cuonzo is the maestro of the courtroom. Seasoned, confident and smart. Few can match him. Daniela Ampollini is charming, considered and great with difficult cases. Achieves spectacular results.’

‘Gabriel Cuonzo has provided excellent strategic oversight and inspires confidence, based on his unrivalled experience of complex patent cases. Luca Pellicciari has been extremely hands-on and really impressed in terms of attention to detail and ability and eagerness to engage with the technical aspects of the case. His advice, responsiveness and quality of his legal submissions has been excellent. Luca is also a pleasure to work with.’

‘Gabriel Cuonzo is a class act. Luca Pellicciari is clearly going places.’

‘They represent many of the world’s leading life sciences companies and have a small but dedicated team. They are head and shoulders above the competition’