Industry focus: Healthcare and life sciences in Italy
The healthcare and life sciences team at Bird & Bird stands out for two core areas of focus: its dedicated team for developing possible litigation strategies on the bases of the Unified Patent Court and Unitary Patents EU initiative, and its focus on personalised medicine, particularly the interaction between technology and life sciences. Chairman Massimiliano Mostardini and Giovanni Galimberti jointly head the IP department, and act for a number of major players in the pharmaceutical industry. Antonella De Gregori, who was made partner in May 2019, primarily acts for clients in the chemistry field. Mauro Turrini is highly regarded as an expert in the life sciences field.
IK Investments Partners
Ospedale San Raffaele
- Assisting Axxam with shareholders’, investment and joint venture agreements.
- Advising IK Investment Partners on the acquisition of two Italian companies, Fasinternational and Faslab.
- Assisting Alia Therapeutics with the negotiation of contracts regarding the transfer of technology from the University of Trento.
BonelliErede's healthcare and life sciences focus team is led by Vincenzo Salvatore, who has extensive experience of complex litigation in EU law, and has specific regulatory and compliance skills in clinical trials, marketing authorisation procedures and pharmacovigilance. His expertise was invaluable in the firm's representation of Novartis Farma before the European Court of Justice. The team was boosted by the arrival in July 2019 of Renato Bocca, who has assisted healthcare clients with the negotiation of collaboration agreements and contracts. The team also has strengths in false and comparative advertising, inspections and enforcement. Monica Fantino is also noteworthy.
‘The lawfirm has gained over the years a strong competence in this field from several aspects, including regulatory.’
‘They are very competent and keen at making their knowledge available for clients also when there is no specific issue to address: their communication initiatives are very efficient and interesting.’
‘I worked with the lawyer Valentina Bonomo, who proved to be very helpful and prepared, handled the relationship with the other party with great professionalism, fixing the fundamental points of negotiation.’
Ospedale San Raffaele
Istituto Ortopedico Galeazzi
- Assisting Zambon with the acquisition of Breath Therapeutics in a deal worth up to €500m.
- Representing Vitalaire before the Council of State in relation to an antitrust matter.
- Assisting Taisho with the acquisition of the entire share capital of UPSA SA in a deal worth $1.6bn.
Praised for its 'empathy, competence' and 'legal support', DLA Piper counts major multinational companies among its clients, including Pfizer and Abbott Medical, as well as high-profile Italian healthcare providers, healthcare investors and insurance companies. Roberto Valenti heads the life sciences team, bringing experience in IP litigation. Vito Bisceglie, highly regarded for his 'preparation, problem solving' and 'responsiveness', advises clients, including Gruppo Zaffiro, on transactions, investments and financings. Marco de Morpurgo, who joined from Allen & Overy - Studio Legale Associato in October 2018, has expertise in EU and national regulatory law.
‘They are always going the extra mile to deliver effective and original solutions.’
‘Thanks to their multidisciplinary competences they can provide assistance to life science companies in all their needs, litigations and compliance matters above all. Thanks to their strong knowledge of this sector they can provide a very specialised service compared to the other law firms.’
‘Antonio Carino is absolutely indispensable for a company operating in the life science sector thanks to his strong expertise in this sector and his strategic approach in criminal litigation matters involving such companies. Also, Veronica Rossetti is highly skilled in this sector and very committed.‘
‘This practice is unique for the level of services provided and for the quality of the response they provide. They know our business very well, and they are always available to support us in any issues that can occur; the response time is another key factor that makes this practice very well regarded, especially compared to other firms.’
‘Giorgia Romitelli is very well-prepared, proactive, and always available and ready to find solutions to our needs. Her strength is her specific knowledge of our business and the medical devices space. Her availability, professionalism and competence are a plus for us.’
Confindustria Dispositivi Medici
Confindustria Dispositivi Medici Servizi
- Defending Abbott Medical against corruption charges before the Court of Parma.
- Assisting GE Healthcare with clinical trial agreements.
- Representing eight former directors of Pfizer who were charged with conspiracy to declare fraudulent bankruptcy.
Hogan Lovells International LLP's cross-practice life sciences team covers a wide range of cases, from corporate M&A and licences to patents, disputes, compliance and product liability. It has been praised for its 'very deep knowledge' of the sector. Team head Christian Di Mauro works for international and Italian clients, specialising in dealing with product issues from a safety and quality perspective. In recent work, the group assisted LivaNova with managing the effect of allegations of patient injury and death connected to the use of the company's devices. The team often liaises with market surveillance authorities and handles regulatory matters and criminal investigations.
‘I believe that the lawyers working in Hogan Lovells are the best IP lawyers in Italy. They have excellent knowledge of the IP laws and are very smart in finding the best approach for supporting their clients either during a litigation and during a negotiation.’
‘Executable advice and great attitude even in crisis.’
‘Francesca Rolla: special knowledge in product liability and life sciences.’
‘Riccardo Fruscalzo is an exceptional practitioner and very knowledgeable in life sciences. He is always very responsive and receptive to the requests and needs of the client.’
CHR Hansen Italia
- Assisting PerkinElmer with the acquisition of Dani Instruments’ gas chromatography and mass spectrometry portfolio.
- Advising Recordati on licencing agreements with Aegerion in Japan in a deal worth $30m.
- Acting for Grünenthal in its product liability litigation in Italy.
Agostino Migone de Amicis, who has been praised for his 'profound knowledge' of the sector, and Gian Paolo Di Santo, head the team at Pavia e Ansaldo. The practice has developed longstanding relationships with some of the largest multinational pharmaceutical and biotechnology companies in the world, and regularly works with Italian regulatory bodies. Migone de Amicis is one of the foremost Italian regulatory advisers in the sector, while Di Santo, head of industrial and intellectual property, represents biotech giants and generics companies in disputes and non-infringement actions.
‘Much of the studio’s credibility in the life sciences sector is due to the competence and reliability of Agostino Migone De Amicis, who is competent, experienced and responsive.‘
‘The firm has a deep knowledge of the life sciences sector and is particularly attentive to the evolution of the regulatory system.’
Fondazione M Tettamanti – M De Marchi
Aristo Pharma Group
- Advising Fondazione MBBM on the establishment of a ground-breaking public/private partnership for paediatric clinical trials.
- Advising a major European medical device company on the application of GDPR for clinical trials.
- Assisting a global US pharmaceutical company with compliance issues.
Portolano Cavallo provides full-service assistance to high-profile clients from the life sciences industry, dealing with all transactional, contractual, contentious and regulatory aspects relating to the pharmaceutical, medical devices and healthcare sectors. Luca Gambini, who is an M&A specialist, heads the life sciences practice group. Marco Blei and Elisa Stefanini are noted for their 'precise legal analysis and hands-on recommendations'. Guilio Novellini, who was promoted to counsel in January 2019, acts in cutting-edge cases for multinational manufacturers of medical devices and pharmacy automation platforms. The team also has considerable experience in multijurisdictional litigation and regulatory cases.
‘Portolano Cavallo is highly competent in intellectual property law.’
‘Very capable and with a very good knowledge of the regulatory questions.’
‘High-level professional assistance and technical expertise in life sciences.’
The team at Studio Professionale Associato a Baker & McKenzie focuses primarily on M&A in the healthcare and life sciences sector, advising a number of high-profile Italian and multinational clients. Aurelio Giovannelli, Pierfrancesco Federici and Roberto Cursano are the practice heads. Cursano and associate Mario Cigno handle pharmaceutical matters from an administrative law perspective, focusing on product recalls, public tender procedures, distribution, promotion activities and the conduct of clinical investigations. The team's expertise was invaluable in assisting Takeda Pharmaceutical with all regulatory, commercial, public procurement and corporate actions relating to its acquisition of Shire, in a global deal worth $62bn.
Wright Medical Italy
- Assisting Abbott Laboratories with all regulatory, commercial, public procurement and corporate actions relating to its acquisition of St. Jude Medical in a deal worth $25bn.
- Advising Stryker EU on product liability, public procurement and various regulatory matters.
- Handling the set-up of Recordati’s manufacturing and distribution flows throughout its European subsidiaries.
The pharmaceutical, healthcare and life sciences business unit at Chiomenti is headed by Luca Liistro, who advises on commercial law and contractual matters. The team, which has been praised for its '"hands-on" approach', focuses primarily on M&A, and regulatory and contractual issues in the sector. It benefits from the 'very sharp business acumen' of administrative law specialist Filippo Brunetti, as well as the administrative expertise of Elio Leonetti and Alfredo Vitale, who were both promoted to counsel in January 2019. The team also has experience handling compliance, patent infringement and litigation.
‘Extensive experience in negotiating complex transactions in the industry, both sell and buy-side. “Hands-on” approach by senior partners, who personally attend all meetings/steps of a transaction. Very good knowledge of legal/technical issues typical of the industry.’
‘The team has extensive experience in negotiating complex transactions in the industry, on both the sale and buy-side. They have also a very good knowledge of all issues related to capital markets. Luca personally attends all meetings and reviews all the documentation, supporting his clients in all steps of a transaction; this is not always the case when dealing with large law firms. Luca is also a very good negotiator, tough where appropriate, but always fair and respectful of his counterparts. Thanks to this, he has excellent relationships within the industry and in the Italian financial community.‘
‘I work with Filippo Brunetti, a firm’s partner; he is really competent, well oriented towards the client needs, and he can also understand very quickly what the client really needs in order to solve her/his issues. I would also outline his capacity to identify links with other practices (e.g. medical practice) and also his speed in non-standard issues.’
Laboratorio Analisi Guidonia
- Advising Laboratorio Analisi Guidonia on its acquisition of the majority of the capital of Laboratorio Analisi Chimiche Dott. A. Giusto in a deal worth €25m.
- Advising Laboratoires Expanscience SA on the reorganisation of its contracts and of its distribution network in Italy.
- Assisting Amplifon with its acquisition of 51% of the equity of Beijing Cohesion Hearing Science & Technology Co.
Gianni, Origoni, Grippo, Cappelli & Partners
Gianni, Origoni, Grippo, Cappelli & Partners is strong in M&A and financial planning for pharmaceutical companies and has been praised for its 'excellent strategic support'. Rosario Zaccà, who heads the life sciences team, also has expertise in joint ventures and multijurisdictional transactions. Massimo Sterpi has strengths in IP patent litigation, and the 'very serious, very knowledgeable' Antonio Lirosi presides over the firm's administrative litigation in the sector. Clients also include biotechnology companies, start-ups and emerging companies, medical device companies, healthcare companies, hospitals, venture capital firms, pension funds and investment banks.
‘Excellent law firm with great experience in healthcare and life sciences that provides excellent overall support. The biggest strength is the ability to work at ease in different jurisdictions, availability to the client and excellent strategic approach.’
‘Gianni, Origoni, Grippo, Capelli & Partners has very good partners for in-house lawyers and management of companies in the healthcare and life sciences sector, especially for public law and assistance in administrative courts.‘
‘I have been working extensively with Rosario Zaccà and Gherardo Cadore. I have been very impressed with both lawyers for their strategic legal advice, attention to the client, excellent technical knowledge and ability to manage complex issues.’
‘The leading partner I can endorse is certainly Antonio Lirosi of the Rome office. Very serious, very knowledgeable, always ready to understand the details of the commercial and economic aspects of the business before giving opinions and always careful to consider the political/institutional aspects before suggesting a course of action.’
Innova Italy 1
GE Medical System Italia
- Representing Medac in patent litigation.
- Acting for Novo Nordisk in an appeal against the Health Department of Sicily.
- Assisting LivaNova with the sale of its Cardiac Rhythm Management business franchise to MicroPort Scientific Corporation and Yunfeng Capital worth €154m.
Herbert Smith Freehills
Herbert Smith Freehills' life sciences team is jointly headed by Laura Orlando ('a key player in the market'), who has notable expertise in IP and the life sciences sector, and Sebastian Moore. Orlando, who is also managing partner of the firm in Italy, advises on clinical trials, product life cycle management, marketing authorisations, advertising, licencing and compliance, and is also an active litigator in multijurisdictional patent cases. Moore is involved in UK and multijurisdictional patent matters. Clients include Gilead, which the firm has been representing in one of the sector's largest ever patent cases.
‘The main strength of the firm regards its ability to reconcile in-depth expertise in industrial property matters with a high level of knowledge in the life sciences sector.’
‘Laura Orlando is certainly characterized by her profound knowledge of the IP field, to which is added an uncommon competence in the life sciences sector, thanks to which she succeeds in playing across the board, with great customer satisfaction. Added to this is the remarkable dynamism of Laura, who over the years has managed to obtain excellent external visibility, as a speaker at conferences or columnist for specialized magazines.‘
‘The team is highly recommended for their IP and regulatory skills, combining advice and litigation capabilities.‘
‘Laura Orlando, a key player in the market; maybe the best IP lawyer in the Life Science industry in Italy as of today. I would also mention Sara Balice and Martina Maffei, two young but skilled associates.‘
‘The team is truly fantastic and Alan Montogmery is a true business partner with exceptional knowledge of the law and market. He understands clients’ needs and anticipates any complexities in a given deal. In the end, he really knows what to do to get things done.‘
‘The lawyers combine the high quality and sophisticated knowledge of a boutique law firm with the approach, mind-set and language skills of an international firm. So what we get is a combination of high-quality legal advice given to us in a very concise, practical and helpful way.’
‘Laura Orlando is the outstanding practitioner there, but she has a very large and strong team too. Laura Orlando stands out for her life sciences sector knowledge. She is to my knowledge the only Italian lawyer combining highly sophisticated IP and regulatory skills.‘
- Advising Eli Lilly on the Italian launch of its new generation product for cluster headaches.
- Representing GlaxoSmithKline in major litigation relating to the patent for its biggest selling anti-HIV drug, in Italy.
- Acting for Millennium in the pan-European defence of its market exclusivity for its Velcade product.
LS CUBE Studio Legale
LS CUBE Studio Legale's life sciences team provides advice in the regulatory space, and has been praised for its 'customer care and speed of execution' as well as its 'in-depth knowledge of the local industry'. Regulatory specialist Paola La Licata ('very prepared and responsive') is highly regarded for her deep technical expertise. The team also assists international life sciences companies entering the Italian market with building relationships with institutional and business stakeholders as well as with hospitals. Paolo Ricci, noted for his 'calm' and 'supportive approach', has many years of experience in corporate and commercial law, and M&A.
‘LSCUBE lawyers have an in-depth knowledge of Italian and European pharmaceutical regulations. They are very smart and fast in managing and solving potential litigations/issues.‘
‘Very good, expert team. Full availability, commercial awareness and commitment are their main strengths and their rates are far more reasonable than those of other players.‘
‘A unique team in the Italian market. Deep regulatory and industry knowledge, leads them to add value in M&A, corporate, commercial, compliance and, more recently, legal public affairs.‘
‘High level of expertise combined with a client oriented approach.‘
‘I usually work with Paola La Licata. She is very smart and well-prepared in regulatory matters. She perfectly knows how to manage relations with public authorities.’
‘Paolo Ricci is the star, thanks to his calm ability to keep everything under control and supportive approach. He is also very easy going and it is always a pleasure to spend time together. Which is a big plus during the long and tough days (and often nights) of negotiations.‘
‘Paolo Ricci is my first choice when it comes to M&A, corporate and commercial matters. He has been assisting pharma companies since the 90s, and he knows perfectly how the industry operates. He’s creative, committed, and always available. Paola La Licata has been practising life sciences regulatory law for over 15 years, and she is in my view the “number one” expert in her field in Italy. Rosanna Sovani’s combination of regulatory expertise, industry knowledge and advocacy abilities make the firm’s service unique and ensures great effectiveness for all projects. She has great connections with institutions and with the other stakeholders, and proved to be able to overcome the most complex situation in any life sciences-related issue, particularly on advanced therapies, where she has an unrivalled expertise.‘
Fintex & Partners
HRA Pharma Italia
Ospedale Bambino Gesù
- Assisting Fintex & Partners (and two other minority sellers) with the sale of the entire share capital of Texus to a listed Israeli multinational.
- Advising Bluebird on its entry into the Italian market with a new gene therapy product.
- Assisting Texsus with a complex product liability case brought by the client against a German supplier before the ICC arbitration panel consisting of two separate proceedings in Berlin and Milan, both subject to German law.
The life sciences practice at Masotti Berger Cassella regularly acts for Italian surgical and medical device companies on corporate and regulatory matters. 'Very skilled' team leader Luca Masotti is on the board of directors of three device manufacturing and distribution companies; he often advises on transactions, licensing and distribution agreements. His expertise was instrumental in the firm's advice to Era Endoscopy, a company which manufactures an innovative robotic device for colonoscopy, as it seeks to break into the international market. Other key clients include Telbios and ab medica.
‘Luca Masotti is a very skilled man, offering pragmatic advice, and acting with a business spirit.’
ab medica Renting
Società Italiana Farmacologia
Officine Ortopediche Rizzoli
ab medica France
- Advising ab medica France on regulatory and compliance matters concerning a possible recall of products due to the non-respect of sterilisation procedures by a sub contractor.
- Acting for ab Medica on the €3m acquisition of WinMedical.
- Advising Officine Ortopediche Rizzoli on the creation of a network of franchising for the sale of orthopedic products in Italy and the offer of services to disabled persons.
Nctm Studio Legale specialises in assisting clients in the pharmaceutical industry primarily with corporate matters. The team is led by Paolo Gallarati and Lorena Possagno, who has been praised for her 'broad knowledge of commercial law' and described as 'professional, competent, effective and efficient'. The firm's work for clients focuses on the drafting and review of agreements and contracts for licences, joint ventures, research and development, and clinical trials. It also handles compliance and regulatory issues, and has experience handling disputes relating to pharmaceutical patents. Key clients include major multinationals AstraZeneca, Gilead and Johnson & Johnson.
‘Lorena Possagno is very capable in remembering all aspects of a lengthy issue and responds swiftly to our requirements.‘
‘The NCTM Team has always been professional, capable, with excellent communication and listening skills.’
Johnson & Johnson Medical
Uriach / Laborest Group
- Assisting Aboca with drafting, negotiating and reviewing licence, distribution and supply agreements for non-implantable medical devices.
- Advising AstraZeneca on compliance and data protection matters.
- Assisting Johnson & Johnson with a project financing related to the renovation of a hospital in Monza.
Osborne Clarke's life sciences team focuses on competition litigation, administrative litigation and clinical trial agreements, and counts several domestic and international pharmaceutical companies among its clients. Team head Maria Grazia Medici advises on the regulations concerning the production and sale of products and medical devices, and represents clients before regulatory agencies and in proceedings before the administrative courts. Federico Ferrara, known for his expertise in IP, and Marialaura Boni are also noted. Highlights included successfully acting for Teva Italia in an important case concerning the company's inclusion in the Italian substitution list.
‘Competence and ability to find solutions to business needs in compliance with current regulations.’
Havas Life Italy
- Defending Grifols against allegations of bid-rigging with a competitor, Kedrion.
- Assisting Nevro with the drafting of a clinical trial agreement for Italy, including advising on the Italian regulatory environment and certain mandatory requirements.
- Advising Havas Life on the process surrounding its recognition as a continuing education provider authorised by the Health Ministry.
Trevisan & Cuonzo's 'top-class', 'responsive and extremely knowledgeable' healthcare and life sciences team, led by name partners Luca Trevisan and Gabriel Cuonzo, is very strong in IP and patent litigation. The 'impressive, sensible and very responsive' Luca Pellicciari is another key team member. The 'incredibly thorough and detail-oriented' Donatella Capelli is a strong trade mark litigator with over 10 years' experience of pharmaceutical and biotech litigation, who also advises on competition law and antitrust issues. Many of the firm's clients are global brands from the pharmaceutical sector, whose matters draw on the team's multijurisdictional assistance and knowledge of EU law.
‘Strong track record in Italian patent litigation, they are responsive and extremely knowledgeable with a good eye on strategy and in-depth understanding of court procedure and options.’
‘There is clear life sciences expertise within the team. They are responsive, happy to engage with clarifying questions and seem to understand client’s commercial goals.’
‘This firm is one of the leading innovator pharmaceutical litigation firms in Italy. They possess a wealth of experience in this sector, and have extremely knowledgeable senior partners, supported by talented partners and associates. They possess a wealth of first-hand knowledge of the interplay between generics and branded pharmaceuticals in their market. They work hard and are a pleasure to work with.’
‘Top-class team in Italy, with good strategic insight to help navigate the Italian litigation landscape and best position the case.’
‘Italy is a tricky market for life sciences. Trevisan & Cuonzo stand out for their excellence in this area.‘
‘Luca Pellicciari has been impressive, sensible and very responsive, with a good turnaround of well thought-through work product. Gabriel Cuonzo: well established as a leading patent litigator in Italy, brings gravitas to the case.‘
‘Gabriel Cuonzo clearly has experience and expertise in life sciences patent litigation and launch strategies. It was an easy working relationship – he clearly understood our questions and advised accordingly.’
‘Gabriel Cuonzo – Gabriel is one of the named partners and there isn’t much he doesn’t know about IP litigation and the pharmaceutical market in Italy. Donatella Capelli is a partner in the firm, an excellent advocate and is incredibly thorough and detail oriented. She also possesses a wealth of experience in this sector. Federica Bocedi and Lorenzo Battarino are up-and-coming associates who add great strength and depth to the team. Their support work is first-rate.‘
‘Name partner and co-founder Gabriel Cuonzo has decades of experience that allows him to steer the strategic direction of the toughest cases with aplomb. Daniela Ampollini is a go-to in Italy for many big life sciences clients and brings a confident, assured and thorough approach.’
‘Gabriel Cuonzo is experienced and canny. He has a great brain. Daniela Ampollini is also excellent. She is responsive and knows the sector really well.’