Industry focus: Healthcare and life sciences in Spain
Clifford Chance’s healthcare and life sciences group handles regulatory advice, M&A transactions and patent infringement litigation. The team has experience in joint ventures, cross-licensing, technology development, co-operative commercial arrangements and collaborative alliances. The multi-disciplinary group also advises healthcare clients across numerous areas, including intellectual property rights, employment matters, tax, business compliance, competition and product liability. The practice is co-led by IP specialist Miquel Montañá, head of the firm’s Spanish tech practice Josep Montefusco and Guillermo Guardia, who is experienced in private equity and joint ventures within the healthcare sector. Highlights included representing Roche in patent infringement proceedings regarding a biosimilar.
F. Hoffmann-La Roche
Nutrition & Santé Iberia, S.L.
Bial Portela & CA
Merck Sharp & Dohme Corp.
Zoetis Services LLC
Esteve Pharmaceuticals S.A.
- Advised AstraZeneca in patent litigation proceedings in relation to the drug Fulvestrant.
- Represented Belgian pharmaceutical company UCB Pharma in patent/SPC revocation and infringement proceedings in Spain against Laboratorios Normon, concerning its product for the treatment of epileptic seizures.
- Advised Novartis Farmacéutica on public procurement matters related to tender procedures for the awarding of supply contracts of medicines by public hospitals.
Gómez-Acebo & Pombo focuses on the research and development side of the healthcare sector, as well as acting for clients in the botanical and animal health sectors. Its full-service healthcare and life sciences offering regularly advises on product development and licensing, M&A transactions, regulatory and compliance work, competition matters and litigation. Other key areas of work include assisting with market entry, EU trade regulation, advertising, judicial and administrative review proceedings, and sanctioning procedures. Eduardo Castillo, who focuses on unfair competition and patent and pharmaceutical sector litigation, and Irene Fernández Puyol, who heads the regulatory side of the practice and is an expert on public procurement, lead the team.
Novartis Internacional AG
Basf Española, S.A.
Catalent Pharma Solutions
Eisai Co. Ltd
The Regents of the University of California (California Riverside)
- Advised Fresenius Kabi, a global healthcare company, on public procurement, regulatory and M&A matters.
- Advised US-based Danaher Corporation, a healthcare and medical devices company, on Spanish healthcare procurement issues.
- Advised UK-based pharmaceuticals group Mundipharma on pan-EU patent litigation.
The team at Uría Menéndez handles both transactional and regulatory matters in the healthcare and life sciences sectors, and has particular expertise in compliance issues, such as internal investigations and setting up structures and policies. Members of the team are regularly seconded to clients in the sector. Teresa Paz-Ares, whose practice focuses on commercial and M&A law, heads the team. Also notable is José Massaguer, who specialises in intellectual property and innovation in healthcare. Recent highlight matters include advising on the potential implementation of a free price policy for pharmaceutical products in Spain, as opposed to the current government-fixed prices.
Johnson & Johnson
Procter & Gamble
Reckitt Benckiser Healthcare, S.A.
- Advised a multinational pharmaceutical company on a complaint against a competitor’s advertising campaign.
- Advised Integra LifeSciences on the Spanish aspects of the acquisition of a neurosurgery business, including the restructuring of the distribution network.
- Advised Rovi on the acquisition of rights to a pharmaceutical product for use in Spain and France.
Baker McKenzie’s multi-disciplinary healthcare practice is noted for its ‘worldwide scope’. Particular strengths include advising on pricing and reimbursement issues and multi-jurisdictional best practice. The team can draw on support from the firm’s tax, competition, employment and IP litigation practices. Regulatory expert Montserrat Llopart and commercial contracting and restructuring specialist Cecilia Pastor head the practice. Ester Navas is also noted for her ‘flexibility’ and ‘expertise’. The firm is representing Chiesi, Isdin and Celgene before the Spanish Supreme Court in a matter relating to price referencing.
- Advised on the integration and reorganisation of the St. Jude medical business and all its subsidiaries across Spain into Abbott.
- Advised Zimmer Biomet, a medical device company, on the reorganisation of the commercial contracts of one of its product lines.
- Advised pharmaceutical companies including B Braun Melsungen and Chiesi on public procurement.
Key areas of focus for Bird & Bird include biotech, digital health, matters in the Unified Patent Court, and supplementary protection certificates and waivers. The full-service group also offers advice on intellectual property, regulatory, product liability, commercial and corporate matters. IP specialist Manuel Lobato and Lourdes Ayala, who has extensive experience in M&A and private equity, head the team. Highlights included advising United BioSource on regulatory requirements relating to clinical trials and observational studies. Raquel Ballesteros left the firm in 2020.
Esteve Pharmaceuticals, S.A.
Sanofi Aventis S.A
Fluidigm France S.A.R.L
Rayner Surgical S.L
Canaan Research & Investment S.L.
Active Bioregeneration Technologies, S.L.
- Advised IMS Health, which focuses on market research and opinion polling, on its relationship with the Spanish Agency of Medicines and Medical Devices.
- Represented Sanofi-Aventis in an appeal against a contract tender decision by the Catalonian health service.
- Advised United BioSource on regulatory requirements for clinical trials and observational studies.
Cuatrecasas handles M&A, regulatory, litigation, digital health, intellectual property, competition, employment and tax matters for clients in the healthcare sector. Key areas of work include advising on clinical trials, pricing and reimbursement procedures, digital health, artificial intelligence, sanctions proceedings, and product commercialisation. The team is headed by M&A specialists Elena Cuatrecasas and Mariano Ucar, regulatory expert Jorge Robles, Jorge Llevat (who has advised on pharmaceutical IP matters, licensing and co-promotion agreements) and Irene Moreno-Tapia, who has extensive antitrust expertise. The group is currently advising Faes Farma on multinational distribution agreements and has assisted Genomica, Isdin and MartiDerm with their operations in Asia.
- Providing ongoing advice to Bayer on matters including antitrust issues relating to the promotion of a medicine.
- Advised Fenin on litigation over the tender documents of three tender procedures for contracts to supply medical devices to hospitals.
- Advised Isdin, a skincare and cosmetics company, on regulatory and advertising matters.
The team at Eversheds Sutherland Nicea provides an ‘excellent service’ in the healthcare and life sciences sector. The practice covers patent litigation relating to pharmaceuticals and biochemicals, product liability matters, regulatory issues, commercial agreements, and business strategy and public affairs advice. Francisco J. (Kiko) Carrión García de Parada, who focuses on patents and product liability, leads the team. Legal director and manager of the firm’s pharma in-house support unit Marta Gonzalez Diaz is also recommended.
Boutique law firm Faus & Moliner handles matters including clinical trials, marketing authorisation procedures, public financing, distribution and supply, pharmacovigilance and product withdrawal. The practice has experience in representing pharmaceutical companies in court proceedings against public authorities. Jordi Faus, a specialist in community and pharmaceutical law, leads the team with Xavier Moliner, who focuses on product liability, public procurement and data protection.
Boutique firm Fieldfisher JAUSAS specialises in the healthcare and life sciences sector, and has a particular focus on regulatory and compliance issues. The practice also deals with matters relating to medical advertising and promotion and market access. Practice head Héctor Jausàs has wide-ranging expertise in the sector, having advised companies in the pharmaceutical, medical devices and cosmetics industries on pricing and reimbursement, competition and EU law, and product liability. Senior associate Gemma Colomer has extensive experience in regulatory and compliance law and as a litigator.
Garrigues has a multi-disciplinary practice in the healthcare sector, covering intellectual property, public procurement, M&A and competition law matters. The team advises on pricing and reimbursement, advertising, quality control and commercial contracts including joint ventures. Intellectual property specialist Carolina Pina and José Fernández-Rañada, who has extensive experience in company sale and purchase transactions, co-head the practice. Recent highlights include advising the Centene Corporation on its acquisition of the majority stake in the company in charge of the University Hospital of Torrejón.
Farmaindustria (the Spanish association for the pharmaceutical industry in Spain)
Bazter, S.L. (and subsidiaries)
Astrazenica Farmaceútica Spain, S.A.
- Advised on the acquisition of the SARquavitae Group by DomusVi.
- Advised the Talladium Group, a manufacturer of dental angled abutments, in relation to a patent infringement lawsuit initiated by a competitor.
- Handled the acquisition of Spanish multinational Gaes by Italian company Amplifon, a manufacturer of medical devices.
The full-service healthcare and life sciences practice at DLA Piper provides advice on regulatory, contractual and commercial, intellectual property and data protection matters. The team can draw on the firm’s global life sciences practice, which has a particular focus on the US and UK. Diego Ramos leads the practice with Paula González de Castejón, who specialises in intellectual property.
St. Jude Medical
Pharmaq (currently part of Zoetis)
- Advised Chemo Group (formerly Insud Pharma) on internal protocols relating to regulatory matters.
The practice at Hogan Lovells International LLP is ‘excellent for multinational clients’, and offers advice on product liability, litigation, regulatory and transactional matters to clients including manufacturers, laboratories, distributors and insurance companies in the healthcare sector. The team is led by the ‘truly remarkable’ insurance-focused Joaquín Ruiz Echauri; Santiago Garrido, who also heads the office’s regulatory practice; intellectual property specialist Ana Castedo; M&A and joint ventures expert Alex Dolmans; and product liability and tort litigation expert Carolina Revenga.
DePuy International Limited (Johnson & Johnson Group)
Ethicon (Johnson & Johnson Group)
Sigre Medicamento y Medio Ambiente
LabCorp (Laboratory Corporation of America Inc.)
- Defended DePuy International and Johnson & Johnson in litigation brought after the worldwide voluntary recall of the ASR hip replacement systems.
- Represented Johnson & Johnson in major product liability claims related to different medical devices.
- Advised Sigre Medicamento y Medio Ambiente, which handles the waste management of medical products, on regulatory and environmental matters.
HOYNG ROKH MONEGIER
HOYNG ROKH MONEGIER has a particularly strong offering in cross-border IP litigation in the healthcare and life sciences sector. Areas of work include the enforcement and defence of patent rights and challenging the launches of generics and biosimilars. Luis Fernández-Novoa heads a team of experienced litigators which includes José Antonio Sanmartín, who represents clients in both civil and criminal matters in the sector; Álvaro Velázquez, who has experience in unfair competition and advertising and labelling; and biotechnology expert Laura Cantero.
Janssen (Johnson & Johnson)
Merck Sharp & Dohme (MSD)
- Advised Janssen on its patent enforcement strategy against generic drugs.
- Represented gene sequencing companies Illumina and Sequenom in patent infringement and invalidity litigation.
- Represented Ferring, a pharmaceuticals company, in relation to an application for a supplementary protection certificate.
The healthcare and life sciences team at Pérez-Llorca acts for regulatory bodies such as the General Board of Official Pharmaceutical Colleges, research laboratories in the medical sector, biotechnology companies and specialist investment funds. Key areas of work include advising on regulatory, procedural, intellectual property and commercial issues. Juan Manuel Rodríguez Cárcamo, who has extensive experience in regulatory matters with a focus on the pharmaceutical sector, leads the team.
Johnson & Johnson
Laboratorios Farmacéuticos Rovi
General Board of Official Pharmaceutical Colleges
Búfalo Werner & Mertz, S.A.
- Represented the Official Colleges of Pharmacists of Alicante, Castellón and Valencia in judicial proceedings on whether certain medicines could be dispensed in pharmacies or only in hospitals.
- Advised Búfalo Werner & Mertz on the use of ecological terminology when labelling cleaning products.
- Advised Cerner Iberia on regulatory issues in relation to electronic prescription support for Spanish hospitals.
Ramón y Cajal Abogados advises on the financing of medicines, payment of pharmacists through local government institutions, advertising of medical products, cosmetic products and food supplements, and the direct supply of medicines to hospitals. Jose Ignacio Vega, who focuses on matters relating to the government and the public sector, and information technology and privacy specialist Norman Heckh head the practice. Recent matters include advising Spain's Personal Healthcare Association (ANEFP) on the advertising and pricing of non-prescription medical products.
Personal Healthcare Association
Spanish Generic Medicines Association
Digital Health Ecommerce Services
- Advised Psyma and Digital Health Ecommerce Services on an online platform for the sale of medicines not subject to prescription.
- Advised the Spanish Generic Medicines Association (Aeseg) and Farmaindustria on the implementation of the Falsified Medicines Directive and on the national traceability body.
- Provided ongoing advice to Aeseg.
Rousaud Costas Duran has ‘great knowledge of the interactions between the public sector and the private sector’. The team specialises in drafting biotechnology agreements and also advises on inbound and outbound cross-border matters with a focus on life sciences. Practice head Ignasi Costas has extensive experience in the innovation and venture capital areas. Judith Saladrigas advises research centres and biotechnology companies on innovation and entrepreneurship.