Industry focus: Healthcare and life sciences in Spain

Clifford Chance

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.

Practice head(s):

Miquel Montañá; Josep Montefusco; Guillermo Guardia

Key clients

Novartis

GlaxoSmithKline

AstraZeneca

Janssen Pharmaceutical

F. Hoffmann-La Roche

Pfizer

UCB Biopharma

Nutrition & Santé Iberia, S.L.

Bial Portela & CA

Merck Sharp & Dohme Corp.

Zoetis Services LLC

Esteve Pharmaceuticals S.A.

Work highlights

  • 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

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.

Practice head(s):

Eduardo Castillo; Irene Fernández Puyol

Key clients

Novartis Internacional AG

Basf Española, S.A.

Ono Pharmaceutical

Catalent Pharma Solutions

Danaher Group

Eisai Co. Ltd

Eurosemillas S.A.

Fresenius Kabi

The Regents of the University of California (California Riverside)

Altan Pharma

Work highlights

  • 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.

Uría Menéndez

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.

Practice head(s):

Teresa Paz-Ares

Key clients

Farmaindustria

GSK

Novartis

Janssen-Cilag

Sanofi Aventis

Johnson & Johnson

Procter & Gamble

Roche

Bayer

Gilead

Lilly

Nordic Pharma

Essity

Reckitt Benckiser Healthcare, S.A.

Work highlights

  • 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

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.

Practice head(s):

Montserrat Llopart; Cecilia Pastor

Key clients

Abbott

AbbVie

Almirall

Astellas

Baush+Lomb

Baxter

Becton-Dickinson

Biogen

Boston Scientific

Celgene

Chiesi

Exactech

Ferrer

ICU Medical

Isdin

Medtronic

Menarini/Menarini Diagnostics

Work highlights

  • 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.

Bird & Bird

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. The ‘strategicRaquel Ballesteros, who is advising on projects in e-health, m-health and telemedicine, heads the team with IP specialist Manuel Lobato and Lourdes Ayala, who has extensive experience in M&A and private equity. Highlights included advising United BioSource on regulatory requirements relating to clinical trials and observational studies.

Practice head(s):

Raquel Ballesteros; Manuel Lobato; Lourdes Ayala

Key clients

Insud Pharma

Tervalis Desarrollo

Biotech Dental

Esteve Pharmaceuticals, S.A.

IMS Health

Sanofi Aventis S.A

United BioSource

Fluidigm France S.A.R.L

Rayner Surgical S.L

Canaan Research & Investment S.L.

Active Bioregeneration Technologies, S.L.

Work highlights

  • 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

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.

Practice head(s):

Elena Cuatrecasas; Mariano Ucar; Jorge Robles; Jorge Llevat; Irene Moreno

Key clients

Ipsen

Faes Farma

Beiersdorf

Ascensia

Isdin

Cinfa

Bayer

Boiron

Puig

Work highlights

  • 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.

Eversheds Sutherland Nicea

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.

Practice head(s):

Francisco J. (Kiko) Carrión García de Parada

Faus & Moliner

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.

Fieldfisher JAUSAS

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.

Practice head(s):

Héctor Jausàs

Work highlights

    J&A Garrigues SLP

    J&A Garrigues SLP 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.

    Practice head(s):

    José Fernández-Rañada; Carolina Pina

    Key clients

    Sanofi

    Grünenthal

    Roche

    Centene Group

    Farmaindustria (the Spanish association for the pharmaceutical industry in Spain)

    Pharma Mar

    GSK

    Bazter, S.L. (and subsidiaries)

    Astrazenica Farmaceútica Spain, S.A.

    Domusvi

    Work highlights

    • 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.

    DLA Piper

    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.

    Practice head(s):

    Diego Ramos; Paula Gonzalez de Castejon

    Key clients

    Novocure

    Pfizer

    Zimmer Gmbh

    West Pharma

    St. Jude Medical

    Biorasi

    Incyte

    Pharmaq (currently part of Zoetis)

    GE Healthcare

    Abbott

    Work highlights

    • Advised Chemo Group (formerly Insud Pharma) on internal protocols relating to regulatory matters.

    Hogan Lovells International LLP

    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.

    Practice head(s):

    Carolina Revenga; Joaquín Ruiz Echauri; Santiago Garrido; Ana Castedo; Alex Dolmans

    Key clients

    DePuy International Limited (Johnson & Johnson Group)

    Merck

    Zimmer Biomet

    Ferring

    Ethicon (Johnson & Johnson Group)

    Sigre Medicamento y Medio Ambiente

    UnitedHealth Group

    Shire (Takeda)

    LabCorp (Laboratory Corporation of America Inc.)

    Work highlights

    • 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.

    Practice head(s):

    Luis Fernández-Novoa

    Key clients

    Abbott

    Ferring

    Illumina

    Intervet

    Janssen (Johnson & Johnson)

    Merck Sharp & Dohme (MSD)

    Sanofi

    Work highlights

    • 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.

    Pérez-Llorca

    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.

    Practice head(s):

    Juan Manuel Rodríguez Cárcamo

    Key clients

    Johnson & Johnson

    Mercadona

    Mylan

    Farmaindustria

    Cerner Iberia

    Laboratorios Farmacéuticos Rovi

    General Board of Official Pharmaceutical Colleges

    Búfalo Werner & Mertz, S.A.

    Pharma Mar

    Servier

    Work highlights

    • 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

    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.

    Practice head(s):

    José Ignacio Vega; Norman Heckh

    Key clients

    Personal Healthcare Association

    Spanish Generic Medicines Association

    Kern Pharma

    Biogen

    Psyma

    Digital Health Ecommerce Services

    Siemens Healthcare

    Lamberts

    Work highlights

    • 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

    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.

    Practice head(s):

    Ignasi Costas