Healthcare and life sciences in Germany
Baker McKenzie covers a broad spectrum of topics in the life sciences area: the practice is one of the most diverse in the market and not only has longstanding experience in transactional advice but also profound expertise in regulatory matters. Public procurement and IP-related mandates are further pillars of the practice, which is led by Thilo Räpple, who regularly advises on market access issues and the Pharmaceutical Market Restructuring Act (AMNOG). With public procurement expert Marc Gabriel in the lead, the team also assisted Novartis with several Germany-wide tenders for open-house pharmaceutical rebate contracts for the Imatinib medication and represented the client in multiple parallel review procedures at the federal public procurement body in order to protect important blockbuster cancer drug Glivec. Constanze Ulmer-Eilfort advised CureVac on a cooperation with Eli Lilly in the area of cancer drugs, which included an upfront payment of $50m and an equity investment of $45m; the team collaborated with the firm’s offices in New York and Washington. In addition to acting for international pharmaceutical corporations, the group acts for companies in the biotechnology and medical products technology sector, as well as a significant number of smaller highly specialised companies. Christian Burholt is also recommended.
Clifford Chance’s practice is jointly headed by Peter Dieners and Ulrich Reese, who are highly renowned legal experts in the healthcare sector. The duo are not only known for their regulatory expertise but also handle significant transactional work. Reese advised Fresenius Kabi on the acquisition of the biosimilars business from Merck and provided comprehensive advice to Pfizer on the reimbursement of a new medication according to AMNOG. Gunnar Sachs handled a number of matters for Sanofi Genzyme, including representing the client in Health Care System Act (HWG) proceedings, advice on product launches and contractual matters and on the use of apps. Counsel Claudia Nawroth also has expertise in the healthcare space.
Hogan Lovells International LLP’s ‘excellent’ team stands out for its high level of niche expertise in various healthcare-related areas. Jörg Schickert, who heads the German life sciences practice, has considerable regulatory expertise; he and Arne Thiermann, who was promoted to partner in January 2018, advised multiple companies belonging to Merz Pharma on matters concerning medical devices, pharmaceutical and compliance issues. In a highlight in the corporate space, the group assisted Centogene with a venture capital financing round totalling over €25bn; Munich-based Nikolas Zirngibl led the advice. Tanja Eisenblätter, who is based in the Hamburg office, utilised her ‘comprehensive experience’ in representing Daiichi Sankyo in several competition law disputes concerning anticoagulants. The firm was also active in the field of product liability law, providing multijurisdictional advice to a medical device manufacturer, and in the patent law area, where Alexander Klicznik represented Agilent in three infringement proceedings around mass spectrometres. ‘Magnificent patent lawyer’ Miriam Gundt; head of the digital health Continental Europe practice Matthias Schweiger; Ina Brock, who heads the global clients and industries group; and ‘gutsy’ patent law practice head Andreas von Falck are all also recommended. Hanns Jörg Herwig, Inken Knief and Désirée Maier were promoted to the partnership in January 2018.
Taylor Wessing’s team ‘stands out for its quick response times, constant availability and deep expertise, which extends to international legal matters’. Key names in the ‘well-positioned’ team include Manja Epping, who leads the life sciences team, and Oliver Kirschner, who heads the healthcare group. The practice advises on transactions, regulatory matters and patent infringement proceedings. Recent highlights include advising Trilantic Capital Partners on the takeover of the Oberberg group from Odewald & Cie, as well as handling numerous matters for international pharmaceutical companies, where Wolfgang Rehmann is the name to note for regulatory issues. The firm also acted for DaVita in transactional and regulatory matters concerning the client’s expansion of its cardiology and nephrology activities. In the patent law area, Christoph de Coster successfully lifted several interim injunctions effected by Mundipharm for ratiopharm, while Christian Lederer is representing Shionogi in infringement proceedings against MSD Sharp & Dohme regarding an HIV drug. The firm acts for a diverse client base, including large pharmaceutical companies such as Hexal and Mylan, numerous medical device manufacturers, providers of outpatient and inpatient care such as Omnicare and Greifswald University Hospital, other clients in the care sector and a health insurance company. Karolina Lange and Xiaowen Paulus-Ye were promoted to the partnership in April 2018 and July 2017, respectively. Oliver Klöck and Daniel Tietjen are also recommended.
With the promotions of Tung-Gia Du and Tobias Wilcke to counsel in May 2018, Bird & Bird further strengthened its already strong patent law practice, which is led by Boris Kreye. Recent mandates reflect the team’s broad expertise, with Alexander Csaki’s stand-out advice to a statutory health insurer on a tender in the medical aid sector a particular highlight; the matter included assistance with public procurement law, among other areas. The team is also adept at handling healthcare-related matters at the intersection with data protection and IT. In one highlight, the team advised Dexcom on strategic issues concerning the use of wearable tissue sugar measurement solutions, which included assisting with competition law and drug advertising law, advice on medical device law and the representation in disputes; Frankfurt-based technology expert Fabian Niemann led the advice. The core team also includes patent lawyer Oliver Jan Jüngst, corporate expert Stefan Münch, employment lawyer Ralph Panzer and Jan Byok, who focuses on public commercial law.
In the healthcare sector, CMS is particularly well versed in regulatory and competition law matters, but also has experience in transactions and distribution law. Jörn Witt provided comprehensive advice to logistics company Apologistics on the regulatory framework for the marketing of pharmaceutical products, while practice head Jens Wagner acted for DePuy International in a matter concerning the voluntary recall of Adept hip implants. Nikolas Gregor advised GE Healthcare on distribution agreements, research and development contracts and compliance regulations. In other work, Wagner and Roland Wiring advised Boehringer Ingelheim on competition and drug advertising law matters relating to prescription drugs. Other clients include Merck & Co., Nordmark Arzneimittel and Lilly Deutschland.
D+B Rechtsanwälte is the largest of the three spin-offs emerging from Dierks + Bohle’s split at the end of 2017. With six partners, the highly specialised boutique is already recognised as one of the most powerful firms on the market and acts for an impressive client base, which includes prominent companies such as AstraZeneca. The firm has comprehensive experience in the sector due to its broad bench strength, with particular strength in the law on statutory health insurers. Ulrich Grau and Constanze Püschel, who jointly head the pharmaceutical team, represented German pharmacy association Deutscher Apothekerverband in temporary relief proceedings and legal actions against an arbitration ruling on annex 3 of the so-called Hilfstaxe, the contractual unit costs of retail pharmacist services. Thomas Bohle, who together with Christian Reuther heads the practice focusing on hospitals, represented hospital association Krankenhausgesellschaft Mecklenburg-Vorpommern in arbitration proceedings at the hospital arbitration board concerning the establishment of a state-wide base rate as the foundation for hospital services fees. Thomas Willaschek led advice to Augenklinik Stadthagen on the establishment of medical care centres, among other matters. Willaschek and Martin Stellpflug jointly head the team, which focuses on the law surrounding statutory health insurance physicians and also includes Christian Pinnow.
Freshfields Bruckhaus Deringer
Freshfields Bruckhaus Deringer has a strong track record in the transactional space, but has further expanded its regulatory practice in the healthcare sector. On the corporate side, highlights included advising Merck on the sale of its global consumer health business to Procter & Gamble for €3.4bn, which involved collaborating with the firm’s London office, and assisting BioNTech with a €230m capital increase. The group also advised BSN Medical on medical device law and compliance matters. In another significant matter, it assisted Genomic Health with issues concerning the reimbursement of gene expression tests. Patent law is another area of strength and Frank-Erich Hufnagel, who has longstanding experience in research and development and license agreements, heads this practice. Other key contacts are Jochen Dieselhorst, Marcel Kaufmann and Michael Ramb. Advent International, Stada Arzneimittel and CTI Biotech are also clients.
Gleiss Lutz’s ‘goal-oriented’ team is considered ‘unreservedly excellent’ and has a focus on providing ‘a high service’. It has a core focus on advising cost bearers on statutory health insurance law, particularly regarding public procurement matters. The group is increasingly handling matters at the intersection with IT and data protection law, including assisting local health insurance fund AOK Baden-Württemberg with social security, data protection and public procurement issues in connection with the development of an online community for insured and interested third parties. In another highlight, it advised local health insurance fund AOK Rheinland-Pfalz/Saarland on the renegotiation of contracts with providers in the area of outpatient palliative care. In the corporate space, Martin Viciano Gofferje acted for an investor in BioNTech in the context of a first financing round, valued at €270m. Co-practice head Reimar Buchner and Marco König, who is recommended for his ‘outstanding expertise’, are other key figures in the team.
Hengeler Mueller expanded its healthcare practice with significant growth at associate level. The firm frequently handles transactional matters, but also has considerable expertise in regulatory and compliance issues. Recent highlights include Dirk Uwer representing AOK Bayern in several social law disputes concerning fundamental legal questions in the area of GP-centred care, including two appeal trials at the Federal Social Court, and the firm’s advice to Oaktree Capital Management on the acquisition of nursing home operator Vitanas, which was led by social security expert Wolfgang Spoerr and corporate lawyers Annika Clauss and Peter Weyland. Counsel Susan Kempe-Müller demonstrated her advertising law expertise in her advice to Euro Diagnostica regarding medical device advertising. Other clients include GlaxoSmithKline, Lilly Deutschland and Bioscientia Institut für Medizinische Diagnostik.
Latham & Watkins LLP is best known for its strong transaction-oriented practice in the healthcare sector. Highlights in this area included the firm’s advice to Carlyle Group on the sale of care service provider Alloheim to Nordic Capital, which was led by practice heads Henning Schneider and Christoph Engeler in collaboration with Nils Röver, and assisting LivaNova with the cross-border sale of its cardiac rhythm management business to MicroPort Scientific. The group also handled several capital market law matters originating in the healthcare sector. In the regulatory space, the team assists SHL Telemedizin with matters including contracts for integrated care and pilot projects with health insurance funds. Other clients include Amedes, Boston Scientific and Merck.
Clients appreciate McDermott Will & Emery Rechtsanwälte Steuerberater LLP’s ‘engagement and deep expertise surrounding the particularities of the healthcare sector’. The group welcomed Rüdiger Herrmann and Jochen Eimer as well as counsel Alicia Hong and Monika Emilia Richter from Dechert LLP to the Frankfurt office in May 2018, resulting in an increase in instructions concerning transactional work and regulatory matters. Under the lead of practice head Stephan Rau, the team has further expanded its services to Sanford Health to include corporate advice and assisted the client with its acquisition of a stake in IsarKlinikum. Counsel Jana Grieb advised a company belonging to the Brunswick group on its entry into the medical devices market, including conformity assessment and labelling and advertising questions. GIMV is a new client; other clients include Medicover, Labor Berlin and Arabellaklinik and its associated companies. The ‘outstanding and focused’ Katharina Wodarz, who joined in 2016 together with counsel Nadine Hartung, left for Raue in January 2019.
‘Outstanding’ boutique firm NOVACOS Rechtsanwälte is considered ‘one of the leading firms in the pharmaceutical area’. The firm specialises in the biotech, healthcare and chemical sectors, where it provides regulatory advice, advice on market entry and cost reimbursement, with additional expertise in product liability and compliance matters. The team is also well versed in contentious matters, both before the authorities and at court, and has in-depth experience advising on transactions. Drug advertisement law and data protection issues also make up the firm’s workload. The ‘very solution-oriented’ Maria Heil represented Boehringer Ingelheim in proceedings at the arbitration board of the FSA regarding an alleged compliance breach, while the ‘very well-connected’ Alexander Natz, who is known for his ‘extensive knowledge of EU healthcare law’ and ‘strength in healthcare policy questions’, advised Orchard Therapeutics on its entry into the German market. Christian Hübner and Christian Stallberg ‘have particularly broad and sound expertise and the necessary creativity and resourcefulness’. Marc Oeben is also recommended.
Bonn-based boutique Sträter Rechtsanwälte has an excellent reputation for its regulatory advice. Key areas of focus include pharmaceutical and medical devices law, where it advises clients from product development to approval and distribution. The team also has longstanding experience in pharmacovigilance issues and product liability matters and deep expertise in statutory health insurance law. Clients include pharmaceutical and medical device manufacturers, as well as doctors and pharmacists. The key contacts are name partner Burkhard Sträter, pharmaceutical law expert Markus Ambrosius and Claus Burgardt, whose expertise lies in medical law and the law surrounding statutory health insurance physicians.
Dentons’ team benefits from Christof Kautzsch’s longstanding experience advising on transactions in the hospital sector, and Ilka Mehdorn’s expertise in contracts involving considerable regulatory issues – such as selective and distribution contracts or contracts concerning clinical trials. Peter Homberg adds expertise in technology transfer-related matters and research and development agreements. The practice acts for a broad client portfolio, where it also regularly advises on employment, antitrust and IP law. In one highlight, the team advised BG Kliniken – Klinikverbund on the development of a unified, centralised healthcare group. Other clients include Aesculap, Bayer and HÄVG Hausärztliche Vertragsgemeinschaft.
Ehlers, Ehlers & Partner
Ehlers, Ehlers & Partner’s focus is on medical, care and hospital law. The highly specialised team, which includes key figure and name partner Alexander Ehlers, Melanie Arndt, Karin von Strachwitz and Christian Rybak, stands out for its advice ranging from the law regulating the medical profession and statutory health insurance physicians to pharmaceutical and medical device law and biotechnology and genetic engineering law. It has been notably active in Amnog issues and is also sought out by hospitals and care providers to advise on fee negotiations with cost bearers and on contract negotiations, but also in liability cases and matters with criminal law aspects. Other areas of expertise include hospital license law and funding legislation.
Möhrle Happ Luther’s expertise centres on drug advertising law, Amnog and compliance matters. The client portfolio predominantly consists of pharmaceutical companies but also includes medical device manufacturers and service providers. The team has additional experience advising start-ups; key figures are Henning Anders, Julia Luther and Martin Luther. Anders successfully obtained a declaration of the unlawfulness of a decision of the German Federal Joint Committee concerning the benefit analysis of the drug Linaclotid for Almirall at the Higher Social Court of Berlin-Brandenburg. The group advises longstanding client AstraZeneca on pharmaceutical law and drug advertising law matters. Other clients include Novartis, Allergan and Amgen.
Oppenländer Rechtsanwälte provides ‘very quick and client-oriented advice in drug advertising law’, with Timo Kieser singled out for his ‘comprehensive knowledge of healthcare law’. The team stands out for its profound experience in advising pharmacies, including the regional association of pharmacists Landesapothekerverband Baden-Württemberg and WEPA Apothekenbedarf. In further evidence of its strength in the pharmacy space, the team represented the Bavarian association of pharmacists Bayerische Apothekerverband at the Higher Regional Court of Munich in proceedings concerning the validity of price fixing for foreign mail-order pharmacies. Other highlights include acting for Bayer Vital in several disputes with a competitor regarding the scope of the restrictions on public advertising according to § 10 of the German Drug Advertisement Act, including three proceedings at the higher regional courts, and Christina Koppe-Zagouras’s advice to a client on pharmaceutical, drug advertising law and food law matters. Other clients include the Deutsche Zahnärztliche Rechenzentrum and GlaxoSmithKline Consumer Healthcare. Katharina Köbler was promoted to partner in 2018.
Preu Bohlig & Partner
Preu Bohlig & Partner is a key name for regulatory advice in the healthcare sector. Practice head Peter Von Czettritz handles a broad range of matters from pharmaceutical and competition law to medical device certification issues, as well as, sometimes registration-related, drug law matters, and also has extensive experience in registration-related third party proceedings. Other areas of focus include food law and cosmetics law, liability law and compliance. Clients include Hexal, kohlpharma and Stada Arzneimittel. Alexander Meier joined from HOYNG ROKH MONEGIER at the start of 2019.
Raue combines ‘comprehensive industry expertise’ with ‘very high availability’. ‘Expert in medical and hospital law’ Maren Bedau represented Sanofi in injunction proceedings against the health insurance fund associations Berlin, Brandenburg and Mecklenburg-Vorpommern to ensure the supply of flu vaccines in the 2018/2019 season. She also advised Dr. Römer Kliniken on the establishment of medical care centres and a nationwide network of oncological practices. A highlight for practice head Wolfgang Kuhla was his comprehensive advice to the Deutsche Herzzentrum Berlin on its merger with Charité’s cardiology facilities. The group also assisted the St. Joseph Krankenhaus Berlin and Franziskus-Krankenhaus hospitals with the applications for funding from the hospitals’ structural funds. Senior associate Stephanie Wiesner is also noted and Katharina Wodarz joined the practice from McDermott Will & Emery Rechtsanwälte Steuerberater LLP at the start of 2019.
WilmerHale’s practice in the healthcare sector particularly stands out for its expertise at the intersection with antitrust and distribution law and data protection, among other areas. The firm often handles matters surrounding clinical studies, pharmacovigilance data and healthcare apps; special counsel Peter Gey led recent advice in this space to the German Pharmaceutical Industry Association. Stefan Ohlhoff defended the national guild for hearing aid audiologists (Bundesinnung der Hörgeräteakustiker) against damages claims in the multimillion-euros; the dispute concerned allegations that hearing aid providers had hindered the shortened supply route. Litigation expert Vanessa Wettner is another key figure in the team, which is led by Hans-Georg Kamann. Kamann and Gey spend part of their time in the Brussels office and the practice is able to leverage their strong EU law credentials.
King & Spalding LLP’s team sits as part of a firm-wide group for life sciences regulatory law and provides advice at the intersection of food and pharmaceutical law and on regulatory issues in drug and medical devices law. The group also advises on purely food law matters, including health claims regulation. The team has longstanding experience providing compliance advice and is expanding its data protection practice due to the increased demand for GDPR-related advice. Practice head Ulf Grundmann’s highlights include acting for chemical manufacturer Kreussler in proceedings for the demarcation of drugs, cosmetics and medical devices, which included proceedings at the Federal Court of Justice, and representing the German homeopathic union DHU-Arzneimittel in competition law disputes concerning homeopathic products. Eckes-Granini, Pfizer Consumer Healthcare and biomo-vital are also clients.
Oppenhoff & Partner
Oppenhoff & Partner is noted for its ‘entrepreneurial thinking paired with very good legal know how’ in the healthcare sector. The ‘highly commended’ team, which is led by practice head Peter Klappich, has profound regulatory expertise and broad experience in IP rights and transactional work. Compliance advice is another pillar of the practice. In recent work, Ronald Meißner led advice to Siemens on Siemens Healthineers’ sale of the Elisa immunodiagnostics business to DiaSorin. Corinna Schmidt-Murra joined Shire Deutschland in September 2017.
Anwaltskanzlei Quaas & Partner
Anwaltskanzlei Quaas & Partner’s principle area of activity lies in hospital law, particularly in matters which require expertise at the intersection with medical and construction planning law. The firm also has longstanding experience in the law surrounding statutory health insurance physicians and the drafting of medical law contracts. The group alsi advises on employment law matters. Key figures include name partner Michael Quaas, Till Flachsbarth and Jens-M. Kuhlmann. The firm has offices in Stuttgart and Dortmund.
Tsambikakis & Partner Rechtsanwälte
Tsambikakis & Partner Rechtsanwälte advises doctors, hospitals and pharmaceutical and medical device companies on criminal medical law. Firm founder Michael Tsambikakis and Daniela Etterer are based in the Cologne office and Volker Ettwig operates from Berlin. The practice has deep expertise particularly in compliance matters but its range of services also extends to preventative advice, such as the review of cooperation agreements, and the representation of individuals in criminal proceedings. It also has notable strength assisting clients with the establishment of compliance management systems. Criminal insolvency cases and public procurement matters also form part of the workload.