Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Adrian van den Hoven

Director General - Medicines for Europe

Adrian van den Hoven was appointed Director General of Medicines for Europe on 1 September 2013. Before this he was Deputy Director General of BUSINESSEUROPE with responsibility for the International Relations and Industry departments. He worked as an International Relations researcher and adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor) prior to joining BUSINESSEUROPE in 2003. He received his doctorate in Political Science from the University of Nice, France in 2000.

Medicines for Europe

Kristof Roox

Partner - Crowell & Moring

Kristof Roox serves as co-managing partner of the firm's Brussels office. He specializes in intellectual property (IP) litigation in a variety of technological and commercial fields, with a particular focus on complex patent litigation in the pharmaceutical and life sciences sector. He has been involved in a number of cases concerning parallel litigation in several jurisdictions and European cross-border issues. He further advises on many aspects of intellectual property portfolio management, including licensing, protection of trade and domain names, trade secrets, combating counterfeiting and piracy, broadcasting and cable retransmission, technology transfer and strategic IP planning. He has also extensive experience in a wide variety of media law issues. In addition to traditional IP litigation and counseling, Kristof is widely recognized for his thought leadership in the regulatory aspects of life sciences. He advises clients on regulatory, IP and commercial issues, including launch and marketing strategies, food supplements, pharmaceutical marketing practices, pricing and reimbursement, distribution models, OTC-products, competition law aspects, etc. Kristof also litigated several high profile cases before the Belgian's highest Administrative Court (Raad van State) challenging/defending Government reforms of the healthcare system, parallel import authorizations, marketing authorizations, etc. He also assists clients in procedures before the European Agency for the Evaluation of Medicinal Products (EMEA), the Ethical Healthplatform Mdeon and the Deontological and Pharmaceutical Ethics Committee. Kristof has also experience with (referrals to) Co-ordination Group for Mutual Recognition and Decentralized Procedures, autogeneric immunological veterinary medicinal product, etc. Furthermore, he advises and represents leading trade associations in the life sciences sector. Kristof is a very experienced litigator in general commercial and civil matters, covering all aspects of dispute resolution including arbitration. As a specialist in private international law issues, he often deals with complex multi-jurisdictional questions. He is reputed for his knowledge of judicial and procedural law issues. Kristof is a qualified lawyer in Belgium and received a law degree cum laude at the Free University of Brussels in 1994. He also obtained a master of laws (LL.M) in intellectual property law at the University of London (Queen Mary and Westfield College) in 1996. Kristof is admitted at the Brussels bar since 1994. In 1998 he became an assistant professor private international law at the University of Gent. He also lectures on various IP topics in several educational institutions, such as patent law at the University of Liège (LL.M in European competition and IP law). He is a frequent speaker at professional and academic conferences and published several articles on intellectual property and private international law matters. He is on the editorial board of IRDI, a leading Belgian journal on intellectual property matters. He is also an active member of various national and international intellectual property associations.

Medicines for Europe

Marcel van Raaij

Director Pharmaceutical Affairs & Medical Technology - Dutch Ministry of Health, Welfare and Sports

Since October 2014 Marcel van Raaij is the Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tissues and cells including organ donation policy. From 2016 until May 2019 Marcel van Raaij was the first chairman of the Steering Committee of the BeNeLuxA initiative where The Netherlands, Belgium, Luxembourg, Austria and Ireland are working together on sustainable access to medicines in their countries. Marcel van Raaij studied Medical Biology at the State University of Leiden (The Netherlands) and received his PhD in Physiology at the same university. At RIVM he led the Center for Integrated Risk Assessment before he became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety.

Medicines for Europe

Sven Bostyn

Associate Professor - University of Copenhagen

Dr. Sven J.R. Bostyn (LLB, Lic. Jur., LLM law, PhD law) is Associate Professor of Biomedical Innovation Law at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL http://cebil.dk), Faculty of Law, University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam. He is also a regular guest professor at CEIPI in Strasbourg. He is specialized in all areas of IP law, with special emphasis on patent law relating to pharmaceuticals, biotechnology, medical devices, software, Artificial Intelligence and SPC's. Sven is one of the most prominent authorities in Europe in the area of patent law. He is also specialised in regulatory exclusivities (data and market exclusivity, orphan drug designation etc.), and researches more generally also innovation incentivising mechanisms. He has written extensively on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system. Sven has also been in private practice for the last 14 years where he advised and advises clients on most aspects of patent law, competition law, licensing and regulatory exclusivities. He also acted and acts as an expert witness in court cases. He was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering. Sven is the single author of more than 60 scientific publications in the aforementioned areas, and is a regular speaker on international conferences, where he speaks on a wide variety of topics, including IP protection in life sciences, pharma patents, SPC's, regulatory exclusivities in life science, IP issues relating to software and artificial intelligence, patent protection for plants and plant variety rights systems.

Medicines for Europe

George Moore

Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation - Mylan George

Moore is Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation, at Mylan. He currently leads the IP team at Mylan for Europe, Australia and Asia, and also the IP Litigation function for all ROW matters. He is a qualified solicitor (England & Wales) with a masters' degree in chemistry. He has over 11 years in-house pharmaceutical experience, having worked at Apotex in Canada and Sandoz in Germany. He previously worked in private practice in the UK, training and qualifying at Bristows, before then working at Allen & Overy.

Medicines for Europe

Sergio Napolitano

Legal and External Relations Director – Medicines for Europe

Sergio Napolitano is Legal and External Relations Director at Medicines for Europe. He has been recently nominated in a list of the 50 most influential people worldwide in IP law, policy and business. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on "The Role of the Congress in Shaping the US Trade Policy". He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).

Medicines for Europe

Agnieszka Deeg-Tyburska

General Counsel - Polpharma Group

Agnieszka Deeg-Tyburska, works as the General Counsel of the Polpharma Group. Currently she manages the team of lawyers in Poland (3 locations), Russia, Kazakhstan, Barcelona and IP teams, on direct reporting or doted line basis. She is also Vice-Chairman of Legal Affairs Committee of Medicines for Europe.
Before that she was a director of the Legal Department of nc+, a Polish premium pay television, where she managed the team of 14 lawyers, half coming from Canal + Cyfrowy S.A. and half from ITI Neovision S.A. In her so far career while with international law firms such as Weil, Dentons and CMS, she handled a number of large and sophisticated transactions, with a particular emphasis on the product acquisitions, investment transactions of venture capital funds, representation of international financial institutions on the acquisitions of Polish bans and leasing companies, as well as in MBO and LBO structures. She represented a number of financial institutions and borrowers in the lending, debt securities issuance programs, and finance lease transactions.

Medicines for Europe

Tomos Shillingford

Associate General Counsel - InsudPharma

Tom is Associate General Counsel IP at Insud Pharma, a diversified biopharmaceutical business based in Madrid, Spain. Tom's previous position was Director IP Litigation at Allergan, which at that time incorporated the Actavis Group of companies. Tom is a dual qualified lawyer (England and Wales, Australia) whom previously worked in private practice in London with Bird & Bird and in Melbourne with Herbert Smith Freehills. Tom has been working in the pharmaceutical industry for over 9 years and has a wealth of experience in patent litigation across the globe. He advises on a range of IP and regulatory issues as well as providing contractual and M&A support. Tom has managed many prominent patent actions, including Actavis v Sanofi (Irbesartan HCT), Actavis v Boehringer Ingleheim (Telmisartan HCT), Actavis v Warner Lambert (Pregabalin) and Actavis v Eli Lilly (Pemetrexed).

Medicines for Europe

Ingrid Sollerer

General Counsel - Sandoz

Dr. Ingrid Sollerer is Global Head Legal and General Counsel at Sandoz. She joined Sandoz GmbH, Austria in April 1998 and moved on to Novartis International AG in Basel, Switzerland where she held the position of a Senior Corporate Counsel , Mergers & Acquisitions and Competition Law from 2001 to 2007. Since 2008 she was heading the Legal Departments for Western Europe, Middle East/Africa, the global Business Units Oncology Injectables and Anti-Infectives and holding the position of the Global Head Legal Biopharmaceuticals and Deputy General Counsel at Sandoz. In 2016 she joined Novartis Oncology as Global Head Legal Transactions and Cell&Gene in East Hanover,USA before rejoining Sandoz in 2019 in her current role. Ingrid holds a degree of law from the University of Innsbruck, a Diploma of international law at the University of Seville/Spain and obtained a doctorate in law in 2001 at the University of Innsbruck.

Medicines for Europe

Bibianne Bon

General Counsel Europe - Teva (inv)

Biography soon available.

Medicines for Europe

Falk Nuernberger

General Counsel Europe - Mylan

Biography soon available.

Medicines for Europe

Matthew Royle

Partner - Taylor Wessing

Matthew specialises in patent litigation, opinion work, SPCs and regulatory advice. He has particular experience of acting for clients in the pharmaceutical and life sciences industry sectors.
Matthew acted in two Supreme Court cases in 2018/19. Mylan v Warner-Lambert (pregabalin) considered the standard of plausible disclosure required to support a second medical use invention and the infringement of second medical use patents by skinny label products. Actavis v Eli Lilly (tadalafil) considered obviousness in the context of a particular dose of tadalafil which was unexpected but had been identified during "routine" clinical trials.
Matthew has acted on litigation relating to biosimilar launches. He acted in Pfizer v Roche in relation to an Arrow declaration on bevacizumab. Hospira v The Kennedy Institute of Rheumatology (infliximab) settled during trial and Inflectra, the first biosimilar monoclonal antibody, was launched in 2014/15. Matthew has also acted on two trials and appeals relating to trastuzumab (both Hospira v Genentech).

Medicines for Europe

Benjamin May

Partner - ARAMIS Societe d'Avocats

One of the founders of Aramis law firm in Paris, Benjamin May was admitted to practice law in 2000. Benjamin specializes in international patent litigation with a focus on pharmaceuticals and biotech. He is a true litigator and at his best in technically complex proceedings, in particular in the context of cross-border litigation. Benjamin is praised by his clients for his litigation skills and understanding of complex technology. A regular speaker in various IP & life sciences forums, Benjamin is the author of several publications on patent law, e.g. in 2019 "patent litigation in France", "Second medical use patents: where do we stand?", "preliminary injunction in the pharma sector". Aramis law firm focuses on patent and SPCs expiry strategies, IP litigation & trade secrets, regulatory matters, distribution and licensing agreements, marketing matters and anti-trust. Aramis acts for pharma companies, medical devices manufacturers as well as several cosmetics and biotech companies. Aramis was recorded in 2018 as the highest turnover increase amongst business law firms in Paris. Contact: may@aramis-law.com

Medicines for Europe

Christoph de Coster

Attorney-at-Law - Taylor Wessing

Biography soon available.

Medicines for Europe

Harald Mische

EDG Competition - European Commission

Harald Mische is an official at the European Commission's Directorate General for Competition, where he currently forms part of the team in charge with antitrust enforcement in the pharma and health services sectors in Directorate E. He joined DG Competition in 2002, first working in the Cartel Unit and then in the Pharmaceuticals, chemicals and basic industries Unit (moving to the newly created Pharma Sector Inquiry Task Force in 2008, which is now as unit responsible for the health sector as part of Directorate E). Prior to joining the Commission, and after qualifying as a lawyer in Germany, Mr. Mische practiced EC and German competition law in the Brussels office of a leading American law firm. Before that, he worked as an intern in DG Competition's Merger Task Force. Mr. Mische obtained a Ph.D. in EC merger control from the Eberhard-Karls-University of Tübingen. He is a regular speaker on antitrust issues, has written various articles on EC competition law and authored "Nicht-wettbewerbliche Faktoren in der Europäischen Fusionskontrolle – Wettbewerbspolitik zwischen Schutzpolitik und Gestaltung" ("Non-competition issues in European merger control"), Wirtschaftsrecht und Wirtschaftspolitik Bd. 175, Nomos, Baden-Baden, 2002.

Medicines for Europe

Brian Malkin

Counsel - Arent Fox LLP

Brian is an attorney in Arent Fox's FDA, Intellectual Property, and Health Care groups. Brian has more than 25 years of food and drug law practice and over 14 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian's regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian's intellectual property experience includes both patent prosecution and litigation. Brian began his legal career at the FDA, where he worked for more than nine years. Following several years in an FDA law firm, Brian went back to school and obtained a degree in biochemistry to address an unmet need to combine FDA with intellectual property law. Prior to Arent Fox, Brian practiced at an intellectual property law firm and led an FDA Group at an international law firm. Brian is an adjunct professor at Yeshiva University for a class in regulatory and intellectual property for its Biotechnology Management and Entrepreneurship masters program and a guest lecturer at Georgetown Law School for several classes in its Health Law LLM. Brian also is active in several state bar associations: New York State Bar Association: Chair, Food, Drug and Cosmetic Law Section and Co-Chair, Committee on Cannabis Law (founder), and DC Bar, Co-Chair Intellectual Property Community.

Medicines for Europe

Stevens & Bolton LLP

Biography soon available.

Medicines for Europe

Alica Daly

World Intellectual Property Organisation (WIPO)

Biography soon available.

Medicines for Europe

Jennifer Sunderland

Senior Patent Litigation Counsel - Mylan

Biography soon available.

Medicines for Europe

Jurgen Figys

Counsel - Crowell & Moring

Biography soon available.

Medicines for Europe

Floris ten Have

Lawyer - Stibbe

With his expertise in all areas of EU and Dutch competition law, Floris advises multinational companies across many industries. He has extensive experience in the pharmaceutical sector and having advised on numerous high-profile transactions, as well as behavioral matters (e.g. related to life cycle management issues). He is well connected to key regulators in the pharmaceutical space.

Medicines for Europe

Rainer Becker

Head of Unit, DG Competition - European Commission

Biography soon available.

Medicines for Europe

Raphaël De Coninck

Vice President - Charles River Associates

Biography soon available.

Medicines for Europe

Kristin Cooklin

Head of Patents - Zentiva Group

Kristin Cooklin is the Global Head of Patents at Zentiva in Prague. Kristin and her team are responsible for supporting and advising clients with respect to all patent issues at all product stages- including development, in-licensing, litigation and launch. In 2014 she joined Novartis where she held several different roles in its Sandoz Division in Munich, Germany, most recently as the Global Head of IP Litigation ex-US. In 2018 Kristin left Novartis to join the Zentiva and lead and develop the patent team during its transformation after divestment from Sanofi. Prior to going in-house at Novartis Kristin spent over a decade in Washington DC working in AmLaw 100 law firms as a patent litigator focusing primarily on pharmaceutical and life sciences litigation. She participated in all stages of cases, from initial strategy through trial and appeal.Kristin is a US attorney at law and patent attorney. She has handled counseling, litigation and launches of pharmaceutical products across the world with a focus on the US and Europe and was responsible for the successful IP strategy and launch of several of the first biosimilar products launched around the world.

Medicines for Europe

Pinsent Masons (TBC)

Biography soon available.

Medicines for Europe

European Patent Office (TBC)

Biography soon available.

Medicines for Europe

Amaryllis Verhoeven

Head of IP Unit, DG Grow - European Commission (inv)

Biography soon available.

Medicines for Europe

Toni Santamaria

Head of IP Europe - Accord

Biography soon available.

Medicines for Europe

Corinna Sundermann

Senior Vice President Intellectual Property - Fresenius Kabi

Corinna Sundermann is heading the IP department of the Pharma Division at Fresenius Kabi. She joined Fresenius Kabi in 2008 as a Manager and built the IP department from 1 to 30 FTE since then. She is Senior Vice President since 2012. Focus is on generics, branded products, clinical nutrition and medical devices. Characteristic for the department is, to a certain extent, internal handling of litigation. Before joining Fresenius Kabi, she worked 10 years for an originator company, 5 years as a Head of Combinatorial Chemistry, 5 years in the IP department and is European Patent Attorney since 2006. She holds a Dr. rer. nat. from the University of Jena and a diploma in chemistry from the University of Frankfurt.

Medicines for Europe

Imre Gonda

Head of IP Department - Chemical Works - Gedeon Richter Plc.

Imre Gonda has been practicing national and international IP law for more than 17 years. Currently he is the head of IP Department one of the largest pharmaceutical company in the Central European region which is very active in both areas, research of originating pharmaceuticals and generic product development. Before he joined Gedeon Richter Plc., he filled different positions in the Hungarian Intellectual Property Office, for 10 years he was the deputy-head of Trademark, Model and Design Department. He was responsible for managing and supervising the operation of national and international trademark, geographical indication and design sectors. He was involved in norm setting procedures including the preparation of amendments of laws and the creation of new international legal instruments. He participates in different international forums on a regular basis at WIPO and EU institutions, he was the elected vice-chair for eight cycles of the WIPO Standing Committee on the laws of Trademarks, Designs and Geographical Indications which forum was chaired by him for two years. He was participating in different forums of EUIPO (e.g. Management Board and Budget Committee; Liaison Meeting) in his national capacity for a considerable time period. He is qualified as a lawyer in Pázmány Péter Catholic University (Budapest) and did post graduate studies in European Law (LLM). He has written and edited a number of publications and books.

Medicines for Europe

Michael Herschdorfer

Patent Counsel - Synthon

Biography soon available.

Medicines for Europe

David Rose

Partner - Mishcon de Reya LLP

Biography soon available.

Medicines for Europe

Roberto Romandini

Board of Appeal - EPO (inv)

Roberto Romandini obtained his law degree from the University of Pisa and his LL.M. degree from the University of Munich, where he specialized in patent law. He completed his Ph.D. thesis on the patentability of human stem cells at the Max Planck Institute for Intellectual Property and Competition Law in Munich before practicing IP law at a leading IP law firm in Milan for 5 years. Since 2013 he has been a Senior Research Fellow at the Max Planck Institute for Innovation and Competition in Munich. His areas of interest are European and international patent law, biotechnological inventions, SPCs and regulatory exclusivities, plant variety rights and trade secrets. From November 2016 to May 2018 he led and coordinated the MPI Study on SPCs for the European Commission.

Medicines for Europe

Karin Pramberger

Intellectual Property Director - Polpharma Group

As the Intellectual Property Director of the Polpharma Group Karin is responsible for all global patent and trade mark related activities, including among others litigation, filings, prosecution, FTO, selection of new products, and launch strategies. Prior to joining the Polpharma Group, Karin worked in various positions in the patent departments of different pharma companies. She started her carreer in a patent law firm in Vienna, Austria, where she became European and Austrian patent and trade mark attorney. She studied Biotechnology in Vienna, Austria, and at the Ecole Nationale Supérieure de Chemie de Paris, France. In addition, she graduated with an LLB from the University of London. Since 2005 she is a tutor at CEIPI, University of Strasbourg, for the pre-exam and the C-part of the European Qualifying Exam, and since 2006 she is an active member of the Legal Affairs Committee of Medicines for Europe.

Medicines for Europe

Christoph Stoller

Senior Vice President - Teva and President - Medicines for Europe

Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe. In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).

Medicines for Europe

16th Legal Affairs Conference

4-5 NOVEMBER 2020

Medicines for Europe

Adrian van den Hoven

Director General - Medicines for Europe

Adrian van den Hoven was appointed Director General of Medicines for Europe on 1 September 2013. Before this he was Deputy Director General of BUSINESSEUROPE with responsibility for the International Relations and Industry departments. He worked as an International Relations researcher and adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor) prior to joining BUSINESSEUROPE in 2003. He received his doctorate in Political Science from the University of Nice, France in 2000.


Medicines for Europe

Kristof Roox

Partner - Crowell & Moring

Kristof Roox serves as co-managing partner of the firm's Brussels office. He specializes in intellectual property (IP) litigation in a variety of technological and commercial fields, with a particular focus on complex patent litigation in the pharmaceutical and life sciences sector. He has been involved in a number of cases concerning parallel litigation in several jurisdictions and European cross-border issues. He further advises on many aspects of intellectual property portfolio management, including licensing, protection of trade and domain names, trade secrets, combating counterfeiting and piracy, broadcasting and cable retransmission, technology transfer and strategic IP planning. He has also extensive experience in a wide variety of media law issues. In addition to traditional IP litigation and counseling, Kristof is widely recognized for his thought leadership in the regulatory aspects of life sciences. He advises clients on regulatory, IP and commercial issues, including launch and marketing strategies, food supplements, pharmaceutical marketing practices, pricing and reimbursement, distribution models, OTC-products, competition law aspects, etc. Kristof also litigated several high profile cases before the Belgian's highest Administrative Court (Raad van State) challenging/defending Government reforms of the healthcare system, parallel import authorizations, marketing authorizations, etc. He also assists clients in procedures before the European Agency for the Evaluation of Medicinal Products (EMEA), the Ethical Healthplatform Mdeon and the Deontological and Pharmaceutical Ethics Committee. Kristof has also experience with (referrals to) Co-ordination Group for Mutual Recognition and Decentralized Procedures, autogeneric immunological veterinary medicinal product, etc. Furthermore, he advises and represents leading trade associations in the life sciences sector. Kristof is a very experienced litigator in general commercial and civil matters, covering all aspects of dispute resolution including arbitration. As a specialist in private international law issues, he often deals with complex multi-jurisdictional questions. He is reputed for his knowledge of judicial and procedural law issues. Kristof is a qualified lawyer in Belgium and received a law degree cum laude at the Free University of Brussels in 1994. He also obtained a master of laws (LL.M) in intellectual property law at the University of London (Queen Mary and Westfield College) in 1996. Kristof is admitted at the Brussels bar since 1994. In 1998 he became an assistant professor private international law at the University of Gent. He also lectures on various IP topics in several educational institutions, such as patent law at the University of Liège (LL.M in European competition and IP law). He is a frequent speaker at professional and academic conferences and published several articles on intellectual property and private international law matters. He is on the editorial board of IRDI, a leading Belgian journal on intellectual property matters. He is also an active member of various national and international intellectual property associations.


Medicines for Europe

Marcel van Raaij

Director Pharmaceutical Affairs & Medical Technology - Dutch Ministry of Health, Welfare and Sports

Since October 2014 Marcel van Raaij is the Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tissues and cells including organ donation policy. From 2016 until May 2019 Marcel van Raaij was the first chairman of the Steering Committee of the BeNeLuxA initiative where The Netherlands, Belgium, Luxembourg, Austria and Ireland are working together on sustainable access to medicines in their countries. Marcel van Raaij studied Medical Biology at the State University of Leiden (The Netherlands) and received his PhD in Physiology at the same university. At RIVM he led the Center for Integrated Risk Assessment before he became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety.


Medicines for Europe

Sven Bostyn

Associate Professor - University of Copenhagen

Dr. Sven J.R. Bostyn (LLB, Lic. Jur., LLM law, PhD law) is Associate Professor of Biomedical Innovation Law at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL http://cebil.dk), Faculty of Law, University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam. He is also a regular guest professor at CEIPI in Strasbourg. He is specialized in all areas of IP law, with special emphasis on patent law relating to pharmaceuticals, biotechnology, medical devices, software, Artificial Intelligence and SPC's. Sven is one of the most prominent authorities in Europe in the area of patent law. He is also specialised in regulatory exclusivities (data and market exclusivity, orphan drug designation etc.), and researches more generally also innovation incentivising mechanisms. He has written extensively on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system. Sven has also been in private practice for the last 14 years where he advised and advises clients on most aspects of patent law, competition law, licensing and regulatory exclusivities. He also acted and acts as an expert witness in court cases. He was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering. Sven is the single author of more than 60 scientific publications in the aforementioned areas, and is a regular speaker on international conferences, where he speaks on a wide variety of topics, including IP protection in life sciences, pharma patents, SPC's, regulatory exclusivities in life science, IP issues relating to software and artificial intelligence, patent protection for plants and plant variety rights systems.


Medicines for Europe

George Moore

Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation - Mylan George

Moore is Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation, at Mylan. He currently leads the IP team at Mylan for Europe, Australia and Asia, and also the IP Litigation function for all ROW matters. He is a qualified solicitor (England & Wales) with a masters' degree in chemistry. He has over 11 years in-house pharmaceutical experience, having worked at Apotex in Canada and Sandoz in Germany. He previously worked in private practice in the UK, training and qualifying at Bristows, before then working at Allen & Overy.


Medicines for Europe

Sergio Napolitano

Legal and External Relations Director – Medicines for Europe

Sergio Napolitano is Legal and External Relations Director at Medicines for Europe. He has been recently nominated in a list of the 50 most influential people worldwide in IP law, policy and business. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on "The Role of the Congress in Shaping the US Trade Policy". He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).


Medicines for Europe

Agnieszka Deeg-Tyburska

General Counsel - Polpharma Group

Agnieszka Deeg-Tyburska, works as the General Counsel of the Polpharma Group. Currently she manages the team of lawyers in Poland (3 locations), Russia, Kazakhstan, Barcelona and IP teams, on direct reporting or doted line basis. She is also Vice-Chairman of Legal Affairs Committee of Medicines for Europe.
Before that she was a director of the Legal Department of nc+, a Polish premium pay television, where she managed the team of 14 lawyers, half coming from Canal + Cyfrowy S.A. and half from ITI Neovision S.A. In her so far career while with international law firms such as Weil, Dentons and CMS, she handled a number of large and sophisticated transactions, with a particular emphasis on the product acquisitions, investment transactions of venture capital funds, representation of international financial institutions on the acquisitions of Polish bans and leasing companies, as well as in MBO and LBO structures. She represented a number of financial institutions and borrowers in the lending, debt securities issuance programs, and finance lease transactions.


Medicines for Europe

Tomos Shillingford

Associate General Counsel - InsudPharma

Tom is Associate General Counsel IP at Insud Pharma, a diversified biopharmaceutical business based in Madrid, Spain. Tom's previous position was Director IP Litigation at Allergan, which at that time incorporated the Actavis Group of companies. Tom is a dual qualified lawyer (England and Wales, Australia) whom previously worked in private practice in London with Bird & Bird and in Melbourne with Herbert Smith Freehills. Tom has been working in the pharmaceutical industry for over 9 years and has a wealth of experience in patent litigation across the globe. He advises on a range of IP and regulatory issues as well as providing contractual and M&A support. Tom has managed many prominent patent actions, including Actavis v Sanofi (Irbesartan HCT), Actavis v Boehringer Ingleheim (Telmisartan HCT), Actavis v Warner Lambert (Pregabalin) and Actavis v Eli Lilly (Pemetrexed).


Medicines for Europe

Ingrid Sollerer

General Counsel - Sandoz

Dr. Ingrid Sollerer is Global Head Legal and General Counsel at Sandoz. She joined Sandoz GmbH, Austria in April 1998 and moved on to Novartis International AG in Basel, Switzerland where she held the position of a Senior Corporate Counsel , Mergers & Acquisitions and Competition Law from 2001 to 2007. Since 2008 she was heading the Legal Departments for Western Europe, Middle East/Africa, the global Business Units Oncology Injectables and Anti-Infectives and holding the position of the Global Head Legal Biopharmaceuticals and Deputy General Counsel at Sandoz. In 2016 she joined Novartis Oncology as Global Head Legal Transactions and Cell&Gene in East Hanover,USA before rejoining Sandoz in 2019 in her current role. Ingrid holds a degree of law from the University of Innsbruck, a Diploma of international law at the University of Seville/Spain and obtained a doctorate in law in 2001 at the University of Innsbruck.


Medicines for Europe

Bibianne Bon

General Counsel Europe - Teva (inv)

Biography soon available.


Medicines for Europe

Falk Nuernberger

General Counsel Europe - Mylan

Biography soon available.


Medicines for Europe

Matthew Royle

Partner - Taylor Wessing

Matthew specialises in patent litigation, opinion work, SPCs and regulatory advice. He has particular experience of acting for clients in the pharmaceutical and life sciences industry sectors.
Matthew acted in two Supreme Court cases in 2018/19. Mylan v Warner-Lambert (pregabalin) considered the standard of plausible disclosure required to support a second medical use invention and the infringement of second medical use patents by skinny label products. Actavis v Eli Lilly (tadalafil) considered obviousness in the context of a particular dose of tadalafil which was unexpected but had been identified during "routine" clinical trials.
Matthew has acted on litigation relating to biosimilar launches. He acted in Pfizer v Roche in relation to an Arrow declaration on bevacizumab. Hospira v The Kennedy Institute of Rheumatology (infliximab) settled during trial and Inflectra, the first biosimilar monoclonal antibody, was launched in 2014/15. Matthew has also acted on two trials and appeals relating to trastuzumab (both Hospira v Genentech).


Medicines for Europe

Benjamin May

Partner - ARAMIS Societe d'Avocats

One of the founders of Aramis law firm in Paris, Benjamin May was admitted to practice law in 2000. Benjamin specializes in international patent litigation with a focus on pharmaceuticals and biotech. He is a true litigator and at his best in technically complex proceedings, in particular in the context of cross-border litigation. Benjamin is praised by his clients for his litigation skills and understanding of complex technology. A regular speaker in various IP & life sciences forums, Benjamin is the author of several publications on patent law, e.g. in 2019 "patent litigation in France", "Second medical use patents: where do we stand?", "preliminary injunction in the pharma sector". Aramis law firm focuses on patent and SPCs expiry strategies, IP litigation & trade secrets, regulatory matters, distribution and licensing agreements, marketing matters and anti-trust. Aramis acts for pharma companies, medical devices manufacturers as well as several cosmetics and biotech companies. Aramis was recorded in 2018 as the highest turnover increase amongst business law firms in Paris. Contact: may@aramis-law.com


Medicines for Europe

Christoph de Coster

Attorney-at-Law - Taylor Wessing

Biography soon available.


Medicines for Europe

Harald Mische

EDG Competition - European Commission

Harald Mische is an official at the European Commission's Directorate General for Competition, where he currently forms part of the team in charge with antitrust enforcement in the pharma and health services sectors in Directorate E. He joined DG Competition in 2002, first working in the Cartel Unit and then in the Pharmaceuticals, chemicals and basic industries Unit (moving to the newly created Pharma Sector Inquiry Task Force in 2008, which is now as unit responsible for the health sector as part of Directorate E). Prior to joining the Commission, and after qualifying as a lawyer in Germany, Mr. Mische practiced EC and German competition law in the Brussels office of a leading American law firm. Before that, he worked as an intern in DG Competition's Merger Task Force. Mr. Mische obtained a Ph.D. in EC merger control from the Eberhard-Karls-University of Tübingen. He is a regular speaker on antitrust issues, has written various articles on EC competition law and authored "Nicht-wettbewerbliche Faktoren in der Europäischen Fusionskontrolle – Wettbewerbspolitik zwischen Schutzpolitik und Gestaltung" ("Non-competition issues in European merger control"), Wirtschaftsrecht und Wirtschaftspolitik Bd. 175, Nomos, Baden-Baden, 2002.


Medicines for Europe

Brian Malkin

Counsel - Arent Fox LLP

Brian is an attorney in Arent Fox's FDA, Intellectual Property, and Health Care groups. Brian has more than 25 years of food and drug law practice and over 14 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian's regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian's intellectual property experience includes both patent prosecution and litigation. Brian began his legal career at the FDA, where he worked for more than nine years. Following several years in an FDA law firm, Brian went back to school and obtained a degree in biochemistry to address an unmet need to combine FDA with intellectual property law. Prior to Arent Fox, Brian practiced at an intellectual property law firm and led an FDA Group at an international law firm. Brian is an adjunct professor at Yeshiva University for a class in regulatory and intellectual property for its Biotechnology Management and Entrepreneurship masters program and a guest lecturer at Georgetown Law School for several classes in its Health Law LLM. Brian also is active in several state bar associations: New York State Bar Association: Chair, Food, Drug and Cosmetic Law Section and Co-Chair, Committee on Cannabis Law (founder), and DC Bar, Co-Chair Intellectual Property Community.


Medicines for Europe

Stevens & Bolton LLP

Biography soon available.


Medicines for Europe

Alica Daly

World Intellectual Property Organisation (WIPO)

Biography soon available.


Medicines for Europe

Jennifer Sunderland

Senior Patent Litigation Counsel - Mylan

Biography soon available.


Medicines for Europe

Jurgen Figys

Counsel - Crowell & Moring

Biography soon available.


Medicines for Europe

Floris ten Have

Lawyer - Stibbe

With his expertise in all areas of EU and Dutch competition law, Floris advises multinational companies across many industries. He has extensive experience in the pharmaceutical sector and having advised on numerous high-profile transactions, as well as behavioral matters (e.g. related to life cycle management issues). He is well connected to key regulators in the pharmaceutical space.


Medicines for Europe

Rainer Becker

Head of Unit, DG Competition - European Commission

Biography soon available.


Medicines for Europe

Raphaël De Coninck

Vice President - Charles River Associates

Biography soon available.


Medicines for Europe

Kristin Cooklin

Head of Patents - Zentiva Group

Kristin Cooklin is the Global Head of Patents at Zentiva in Prague. Kristin and her team are responsible for supporting and advising clients with respect to all patent issues at all product stages- including development, in-licensing, litigation and launch. In 2014 she joined Novartis where she held several different roles in its Sandoz Division in Munich, Germany, most recently as the Global Head of IP Litigation ex-US. In 2018 Kristin left Novartis to join the Zentiva and lead and develop the patent team during its transformation after divestment from Sanofi. Prior to going in-house at Novartis Kristin spent over a decade in Washington DC working in AmLaw 100 law firms as a patent litigator focusing primarily on pharmaceutical and life sciences litigation. She participated in all stages of cases, from initial strategy through trial and appeal.Kristin is a US attorney at law and patent attorney. She has handled counseling, litigation and launches of pharmaceutical products across the world with a focus on the US and Europe and was responsible for the successful IP strategy and launch of several of the first biosimilar products launched around the world.


Medicines for Europe

Pinsent Masons (TBC)

Biography soon available.


Medicines for Europe

European Patent Office (TBC)

Biography soon available.


Medicines for Europe

Amaryllis Verhoeven

Head of IP Unit, DG Grow - European Commission (inv)

Biography soon available.


Medicines for Europe

Toni Santamaria

Head of IP Europe - Accord

Biography soon available.


Medicines for Europe

Corinna Sundermann

Senior Vice President Intellectual Property - Fresenius Kabi

Corinna Sundermann is heading the IP department of the Pharma Division at Fresenius Kabi. She joined Fresenius Kabi in 2008 as a Manager and built the IP department from 1 to 30 FTE since then. She is Senior Vice President since 2012. Focus is on generics, branded products, clinical nutrition and medical devices. Characteristic for the department is, to a certain extent, internal handling of litigation. Before joining Fresenius Kabi, she worked 10 years for an originator company, 5 years as a Head of Combinatorial Chemistry, 5 years in the IP department and is European Patent Attorney since 2006. She holds a Dr. rer. nat. from the University of Jena and a diploma in chemistry from the University of Frankfurt.


Medicines for Europe

Imre Gonda

Head of IP Department - Chemical Works - Gedeon Richter Plc.

Imre Gonda has been practicing national and international IP law for more than 17 years. Currently he is the head of IP Department one of the largest pharmaceutical company in the Central European region which is very active in both areas, research of originating pharmaceuticals and generic product development. Before he joined Gedeon Richter Plc., he filled different positions in the Hungarian Intellectual Property Office, for 10 years he was the deputy-head of Trademark, Model and Design Department. He was responsible for managing and supervising the operation of national and international trademark, geographical indication and design sectors. He was involved in norm setting procedures including the preparation of amendments of laws and the creation of new international legal instruments. He participates in different international forums on a regular basis at WIPO and EU institutions, he was the elected vice-chair for eight cycles of the WIPO Standing Committee on the laws of Trademarks, Designs and Geographical Indications which forum was chaired by him for two years. He was participating in different forums of EUIPO (e.g. Management Board and Budget Committee; Liaison Meeting) in his national capacity for a considerable time period. He is qualified as a lawyer in Pázmány Péter Catholic University (Budapest) and did post graduate studies in European Law (LLM). He has written and edited a number of publications and books.


Medicines for Europe

Michael Herschdorfer

Patent Counsel - Synthon

Biography soon available.


Medicines for Europe

David Rose

Partner - Mishcon de Reya LLP

David is a highly experienced litigator and one of only a small number of IP lawyers in the UK who have taken both patent and trade mark cases to the Court of Justice of the European Union.
David advises on patent infringement, validity and ownership disputes, the scope of protection of SPCs, and disputes over standard essential patents (SEPs) including their licensing on FRAND terms (principally for implementers). He also has considerable experience advising on "clearing the way" strategies in relation to pharmaceutical patents. Recent representations include acting for Lupin in its successful application to revoke Gilead's SPC for the HIV treatment Truvada® following hearings before the Grand Chamber of the Court of Justice of the EU and the Court of Appeal in London. Additional high profile patent actions include: HTC v Gemalto; Napp v Sandoz; ratiopharm v Alza; Arrow Generics v Merck; Cairnstores v Astra Zeneca; and Servier v Lupin.
David is one of only four UK IP lawyers listed in the Legal 500 "Hall of Fame", is ranked as a leading individual in Chambers (IP, life sciences and patent litigation), IAM Patent 1000 (patents and life sciences), Who's Who Legal (patents, life sciences and trade marks) and is recognised as one of World Trademark Review's "Global Leaders". Recent commentary from the directories includes: "outstanding experience in this arena makes him a force of nature in the courtroom" (IAM Patent 100) and "has impeccable judgement on strategic matters" (Chambers).


Medicines for Europe

Roberto Romandini

Board of Appeal - EPO (inv)

Roberto Romandini obtained his law degree from the University of Pisa and his LL.M. degree from the University of Munich, where he specialized in patent law. He completed his Ph.D. thesis on the patentability of human stem cells at the Max Planck Institute for Intellectual Property and Competition Law in Munich before practicing IP law at a leading IP law firm in Milan for 5 years. Since 2013 he has been a Senior Research Fellow at the Max Planck Institute for Innovation and Competition in Munich. His areas of interest are European and international patent law, biotechnological inventions, SPCs and regulatory exclusivities, plant variety rights and trade secrets. From November 2016 to May 2018 he led and coordinated the MPI Study on SPCs for the European Commission.


Medicines for Europe

Karin Pramberger

Intellectual Property Director - Polpharma Group

As the Intellectual Property Director of the Polpharma Group Karin is responsible for all global patent and trade mark related activities, including among others litigation, filings, prosecution, FTO, selection of new products, and launch strategies. Prior to joining the Polpharma Group, Karin worked in various positions in the patent departments of different pharma companies. She started her carreer in a patent law firm in Vienna, Austria, where she became European and Austrian patent and trade mark attorney. She studied Biotechnology in Vienna, Austria, and at the Ecole Nationale Supérieure de Chemie de Paris, France. In addition, she graduated with an LLB from the University of London. Since 2005 she is a tutor at CEIPI, University of Strasbourg, for the pre-exam and the C-part of the European Qualifying Exam, and since 2006 she is an active member of the Legal Affairs Committee of Medicines for Europe.


Medicines for Europe

Christoph Stoller

Senior Vice President - Teva and President - Medicines for Europe

Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe. In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).