Dr. Christian B.Fulda

Partner

München + 49.89.20.60.42.200

Connect

Share

Dr. Christian Fulda berät Arzneimittel- und Medizinproduktehersteller und ist sowohl für große europäische, amerikanische und japanische Multinationals als auch für Biotechnologie-Unternehmen tätig. Er verfügt über breite Erfahrung in den verschiedenen Rechtsfragen, die die stark regulierte Industrie beschäftigen, angefangen von Produktentwicklung und der Sicherung von gewerblichen Schutzrechten, dem Abschluss von Entwicklungsverträgen und der Durchführung klinischer Studien, über die Beratung bei Arzneimittelzulassungen und beim Abschluss von Herstellungs-, Vertriebs- und sonstigen Verträgen, bis hin zur Entwicklung und Implementation von Digital Health/eHealth und Telehealth Anwendungen, einschließlich der damit verbundenen Datenschutzfragen. Dr. Fulda unterstützt Mandanten im täglichen operativen Geschäft, einschließlich Heilmittelwerberecht, Fragen der Kostenerstattung und Kooperation mit Leistungserbringern, sowie Produkthaftungsrecht. Er führt regelmäßig internationale Projekte für Life Sciences-Mandanten durch. Er unterstützt überdies Mandanten bei M&A-Transaktionen.

Herr Dr. Fulda hat Mandanten in zahlreichen Rechtsstreitigkeiten vertreten, sowohl in Verfügungs- und Hauptsacheverfahren vor staatlichen Gerichten, als auch in Schiedsverfahren.

Herr Dr. Fulda ist Fellow des International Institute for Law and Medicine und Mitglied der BIO Deutschland (Arbeitsgruppen Regulatorische Angelegenheiten und Gesundheitspolitik), LES Deutschland (Arbeitskreis Life Sciences), Bundesverband der Arzneimittelhersteller (BAH), Mittel-Europäische Gesellschaft für Regulatory Affairs (MEGRA), Deutsche Institution für Schiedsgerichtsbarkeit (DIS), sowie Food and Drug Law Institute (FDLI).

Erfahrung

  • Valmet acquires process gas chromatography business of Siemens AGJones Day advised Valmet Oyj in the €102.5 million acquisition of the process gas chromatography business of Siemens AG.
  • Monolithic Power Systems acquires Axign B.V.Jones Day represented Monolithic Power Systems, Inc., a leading company in high-performance power solutions, in the acquisition of Axign B.V., a Netherlands-based fabless semiconductor startup that specializes in programmable multicore DSP (digital signal processors) that demonstrate near-zero distortion signals with significantly reduced power consumption for automotive and consumer audio systems.
  • Elaia Partners leads €3.6 million seed financing of hema.toJones Day advised Elaia Partners in connection with the €3.6 million seed financing of hema.to, a Munich-based medtech startup developing an artificial intelligence software dedicated to blood cancer diagnostic.
  • LyondellBasell invests in APK, a German plastics recycling companyJones Day represented LyondellBasell as the lead investor in the latest financing round of APK AG, a German plastics recycling company.
  • Rejuvenate acquires entire business operations of cell transplants manufacturer co.don AktiengesellschaftJones Day advised Rejuvenate GmbH, a subsidiary of ReLive Biotechnologies, in connection with the acquisition of the business operations of co.don Aktiengesellschaft ("CO.DON") (including all shares in its Dutch, UK and Swiss subsidiaries).
  • Eurobio Scientific acquires GenDxJones Day advised Eurobio Scientific SA in the acquisition and financing of the Dutch company Genome Diagnostics BV (GenDx) from its founder and its shareholders for €135 million (net of adjusted cash).
  • LyondellBasell forms joint venture to build plastic waste sorting and recycling facilityJones Day advised LyondellBasell Industries Holdings B.V. in the formation of a joint venture with 23 Oaks Investments GmbH to create Source One Plastics, a joint venture that will build an energy efficient, advanced plastic waste sorting and recycling facility in Germany.
  • EDAP completes follow-on public offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on public offering of 3,066,667 American Depositary Shares (ADSs) on the Nasdaq Global Market.
  • ArchiMed acquires PlasmidFactoryJones Day advised ArchiMed, a leading trans-atlantic private equity healthcare specialist, on its acquisition of PlasmidFactory, a globally renowned high-quality producer of plasmid DNA with strong research capabilities, from IP due diligence to structuring of acquisition and rollover re-investment.
  • iSTAR Medical enters into strategic alliance with AbbVieJones Day advised iSTAR Medical SA in its strategic alliance with AbbVie (NYSE: ABBV).
  • NGK SPARK PLUG announces strategic partnership with neoplas med GmbHJones Day advised NGK SPARK PLUG in its strategic partnership with neoplas med GmbH, a German medical company that specializes in innovative cold plasma jet technology.
  • Idenix enforces patent against Gilead in Germany over sofosbuvirJones Day represented Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in patent litigation against Gilead in Landgericht Düsseldorf in Germany over sofosbuvir, the active ingredient in Sovaldi® and Harvoni®, Gilead's blockbuster drugs for treating Hepatitis C.
  • Idenix defends nucleoside analogue patent in EPO opposition against five opponentsJones Day represented Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in opposition proceedings before the EPO related to Idenix patent covering nucleoside analogs and prodrugs.
  • ArchiMed acquires Cube Biotech GmbHJones Day advised ArchiMed, a leading Trans-Atlantic private equity healthcare specialist, on its acquisition of Cube Biotech GmbH, a leading provider of expression, purification, and crystallization services and products for membrane proteins.
  • Cardinal Health sells its Cordis business to Hellman & Friedman for approximately $1 billionJones Day advised Cardinal Health in connection with the divestiture of its Cordis business to Hellman & Friedman for approximately $1 billion.
  • EMERAM Capital Partners sells portfolio company MEONA to Trill ImpactJones Day represented EMERAM Capital Partners GmbH, one of the leading investment companies for medium-sized companies in the German-speaking region, in the sale of its portfolio company MEONA, an innovation leader for clinical software, to the private equity firm, Trill Impact.
  • STERIS acquires Cantel Medical for $3.6 billionJones Day advised STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • EDAP completes follow-on offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on offering of 4,150,000 American Depositary Shares (ADSs) on the Nasdaq Global Market.
  • Wellington Partners, MIG GmbH & Co. Fonds 16, and Salvia GmbH invest €15 million in growth financing of Creative BalloonsJones Day represented Wellington Partners Life Sciences V, a leading European Venture Capital firm investing in early- and growth-stage Life Science companies, together with MIG GmbH & Co. Fonds 16 and Salvia GmbH, in connection with their €15 million growth investment in Creative Balloons GmbH, a specialist in researching and developing ultra-thin polyurethane (PUR) balloons for medical device applications, namely catheter manufacturing.
  • Astellas returns rights to Eligard® in Europe, Middle East, CIS, and Asia to TolmarJones Day represented Astellas Pharma Europe Ltd. in connection with a series of transactions, including the sale of related assets, in which Astellas returned its in-licensing rights to Eligard® (leuprorelin acetate for injectable suspension), a treatment for advanced prostate cancer, sold by Astellas in Europe, the Middle East, the Commonwealth of Independent States (CIS) and Asia, to Tolmar International Limited.
    •

    August 2024 Alert

    Epitope Claims Live On at the European Patent Office

    July 2024 Commentary

    EU Parliament Adopts SPC Reform Proposals: Clarifying the Protection Scope for Biologics

    March 2024 Alert

    FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

    March 2024 Alert

    Finish in Eight Months: The EPO Sets Timeline for New Accelerated Opposition Practice

    March 2024 Alert

    Unified Patent Court Publishes Its First Case Load Statistics

    February 2024 Alert

    Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

    November 2023 Commentary

    The EPO Adopts a Patentee-Friendly Approach on Assessing Formal Priority Entitlement

    February 2023 Commentary

    EU Commission Proposes Extended Deadlines to Comply with the Medical Device Regulation and In Vitro Diagnostic Regulation

    January 2023 Commentary

    EU Anti-Counterfeit Regulation Does Not per se Allow Repackaging of Parallel Imported or Parallel Traded Pharmaceuticals

    January 2023 White Paper

    Key Lessons from UK National Security and Investment Regime's First Year
    Weitere Veröffentlichungen

    • November 20, 2014
      December 4, 2014
      EMA Disclosure of Marketing Authorization Data
    • November 13/14, 2014
      Transparency: The Inevitable Emergence of an Epic Issue, panelist, Food & Drug Law Institute European Conference
    • October 6, 2014
      BioM-Forum: IPO in the US - a reality
    • September 24, 2014
      How to Align your Regulatory Pathway for Marketing Authorisation of your Drug with the CE marking of a Companion Diagnostic and How to Secure a Successful Companion Diagnostic Strategy, C5 EU Pharmaceutical Regulatory and Competition Conference
    • July 7, 2014
      How pharmaceutical companies can prepare for release of confidential data by EMA and national authorities, Infotag of the German Pharmaceutical Industry Association (BPI) on the EMA Disclosure Policies
    • June 6, 2014
      Litigation Strategies for Life Sciences Patents under the Unified Patent Court, panelist, Union-IP Congress, Workshop Life Sciences
    • May 19, 2014
      Developing IIS Contracts & Ensuring Corporate Investment Protection, 4th Annual EU Investigator Initiated Studies Conference, Q1 Productions
    • May 6, 2014
      The Continuing Expansion of Health Care Enforcement by U.S. and International Authorities: Key Developments and Implications for the Future
    • April 10. 2014
      Supplementary Protection Certificates (SPC), Recent Case Law of the Court of Justice of the European Union, Opportunities for patent term extensions for the pharmaceutical Industry, German Pharmaceutical Industry Association (BPI), Patent Day
    • March 20, 2014
      Jeopardizing Research Investments through Publication. Publication of commercially confidential information by regulatory authorities - advantage to competitors and risk for patent applications? German Pharmaceutical Industry Association (BPI), CEO Day
    • November 28, 2013
      Predictability and Manageability of the SPC System. An Industry Perspective. German Patent and Trademark Office, SPC Roundtable
    • July 15, 2013
      Europe's New Unitary Patent and Unfied Patent Court: Supplementary Protection Certificates Under the New System
    • June 25, 2013
      Product Liability for Medical Devices, Forum MedTech Pharma, Market Access for Medical Devices Workshop
    • April 12, 2013
      Companion Diagnostics - Regulatory and Reimbursement Aspects, Licensing Executives Society (LES) Meeting
    • January 28, 2013
      The Patent-Regulatory Interface in the EU, EU Pharmaceutical Regulatory Law Boot Camp
    • November 29, 2012
      Utilising Supplementary Protection Certificates (SPC) to Extend Your Patent Lifecycle, Biosimilars Forum 2012
    • October 18, 2012
      Panel Discussion on Personalized Medicine, Symposium "Biotec+ICT=New Business"
    • September 24, 2012
      Managed Access Programs: The Regulatory Environment in the EU & RoW, Managed Access Programs Workshop at the Outsourcing in Clinical Trials Conference
    • September 19, 2012
      Medical Devices: Product Safety and Product Liability in the US, Forum MedTech Pharma, Workshop Market Access USA
    • September 13, 2012
      Healthcare Reforms in Key European Markets and Impact on Diagnostics, 3rd EU Diagnostic Reimbursement & Market Access Conference
    • July 19, 2012
      Pricing and Reimbursement Considerations for Access Programs in Europe, 5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs
    • May 4, 2012
      Biosimilars - The European Regulatory Pathway, Licensing Executives Society (LES) Meeting
    • February 7, 2012
      Developing Drug & Diagnostic Combination Products in the EU, IVD Regulations and Performance Evaluations Conference
    • September 6, 2011
      Impact of Pharmaceutical Reimbursement Changes on Diagnostics, European Diagnostic Reimbursement & Market Access Conference
    • August 4, 2011
      EU Biotech and Pharma Regulations: The IP Angle, Jones Day Client Seminar on Global Patent Trends in Life Sciences
    • June 21, 2011
      European Perspectives on Nanotechnology: Seizing Opportunities, Protecting Technology, and Avoiding Risks
    • 2011
      Third party changes changes to IVD. The One Touch Ultra Case and Beyond, European Diagnostic Performance Evaluation and Regulatory Conference
    • 2010
      Nanotechnologies - Opportunities and Risks: The regulatory framework for nanotechnology in Europe, JDialog Jones Day Client Seminar
    • 2009
      Market Access for Pharmaceuticals - Impact on License Agreements, Licensing Executives Society (LES) Meeting
    • 2009
      Liberalisation of Pharmaceutical Marketing, BPI Bayern Presentation
    • 2009
      Liberalisation of Pharmaceutical Marketing, Jones Day Client Seminar
    • 2008 / 2009
      New Requirements for the Distribution of Medical Devices, Seminars for Clinical Professionals
    • 2008
      European Pharmaceutical Marketing, Jones Day Client Seminar
    • 2008
      European Pharmaceutical Marketing, BPI Nordrhein-Westfalia Seminar
    • 2007
      Regulatory Issues in Biotech Transactions, Bio-M

    Bitte beachten Sie vor dem Versenden:

    Die Informationen auf unserer Website sind für den allgemeinen Gebrauch und stellen keine Rechtsberatung dar. Der Versand dieser E-Mail ist nicht dazu bestimmt, ein Mandatsverhältnis zu begründen, und der Erhalt dieser E-Mail stellt kein Mandatsverhältnis dar. Alles, was Sie an jemanden in unserer Kanzlei senden, ist nicht vertraulich oder privilegiert, es sei denn, wir haben zugestimmt, Sie zu vertreten. Wenn Sie diese E-Mail versenden, bestätigen Sie, dass Sie diesen Hinweis gelesen und verstanden haben.