Tine Carmeliet

Tine Carmeliet

Senior Associate

Email

tine.carmeliet@aoshearman.com

Phone

+32 2 780 25 62

Offices

Brussels

V-CARD
Tine specializes in life sciences patents litigation and advises clients on regulatory issues and commercial transactions in the life science sector. Her litigation experience includes both representing clients before the Belgian and European courts and assisting clients with multi-jurisdictional proceedings.

She advices multinational companies and start-ups as well as research institutes in the pharmaceutical, biotech and medical devices sectors on a variety of complex matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, MDR and IVDR, digital health solutions, artificial intelligence, real world data and transparency regulations. She regularly assists clients with drafting and negotiating high value IP licenses, R&D collaborations, tech transfer and spin-out deals and has particular expertise with cell and gene therapy products.

In addition, Tine has extensive experience advising on agro(bio)tech and food and feed regulations (new breeding techniques and Nagoya Protocol).

She also has a sound life sciences policy understanding thanks to her secondment to the European Federation of Pharmaceutical Industries Associations legal team, where she focused on regulatory and IP policy

Expertise

Industries

Experience

Representative matters

  • A global pharmaceutical and healthcare company on a wide range of regulatory matters, both at EU and Belgian level. This includes advising on our client’s yearly reporting obligations and the scope of their reimbursement agreement with the Belgian government; on the status of orphan medicines; on parallel import issues.
  • A leading pharmaceutical company on the complex European regulatory system on early access programs and urgent medical need programs (including whether or not patients for which al treatment options have failed would qualify for off label use of certain medicines).
  • A Belgian pharmaceutical group on the regulatory approval pathway to bring certain pharmaceuticals to market, as well as on the regulatory requirements in Belgium and the EU for unlicensed medicines.

Pro bono

  • Tine supported the draft of the Partnership Agreement between the Saint Baldrick’s Foundation and the European Science Foundation (ESF) on the creation of an innovation award (the so-called FIGHT KIDS CANCER & St Baldrick’s Foundation Arceci Innovation Award). This award is funding opportunities to support the career of mid-career scientists working on curing kids cancers. 

Published Work

  • CARMELIET, T., D’JOOS, E., et al., (2022) ""Paediatric Medicines"", LexisNexis, Practice Note
  • CARMELIET, T., VAN ESPEN, L., (2021) ""AstraZeneca ordered to deliver vaccines to the EU"" (ed. Lawtext Publishing Limited), Bio-Science Law Review, Volume 18, Issue 2, Page 57 
  • VAN DYCK, P., CARMELIET, T., (2019) ""It’s time to amend the Enforcement Directive to ensure all EU Member States provide for declarations of non-infringement of EUTMs and Community designs."" (ed. STONE, D. & POTTS, B.), Journal of Intellectual Property Law & Practice, Volume 14, Issue 10, Pages 754–760
  • CARMELIET, (2018) ""The Gx contribution to multilateral trade governance: balancing efficiency and inclusiveness"", Hart Publishing
  • GLAS, G., T. CARMELIET, (2017) ""The European Court of Justice to rule on milestone in European GMO legislation: the legal classification of mutagenesis in plant breeding"", the Bioscience Law Review, Volume 16, Issue 2, Page 91
  • CARMELIET, T., VAN KEYMEULEN, E., (2017) """"Sunshine"" in Belgium: new statutory transparency requirements for life sciences companies"", European Pharmaceutical Law Review, Pages 26-31
  • CARMELIET, T., KOSMIDOU, G., (2015) ""Enforcing Europe’s Foundational Values. Central and Eastern Europe: A Case in Point"", European Judicial Systems as a Challenge for Democracy, Intersentia, Antwerp
  • T. CARMELIET, (2013-2014) ""A Critical Analysis of the Procedural Fairness of the Leniency Instrument Finding the Right Balance Between Efficiency and Justice in EU Competition Law"", Jura Falconis, Page 2

Speaking Engagements

  • Guest Speaker, EU Pharmaceutical Law Forum, 2023
  • Guest Speaker, Life Sciences Strategy Summit on IP & Exclusivity, 2023
  • Guest Speaker, European Pharma Law Academy, 2019

Leadership Positions And Professional Affiliations

  • Co-Founder, ChIPs Belgium
  • Member, ChIPs (worldwide)
  • Part-time academic research assistant, Institute for European law, KU Leuven

Awards

  • Trailblazer in most influential women in IP -World Intellectual Property Review, 2020
  • “Rising star” Managing IP – IP Stars 2023
  • Shortlisted as "Intellectual Property Rising Star" LMG EMEA Life Sciences Awards 2023  

Qualifications

Academic

LLM, University of Leuven, 2013
Master of Arts, The Johns Hopkins University Paul H. Nitze School of Advanced International Studies, 2015

Languages

Dutch, English, French
Disclaimer
A&O Shearman was formed on May 1, 2024 by the combination of Shearman & Sterling LLP and Allen & Overy LLP and their respective affiliates (the legacy firms). Any matters referred to above may include matters undertaken by one or more of the legacy firms rather than A&O Shearman.