ADMISSION

^◼ 1994

LANGUAGES

^◼ Dutch
^◼ French
^◼ English
^◼ Italian

EDUCATION

^◼ Graduated in the negotiation course by Professor Van Poucke, 2014
^◼ IFB (MA, Pharmaceutical Industry Management, 2008- 2009)
^◼ European College of Parma (Italy) (LLM, Law, Economics and EU Politics, 1994)
^◼ Universities Namur and Leuven (Law, first and second degree 1993)
^◼ Heilig Hart Heverlee (Latin, Greek, mathematics, 1988)

PROFESSIONAL EXPERIENCE

^◼ Trainee and associate at Derks Star Busmann Hanotiau/ Cameron mc Kenna 1994- December 1998
^◼ Associate NautaDutilh January 1999-2004
^◼ Partner NautaDutilh 2004-2011
^◼ Partner Hoyng Rokh Monegier 2011- (ongoing)
^◼ Managing partner Brussels office Hoyng Rokh Monegier (2020, ongoing) and Member of international Excom Hoyng Rokh Monegier (2021, ongoing)

PROFESSIONAL AFFILIATIONS

^◼ IRDI, Member of the Editorial Board
^◼ Belgian Council for Intellectual Property (advisory council on IP to the minister of economic affairs), Member
^◼ Belgian Regulatory Affairs Society (BRAS)
^◼ AIPPI
^◼ IFB

CURRICULUM VITAE LIESBETH WEYNANTS

tel: 0032477 625274 email: [email protected]

Liesbeth's practice combines patent litigation and regulatory work with a focus on the life sciences sector.

Her work includes regulatory affairs (MA procedures, pricingreimbursement, clinical trials, compliance and advertising issues, pharmaco- and materiovigilance, supply chain management etc.), as well as advice and litigation on unfair competition, privacy and data protection laws. She also drafts agreements in all of the above fields. Liesbeth often gives compliance trainings as well as lectures on the above matters and is in frequent contact with the authorities and industry bodies.

Liesbeth has extensive experience in late life-cycle management through regulatory and patent-based actions against early generic entry. She provides pre-litigation advice and helps to develop patent portfolio strategies.

Liesbeth's clients in the life sciences sector include large research-oriented pharmaceutical, medical device and biotech companies, industry bodies and universities, foreign (UK, German, French, US essentially) law firms with advice on local law. Clients for which Liesbeth regularly provides regulatory advice include AbbVie, Biogen, Boehringer Ingelheim, BMS, Daiichi Sankyo, J&J, Lundbeck, Menarini, Merck, Novartis, Sanofi, Takeda, Teva (innovative branch) and many others.

Liesbeth also assists industrial clients such as in the automotive industry Porsche EEC racing cars and Tecnicas-Espindesa.

In addition to her extensive practical experience, Liesbeth also teaches yearly classes at VUB, ULiège, IFB, speaks at the EU Pharma Law Forum, FEB/VBO and publishes a number of articles on selected topics in her fields.

REPRESENTATIVE MATTERS

^◼ Teva (innovatve) / generics re Copaxone FoGAs (ongoing)
^◼ Sanofi v. Sandoz. Assisting Sanofi in enforcing its SPC on the combination of irbesartan and hydrochlorothiazide against generic entry, with parallel actions ongoing in various other Member States (2012 to date).
^◼ Lundbeck v. Tiefenbacher et al. Representing Lundbeck in various actions to enforce its escitalopram SPC and block the premature launch of generic products (2011 to date). As well as in various regulatory actions to invalidate generic marketing authorizations.
^◼ Several proceedings before the Belgian council of state on behalf of innovative industry against decisions by the Belgian state re marketing authorization grant and/or pricing reimbursement decisions for AbbVie, Lundbeck, Sanofi, Novartis, Merck, Medical Brands.
^◼ AstraZeneca v. Teva/Sandoz. Patent litigation against early generic entry for AstraZeneca's blockbuster "Seroquel".
^◼ Boehringer Ingelheim v. Teva. Patent litigation on Boehringer Ingelheim's blockbuster "Spiriva".
^◼ Daiichi Sankyo v. PI Pharma. Parallel import case on trade mark and

regulatory aspects of parallel import by which PI Pharma repackages generic Ranbaxy product as original Daiichi Sankyo product.

^◼ Porsche v. G. Schmitz. Patent Litigation on Porsche WEC racing cars
^◼ Tecnicas-Espindesa/YARA: trade secrets case (ongoing)

SPEAKING ENGAGEMENTS

^◼ VUB, yearly class on « Business Aspects of Biotechnology IPR »
^◼ ULiège, yearly class on IPR and other aspects relevant for pharmaceutical industry (as of 2021)
^◼ IFB, yearly class on IPR and pharmaceutical industry for high profile industry members
^◼ FEB/VBO, AIPPI speeches on trade screts
^◼ EU Pharma law forum, speaking and moderator slots (a.o. on biosimilars)
^◼ In-house trainings at clients on compliance, anti-bribery, anticorruption, data protection, intellectual property, late life-cycle management, patent and regulatory strategies

PUBLICATIONS

^◼ Regular contributions as editorial board member IRDI
^◼ Practical Law Commercialisation of Healthcare Global Guide, Belgium Q&A (2021)
^◼ Co-author of the Belgian chapter of P. JORDAN (ed.), International Advertising Law: A Practical Global Guide, Globe Law and Business, 2014.
^◼ Co-author of pharma.be's Codex Pharma Commenté Loi du 25 mars 1964 sur les médicaments – Becommentarieerde Codex Pharma Wet van 25 maart 1964 op de geneesmiddelen, KnopsPublishing, 2013.
^◼ "Off-label Use and Promotion: Risks and Potential Liability", BioScience Law Review (2011). Co-authored with Carla Schoonderbeek.
^◼ "The new EU pharmacovigilance rules: a disproportionate burden on industry?'', SCRIP Regulatory Affairs, March 2011. Co-authored with Carla Schoonderbeek.

WHAT OTHERS SAY – TOP TIER LEVELS IN LEGAL DIRECTORIES RE PATENTS, IP, REGULATORY

^◼ "Excellent" Chambers & Partners 2021
^◼ "She is very skilled, has a lot of experience, is very efficient and works very quickly." Chambers Europe 2020
^◼ "Collaborative and produces high-quality pleadings." Chambers Europe 2020
^◼ "Very reactive and knowledgeable." Chambers Europe 2020
^◼ "You can only sing the highest praises of Liesbeth. She is excellent, immensely experienced and knows the industry like the back of her hand." IAM Patent 1000 2020
^◼ "Stands out for her professionalism." Legal 500 2020
^◼ "Excellent" Chambers Europe 2019
^◼ "Exceptionally easy to work with and a real team player. She is a highly effective strategist with a deep knowledge of the Belgian court system and one of the best practitioners around." IAM Patent 1000 2019
^◼ "Highly experienced and knowledgeable" Legal 500 2019
^◼ "Enthusiastic, energetic and no-nonsense." Chambers Europe 2018
^◼ "An excellent communicator, who is a pleasure to work with but can be very tough when needed." Chambers Europe 2018

AI Terminal

Mithra Pharmaceuticals S.A.

3977_rns_2021-04-20_cbff74bd-ba0e-4fc0-8a92-cc6c44c07319.pdf