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In brief

2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialisation, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer.

“EU reforms in the pharmaceutical sector – a pivotal year of change ahead  ” provides an analysis of the major reforms lying ahead under the EU Pharmaceutical Strategy and IP Action Plan. These include the proposed scaling back and conditionality of regulatory exclusivities granted to new medicines, whereby the period of standard data protection would be reduced from eight years to six unless the product meets an unmet medical need or is marketed across the EU within two years of receiving authorization (both representing restrictively high thresholds). Similarly, for orphan drugs, the fixed 10-year market exclusivity period may be replaced with a variable-duration exclusivity period calculated based on the characteristics of the medicines.

We also address the Commission’s harmonisation efforts regarding compulsory licensing and supplementary protection regimes. Importantly, these changes are further discussed against the broader context of increased scrutiny from competition authorities, as seen by the recent wave of investigations into alleged abuses of the patent system by pharmaceutical companies.

Our article showcases the importance of assembling multidisciplinary teams, drawing from IP, regulatory, commercial, and competition expertise to best prepare for, and to mitigate risks from, a new political and legal environment. We hope you find it helpful in highlighting some of the key headlines of the far reaching changes approaching.


Fiona Carlin is the head of the EU Competition & Regulatory Affairs practice in Brussels. She is the former Chief Executive of much of Baker McKenzie’s EMEA Region and the former Chair of the Firm’s Global Competition and Antitrust Law Practice comprising more than 320 lawyers in over 40 countries. She has remained an active practitioner throughout her various leadership roles with a particular focus on regulated industries.
Fiona is also the Chair of the European Advisory Board of Catalyst, a leading non-profit organisation dedicated to expanding opportunities for women and business. She was a founding and long-standing member of Baker McKenzie's Global Diversity & Inclusion Committee and is dedicated to creating an inclusive high performance culture where the talent of our lawyers and business professionals can flourish.
Fiona has been listed in "The International Who’s Who of Competition Lawyers" since 2009, and is among Global Competition Review's Top 100 Women in Antitrust. Chambers quotes clients as citing her "legal and pragmatic advice" and describing her as "globally minded".


Hiroshi Sheraton's practice covers all aspects of intellectual property law with a particular emphasis on contentious patent and trade mark matters and life sciences. Much of his work is cross-border in nature. He regularly co-ordinates pan-European and global IP litigation and advises clients on international IP strategies for patent litigation and brand protection. He represents clients in the UKIPO, EPO, OHIM, the English Courts and the CJEU. He has experience of IP matters across Europe and has litigated IP cases in Germany, France, Spain, Italy, the Netherlands, Belgium, Austria, Ireland, Northern Ireland and Luxembourg, the USA and Asia Pacific. Although he has a first degree in biochemistry and molecular biology, he covers all areas of technology from pharmaceuticals/biotech products and agrochemicals to electronics and software.


Tanvi is a Senior Associate and Solicitor-Advocate in Baker McKenzie's London Intellectual Property team, having joined the firm in August 2016. She has particular expertise in patents and is recognised by the Legal 500 as a key lawyer in the UK for Patents (Contentious and Non-Contentious). During her career Tanvi has also gained in-house experience having been seconded for a year to the in-house R&D legal team of a global pharmaceutical company, focused on providing legal support for clinical trials across Europe, and for three months (on a pro bono basis) to Cancer Research UK's legal team. Prior to becoming a solicitor Tanvi obtained an MSc degree in Chemistry from Imperial College London and carried out research in the field of biophysical chemistry at the Ludwig-Maximilians Universität, Munich (Germany).


Shira Sasson is an Associate in Baker McKenzie, London office.

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