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 8 years to 6 unless the product meets an unmet medical need or is marketed across the EU within 2 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.


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Author

Fiona Carlin is the head of the EU Competition & Regulatory Affairs practice in Brussels.

Author

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.

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Tanvi Shah is a patents specialist in our London IP team and regularly advises clients in the healthcare and life sciences sector on regulatory and IP issues, drawing on her past in-house experience and technical background.

Author

Shira Sasson can be reached at Shira.Sasson@bakermckenzie.com.