Sector

We advise companies as they engage with complex EU and international regulatory frameworks, from development to market access and beyond.

Our approach combines deep sector expertise with commercial understanding, helping clients manage legal complexity efficiently. We advise pharmaceutical and biotech clients on marketing, manufacturing and wholesale distribution authorisations, as well as marketing and advertising compliance. Our work also covers reimbursement, crisis management and corrective actions, including product recalls and regulatory investigations.

We have an active product liability defence practice. We protect our clients’ interests in all types of commercial disputes and have extensive experience in challenging government agency decisions through judicial review proceedings.

Recent Work

  • Acting for Neuraxpharm in the defence of patent infringement proceedings and bringing a counterclaim for invalidity relating to the launch of a generic MS treatment on the Irish market.

  • Advised NYSE-listed Biohaven Pharmaceuticals on the Irish IP and tax law aspects of the sale of the Biohaven group companies that own and commercialise its Nurtec and Vysera products to Pfizer for more than $11.8 billion.

  • Advising McKesson Corporation on its acquisition of the pharmaceutical distribution business, UDG Healthcare plc, an Irish FTSE 250 company, for €408 million.

  • Providing EU regulatory advice to a global pharmaceutical company relating to the application of the AI Act to drug development and clinical research activities.

  • Advising a global pharmaceutical company on its partnership with a patient support app regarding the administration of one of its medicines.

  • Advising a global pharmaceutical company on its obligations under NIS2 throughout the EU.

  • Acting for Fresenius in patent infringement proceedings regarding the launch of Amgevita® by Amgen.

  • Acting for Teva Pharmaceuticals Industries Limited in separate SPC and patent revocation proceedings before the Commercial Court.

  • Acting for and advising Arthropharm (Europe) Limited on a multi-million-euro pharmaceutical product the subject of judicial review proceedings against the Health Products Regulatory Authority.

  • Advising West Pharmaceutical Services on the procurement and fast-tracked completion of the design and construction of a substantial new pharma manufacturing facility in Dublin.

  • Acting for Novartis Pharma AG in dealing with High Court litigation against Eli Lilly and Company, Eli Lilly Nederland B.V. and Eli Lilly Kinsale Limited.

Dedicated Team

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Michaela Herron

Michaela Herron

Partner

Head of Life Sciences Regulatory, Product Liability

+353 86 607 6005 mherron@mhc.ie View Profile on MHC.ie
Jamie Gallagher

Jamie Gallagher

Partner

Regulatory, Product Liability

+353 86 068 9361 jamesgallagher@mhc.ie View Profile on MHC.ie
Julie Austin

Julie Austin

Partner

Cyber Security, Data Privacy

+353 86 137 2136 jaustin@MHC.ie View Profile on MHC.ie
Oliver FitzGerald

Oliver FitzGerald

Partner

Real Estate, Construction

+353 86 027 8838 ofitzgerald@mhc.ie View Profile on MHC.ie
Martin Kelleher

Martin Kelleher

Partner

Head of Corporate Transactional

+353 86 810 7838 mkelleher@mhc.ie View Profile on MHC.ie
Gerard Kelly SC

Gerard Kelly SC

Partner

Head of Intellectual Property, Co-Head of Dispute Resolution

+353 86 820 8066 gkelly@mhc.ie View Profile on MHC.ie
Brian McElligott

Brian McElligott

Partner

Head of Artificial Intelligence

+353 86 150 4771 brianmcelligott@mhc.ie View Profile on MHC.ie
Nicholas Metcalfe

Nicholas Metcalfe

Partner

Corporate Governance

+353 86 047 4602 nmetcalfe@mhc.ie View Profile on MHC.ie