Gareth has experience in all areas of contentious and non-contentious intellectual property law with a particular focus in the Life Sciences and Healthcare sector, including:
- counselling on multi-jurisdictional patent litigation and enforcement strategies;
- contractual disputes and High Court contract litigation;
- negotiating commercial agreements including licences, technology transfer agreements and collaboration and development agreements;
- advising on contentious medicinal regulatory matters before the English and European courts, including judicial review proceedings;
- providing strategic advice on pharmaceutical product exclusivity, product lifecycle management and associated governmental affairs matters; and
- advising on the interpretation of EU medicines law and EMA/MHRA guidance documentation.
Gareth has acted in many landmark UK IP trials concerning patent entitlement, biotechnology patent validity and infringement, SPCs (including EU Court of Justice references) and the interpretation of IP licences.
In addition, Gareth represents clients in judicial review proceedings concerning medicinal product marketing authorisations. He regularly advises life sciences companies on the judicial review of medicines agency decisions before the EU General Court and Court of Justice in Luxembourg and national Member State courts in the EU. Gareth is English and Irish qualified, and post-Brexit he will operate his regulatory practice from our Polish office.
Gareth has advised pharmaceutical and biotechnology clients on aspects of orphan exclusivity, paediatric exclusivity, Biosimilar applications, centralised procedure applications, CHMP referral procedures, interpretation of the medicines directives and associated guidance. He also provides legal and technical advice concerning CHM appeals, scientific advice meetings and CHMP referrals.
Gareth Morgan is ranked as a leading individual in patent litigation in the UK and also as life sciences regulatory practitioners in the UK.