Inside Life Sciences

Schrems II – sending data to the US (and other non-EEA countries) is now a major challenge

Businesses which are currently sending data to the US in reliance on the Privacy Shield need urgently to replace those arrangements. The big question is "with what?". The CJEU's recent decision in "Schrems II" means that the alternative route – Standard Contractual Clauses – is open to challenge too.

CJEU rejects SPCs for second medical uses

A rare decision of the Grand Chamber of 13 judges of the Court of Justice of the European Union (CJEU) has concluded that supplementary protection certificate (SPCs) should not be available for new applications of previously authorised products.

Focus on excessive pricing in the pharmaceutical sector continues in the UK and EU

Pharmaceutical pricing remains a key area of interest for competition authorities in the UK and EU.

The Caldicott Principles – are they good enough?

In the current health climate and the fight against COVID-19, access to health data is essential, but should not come at the expense of protecting patients' confidential information.

Supreme Court finds transgenic mice patents invalid for insufficiency

A patent represents a bargain between the patentee and the public - in return for a valuable 20 year monopoly right over use of the invention, the patentee discloses the invention to the world, thereby offering the ability to others to 'work the invention' after the monopoly has expired.

CBD: a point of reflection

The law and regulation in the UK of medical cannabis and the sale of cannabidiol (CBD) is complex, often contradictory and regularly developing.

Court of Appeal upholds rejection of interim injunction as damages were adequate remedy

Clinical Trials after the end of the Brexit transition period

Since 1 February 2020, the UK has withdrawn from the EU and become a 'third country'. Until the end of the transition period (31 December 2020), EU law still applies in the UK.

SPC Manufacturing Waiver in the UK

In July 2019, a new SPC manufacturing waiver took effect in the EU.

Lundbeck 'pay for delay' case: Advocate General Opinion

In her recent opinion in Case C-591/16 P, Lundbeck v Commission, Advocate General (AG) Kokott has recommended that the Court of Justice of the European Union uphold the judgment of the General Court that patent settlement agreements reached between Lundbeck and several generics manufacturers in the pharmaceutical sector constituted a restriction of competition "by object".