How can genetic data collected by in vitro diagnostics providers be legitimately processed under GDPR?

In vitro diagnostics offerings necessarily involve the collection of vast amounts of sensitive health data. This information is an invaluable resource for better understanding the genomic basis of disease, and making improvements to diagnostic offerings. It is imperative that stakeholders get it right when it comes to processing individuals' data and maintaining public trust, so that they can continue to exploit these rich datasets. Over the coming weeks HSF will publish a series of posts exploring issues that arise when processing this kind of data in accordance with the GDPR. Read more

NHS fails in appeal on ‘unlawful means tort’ in claim for damages allegedly caused by Servier’s actions in delaying generic market entry

There seems to be growing trend whereby the UK NHS is taking proactive steps to seek damages from pharmaceutical originators based on allegations that the originators wrongly prevented generic products from entering the market as early as they otherwise would have done.  In the latest example, in circumstances where it seems the NHS did not obtain an undertaking from Servier to pay damages to the NHS for an interim injunction obtained in 2006, the NHS has taken a claim for £220 million damages from Servicer, based on the tort of causing loss by unlawful means, all the way the UK Supreme Court. Read more

Federal Court overturns ‘absurd’ Patent Office ruling on patent term extensions for pharmaceutical substances

The Federal Court has rejected the Australian Patent Office’s historical approach to patent term extension (PTE) applications, upholding a challenge brought by two major pharmaceutical companies against an earlier decision of Australia’s Commissioner of Patents. KEY TAKEAWAYS Justice Beach has confirmed that PTE applications must be filed within six months of the first inclusion on … Read more

UK IPO Consultation on the UK’s future exhaustion of IP rights regime

The UK Intellectual Property Office has published a consultation on the UK's exhaustion of intellectual property rights regime and what changes might be appropriate post-Brexit, including how such changes should be implemented. The consultation runs for 12 weeks until 31 August 2021. Here we outline the principles behind the different types of exhaustion regime, and summarise the options proposed by the consultation, highlighting the issues associated with each. Read more

Pharmaceutical patent term extensions: federal court hears challenge to “absurd” Australian patent office ruling

Two major pharmaceutical companies have challenged Australia’s Commissioner of Patents in the Federal Court about the time limits within which an application can be made to extend a patent term. KEY TAKEAWAYS Ono Pharmaceutical and Bristol Myers Squibb have sought judicial review by the Federal Court of an Australian Patent Office (APO) ruling which rejected … Read more

EU Action Plan on IP – the challenge ahead

Herbert Smith Freehills' European IP team have had a feature article on the EU's IP Action Plan published in the April edition of PLC Magazine – see EU Action Plan on IP – the challenge ahead here. The article looks at the current challenges for the EU in relation to IP, its key focus areas and plans for future regulation and legislation, including: • The Unified Patent Court (UPC) • Supplementary Protection Certificates (SPCs) • Compulsory licensing • Standard Essential Patents (SEPs) • AI and emerging technologies • Counterfeiting • Designs • Geographical Indications • Data • The Pharmaceutical Strategy for Europe Read more

Judicial review – another weapon in Big Pharma’s disputes arsenal?

The life sciences and healthcare sector is subject to complex regulation and decisions of Government bodies can have a significant impact on the availability and production of pharmaceutical products.  Where Government bodies take decisions of this nature, and there is no other recourse available, judicial review provides an avenue to healthcare companies and others to challenge Government decisions. Herbert Smith Freehills has had a practice note published in Practical Law which considers the various grounds of judicial review, the application of these grounds to specific cases in the healthcare sector and some particular considerations to be taken into account when making a judicial review application. Read more