On 4 January 2022, after approximately four years from the UK government’s first attempt to reform the UK national security screening regime, the National Security and Investment Act 2021 (NSIA) became operational. The NSIA represents a radical overhaul to investment screening in the UK as it introduces for the first time a mandatory and suspensory filing obligation for transactions in 17 sectors considered as particularly sensitive (among which are Synthetic Biology and Artificial Intelligence).

Alongside a mandatory and suspensory regime for certain transactions, parties are also encouraged to notify transactions voluntarily if—regardless of the sector concerned—the transaction might have national security implications based on (i) nature/identity of the acquirer, (ii) target’s activities, and/or (iii) nature and degree of control acquired. Unlike the mandatory filing obligation which only captures acquisition of entities, the voluntary regime also captures the acquisition of tangible and intangible assets—thereby including the acquisition, assignment and/or licensing of IP rights over e.g. molecules, compounds, methods or technologies.

Continue Reading The UK National Security and Investment Act 2021 (NSIA) – Implications for Life Sciences

As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU

Advocate General Kokott issued her opinion last week in the preliminary ruling referral from the UK Competition Appeal Tribunal (CAT). The CAT proceeding is itself an appeal against an infringement finding against a number of companies (except one, IVAX, which is now part of TEVA, which received a ‘No Grounds for Action’ letter).

AG Kokott finds that an agreement to settle a patent dispute may constitute a restriction of competition by object or by effect and that entering into such an agreement may be an abuse of a dominant position. This is in line with the General Court’s recent judgments in Perindopril and Lundbeck, but her views diverge on market definition where she seems to side with the CAT on a narrow, molecule-level definition.

Continue Reading Paroxetine: AG Rules on Reverse Payment Settlement Referral

On 28 January 2019, the European Commission (Commission) published its Report to the Council and the European Parliament on Competition Enforcement in the pharmaceutical Sector (2009-2017) (Report). This takes stock of all the pharma cases that the Commission has pursued at EU level and that national competition authorities have investigated over the past 10 years.  It responds to recent concerns raised by the Council and European Parliament that anti-competitive practices of pharmaceutical companies may prevent patients’ access to affordable and innovative medicines.

In parallel, the UK Competition and Markets Authority (CMA) has been very active in investigating the pharma sector and currently has some eight ongoing investigations. Some of these investigations are being narrowed but the overall mood music is that authorities regard pharma cases a high priority. This trend is likely to continue for some time yet.

The key takeaways are (i) pharma cases are likely to continue to be of interest to competition authorities (ii) entry restrictions, high price strategies and loss of exclusivity are key areas of concern together with, going forward, the entry of biosimilar competition.

Continue Reading European Competition enforcement in the pharmaceutical sector: more to be expected?

This week, the EU General Court partially overturned the EU Commission’s decisions in Perindopril (Servier v Commission and Krka v Commission).

The judgment was handed down pretty much on the tenth anniversary of the original dawn raids in November 2008. The raids came as a follow-up from the European Commission’s pharma sector enquiry and led to a number of infringement decisions that have also found their way up to the General Court and to the Court of Justice of the EU. The key theory which the EU Commission advanced in the cohort of these so-called ‘pay-for-delay’ cases is, very broadly, that EU competition law can intervene in patent settlement cases in certain circumstances (both under the rules on abuse of dominance and restrictive agreements). These circumstances are (again, very broadly) where (i) the settlement proposal restricts entry by an actual or potential generic competitor—the delay element, and (ii) where the originator company makes a value transfer to the potential generic entrant – the payment element. This could be by way of a lump-sum payment or through some other way (e.g., through a beneficial distribution agreement). On abuse of dominance, the theory is that unilateral conduct aimed at “shutting out a competing technology and buying out a number of competitors” constitutes an abuse. These theories are now being tested in the European Courts.

In parallel, the UK’s Competition and Markets Authority (CMA)—or OFT, as it then was—investigated similar issues in Paroxetine, a case which the European Commission pushed to the CMA because of an EU limitation issue and which the CMA pursued as the UK does not have a limitation period for competition law infringements. That case is currently under appeal before the Competition Appeal Tribunal which in turn has referred a number of questions to the European Court of Justice.

Continue Reading Perindopril: Pay-for-delay but not as you know it

On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit.

What is exhaustion?

As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from using that right to stop the importation of a product into an EU country where it has been lawfully placed on the market in another country in the European Economic Area (EEA). In other words, an IP holder cannot use its IP rights to prevent parallel import (sometimes called grey imports) of goods from within the EEA. Unless the law is changed, this will not apply after Brexit, because the UK will no longer be part of the EEA. The proposed legislation seeks to change this so that exhaustion still applies to any goods brought into the UK, provided they have been placed on an EEA market with the IP owner’s consent. This will apply irrespective of whether there is a Brexit deal or not, and it is intended that this comes into effect on Brexit-day, if approved by Parliament.

Continue Reading Brexhaustion: IP Rights and Exhaustion Post-Brexit

On 5 December 2018, the High Court rejected Concordia’s application to obtain full access to the information underpinning the Competition and Markets Authority’s (CMA) application for a warrant for a dawn raid, over which the CMA had claimed public interest immunity (PII). The judge did, however, allow Concordia access to some information.

Continue Reading Battle for access to information underlying the UK CMA dawn raid of Concordia

Last week, the CJEU gave its decision in another procurement case in the healthcare area, Case C‑413/17 Roche Lietuva UAB. The case concerned the scope of technical specifications included as part of a tender by the Polyclinic for the Dainava District of Kaunas in Lithuania. The tender set out details of the medical diagnostic equipment and materials the authority wished to procure. Roche claimed that the specifications unreasonably restricted competition among suppliers due to their high specificity, and that in reality, the specifications corresponded to the products of certain manufacturers and excluded others.

The question referred to the Court concerned the limits to the margin of appreciation of a contracting authority to set out specifications in the tender, based on the quality of testing and the value of healthcare that it needs. The Court set out a useful summary of when technical specifications can be included in a tender and the principles for applying such specifications.

Continue Reading European Court clarifies use of technical specifications in healthcare tenders