Competition

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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

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

Arnold & Porter’s Future Pharma Forum invites you to a complimentary competition/antitrust seminar aimed at junior lawyers and professionals new to the UK/EU life sciences industry. This seminar will provide a refresher of key EU and UK competition law topics, cover some key issues from an in-house practitioner’s perspective and touch on the implications of…

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 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication may fall within the same relevant product market.

Background

Genentech’s drugs Avastin (which is licensed to Roche) and Lucentis (licensed to Novartis) are based on different active substances but are derived from the same antibody and have similar mechanisms of action. Avastin obtained marketing authorisation first, for treatment of certain types of cancer and Lucentis later obtained marketing authorisation for treatment of certain ophthalmologic conditions. However, during the interval between grant of the two marketing authorisations, a number of medical practitioners used Avastin in smaller doses to treat ophthalmologic conditions. Furthermore some practitioners have continued to use Avastin even after grant of marketing authorisation for Lucentis because of the substantially lower treatment cost of Avastin.Continue Reading Hoffman-La Roche – AG finds unlicensed use should be included in relevant product market