Competition law and biosimilars: Time for a new approach or not yet?

Competition law enforcement in the pharmaceutical sector has been vigorous in recent years with regulators focusing on a variety of issues including denigration strategies, lifecycle management patent strategies, pricing rebates, and excessive pricing.

In an article recently published in Concurrences, we examine the case law and enforcement practice in this area and apply it to a particular type of pharmaceutical product: biologic drugs and biosimilars.

The article considers market definition concerning biologic drugs and biosimilars, reviewing European Commission and national case law concerning mergers and abuse of dominance cases involving biologics/biosimilars. It then examines how the existing framework in abuse of dominance cases can be applied in the area of biologics/biosimilars taking the specific characteristics of those products into account.

The article concludes that, although several elements from the existing cases could be implemented in biosimilar cases, various fact-specific differences will likely lead to a more nuanced legal approach both in market definition and in the assessment of potentially anti-competitive conduct.

The full text of the article can be accessed on the Concurrences website here (no subscription required).

This article was written for Concurrences and co-authored by Kyriakos Fountoukakos (Global Head of Competition, Regulation and Trade) and Violetta Meli (previously an Associate (Intern) at Herbert Smith Freehills, currently an Associate at Gowling WLG).

 

Kyriakos Fountoukakos
Kyriakos Fountoukakos
Partner, Brussels
+32 2 518 18 40
Peter Rowland
Peter Rowland
Of Counsel, Brussels
+32 2 518 18 470
Max Kaufman
Max Kaufman
Senior Associate, London
+44 20 7466 2898
Emily Bottle
Emily Bottle
Senior Associate, Milan
+39 02 3602 1402
Priyanka Madan
Priyanka Madan
Senior Associate, Milan
+39 02 3602 1389

It all comes back to construction – long-awaited judgement in UK High Court mirabegron case

On 17 October 2023, Mr Justice Mellor of the UK High Court handed down the long-awaited judgment (some 14 months after trial) in the patent infringement action commenced by Astellas against Teva and Sandoz, in relation to their proposed generic mirabegron tablets, which is used to treat overactive bladder.

The action between the parties concerned EP 2,345,410 (EP’410), a modified release formulation patent with a priority date of 2008.  The defendants alleged that the patent was invalid for insufficiency and obviousness, arguing that the claims of EP’410 were excessively broad and exceeded any relevant technical contribution to the art.

The problem allegedly solved by EP’410 was reducing the ‘food effect’ associated with conventional formulations of mirabegron (that is, pharmacokinetic differences between patients in fed vs fasted states).  The claims of EP’410 recite a modified release formulation of mirabegron comprising specified additives, and having a prescribed drug dissolution rate.

In summary, the case turned on the correct construction of claim 1 of the patent.  Mellor J found that, on his construction of EP’410, the patent as amended was valid but not infringed.  Conversely, if his construction was incorrect (and under the construction proposed by the patentee itself), then EP’410 was invalid.  This is a win for the defendants as, two months earlier, their challenge to another Astellas patent covering mirabegron (the method of treatment patent, EP 1,559,427) was unanimously dismissed by the UK Court of Appeal.

The issue on construction related to whether or not the term “a pharmaceutical composition for modified release” in claim 1 required a reduction in food effect.  The patentee argued that claim 1 only required that the formulation had the recited composition and satisfied the claimed dissolution test.  Conversely, the defendants argued, and the Court accepted, that the outcome is an element of the claim.  On the patentee’s argument that such a construction may require costly and time-consuming in vivo studies to prove infringement, Mellor J had little sympathy observing it was for them to draft the patent in a way to avoid such requirements.

On the ground of insufficiency, the defendants argued that it was not plausible that the invention worked with substantially all formulations falling within the scope of claim 1, on the basis of the sole experimental example in the patent that presents pharmacokinetic data in humans.  After a highly detailed analysis of the description of the patent and the expert evidence, Mellor J did not agree.

In relation to inventive step, all three pieces of prior art relied upon aspects of an oral controlled absorption system developed in the early 2000s by a company now owned by the patentee.  Mellor J had to grapple with heated dispute between the parties as to the meaning and impact of the various prior art documents.  The finding of obviousness depended on which construction of claim 1 was accepted – on the patentee’s own construction, which did not require the amelioration of food effects as an integer, EP’410 would be obvious in light of the prior art, whereas on the defendant’s construction, it would not be.

Finally, on infringement, Sandoz had disputed that its proposed product fell within the scope of the claims and Mellor J agreed that, on his construction of the claims, infringement had not been established as there was no evidence of the reduction of food effects of the Sandoz formulation as compared to a conventional formulation of the drug.  The infringement of Teva’s revised product could not be determined at trial.

Thus Astellas is left with another valid patent in its mirabegron arsenal, but one that may be more difficult to assert against generics.

Key contacts 

George McCubbin
George McCubbin
Senior Associate, London
+44 20 7466 2764

Sebastian Moore
Sebastian Moore
Partner, London/ Milan
+44 207 466 2801

Jonathan Turnbull
Jonathan Turnbull
Partner, London
+44 20 7466 2174
Andrew Wells
Andrew Wells
Partner, London
+44 20 7466 2929

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, available here, in which HSF judicial review experts Andrew Lidbetter and Sanam Zulfiqar Khan explore judicial review in England and Wales in the life sciences and healthcare sector. In their analysis, Andrew and Sanam consider 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.

Please also see the HSF podcast on this topic available here.

The European Commission considers the future of health in Europe with new Pharmaceutical Strategy and Action Plan on IP

The European Commission has this week published a wide-ranging and ambitious Pharmaceutical Strategy for Europe, and an Action Plan on Intellectual Property.

Pharmaceutical Strategy for Europe

The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union speech. It covers the full lifecycle of a medicine including R&D, clinical trials, marketing authorisation, manufacturing, pricing and reimbursement, access and IP protection.

The aims of the strategy are to promote accessibility and affordability of medicines, and to ensure the European pharmaceutical sector remains innovative and world-leading. The coronavirus pandemic has brought the health sector into sharp focus this year, and a goal of the strategy is to help to establish a crisis-resilient EU pharmaceutical system.

The strategy sets out four main objectives:

  • Ensure access to affordable medicines and address unmet medical needs (e.g. in the area of cancer)
  • Support innovation, competitiveness and sustainability of the EU’s pharma industry and the development of high quality, safe, effective and greener medicines
  • Enhance crisis response mechanisms and address security of supply
  • Ensure a strong EU voice in the world by promoting a high level of quality, efficacy and safety standards

In term of next steps:

  • The strategy will be discussed at political level at the EPSCO (Employment and Social Affairs Council) meeting of 2 December 2020.
  • Implementation will start immediately after adoption and will include legislative and non-legislative actions.
  • The actions will be rolled out gradually starting with the first proposals in the coming months, including the revision of the legislation on rare diseases (Orphans and Paediatric Regulations).
  • An EU Health Emergency Response Authority is proposed for 2021.
  • Depending on the evaluation process, the strategy plans a proposal for revision of the basic pharmaceutical acts (i.e. Directive 2001/83/EC relating to medicinal products for human use; and Regulation 726/2004 laying down EC procedures for the authorisation and supervision of medicinal products) in late 2022.

The strategy is mostly focussed on IP and regulatory issues, but notes that the proposed policies will be accompanied by enforcement of the EU competition rules. In particular, it refers to the 2019 Report on competition enforcement in the pharmaceutical sector.

Action Plan on Intellectual Property

The new Intellectual Property Action Plan aims to build on the EU’s strengths in the IP sector by “upgrading the EU’s framework, where needed, and putting in place well-calibrated IP policies to help companies capitalise on their inventions and creations, whilst at the same time ensuring that inventions and creations are serving economy and society at large“. It identifies 5 current challenges and 5 key focus areas, with specific proposals for action to:

  • upgrade the system for IP protection,
  • incentivise the use and deployment of IP, notably by SMEs,
  • facilitate access to and sharing of intangible assets while guaranteeing a fair return on investment,
  • ensure better IP enforcement, and
  • improve fair play at global level.

Within these 5 key focus areas, some highlights of what the action plan discusses are:

  • supporting the launch and rapid roll out of the unitary patent system in 2021. It also floats the possibility of introducing “a unified SPC grant mechanism and/or create a unitary SPC title
  • new licensing tools and a system to coordinate compulsory licensing (20212022)
  • revising the EU legislation on design protection (Q4 2021)
  • a new approach to the way geographical indications (GIs) are protected, and the possibility of an EU protection system for non-agricultural GIs (Q4 2021)
  • evaluating the plant variety legislation (Q4 2022)

The wider picture

Both the strategy and action plan are in synergy with the new Industrial Strategy for Europe and the priorities outlined in the European Green DealEurope’s Beating Cancer Plan, and the European Digital Strategy.

 

Emily Bottle
Emily Bottle
Senior Associate, London/Milan
+44 207 466 2525/+39 02 3602 1402
Dafni Katrana
Dafni Katrana
Senior Associate, Brussels
+32 2 518 1846
Martina Maffei
Martina Maffei
Senior Associate, Milan
+39 0236021388