On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its development through a disparagement campaign.

No public version of the decision is available yet, nonetheless the FCA has already published a detailed press release (available in French).

WHAT HAPPENED

Durogesic is a powerful opioid analgesic, which active substance is fentanyl, usually prescribed in the form of transdermal patch for the treatment of severe pain, including chronic cancer pain. In 2007, a competing pharmaceutical company launched its generic equivalent.

After receiving a market authorization in Germany, the competing pharmaceutical company started a mutual recognition procedure in the European Union. The European Commission (the Commission) granted the market authorization in October 2007 and instructed the other Member States to do the same within a 30-day deadline. It is in this context that, according to the FCA, the sanctioned laboratory has intervened in order to hinder the market entry and development of the generic in France.

Following a complaint filed by the generic manufacturer, the FCA found two distinct anticompetitive practices:

  1. A legally unjustified intervention with the French National Agency for Medicines and Health Products Safety

First, the FCA established that, during the market authorization of generic specialties process, the sanctioned laboratory wrote to the French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, the ANSM) on several occasions and requested a meeting to discuss the side effects of the generic. During those exchanges, it questioned the decision of the Commission, suggesting that the ANSM could take a different decision, disregarding the fact that the Commission’s decision is legally binding on the ANSM.

To convince the ANSM, the laboratory put forward risks to human health that the substitution could entail for some patients, such as ineffectiveness or adverse effects causing even greater pain.

Sensitive to these arguments, the ANSM, whose mission is to ensure health security, initially refused to acknowledge the generic status to medicines competing with Durogesic, thereby allowing the laboratory to temporarily achieve its objective to delay their market entry in France. More than a year later, the ANSM finally granted the generic status, accompanying its market authorization with a warning message recommending medical supervision of certain patients (including older people and children) in the event of a change of specialty (e.g. a reference specialty by a specialty generic, a specialty generic by a reference specialty, or a specialty generic by another specialty generic) based on fentanyl.

  1. A global and structured disparagement campaign

Second, the FCA established that, after the issue of the market authorization for the generic, the sanctioned laboratory massively disseminated an alarmist message on the risks of prescribing or dispensing the generic. This characterized a disparagement campaign, which was based on the differences between the originator product and the generic, including the size and the amount of active ingredient present. According to the FCA, the idea was to instill doubts regarding the effects of a possible change of treatment from Durogesic to a generic.

In this context, the laboratory mobilized and formed 300 medical sales representatives to spread the message to all doctors and pharmacists in hospital or private practice. A health information letter was also widely distributed by mail, email, fax and in specialized press. The campaign was further supplemented by distance training of doctors and pharmacists and phone calls.

In addition, the FCA considered that the laboratory misrepresented the content of the warning message issued by the ANSM by circulating an inaccurate and incomplete presentation of the risks associated with the substitution. In the above-mentioned health information letter, only the risk associated with Durogesic’s substitution with generics was emphasized whereas ANSM’s warning message was general and mentioning all cases involving substitution, including the substitution of the generic specialty by the reference specialty.

This misleading message contributed to a very low penetration of the Durogesic’s generic on the market. The substitution objectives were not achieved and the substitution rate observed was even lower than what the fined laboratory anticipated.

Consequently, the FCA imposed a EUR 25 million fine jointly and severally to the pharmaceutical laboratory and its parent company, for delaying the market entry of the Durogesic’s generic and for hindering its development by using a disparagement campaign with an aim to influence doctors and pharmacists in order to slow down as much as possible the generic substitution process.

WHAT THIS MEANS

In this case, the FCA has, for the third time, addressed the issue of the obstruction to generic entry or development through disparagement of competing generics companies’ products. In 2013, Sanofi-Aventis and Schering-Plough were fined by the FCA on similar grounds, respectively EUR 40.6 million and EUR 15.3 million, for their Plavix and Subutex products.

In line with its previous case law and its Opinion No. 13-A-24 of 19 December 2013, the FCA’s decision is a clear illustration of European competition authorities’ increasing skepticism concerning originator companies’ attempts to prevent or delay generic entry. Therefore, pharmaceutical companies should be particularly cautious in their communications with medical professionals, especially when discussing competing generic products.

Moreover, combined with the recent announcement (20 November 2017) by the FCA of the launch of another sector inquiry on the functioning of competition in the medicinal products sector, this decision sends a clear message that the pharmaceutical sector remains one of the FCA’s main priorities.

Between 2012 and 2013, Marine Harvest ASA (“Marine Harvest”), a Norwegian seafood company, acquired Morpol ASA (“Morpol”), a Norwegian producer and processor of salmon. Marine Harvest notified the transaction to the European Commission under the European Union’s Merger Regulation (“EUMR”), but implemented it prior to the European Commission having granted clearance. In 2014, the European Commission imposed a EUR 20 million fine on Marine Harvest for “jumping the gun”. On 26 October 2017, the General Court of the European Union (“General Court”) confirmed the European Commission’s decision (“Decision”).

WHAT HAPPENED:

On 14 December 2012, Marine Harvest entered into a share and purchase agreement (“SPA”) with companies owned by Jerzy Malek, the founder and former CEO of Morpol. Under the SPA, Marine Harvest acquired 48.5% of the shares in Morpol (“Initial Transaction”). The Initial Transaction was closed on 18 December 2012. On 15 January 2013, Marine Harvest submitted a mandatory public offer for the remaining 51.5% of the shares in Morpol (“Public Offer”). Following settlement and completion of the Public Offer in March 2013, Marine Harvest owned a total of 87.1% of the shares in Morpol (together, the “Transaction”).

Marine Harvest established first contact with the European Commission on 21 December 2012 by submitting a “Case Team Allocation Request”, which initiates the pre-notification process under the EUMR. After submitting various drafts and answers to requests for information, Marine Harvest formally notified the Transaction on 9 August 2013. On 30 September 2013, the European Commission cleared the Transaction subject to some conditions.

On 31 March 2014, the European Commission formally launched a separate investigation into alleged “gun jumping” by Marine Harvest, and in the decision of 23 July 2014, the European Commission imposed a fine of EUR 20 million on Marine Harvest (“Fining Decision”). The European Commission held that Marine Harvest, by implementing the Initial Transaction, had acquired de facto control over Morpol. By acquiring de facto control, Marine Harvest had infringed Art. 7(1) EUMR (“Standstill Obligation”). Under the Standstill Obligation, transactions requiring notification to, and clearance by, the European Commission may not be implemented prior to clearance.

The European Commission rejected Marine Harvest’s argument that the implementation of the Initial Transaction was covered by an exemption provided for in Art. 7(2) EUMR (“Public Bid Exemption”). Under the Public Bid Exemption, the acquisition of control from various sellers through a public bid, or a series of transactions in securities, can be implemented prior to clearance. However, this applies only if the transaction is notified without delay to the European Commission, and if the acquirer does not exercise the respective voting rights. According to the European Commission, the Public Bid Exemption is not intended to cover situations involving the acquisition, from a single seller, of a “significant block of shares” which in itself confers de facto control.

Marine Harvest appealed against the Fining Decision to the General Court. However, with the Decision, the General Court confirmed the European Commission findings, both on substance on with respect to the level of the fine.

WHAT THIS MEANS:

The Decision is an impressive reminder that gun jumping, i.e. the implementation of transactions prior to clearance by the relevant antitrust authorities, can entail severe consequences. Under European merger control law, the European Commission can impose fines of up to 10% of the group’s total turnover on companies infringing the Standstill Obligation. Antitrust authorities in most other major antitrust jurisdictions have comparable sanctioning tools.

The Decision also confirms that the acquisition of a minority stake may well be considered as conferring de facto control. This applies in particular to situations where the minority shareholder is highly likely to achieve a majority at the shareholders’ meetings, taking account of the size of its shareholding and the level of attendance of other shareholders at shareholders’ meetings in preceding years. The General Court furthermore emphasises that the mere possibility to exercise control is sufficient for a breach of the Standstill Obligation. Whether the acquirer actually makes use of that possibility (Marine Harvest argued it did not) is of no relevance.

Finally, the Decision clarifies that the European Commission is entitled to apply a narrow interpretation of the Public Bid Exemption. Parties who intend to rely on the Public Bid Exemption for (partly) implementing transactions prior to clearance should do so, if possible, only after consulting with the European Commission. Indeed, the European Commission, confirmed by the General Court, held that Marine Harvest acted negligently in not having consulted with the European Commission. Marine Harvest’s negligence was a main factor for the European Commission to conclude that a significant fine should be imposed – even though, as Marine Harvest argued throughout the proceedings, the European Commission did not impose a fine in a very similar, previous merger case.

On 7 September 2017, the European Court of Justice issued a decision (Decision) on the interpretation of the European Union Merger Regulation (EUMR). The Decision clarifies the conditions under which the EUMR applies to the setting-up of joint venture companies.

WHAT HAPPENED:

  • 3(4) of the EUMR stipulates that the “creation” of joint ventures requires a notification only if the joint venture “performs the functions of an autonomous economic entity” (Full-Function JV).
  • Companies with management dedicated to its day-to-day operations, as well as access to sufficient resources including staff, finance and assets usually qualify as Full-Function JV. If the joint venture has only one specific function for the parent companies (e.g. supplying input products or services), and has no or only very limited own resources, it is unlikely to be considered a Full-Function JV.
  • There has been considerable uncertainty whether Art. 3(4) EUMR applies only to the creation of a new company (greenfield operation), or whether it also applies if joint control is acquired over an existing company.
  • The European Commission significantly contributed to this uncertainty by repeatedly taking inconsistent and contradictory positions. In a fairly unusually move, the ECJ’s Advocate General chastised the European Commission, calling it “extremely regrettable” that the European Commission did notcommit to a clear and uniform approach and then apply it consistently”.
  • The ECJ’s Decision comes at the request of an Austrian court. The Austrian court had to decide whether the acquisition of joint control over a small asphalt plant–which does not qualify as Full-Function JV–requires notification and clearance under the EUMR by the European Commission.
  • The ECJ has now held that the change of sole control to joint control only requires a notification under the EUMR if the newly created joint venture qualifies as a Full-Function JV.

WHAT THIS MEANS:

  • The Decision brings much-awaited clarity to a key issue of European Union merger control.
  • If two or more companies create a joint venture company, it will be subject to the EUMR only if it qualifies as s Full-Function JV. This applies both to greenfield operations, where a new company is created, and the change from sole to joint control over an existing company. Whether a notification to the European Commission is actually required, will depend on whether the jurisdictional turnover thresholds under the EUMR are met.
  • The creation of joint ventures which do not qualify as Full-Function JV does not require notification to and clearance by the European Commission. However, these joint ventures may still be subject to merger control in one or several EU Member States.
  • The European Commission required and accepted in the past the notification of transactions which involved the creation of joint ventures not qualifying as Full-Function JV. Following today’s decision by the ECJ, it appears that the European Commission did not have jurisdiction. An interesting question to be explored in the coming weeks and months is therefore whether the Decision somehow affects the legality of these transactions.

McDermott’s Antitrust M&A Snapshot is a resource for in-house counsel and others who deal with antitrust M&A issues but are not faced with these issues on a daily basis. In each quarterly issue, we will provide concise summaries of Federal Trade Commission (FTC), Department of Justice (DOJ) and European Commission (EC) news and events related to M&A, including significant ongoing investigations, trials and consent orders, as well as analysis on the trends we see developing in the antitrust review process.

Read the full report here.

WHAT HAPPENED:

  • Rolls-Royce and SENER have a 47 percent/53 percent joint-venture in Industrial de Turbo Propulsores (ITP)–an aircraft engine components manufacturer.
  • Rolls-Royce, together with ITP, MTU and Safran, are members of a military engine consortium–Europrop International (EPI)–that supplies the engine to the Airbus’ A400M, the primary competitor to the Lockheed Martin C-130J.
  • The European Commission (EC) had concerns that Rolls-Royce’s full ownership of ITP would increase its influence in EPI such that Rolls-Royce could undercut the competitiveness of the EPI engine, and consequently subvert Airbus’ competitiveness vis-à-vis Lockheed Martin.
  • The EC and Rolls-Royce agreed to a behavioral remedy focused on EPI’s governance rules that would eliminate the potential conflict of interest and maintain EPI’s competitiveness. While the EC press release does not provide details, the agreement likely allows MTU and Safran to control the consortium’s decision making.

WHAT THIS MEANS:

  • Antitrust enforcers continue to investigate competitive impacts from vertical transactions.
  • While antitrust enforcers have a strong preference for structural remedies, when addressing vertical competition issues, there is greater potential that enforcers will accept a behavioral fix.
  • Antitrust enforcers continue to focus on antitrust impacts in narrow markets. Here, the remedy is designed to maintain competition between the Airbus A400M and Lockheed Martin’s C-130J – military turboprop transport aircraft.

On 4 March 2017, the European Commission (Commission) published a notice concerning the notification of the proposed acquisition of the Spanish aircraft company Industria de Turbo Propulsores SA (Spain, ITP), by Rolls-Royce Holdings plc. (UK, Rolls-Royce). Interested third parties, such as competitors, suppliers or customers can provide the Commission with their observations on the likely impact of the proposed transaction on competition in order to facilitate its substantive assessment.

Interested third parties’ observations must reach the Commission no later than 14 March 2017.

Rolls-Royce is active in the development and manufacture of aircraft engines and power systems for civil aerospace, defense aerospace, marine and energy applications. ITP is a joint venture between Rolls-Royce and Sener Grupo de Ingenieria SA, and it is active in the design and manufacture of aircraft engine components.

McDermott’s Antitrust M&A Snapshot is a resource for in-house counsel and others who deal with antitrust M&A issues but are not faced with these issues on a daily basis. In each quarterly issue, we will provide concise summaries of Federal Trade Commission (FTC), Department of Justice (DOJ) and European Commission (EC) news and events related to M&A, including significant ongoing investigations, trials and consent orders, as well as analysis on the trends we see developing in the antitrust review process.

Read the full report here.

 

UNITED STATES:

Continuing an active first half of 2016, the Federal Trade Commission (FTC) and US Department of Justice (DOJ) have challenged several large mergers and acquisitions. In fact, trials for the two national health insurer deals are slated to begin Q4 of 2016 in Washington, DC, where the agencies have had success in obtaining preliminary injunctions this year. Adding to the regulators’ successes in Q3 was a victory for the FTC on appeal in the Penn State Hershey Medical Center/PinnacleHealth System transaction, in which the Third Circuit overturned the district court’s formulation of the geographic market. Indeed, with another appeal in a hospital merger outstanding in the Seventh Circuit, Health Care M&A is an active sector to monitor.

In addition to the agencies’ operations, the upcoming US presidential election has also propelled antitrust policy into a national discussion. For the first time in a few decades, antitrust has appeared on the Democratic Party’s platform, and Hillary Clinton has also issued a statement promising to strengthen antitrust enforcement if elected president.

EUROPEAN UNION:

The July to September period has seen 87 merger control notifications, the vast majority being candidate cases for simplified procedure. There were also eight clearance decisions, five of which were Phase I cases with remedies—in each case, structural remedies were preferred by the European Commission (EC).

Antitrust intervention seems to have been focused more on the telecoms and pharmaceutical sectors, with divestitures being offered in every telecom and pharma Phase I and Phase II clearance decision since July.

Read the full article here.