On September 27, 2016, the US Court of Appeals for the Third Circuit handed an important victory to the Federal Trade Commission and the Commonwealth of Pennsylvania in a closely watched hospital merger case. The decision provides clear guidance on the appropriate tests for determining geographic markets in hospital merger cases, while also suggesting that efficiencies claimed in many hospital transactions may face increased scrutiny in future cases.
On 8 September 2016 the General Court (“GC”) dismissed Heiploeg’s appeal against the European Commission’s (“Commission”) decision in Shrimps (AT.39633) and confirmed that the Commission may rely on recordings seized lawfully in a “dawn raid” even if the recordings were made illegally by a third party (T-54/14). This judgment reminds us of the delicate balance between the right to respect for private life and the Commission’s need to obtain high probative evidence when investigating cartels.
On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, an originator company, and Merck (the parent company of Generics), Arrow, Alpharma and Ranbaxy, four generic companies. The Commission found that the companies had entered into anticompetitive “pay-for-delay” settlement agreements whereby Lundbeck paid a lump sum to the generic companies in exchange for their agreement to delay their entry on the market for Citalopram, an anti-depressant drug.
This ruling is notable in that it is the first time that the GCEU has been asked to rule on patent settlements between originators and generic companies. The GCEU upheld the Commission’s reasoning, noting that the Commission’s reasoning in this case reflects the provisions of its Guidelines on the application of Article 101 of the Treaty on the Functioning of the EU (TFEU) to technology transfer agreements.
The ultimate effectiveness of the corporate compliance program depends on its ability to mitigate risks arising from all substantive laws materially affecting the company — not only the most visible or notorious ones. Yet, both experience and impression suggest that many health company compliance programs are primarily focused on addressing concerns arising from the anti-fraud and abuse, self-referral and reimbursement rules. This level of focus is understandable, given the historical prominence of these rules and the strong public voice of the U.S. Department of Health and Human Services Inspector General. However, such program imbalance can itself lead to significant compliance concerns given the increasing extent to which the civil and criminal antitrust laws are applied to the health care sector.
The fundamental purpose of a corporate compliance program is to detect the particular types of misconduct most likely to occur in a particular corporation’s line of business. The parameters of most programs are based upon the core “effectiveness” principles set forth in the Federal Sentencing Guidelines. Specific details of particular programs often reflect guidance provided by regulators with particular interest in certain industries. For example, the compliance programs of many health industry companies follow DHHS regulations that set forth basic principles of such programs, and specific anti-fraud elements that companies should consider when designing and implementing their programs.
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In May 2015, the European Commission (the Commission) launched a sector inquiry in the field of e-commerce in the context of its Digital Single Market strategy. Its aim was to obtain an overview of prevailing market trends, gather evidence on potential barriers to competition linked to the growth of e-commerce and understand the prevalence of certain, potentially restrictive, business practices and the underlying rationale for their use.
In the course of this inquiry, the Commission gathered evidence from nearly 1,800 companies active in the e-commerce of consumer goods and digital content and analyzed around 8,000 distribution contracts. On 18 March 2016, the Commission published its initial findings showing that geo-blocking is widespread in the European Union due to unilateral decisions by companies not to sell abroad as well as contractual barriers set up by companies preventing consumers from shopping online across EU borders.
On 15 September 2016, the Commission completed its preliminary report (the Preliminary Report), which confirms the fast growth of e-commerce in the European Union and identified business practices that might restrict competition and limit consumer choice. Continue Reading
This article, published in Getting the Deal Through, reviews the legislation that creates the pharmaceutical regulation framework in Italy, particularly with regard to mergers and acquisitions, anticompetitive conduct, product development and licensing agreements, and marketing agreements.
Financial regulatory authorities such as the US Security and Exchange Commission (SEC) and the French Autorité des marchés financiers frequently impose on companies that are listed on a stock exchange the obligation to disclose key information to investors to help them make informed investment decisions.
The difficulties for companies lie principally in the nature of the information to be disclosed, the timing of the disclosure, and the balance of the obligation towards financial regulatory authorities on one hand, and competition authorities on the other.
In May, the Federal Trade Commission (FTC) required Hikma Pharmaceuticals PLC to divest its 23 percent interest in Unimark Remedies, Ltd. and its US marketing rights to a generic drug under manufacture by Unimark as a condition to allowing Hikma to complete its acquisition of Roxane Laboratories. The FTC was concerned that Hikma’s continued holding of a 23 percent interest in Unimark after consummation of its proposed acquisition of Roxane would create the incentive and ability for Hikma to eliminate future competition between Roxane and Hikma/Unimark in the sale of generic flecainide tablets (a drug used to treat abnormally fast heart rhythms) in the United States.
The FTC’s divestiture requirement was unusual but not unprecedented. The Horizontal Merger Guidelines identify three theories of competitive harm associated with an acquisition or holding of a small but significant minority interest in a competitor.
- Minority ownership, and any associated rights, such as veto rights over the competing firm’s budget or strategic decisions, or representation on its board of directors, may allow the shareholder to forestall, delay or otherwise hamper the competing firm’s further development or marketing of competitive products
- The holder of a minority interest in a competing firm has diminished incentives to compete aggressively with the competitor firm because the holder obtains an economic benefit from the success of the competing firm through its partial ownership of that competitor.
- The holder of a minority interest in a competing firm may have access to non-public, competitively sensitive information of the competing firm, and thus may be better able to coordinate its business decisions—such as pricing, output, or research and development efforts—with those of the competing firm, thus diminishing competition.
These theories of potential antitrust harm from minority interest acquisitions are not unique to the United States; other competition agencies, including the European Union’s competition directorate, accept and apply these theories when considering the competitive impact of a firm’s actual or proposed partial ownership interest in a competitor. However, the United States applies a significantly lower threshold than the European Union (and other competition agencies) for the pre-acquisition notification of an entity’s acquisition of a minority, non-controlling interest in another firm.
Read the full article here.
In the European Union (EU), at the inception of a joint venture (JV), parent companies must determine whether the newly created structure presents a full-functionality nature, which depends on its degree of autonomy. The answer to this question will determine the legal framework applicable to it.
On the one hand, if the JV is full-function it will fall within the scope of the EU Merger Regulation (Council Regulation (EC) No 139/2004 of 20 January 2004), assuming that the turnover thresholds set out in the Regulation are met. Under these circumstances, the European Commission (EC) will assess the impact of the JV on competition on an ex ante basis.
On the other hand, if the JV is not full-function and takes the form of a partnership formalized by a legal structure to a large extent dependent on its parent companies, the creation of a JV will not have to be notified but the EC may operate a control ex post, in the light of Article 101(1) of the Treaty on the Functioning of the EU which prohibits anticompetitive agreements between undertakings. In such a context, it is up to the parent companies creating a JV to determine whether their JV is compatible with competition law rules.
The ex post control has the advantage of avoiding the notification process that delays the implementation of the JV. However, within that framework, companies may not obtain a clearance decision and the fate of their JV is subject to legal uncertainty. It is thus generally preferable for companies to make sure that their JV will fall within the scope of the Merger Regulation because a clearance decision is irrevocable and unlimited.
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In the last two years, the Federal Trade Commission (FTC) and the Antitrust Division of the US Department of Justice (DOJ) brought, and won, several litigated merger cases by establishing narrow markets comprised of a subset of customers for a product. This narrow market theory, known as price discrimination market definition, allowed the agencies to allege markets in which the merging parties faced few rivals and, therefore, estimate high post-merger market shares. By their nature, price discrimination markets can lead to a challenge of a high-value deal where only a small number of the merging parties’ customers are allegedly harmed. Given the increased usage by the agencies and now judicial acceptance of the theory, counsel for merging parties must consider the potential for price discrimination market definition in assessing the antitrust risks for transactions.
Read the full article here.