ANTITRUST ALERT
ANTITRUST ALERT
A Global Resource for Compliance Officers & Legal Advisors
ANTITRUST ALERT
A Global Resource for Compliance Officers & Legal Advisors
FTC Developments
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THE LATEST: FTC Fixes Consummated Pharma Transaction Involving Pre-Phase 3 Product Because It Eliminated a “Nascent Threat”—Tacks on $100 Million Disgorgement Penalty

by and | Mar 7, 2017 | , ,

The Federal Trade Commission (FTC) challenged a consummated transaction using a monopolization theory to allege that the acquisition would eliminate “nascent” competition for therapeutic adrenocorticotropic hormones (ACTH) in the United States.

WHAT HAPPENED:
  • Questcor Pharmaceuticals, Inc.’s (Questcor) H.P. Acthar Gel (Acthar) is the only ACTH product sold in the US, is the standard of care for infantile spasms and is indicated for several other diseases.
  • In 2013, Questcor acquired the US rights to Synacthen Depot (Synacthen) from Novartis. Questcor was subsequently acquired by Mallinckrodt.
  • Synacthen is pharmacologically very similar to Acthar, as the active ingredient in both drugs is an ACTH molecule.
  • At the time of the acquisition by Questcor, Novartis’ Synacthen had been used safely and effectively for decades in Europe, Canada and other parts of the world to treat patients suffering from infantile spasms and other diseases. Synacthen had not yet begun US clinical trials.
  • The FTC alleged a monopolization theory—that Questcor had “extinguished a nascent competitive threat to its monopoly” by outbidding several other companies who were interested in bringing Synacthen to market in the US to compete with Questcor’s Acthar.
  • Then FTC Chairwoman Edith Ramirez (she has since resigned) noted that Questcor had a history of taking advantage of its monopoly, repeatedly raising the price of Acthar “from $40 per vial in 2001 to more than $34,000 per vial today—an 85,000 percent increase.”
  • The FTC settlement requires a $100 million monetary payment and that Mallinckrodt (Questcor was acquired by Mallinckrodt) license Synacthen for treating infantile spasms and nephrotic syndrome to an FTC approved licensee.
WHAT THIS MEANS:
  • In some circumstances, an action by a monopolist to block a nascent threat to its monopoly can violate the antitrust laws.
  • Typically, the FTC does not challenge pharmaceutical overlaps involving pharmaceuticals that have not yet entered Phase 3 clinical trials because there is still significant uncertainty that a product will ultimately come to market.
  • The FTC appears to have made an exception to its typical practice because Synacthen was anticipated to gain US approval easily and compete significantly with Acthar. Synacthen was approved outside the US for decades and was understood to be a safe and effective ACTH treatment.
  • The FTC may bring an action at any time under Section 7 to determine the legality of an acquisition. However, the FTC challenged this consummated transaction under a Section 2 theory of monopolization. The FTC has many tools to challenge actions under the antitrust laws.


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THE LATEST: FTC Determines Behavioral Remedies are Sufficient to Fix Offshore Natural Gas Pipeline Overlap

by | Mar 2, 2017 | ,

The Federal Trade Commission (FTC) recently granted US antitrust clearance for Enbridge’s acquisition of Spectra after the parties agreed to behavioral commitments to remedy an overlap for natural gas pipeline transportation from the wellhead in three markets off the coast of Louisiana (Green Canyon, Walker Ridge and Keathley Canyon).

WHAT HAPPENED:
  • The merging parties each own interests in competing natural gas pipelines – Enbridge is the sole owner of the Walker Ridge Pipeline; and Spectra holds a minority interest (~7.6%) in the Discovery Pipeline via its interests in DCP Midstream.
  • As part of Spectra’s minority interest in the Discovery Pipeline, Spectra had access to detailed information on the pipeline’s pricing and other competitively sensitive information. In addition, Spectra had board voting rights over the pipeline’s significant capital expenditures including expansions needed to connect to new wells.
  • FTC determined that in certain areas within each of the three geographic markets, the Walker Ridge and Discovery Pipeline were the closest pipelines to new wellheads in development and therefore the lowest priced options.
  • In granting antitrust clearance, the FTC required that Enbridge and Spectra erect firewalls such that information related to the Walker Ridge Pipeline would not be shared with any of Spectra’s partners in the Discovery Pipeline and that Discovery Pipeline information is not shared with any Enbridge individuals involved in the Walker Ridge Pipeline business.
  • The FTC also required any board members appointed by Enbridge or Spectra to DCP Midstream recuse themselves from any vote pertaining to the Discovery Pipeline, unless the vote involves expanding the Discovery Pipeline beyond natural gas pipeline services in the Gulf of Mexico or changing the entities’ ownership interests in the Discovery Pipeline.
WHAT THIS MEANS:
  • FTC could investigate and require remedies in overlaps involving minority ownership interests (even when less than 10%), particularly when the overlapping entities are close competitors and the acquisition would give access to competitively sensitive information and control over the entity.
  • The FTC continues to apply narrow product and geographic market definitions in oil and gas cases. Here the FTC alleged relevant markets involving natural gas pipeline transportation in particular areas in the Gulf of Mexico.
  • While the FTC has stated a strong preference for structural remedies when fixing horizontal overlaps, there are situations in which the FTC will conclude that a behavioral remedy is sufficient.


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THE LATEST: Learnings from Merger Remedies Study Underscores FTC’s Heightened Focus on Remedy Packages and Proposed Buyers

by and | Feb 22, 2017 | ,

WHAT HAPPENED:
  • In early February, the FTC released its Merger Remedies Study (the Study), which focused on transactions from 2006-2012 in which the FTC found a competitive problem that did not require a block outright, and allowed the transaction to gain clearance so long as the merging parties agreed to what the FTC determined were appropriate remedies to restore competition to the impacted market.
  • Via case study method, questionnaires and data, the FTC analyzed the outcomes of 89 remedial orders and self-critiqued its success in restoring competition and used the learnings to refine its internal best practices.
  • The report serves as an update to practitioners for understanding what is required to develop an effective remedy package, what qualities the FTC seeks in a buyer of the remedy package and how the FTC will seek to implement the remedy.
WHAT THIS MEANS:
  • On balance, the Study supported the FTC’s current practices.
  • Remedy packages consisting of an ongoing business were all successful—which confirms FTC’s long-held conviction that these kinds of divestitures are highly likely to succeed in restoring competition.
  • There will be heightened focus when the remedy package consists of selected assets (that is, not an ongoing business) and a heightened focus on the financing/funding of the divestiture buyer.
  • In these situations, merging parties should expect a fact intensive inquiry by the FTC, the potential for the FTC to seek larger asset packages that include products outside of the competitive problem area (if needed to make the proposed buyer competitive) and increased information sharing with the proposed buyer (and future competitor) to transition the business.
  • FTC has a strong preference for proposed buyers with experience and strong financial commitment to the business. These kinds of proposed buyers are more effective at securing the right personnel, understanding what’s needed to effectively compete (e.g., assets, supply agreements, production processes) and implementing the transition.


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The LATEST: FTC “Second Requests” to be Narrower in Scope under Ohlhausen’s Leadership

by , and | Feb 17, 2017 | ,

Transactions that meet the Hart-Scott-Rodino thresholds for notification must be reported to the Federal Trade Commission (“FTC”) and Department of Justice. Where a notified transaction raises competition concerns, the reviewing agency may decide to launch an in-depth investigation and request additional information from the merging parties, known as a “Second Request,” which can take several months and cost companies millions of dollars to fully respond. Under FTC Acting Chairwoman Maureen Ohlhausen’s leadership, however, the burden of a Second Request may decrease, as she intends to narrow their scope.

WHAT HAPPENED:
  • Acting Chairwoman Ohlhausen has signaled that Second Requests will be more limited under her leadership, based on comments made on February 15, 2017 at a Washington conference.
  • The standard for initiating a Second Request will not change. However, once initiated, Second Requests will be narrower in scope, in terms of markets assessed and data requested from companies.
WHAT THIS MEANS:
  • The standard used by the FTC to initiate such investigations will not change; thus, complex transactions raising competition concerns will likely still face a Second Request.
  • However, the time and cost associated with complying with a Second Request may be reduced, which will be good news for companies who may face a shorter review at a lower cost.
  • This business-friendly approach is consistent with Commissioner Ohlhausen’s guiding principles of “regulatory humility, […] the power of competitive markets, and a devotion to empiricism” and her objective to “minimiz[e] the burdens on legitimate businesses”. As such, it may be one of further changes to come in FTC enforcement.

The FTC’s Path Ahead.

Statement of Acting FTC Chairman Ohlhausen on Appointment by President Trump.



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Flurry of Antitrust Merger Enforcement Actions as Obama Presidency Comes to a Close

by | Feb 2, 2017 | , ,

The Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) announced several antitrust enforcement actions in advance of the inauguration of President Trump, including settlements for failures to file under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), a challenge to an unreportable deal and a settlement of a “gun-jumping” claim under the HSR Act. These cases illustrate the importance of compliance with the often complex reporting, waiting period and substantive aspects of antitrust laws in connection with acquisitions of various types, whether or not those acquisitions require premerger reporting. Failure to comply can result in significant financial penalties.

Two HSR “Failure to File” Settlements. On January 17, 2017, the FTC announced two settlements for failures to submit HSR filings and observe the statutory waiting period under the HSR Act prior to consummating acquisitions that met the relevant thresholds. The HSR Act requires notification of certain acquisitions of voting securities, assets and non-corporate interests if the value held as result of the transaction is in excess of certain notification thresholds and size of person thresholds (if applicable), and the transaction is not otherwise exempt. Parties to reportable transactions must observe the statutory waiting period prior to closing. If they fail to file, or otherwise do not observe the waiting period under the HSR Act, the parties may be liable for civil penalties of up to $40,654 per day (which was recently increased from $40,000, effective February 24, 2017).

In the first settlement, Ahmet Okumus agreed to pay $180,000 in connection with failing to notify for his purchases of voting securities of Web.com Group, Inc. (Web.com). According to the complaint, in September 2014, Okumus acquired voting securities of Web.com and as a result, held approximately 13.5 percent of the voting securities of Web.com. Okumus continued to acquire voting securities of Web.com through November 2014. Okumus did not file an HSR notification prior to making these acquisitions, relying on the “investment only” exemption, which exempts acquisitions resulting in holdings of 10 percent or less of the issued and outstanding voting securities if the shares are held solely for the purpose of investment (see 15 U.S.C. § 18a(c)(9) and 16 C.F.R. § 802.9). However, because Okumus held in excess of 10 percent, this exemption was not applicable. In late November of 2014, Okumus made a corrective filing that allowed him to acquire additional Web.com voting securities for approximately five years, provided that the value of the voting securities he held as a result of any acquisition did not exceed the $100 million (as adjusted) notification threshold. In a letter that accompanied his corrective filing, he indicated that the failure to file was inadvertent. The FTC did not seek civil penalties in that instance.

In June of 2016, Okumus began acquiring additional voting securities of Web.com. Later that month he acquired 236,589 voting securities of Web.com, and as a result of that acquisition, Okumus held voting securities valued (per the HSR rules) in excess of the $100 million (as [...]

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Antitrust M&A Snapshot: October – December 2016 Update

by , and | Jan 30, 2017 | , , , , ,

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.

 



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Musical Chairs at the FTC—Ohlhausen is New Acting Chairwoman

by | Jan 27, 2017 | ,

This month has seen significant changes in the landscape of federal leadership and the changes have now reached the Federal Trade Commission (FTC). On January 13, current Chair Edith Ramirez announced that she would resign from her position effective February 10, 2017. This Wednesday, January 25, the new administration designated Maureen Ohlhausen as Acting Chair. Ohlhausen, a Republican, was one of two remaining commissioners at the agency, along with Democrat Terrell McSweeny.

Ramirez served as a commissioner since 2010 and chair since early 2013 by designation of fellow Harvard Law Review member, President Obama. She spent her early career as a litigator with Quinn Emanuel and focused on antitrust, unfair competition and Lanham Act work. From the beginning of her tenure as chair, Ramirez developed a reputation as a hard-working and effective leader who was experienced, even-handed and not afraid to bring mergers to court. As a Latina and the daughter of Mexican immigrants, Ramirez was the first member of an ethnic minority to oversee the agency. During her tenure, she also secured a number of high-profile wins for the commission.

Ohlhausen has been a commissioner since 2012, though she started at the FTC’s General Counsel’s Office back in 1997. She has also worked as an advisor to former FTC Commissioner Orson Swindle and has been Deputy Director and then Director of the Office of Policy Planning. Ohlhausen stated at a Heritage Foundation antitrust conference this month that “all signs point to a new antitrust policy.” She discussed narrowing the scope of “Second Requests” in merger reviews by making them more targeted and therefore less burdensome. She also expressed a priority of greater protection for intellectual property rights, complaining that the agency has been too quick to accuse standard essential patent (SEP) holders of anticompetitive behavior when suing to defend their rights.

Meanwhile, the new administration’s position on merger activity hasn’t been clear. While in October 2016, Donald Trump described the AT&T-Time Warner deal as “a deal we will not approve in my administration because it’s too much concentration of power in the hands of too few,” and said that Comcast’s acquisition of NBC Universal “concentrates far too much power in one massive entity that is trying to tell the voters what to think and what to do,” he has subsequently chosen advisers on telecom and antitrust issues who appear to apply traditional antitrust analysis that is more merger-friendly than the prior administration.

Republican and Former Commissioner Joshua Wright leads the new administration’s transition of the FTC. The incoming administration will need to find three new commissioners for the five-member panel. At least one of the three must be a Democrat. The new appointments will be very important to follow for clients considering mergers in the near future.



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Notification Threshold Under the Hart-Scott-Rodino Act Increased to $80.8 Million

by | Jan 26, 2017 | ,

Pursuant to the amendments passed by the US Congress in 2000, the FTC announced revised thresholds for HSR pre-merger notifications on January 19, 2017. These increased thresholds will become effective 30 days following publication in the Federal Register. These new thresholds apply to any transaction completed and any HSR pre-merger notifications filed on or after the effective date, expected in late February.

Read the full article here.



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DOJ and FTC Release New Antitrust Guidelines for International Enforcement and Cooperation

by and | Jan 20, 2017 | ,

On Friday, January 13, 2017, the Department of Justice (DOJ) and Federal Trade Commission (FTC) released the new Antitrust Guidelines for International Enforcement and Cooperation. These guidelines were jointly developed by the agencies and serve to update the Antitrust Enforcement Guidelines for International Operations that have been in place since April 1995. The new guidelines include a revised discussion on conduct involving foreign commerce, a new chapter on international cooperation, and updated language, case law, and illustrative examples throughout.

Read the full article here.



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FTC and DOJ Update Antitrust Guidelines for the Licensing of Intellectual Property

by and | Jan 18, 2017 | , ,

On January 13, 2017, the Federal Trade Commission (FTC) and the Antitrust Division of the US Department of Justice (DOJ) issued updated Antitrust Guidelines for the Licensing of Intellectual Property (the Guidelines). The revised Guidelines follow nearly half a year of consideration and public commentary. According to the FTC, the updates were “intended to modernize the IP Licensing Guidelines without changing the agencies’ enforcement approach with respect to intellectual property licensing or expanding the IP Licensing Guidelines to address other topics.” In that vein, the modest updates to the Guidelines affirm that the antitrust agencies still believe that IP issues do not require an altered analysis and that the licensing of intellectual property is generally procompetitive.”

Read the full article here.



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