Five Lessons: Ninth Circuit Upholds Decision to Block Idaho Healthcare Merger

amurinoFeatured Expert Column – Antitrust/Federal Trade Commission

Andrea Agathoklis Murino, Wilson Sonsini Goodrich & Rosati*

On February 10, the United States Court of Appeals for the Ninth Circuit affirmed a lower court ruling blocking the merger of St. Luke’s Health Systems, Ltd. (St. Luke’s) and Saltzer Medical Group (Saltzer), and handed the Federal Trade Commission (FTC) yet another victory in its efforts to halt consolidation in the healthcare sector.  This opinion is instructive both because of what it reveals on the macro-level about merger review today, and for what it may portend in future healthcare consolidation cases. Continue reading

The D.C. Circuit’s “POM Wonderful” Decision: Not So Wonderful for FTC’s Randomized Clinical Trial Push

FTC_Man_Controlling_TradeThe U.S. Court of Appeals for the D.C. Circuit last Friday largely upheld the Federal Trade Commission’s (“FTC”) ruling that POM Wonderful, Inc. violated the Federal Trade Commission Act by making unwarranted disease-prevention claims for its pomegranate juice products. But the ruling is far from the sweeping endorsement of FTC advertising-control measures that the Commission might have been hoping for. In particular, the ruling provides little, if any, support for the FTC’s recent assertions that food and dietary supplement manufacturers are largely barred from including health-related claims on product labels unless their claims are supported by randomized and controlled human clinical trials (“RCTs”). To the contrary, the appeals court made clear medical studies that do not meet RCT standards may nonetheless have considerable value, and that the FTC’s regulation of advertising is subject to strict First Amendment limitations. The decision suggests that courts may be very reluctant to uphold the FTC’s application of RCT standards to claims that a product promotes general health and nutrition, as distinct from claims that a product is effective in preventing or curing specific diseases.

POM’s ads were an easy target for the FTC. The ads touted POM’s products as effective in preventing a variety of diseases/conditions, including cardiovascular disease, prostate cancer, and erectile dysfunction (“ED”). Yet they failed to mention numerous shortcomings in the medical studies on which the disease-prevention claims were based—including that the studies’ findings were directly contradicted by other, larger clinical studies. Indeed, the D.C. Circuit held that it would have concluded that the ads were deceptive even had it chosen to apply a de novo standard of review to the FTC’s findings. (Because the case was on appeal from an FTC administrative proceeding, the D.C. Circuit reviewed those findings under a far more deferential “substantial evidence” standard.) Continue reading

FTC Commissioner Looks Back, and Ahead, on Patent Litigation Reform Efforts

FTC_Man_Controlling_TradeCommissioner Julie Brill of the Federal Trade Commission (FTC) offered some interesting year-end thoughts on abusive litigation by patent-assertion entities (“PAE”, or to some, “patent trolls”) in a speech last week. Most notable in Commissioner Brill’s comments was her call for legislative change even as FTC and the federal courts are addressing some of the legal and economic incentives for abusive patent litigation.

Brill discussed the Commission’s ongoing study of patent-assertion entities (the so-called 6(b) study), for which a final report is anticipated by the end of 2015. She emphasized that one of the issues FTC is assessing is the practice of “privateering,” where an operating company sells or licenses a patent to an assertion entity, which in turn enforces the patent against the operating entity’s market rivals. A May 2014 Washington Legal Foundation Web Seminar, Patent Assertion and “Privateering”: When Do Antitrust Law Concerns Arise When the Patent Is the Product?, focused on this practice.

The speech also referenced the Commission’s first enforcement action against a patent-assertion entity, which resulted in a November 13 consent decree. The action involved notorious “scanner troll” MPHJ, which sent thousands of licensing demand letters that threatened litigation unless the target business paid MPHJ upwards of $1,000 per employee. FTC charged that MPHJ had fraudulently asserted that it had entered into licenses with some of its targets, and falsely claimed that litigation was imminent.

thumbnailTrollCommissioner Brill went on to stress the impact several 2014 Supreme Court decisions had on the larger patent-assertion problem. She focused on the indefinite nature of many PAE-held patents, an issue that the Court addressed in Nautilus Inc. v. Biosig Instruments, Inc.; the tendency of PAEs to “pass off old abstract ideas as inventions merely by implementing them using a computer,” which arose in Alice Corp. Pty. Ltd. v. CLS Bank Int’l; and the difficulty patent defendants had in seeking attorneys’ fees when they prevailed in court against PAEs, which the justices addressed in Octane Fitness, LLC v. Icon Health & Fitness, Inc. and Highmark v. Allcare Health Mngt. Systems, Inc.

She then stated that “despite these recent cases, there are still important issues for Congress to address.” We were pleased to see that among the areas Commissioner Brill highlighted as meriting continued congressional attention was that patent “complaints [must] provide specific allegations of what infringes a patent’s claim and how the defendant infringes them.” The current pleading standard, governed by the antiquated form (Form 18) Federal Rule of Civil Procedure 84 dictates for patent suits, encourages frivolous litigation, as we’ve argued previously.

It is unclear what lies ahead for patent litigation reform in the 114th Congress. But one can trust that with so much at stake, Senators and Representatives will heed Commissioner Brill’s admonition that Congress not “wait for completion of our 6(b) study” to move the debate forward.

Also published by Forbes.com on WLF’s contributor page

WLF Briefing: Private Ordering Solutions Advance Patent Non-Aggression

This November 10, 2014 WLF Media Briefing, Toward Patent Non-Aggression: Market-Based Approaches to Deterring Legal Risks and Neutralizing Litigation, featured presentations by three innovators whose ideas are minimizing operating companies’ exposure to abusive patent lawsuits:

  • Keith Bergelt, CEO of the Open Invention Network;
  • Kevin Jakel, CEO of Unified Patents, Inc.; and
  • Tim Kowalski, Senior Patent Counsel to Google Inc. and Director, License on Transfer Network

Our speakers make reference to PowerPoint slides, which can be downloaded here.

If you would prefer to watch the presentation in higher resolution video where you can view the slides synched with the presentations, WLF has posted it in its online archive of on-demand videos here.

Antitrust and Health Care: FTC’s Off-Again, On-Again Challenge to Georgia Hospital Merger

amurinoFeatured Expert Column – Antitrust/Federal Trade Commission

Andrea Agathoklis Murino, Wilson Sonsini Goodrich & Rosati

Consolidation in the health care industry, and the Federal Trade Commission’s (“FTC” or “Commission”) perspective on such activity, are being closely watched in antitrust law and policy circles. In April 2011, the FTC challenged the acquisition of Palmyra Park Hospital by Phoebe Putney Health System Inc. (“Phoebe”) in Albany, Georgia. The Commission argued that the combination would result in unduly high market shares (>85%) in the provision of acute care services in a six-county region and result in anticompetitive price increases. Shortly thereafter, the FTC sought and obtained a preliminary injunction (“PI”) from the United States District Court for the Middle District of Georgia halting the transaction pending trial. Typical enough. But here’s where our story starts to take some strange twists. What began that April in a federal district court is an adventure leading from the Supreme Court to local Georgia healthcare regulatory bodies…and possibly, back again. Here’s what happened.

Phoebe responded to the PI not by throwing itself into a trial on the merits, but rather by filing a motion to dismiss on the grounds that by virtue of the state action doctrine, Phoebe’s conduct was permissible. Generally, the state action doctrine provides that where (1) there is a clearly articulated state policy to displace competition and (2) there is active supervision by the state of the policy or activity, otherwise anticompetitive activity will be permitted. Here, Phoebe argued that because it was owned by the Hospital Authority of Albany-Dougherty County, and operated under Georgia’s Hospital Authorities Law, it was immune. Phoebe prevailed on its motion to dismiss in the district court and then again at the U.S. Court of Appeals for the Eleventh Circuit. Phoebe then completed its purchase of Palmyra, closing the transaction. Continue reading

Education and Information Sharing: Underutilized Tools in FTC’s Data Security Work

150px-US-FederalTradeCommission-Seal.svgThe Federal Trade Commission (FTC) has brought 52 enforcement actions involving data breaches. Fifty of those businesses, whose computer systems were illegally accessed by hackers, settled rather than fight FTC’s accusations that they acted “deceptively” or “unfairly” under § 5 of the FTC Act. And yet, the data breaches just keep on coming, with unlawful intrusions on Home Depot’s payment-card processing system and the federal HealthCare.gov website occurring just this past week. It’s high time the Commission utilized tools at its disposal aside from the enforcement hammer to address data security.

WLF is not the only organization advancing this notion. On March 25, 2014, Consumer Action, Consumer Federation of America, National Consumer League, and the Privacy Rights Clearinghouse wrote FTC Chairwoman Edith Ramirez, asking the Commission to “convene a public forum, bringing stakeholders together to discuss strategies for combating the growing threat of data breaches.”

FTC Commissioners routinely note in public statements that in addition to enforcement and advocacy, the Commission protects consumers and competition through education and information sharing. Public forums, workshops, and other events of the type the consumer groups sought in their letter have long been an integral part of FTC’s “educate and inform” function. Such events educate not only the public, but also the Commission and its staff. Continue reading

Court Upholds FTC Rule for Pharma Patent License Transfers

amurinoFeatured Expert Column – Antitrust/Federal Trade Commission

Andrea Agathoklis Murino,Wilson Sonsini Goodrich & Rosati

Last November, I wrote about a new Federal Trade Commission (FTC) rule which, in a change to long-standing policy, made the transfer of a license providing an exclusive licensee with “all commercially significant rights” over a patent within a therapeutic area reportable under the Hart-Scott-Rodino Act. In practice, this meant that licensing agreements which previously required only the signatures of the two parties, now required a waiting period and an FTC blessing.

Shortly before the rule was to become operative, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group representing biopharmaceutical researchers and biotechnology companies sued to block it. The group argued that the FTC had not observed the appropriate procedures under the Administrative Procedures Act and that the FTC lacked authority to issue an industry-specific rule rather than a rule of general application, among other claims.

In a lengthy opinion on May 30, 2014, Judge Beryl A. Howell of the United States District Court for the District of Columbia, sided with the FTC and tossed PhRMA’s claims, finding that the FTC had followed the correct processes, had a reasoned basis for creating and instituting this rule, and should be shown deference. This bottom line is this puts us right back to where the FTC hoped it would be back in November: the transfer of “all commercially significant rights” over a patent is a HSR-reportable event.

That’s the headline but there are at least two questions that result from the opinion worth pausing to consider. First, this rule continues to only apply to the pharmaceutical industry. There are virtually no other industries with HSR-specific rules applicable only to them. Does this mean the FTC plans to extend HSR-specific rules to other industries? Or is the pharma industry so important in its own right that proper antitrust enforcement demands a different set of rules? Only time will tell. More importantly, perhaps, the FTC has not defined the phrase “all commercially significant rights.” What are the contours of this definition? What’s included or excluded? How, if at all, will the FTC provide guidance to the pharma community? PhRMA has up to 60 days to appeal so this may not be the last word. Stay tuned.