On April 14, 2016, the U.S. Department of Justice and two West Virginia hospitals entered into a consent decree requiring the hospitals to cease allocating territories for marketing their healthcare services. The complaint and consent decree can be viewed here and here. This consent decree follows a similar consent decree that the DOJ entered into with three Michigan hospitals in June 2015, perhaps signaling the DOJ’s increased focused in policing allegedly anticompetitive agreements among hospitals and medical centers.
This alert, the title of which is adapted from a March 30, 2016 FTC Staff Attorney blog post, considers the FTC’s first lawsuit challenging a so-called “no-AG” agreement. No-AG agreements are components of Hatch-Waxman patent infringement litigation settlements in which the brand manufacturer agrees, expressly or through exclusive licenses, not to launch an “Authorized Generic” for a period of time after the generic manufacturer’s entry. The FTC’s complaint attacks two such settlements that Endo Pharmaceuticals Inc. and the Japan-based patent holder for one of the relevant patents reached with generic manufacturers Watson Laboratories (and Watson’s current owner, Allergan plc) and Impax Laboratories, to settle Hatch-Waxman litigation involving Endo’s two most important products—the pain relievers Opana ER® and Lidoderm®. The FTC’s complaint, and its simultaneous settlement with the Japanese patent holder and its U.S. subsidiary (collectively, “Teikoku”), are less a window into the FTC’s thinking, which at this point is hardly unpredictable, than they are into its litigation strategy and what drug manufacturers need to consider regarding potential FTC and private actions as they continue to wrestle with the many issues that remain unresolved post-Actavis.
Members of Orrick’s Life Sciences practice with experience addressing pharmaceutical industry antitrust and IP issues recently published an article analyzing the recent decision of the U.S. Court of Appeals for the Federal Circuit in In re Loestrin, No. 14-2071 (1st Cir. Feb. 22, 2016). In that decision—only the second appellate decision applying the Supreme Court’s seminal 2013 decision in FTC v. Actavis , the First Circuit addresses a few of the antitrust issues surrounding so-called “reverse-payment” settlements of patent infringement litigation between branded and generic drug manufacturers. To read the published article, please click here.
The Consumer Rights Act 2015 (“CRA”) comes into force today, 1 October 2015.1 It introduces major reforms to the antitrust damages actions regime in the UK.2 In particular, the CRA broadens the type of cases that can be heard by the UK’s specialist antitrust court, the Competition Appeal Tribunal (the “CAT”), to include opt-out class actions, and makes other procedural amendments aimed at facilitating and streamlining private damages actions in the UK.
For the first time in its 101-year history, the Federal Trade Commission yesterday issued a policy statement outlining the extent of its authority to police “unfair methods of competition” on a “standalone” basis under Section 5 of the Federal Trade Commission Act. In a terse Statement of Enforcement Principles, the Commission laid out a framework for its Section 5 jurisprudence that was predictably tethered to the familiar antitrust “rule of reason” analysis but also sets forth a potentially expansive approach to enforcement. Indeed, the Commission’s approach could encompass novel enforcement theories premised on acts or practices that “contravene the spirit of the antitrust laws” as well as those incipient acts that, if allowed to mature or complete, “could violate the Sherman or Clayton Act.” Commissioner Ohlhausen’s lone dissent recognizes these potentially disconcerting developments for private industry. Read More
On July 30, 2015, the Ninth Circuit issued one of the most significant appellate opinions regarding standard essential patents (SEPs) subject to commitments to license on fair, reasonable and non-discriminatory (FRAND, or simply RAND) terms. In Microsoft Corp. v. Motorola, Inc. (Case No. 14-35393), the Court upheld determinations by U.S. District Court Judge James Robart (W.D. Wash.) as to (i) when a member of a Standard Setting Organization (SSO) is obligated to license that member’s SEP on FRAND terms, (ii) what the proper methodology is for calculating a FRAND royalty rate, and (iii) what remedies are available for breach of an obligation to license a SEP on FRAND terms. The affirmance represents a major victory for Microsoft and other SEP licensees, and provides significant guidance regarding future FRAND disputes.
On July 16, 2015, the EU’s highest court, the Court of Justice, rendered its long-awaited ruling on whether seeking an injunction for a standard-essential patent (“SEP“) against an alleged patent infringer constitutes an abuse of a dominant position pursuant to Article 102 TFEU. The judgment was in response to a request for a preliminary ruling from the Landgericht Düsseldorf (Regional Court of Düsseldorf, Germany) in the course of a dispute between Huawei Technologies Co. Ltd (“Huawei“) and ZTE Corp. together with its German subsidiary ZTE Deutschland GmbH (together, “ZTE“).
On June 22, 2015, in a 6-3 decision in Kimble et al. v. Marvel Enterprises, LLC, 576 U.S. (2015), the United States Supreme Court reaffirmed its holding in Brulotte v. Thys, 379 U.S. 29 (1964), that it is per se patent misuse for a patentee to charge royalties for the use of its patent after the patent expires. While acknowledging the weak economic underpinnings of Brulotte, the Court relied heavily on stare decisis and Congressional inaction to overrule Brulotte in also declining to do so itself. Although Kimble leaves Brulotte intact, the decision restates the rule of that case and provides practical guidance to avoid its prohibition on post-expiration royalties. Critically, the Court appears to condone the collection of a full royalty for a portfolio of licenses until the last patent in the portfolio expires. In addition, the Court’s reasoning provides guidance as to how patent licensors can draft licenses to isolate the effect of a later finding that patents conveyed under those licenses were previously exhausted.
On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva Pharmaceutical Industries Ltd., resolved long-running antitrust litigation stemming from four “reverse payment” settlements of Hatch-Waxman patent infringement cases involving the branded drug Provigil®. Pursuant to its settlement with the FTC (the “Consent Order”), Cephalon agreed to disgorge $1.2 billion and to limit the terms of any future settlements of Hatch-Waxman cases. The FTC and its Staff have celebrated and promoted the terms of the settlement as setting a new standard for resolving reverse-payment cases. But their enthusiasm may be more wishful thinking than reality, and their speculation that the agreement may exert force on market behavior does not appear to be supported by a fair assessment of the state of the law. First, the restrictions on Cephalon’s ability to enter into settlements of Hatch-Waxman cases exceed anything a court has ever required, and conflict with settlement terms apparently approved in the U.S. Supreme Court’s seminal reverse-payment decision, Federal Trade Commission v. Actavis, 133 S. Ct. 2223 (2013). Second, the FTC’s use of disgorgement as a remedy remains controversial and Cephalon, despite initial opposition, might have voluntarily embraced that remedy as part of a strategy to achieve a global resolution of remaining private litigation. We write to put the Consent Order in perspective, so that industry participants can better assess its meaning.
In late May, the U.S. Court of Appeals for the Second Circuit issued the first appellate decision addressing the pharmaceutical industry practice called by some “product hopping”—a two-step process in which a drug approaching the end of its patent term is withdrawn or made less desirable to customers so that patients will switch to a successor product with more exclusivity remaining. In this way, drug manufacturers may seek to protect sales from generic competition. “Product hopping” cases are often analyzed under the antitrust rules developed to assess claims of “predatory innovation” or related conduct, as exemplified by well-known cases involving Microsoft and Kodak. In this article, just published in Law360, lawyers from Orrick’s Intellectual Property and Antitrust groups weigh in on the Second Circuit’s decision, focusing on aspects of the analysis that may not be applicable in different cases and contexts.
Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court’s application of the Rule of Reason to the antitrust analysis of so-called “reverse payment” patent settlements (and rejected plaintiffs’ arguments that settlement payments exceeding the costs of litigation or other services are per se unlawful), but also set forth a specific “structured” Rule of Reason analysis to be applied in analyzing such settlements. A copy of the decision can be found here.
On Feb. 25, 2015, the U.S. Supreme Court held, in a 6-3 decision, that a state board with a controlling number of decision-makers, who are active market participants in the occupation the board regulates, does not enjoy state action immunity from federal antitrust laws unless “the State has articulated a clear policy to allow the anticompetitive conduct, and, the State provides active supervision of [the] anticompetitive conduct.” N.C. State Bd. of Dental Exam’rs v. F.T.C., 135 S. Ct. 1101, 1112 (2015). (Click here for a copy of the opinion.)
On Mar. 2, 2015, China’s National Development and Reform Commission (“NDRC”) published its decision in the Qualcomm case, which resulted in a $975 million fine against Qualcomm for alleged violations of the Anti-Monopoly Law. The decision provides useful guidance with respect to the NDRC’s views regarding several intellectual property licensing practices involving standard-essential patents (“SEPs”).
China’s State Administration for Industry & Commerce has published its long-awaited regulations regarding the use of intellectual property rights to eliminate or restrict competition. The Regulations, which are designed to foster innovation and competition, improve economic efficiency and protect consumer welfare, address both monopolistic agreements and the abuse of dominant market positions resulting from the ownership of IP rights. They go into effect on August 1, 2015.
On Feb. 25, 2015, the European Commission set out its strategy to achieve a European Energy Union with a forward looking climate change policy (“Framework Strategy”). Reforming and reorganizing Europe’s energy policy into a single energy market was outlined as a top priority by Jean-Claude Juncker, President of the Commission, in his political guidelines. The project is based on the three objectives of EU energy policy: (i) competitiveness; (ii) security of supply; and (iii) sustainability of infrastructure. The EU is the largest energy importer in the world, importing 53% of its energy, at an annual cost of around €400 billion.
On Feb. 12, 2015, the Court of Appeal to England and Wales dismissed Ryanair’s appeal against a judgment of the UK’s Competition Appeal Tribunal (“CAT”). The CAT had, on May 7, 2014, rejected Ryanair’s application for review of the findings of the Competition Commission (“CC”) in connection with Ryanair’s acquisition of a minority shareholding in Aer Lingus. In its final report, dated Aug. 28, 2013, the CC found that Ryanair and Aer Lingus had ceased to be distinct as a result of Ryanair’s minority shareholding (29.82%) that gave it the ability to exercise material influence over the policy of Aer Lingus. The CC reached its view by having regard to Ryanair’s ability to block special resolutions and the sale of slots at London Heathrow Airport. The CC then concluded that the minority stake resulted in a substantial lessening of competition because, in particular, Ryanair’s incentives as a competitor were likely to outweigh its incentives as a shareholder. The CC decided that a reduction of Ryanair’s holding to 5% would be an effective remedy.
The European Union’s Commissioner for Competition, Margrethe Vestager, who began her five-year mandate on Nov. 1, 2014, has indicated that there is more work to be done on the Commission’s initiative to close an enforcement gap related to minority shareholdings. The proposal—which would reform the EU Merger Regulation in order to give the Commission the power to scrutinise the acquisition of non-controlling minority interests—was one of the issues put out for consultation in the Commission’s White Paper, published July 2014. In a speech delivered Mar. 12, 2015, Vestager stated that the replies to the consultation had indicated that the proposal had not struck the right balance between the issues raised and the proposal’s procedural burden. The modalities of the system would now be discussed again within the Commission as well as Member States and other stakeholders. The White Paper had proposed a targeted transparency system that would enable parties to self-assess whether a transaction creates a competitively significant link and, if so, submit an information notice to the Commission. In the event that an information notice is submitted, the Commission would then decide whether to investigate the transaction.
On Feb. 17, 2015, the Court of Justice of the European Union (“CJEU”) brought an appeal before the Court of Justice against an order of the General Court that had found that the CJEU was the correct representative of the EU in an action for damages. The action for damages—that seeks to engage the non-contractual liability of the EU—arises as a result of a General Court failure to deliver a judgment within a reasonable time. As the latest development in a tussle that began in February 2006, the CJEU is contesting its liability for a breach committed by one of its own courts. The General Court’s responsibility for the excessively long proceedings (approximately five years and nine months) has already been confirmed.
On Mar. 9, 2015, the General Court confirmed the European Commission’s decision prohibiting the proposed merger between Deutsche Börse and NYSE Euronext. The merger—which would have brought together the two largest exchanges in the world for European financial derivatives— was blocked by the Commission in February 2012. The Commission’s investigation had found that the merger would lead to a significant impediment to effective competition by creating a near-monopoly position. In particular, the transaction would have led to a single vertical structure, trading and clearing more than 90% of the global market of European exchange-traded derivatives.
On Mar. 26, 2015, the Consumer Rights Act received Royal Assent. Schedule 8 of the Act, which amends the UK’s Competition Act, gives the UK Competition Appeal Tribunal (“CAT”) the power to hear stand-alone private damages actions as well as actions arising from an infringement decision with respect to a finding of a cartel or an abuse of dominance. Infringement decisions by both the UK Competition and Markets Authority (“CMA”) and the European Commission will be relevant for the purposes of a private damages action before the CAT. The Act permits collective proceedings to be brought before the CAT, either as opt-in or opt-out proceedings, and the CAT will also have the power to approve the settlement of claims in collective proceedings. Furthermore, the Act makes it possible for redress schemes to be approved by the CMA.
The measures are expected to come into force on Oct. 1, 2015.