Patents Settlements

Anticompetitive practices

EU / US Patent Settlements: An overview of leading cases
Sidley Austin (London)
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Sidley Austin (Brussels)
1. Introduction 1.1 In October 2013, the authors penned a foreword to a special edition of Concurrences on patent settlement agreements. 1.2 A lot has happened since that foreword was published. The European Commission (“Commission”) has issued – and published – infringement decisions in a (...)

The EU Commission sends a statement of objection to a pharmaceutical company regarding possible pay-for-delay agreement (Teva / Cephalon)
European Commission - DG COMP (Brussels)
Antitrust: Commission sends Statement of Objections to Teva on ’pay for delay’ pharma agreement* The European Commission has informed pharmaceutical company Teva of its preliminary view that an agreement concluded with Cephalon was in breach of EU antitrust rules. Under the agreement, Teva (...)

The EU General Court confirms the decision of the Commission concerning its first pharma pay-for-delay case (Lundbeck)
University of East Anglia - CCP (Norwich)
General Court’s pay for delay judgment in Lundbeck – some guidance, but worries remain*On 8 September, the General Court handed down its eagerly awaited decision in Lundbeck – the first ever European judgment concerning so-called pay for delay settlements. The Commission’s decision in this case was (...)

The EU General Court confirms the decision of the EU Commission concerning its first pharma pay-for-delay case (Lundbeck)
European Commission - DG COMP (Brussels)
Antitrust: Commission welcomes General Court judgments upholding its Lundbeck decision in first pharma pay-for-delay case Today the General Court upheld the Commission’s Lundbeck decision and ruled for the first time that pharma pay-for-delay agreements breach EU antitrust rules. In such (...)

The EU General Court rules on the legitimacy of settlement agreements in the pharmaceutical sector (Lundbeck)
Peters & Peters
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Peters & Peters
Lundbeck - Buying off the competition* On 8 September 2016, the ECJ handed down its judgment in the latest battle between pharmaceutical companies and competition authorities over “pay for delay” agreements. The appeal of H Lundbeck A/S and Lundbeck Ltd (together “Lundbeck”) against the decision (...)

The EU General Court upholds the Commission’s landmark patent settlement agreement decision (Lundbeck)
Sidley Austin (London)
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Sidley Austin (London)
EU General Court upholds Commission’s landmark Patent Settlement Agreement decision* In a much-anticipated series of judgments, running to some 579 pages, the EU’s General Court on 8 September 2016 upheld a 2013 decision of the European Commission that imposed fines of almost €150 million on the (...)

The EU Court of Justice rules that payment of royalties under a licence agreement where the patent was held invalid may be compatible with Article 101 TFEU (Genentech / Hoechst)
Blackstone Chambers
License fees, invalid patents and Article 101 TFEU: Genentech v Hoechst and Sanofi Aventis* Consider an agreement under which a license fee is payable for use of a patented technology even if it transpires that the patent is invalid. Is such an agreement contrary to Article 101 TFEU? The answer (...)

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)
Constantine Cannon (New York)
First Circuit boosts antitrust challenges to pay-for-delay settlements by finding non-cash deals subject to Actavis scrutiny*Antitrust challenges to so-called “pay-for-delay” settlements—in which brand-name drug makers temporarily keep generics out of the market by making payments to would-be (...)

The U.S. FTC urges the Court of Appeals for the First Circuit to consider that a reverse payment need not be in cash (Loestrin)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC urges the Appeals Court to revive the Loestrin Suit* On December 7, 2015, during oral argument, the U.S. FTC urged the Court of Appeals for the First Circuit to revive the Loestrin suit. The case concerns a so-called reverse payment settlement. In 2009 Watson Pharmaceuticals agreed (...)

The UK Competition and Markets Authority fines pharmaceutical companies for pay-for-delay deals (GSK)
Constantine Cannon (London)
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Constantine Cannon (London)
UK Antitrust Watchdog slaps $65 million fine on Pharma Companies in UK’s first pay-for-delay case*On 12 February 2016, the Competition and Markets Authority (“CMA”), UK’s competition regulator, fined a number of pharma companies for anti-competitive conduct and agreements in relation to the supply (...)

The UK Competition Authority fines several pharmaceutical companies for pay-for-delay settlements (GlaxoSmithKline)
UK Competition and Markets Authority (CMA) (London)
CMA fines pharma companies £45 million* The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine. The CMA’s decision relates to conduct and agreements between 2001 and 2004 in which GlaxoSmithKline plc (GSK), the (...)

The US District Court for the Southern District of New York dismisses lawsuit over patent settlement where generics were granted early-entry licenses with acceleration clauses (Takeda Pharmaceuticals)
Patterson Belknap Webb & Tyler
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Patterson Belknap Webb & Tyler
Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with Acceleration Clauses* On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three (...)

The US FTC subjects to public comment the consent agreement proposed by two pharmaceutical companies that implemented an unlawful agreement not to compete (Concordia and Par)
US Federal Trade Commission (FTC) (Washington)
Pharmaceutical companies settle ftc charges of an illegal agreement not to compete, which resulted in higher prices for generic version of ADHD drug* Pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. have settled FTC charges that they entered into an unlawful (...)

The US District Court for the District of Massachusetts rejects a request for a new trial to challenge a “pay-for-delay” agreement (Nexium)
Wolters Kluwer (Riverwoods)
Judgment for Drug Companies Unlikely the End of the Road in Nexium Case* The federal district court in Boston has rejected a request from purchasers of AstraZeneca LP’s heartburn medication Nexium for a new trial to challenge a “reverse payment” or “pay-for-delay” agreement between AstraZeneca and (...)

The US District Court for the Northern District of California upholds assignment of antitrust claims to indirect purchasers (United Food / Teikoku Pharma)
Patterson Belknap Webb & Tyler
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Patterson Belknap Webb & Tyler
Northern District of California Upholds Assignment of Antitrust Claims to Indirect Purchasers* Portions of a reverse payment suit against Endo Pharmaceuticals and others were recently dismissed by Judge William H. Orrick of the Northern District of California. The case [1] was brought by (...)

The U.S. Court of Appeals for the Third Circuit concludes that the Actavis ruling applies to non-cash payments (Lamictal)
Rutgers University
On June 26, 2015, in the first federal appellate drug patent settlement ruling since the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the U.S. Court of Appeals for the Third Circuit overturned a lower court decision granting a motion to dismiss for defendants. Writing for (...)

The US FTC reaches settlement in post-Actavis reverse payment case (Cephalon)
O’Melveny & Myers (Washington)
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O’Melveny & Myers (Los Angeles)
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O’Melveny & Myers (Washington)
The Federal Trade Commission (“FTC”) has reached a settlement resolving its claims that Cephalon, Inc. violated the antitrust laws by entering into reverse payment settlements to delay generic competition for Provigil. This is the first FTC settlement of a reverse payment case post-Actavis, and (...)

The US FTC reaches a settlement with a pharmaceutical company and continues march “to set a standard for the industry” in pay-for-delay settlements cases (Cephalon)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
Federal Trade Commission Continues March “to Set a Standard for the Industry” with Cephalon Settlement* On May 28, the Federal Trade Commission (“FTC”) announced it had reached a $1.2 billion settlement with Teva Pharmaceuticals, which acquired Cephalon in 2012, over reverse payment for its (...)

The US FTC reaches record $1.2 billion proposed “pay for delay” settlement and injunctive relief restricting future similar settlements of patent infringement cases (Cephalon)
Weil, Gotshal & Manges (New York)
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Weil, Gotshal & Manges (New York)
Federal Trade Commission Reaches Record $1.2 Billion Proposed “Pay for Delay” Settlement with Cephalon and Injunctive Relief Restricting Future Similar Settlements of Patent Infringement Cases* Last week, on the eve of trial, the Federal Trade Commission (“FTC”) reached a proposed settlement in (...)

The California Supreme Court delineates a structured rule of reason analysis for evaluating reverse payments or pay-for-delay settlements (Cipro)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
California Supreme Court Delineates a Structured Rule of Reason Analysis for Evaluating Reverse Payment or Pay-for-Delay Settlements* On May 7, 2015, the California Supreme Court issued its long-awaited decision in In re Cipro Cases I & II, Case No. S198616 (May 7, 2015) (Cipro). Cipro (...)

The California Supreme Court crafts "structured rule of reason" test for evaluating pay-for-delay settlements (Cipro)
Patterson Belknap Webb & Tyler
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Patterson Belknap Webb & Tyler
Following Actavis, California Supreme Court Crafts “Structured Rule of Reason” Test for Evaluating Pay-for-Delay Settlements* Last Thursday the Supreme Court of California decided In re Cipro Cases I & II, No. S198616 (Cal. May 7, 2015), holding that reverse payment, or “pay-for-delay,” (...)

The US Supreme Court hears arguments before deciding on whether post-expiration license royalty obligations are caught in the web of patent policies or antitrust analysis (Kimble / Marvel)
Constantine Cannon (Washington)
Supreme Court Seeks To Untangle Patent And Antitrust Principles Caught In Spider-Man’s Web* The Supreme Court heard oral argument today on whether litigation over a toy based on Spider-Man’s web should be used to vanquish a 50-year-old precedent precluding patent owners from collecting patent (...)

The U.S. District Court for the Eastern District of Pennsylvania sends second reverse-payment case to trial (Cephalon)
Rutgers University
On January 28, 2015, Judge Mitchell Goldberg of the U.S. District Court for the Eastern District of Pennsylvania denied defendants’ summary judgment motions, sending the second reverse-payment-settlement case to trial. In King Drug Company of Florence v. Cephalon, 2015 WL 356913 (E.D. Pa. Jan. (...)

The US District Court for the Eastern District of Pennsylvania holds that Actavis does not require plaintiffs to meet any sort of “threshold burden” for establishing that a large reverse payment is unjustified to trigger analysis under the antitrust rule of reason (Modafinil)
Kaye Scholer (New York)
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Arnold & Porter (Washington)
In re Modafinil Litigation Finds No “Threshold Burden” in Reverse Payment Suit* On Wednesday, January 28, in King Drug Company of Florence, Inc. v.Cephalon, Inc. (In re Modafinil), the US District Court for the Eastern District of Pennsylvania held that FTC v. Actavis, 133 S. Ct. 2223 (2013), (...)

The US FTC bars a patent assertion entity from using deceptive tactics through a settlement (MPHJ)
Stanford University - Stanford Law School
FTC settlement bars patent assertion entity from using deceptive tactics* On 6 November 2014, the Federal Trade Commission communicated that MPHJ Technology Investments (“MPHJ”) and its law firm have agreed to settle Federal Trade Commission charges that they used deceptive sales claims and (...)

A US appellate panel questions whether reverse payments need to be in cash to put the patent settlement under the scrutiny of antitrust laws (GlaxoSmithKline)
DLA Piper Weiss-Tessbach (Vienna)
Reverse payments can be non-cash according to appellate judges* On 19 November 2014 in a hearing regarding the possible reopening of a lawsuit over whether GlaxoSmithKline (GSK) unfairly extended the monopoly on its drug Lamictal, an appellate panel of the Third Circuit suggested that reverse (...)

A US District Court reminds that even if a Court accepts the premise of a reverse non-monetary payment after Actavis, plaintiffs may have to allege facts to allow an estimate of the monetary value of that settlement or risk facing dismissal (Lipitor)
Patterson Belknap Webb & Tyler
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Patterson Belknap Webb & Tyler
Plausibly Alleging Non-monetary Settlements as Reverse Payments After Actavis* In In re Lipitor Antitrust Litigation, No. 12 Civ. 2389 (D.N.J.), U.S. District Judge Peter G. Sheridan has confirmed his prior ruling that under the Supreme Court’s decisions in Twombly, Iqbal, and FTC v. Actavis, (...)

The EU Court of Justice provides further clarity on when an agreement has the object of restricting competition (Groupement des cartes bancaires)
St John’s Chambers
Restrictions by object: duck and elephant hunting with the Court of Justice* Inductive reasoning is sometimes explained by using either the ‘duck test’ (“if it looks like a duck, swims like a duck and quacks like a duck, then it probably is a duck”) or the ‘elephant test’ (“it is difficult to (...)

The EU Court of Justice invites to rethink the approach to pay for delay settlements in its recent case law (Groupement des Cartes Bancaires)
University of East Anglia - CCP (Norwich)
European Pharmaceutical Antitrust after Groupment des Cartes Bancaires – Time to Rethink the Approach to Pay For Delay Settlements?* Over the last year the European Commission has stepped up its enforcement efforts against pay for delay settlements. In June 2013 they imposed a fine for the (...)

The US FTC files a federal antitrust complaint for the Eastern District of Pennsylvania for entering into an agreement to maintain a monopoly over and restrain generic competition (AbbVie, Abbott, Besins Healthcare and Teva)
Skadden, Arps, Slate, Meagher & Flom (New York)
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Skadden, Arps, Slate, Meagher & Flom (Washington)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The US FTC files a complaint before the District Court for the Eastern District of Pennsylvania asserting that reverse payments do not have to be cash or monetary in order to violate antitrust laws (AbbVie)
Constantine Cannon (New York)
Regulators Prescribing Higher Dose Of Pharmaceutical Antitrust Enforcement* Antitrust enforcers returned to their offices after Labor Day, refreshed and ready to tackle what they view to be anticompetitive practices by pharmaceutical companies to delay entry of lower-priced generic drugs. In (...)

The US FTC files a complaint against five pharmaceutical companies for pay-for-delay settlements (AbbVie)
Skadden, Arps, Slate, Meagher & Flom (New York)
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Skadden, Arps, Slate, Meagher & Flom (Washington)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The U.S. District Court for the District of Rhode Island issues concerning ruling on drug patent settlements (Loestrin)
Rutgers University
On September 4, 2014, Judge William Smith of the U.S. District Court for the District of Rhode Island issued a concerning ruling on drug patent settlements. In In re Loestrin 24 FE Antitrust Litigation, 2014 WL 4368924 (D.R.I., Sept. 4, 2014), Judge Smith misapplied the Supreme Court’s landmark (...)

The US District Court for the Eastern District of Pennsylvania holds that a firm which has engaged in fraud on the patent office cannot stand on its patent to defend reverse payment antitrust claims (Cephalon)
Sheppard Mullin (San Francisco)
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Paul Hastings (Washington)
Last year in a landmark decision, the Supreme Court ruled that pharmaceutical “reverse payment” settlements in Hatch-Waxman Act “Paragraph 4” patent litigation are subject to challenge, departing from the rule that most Circuits had adopted. FTC v. Actavis, 133 S.Ct. 2223 (2013). In these cases, (...)

The EU Commission imposes a fine of € 427.7 million on a French pharma manufacturer and five generic companies as regards pay-for-delay settlements impeding price competition on the market for blood pressure medicines (Servier)
University of East Anglia - CCP (Norwich)
Article published on Centre for Competition Policy blog. The EU Commission Decision against Servier – a New Dimension to European Pharmaceutical Antitrust?* On 9 July 2014 the European Commission announced its decision to impose a fine of €427.7 million on French drug maker Servier and five (...)

The US FTC files an amicus brief in the Court of Appeals explaining that commitment not to compete raises the same antitrust concerns as the reverse-payment patent settlements (King Drug / SmithKlineBeecham)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files an amicus brief in the Court of Appeal urging to reverse the District Court finding in the Lamictal Direct Purchase Antitrust Litigation* On 28 April, 2014 the Federal Trade Commission (“FTC”) filed an amicus brief in the Court of Appeals for the Third Circuit in the (...)

The EU Commission announces its adoption of a revised technology transfer block exemption regulation and new accompanying guidelines
Norton Rose Fulbright (London)
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Norton Rose Fulbright (London)
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Norton Rose Fulbright (London)
Introduction The European Commission has recently announced its adoption of a revised Technology Transfer Block Exemption Regulation and new accompanying Guidelines, which will come into force on 1 May 2014 and apply for twelve years. This will impact on the risk of including certain clauses (...)

The EU Commission imposes fines of € 16M on pharmaceutical companies for delaying market entry of generic pain-killer (Johnson & Johnson and Novartis)
European Commission (Brussels)
European Commission imposes Fines of € 16 000 000 on Johnson & Johnson and Novartis for delaying Market Entry of generic Pain-Killer Fentanyl* On 10 December 2013, the European Commission imposed fines of € 10 798 000 on the US pharmaceutical company Johnson & Johnson (J&J) and € 5 (...)

The EU Commission publishes its fourth report on the monitoring in Europe of patent settlements
White & Case (Brussels)
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White & Case (Brussels)
Executive Summary On 9 December 2013, DG Comp published its fourth report on the monitoring in Europe of patent settlements. Like its predecessors, the report welcomes the continuously low level of settlements that may give rise to antitrust concerns and trumpets that the overall number of (...)

The EU Commission fines pharmaceutical companies for delaying market entry of generic medicines (Lundbeck)
Stanford University - Stanford Law School
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RSM US
European Commission fines Lundbeck and other pharmaceutical companies for delaying market entry of generic medicines* On 19 June 2013 the European Commission issued a press release stating that it had imposed fines in the amount of € 93,8 million on Lundbeck (a Danish pharmaceutical company) (...)

The EU Commission imposes fines totalling € 145 M on Danish pharmaceutical group over “pay-for-delay” agreements (Lundbeck)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis
On 19 June 2013, the European Commission announced that it had imposed a fine of € 93.8 million on Danish pharmaceutical group Lundbeck and fines totalling € 52.2 million on several generic medicines producers over their conclusion of so-called “pay-for-delay” agreements intended to hinder the (...)

The EU Commission fines pharmaceutical companies for delaying market entry of generic medicines through pay-for-delay agreements (Lundbeck)
European Commission (Brussels)
European Commission: Lundbeck and other Pharmaceutical Companies fined for delaying Market Entry of Generic Medicines through pay-for-delay Agreements* On 19 June 2013, the European Commission (the Commission) imposed a fine on the Danish pharmaceutical company Lundbeck and a number of (...)

The US Supreme Court holds that “reverse payment” patent settlements between brand-name drug manufacturers and would-be generic competitors should be reviewed under the antitrust rule of reason (Actavis)
Arnold & Porter (Brussels)
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Arnold & Porter (Washington)
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Arnold & Porter (Washington)
On Monday, June 17, the Supreme Court handed down a decision in FTC v. Actavis, Inc., bringing some clarity to the antitrust treatment of so-called reverse payment patent settlements between brand-name drug manufacturers and would-be generic competitors, but leaving many open questions as (...)

The US Supreme Court establishes a rule that blurs the lines between antitrust and patent law (Actavis)
Sheppard Mullin (Chicago)
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Sheppard Mullin (Washington)
FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?* On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade (...)

The US Supreme Court opens reverse payment patent settlement agreements to antitrust challenge (Actavis)
Wolters Kluwer (Riverwoods)
A “reverse payment” settlement agreement is not entitled to “near-automatic antitrust immunity” simply because its anticompetitive effects fall within the scope of the exclusionary potential of the patent, the U.S. Supreme Court ruled earlier this week in a five-to-three decision. Although such (...)

The US Supreme Court holds that patent protection does not confer immunity from antitrust attack (Actavis)
Stanford University - Stanford Law School
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RSM US
U.S. Supreme Court reverses Eleventh Circuit opinion in FTC v. Actavis, Inc* On 17 June 2013, the U.S. Supreme Court (“the Court”) reversed a decision by the Court of Appeals (Eleventh Circuit). The Court of Appeals had upheld a dismissal of a complaint made by the Federal Trade Commission (...)

The US Supreme Court rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis)
European Commission - DG Internal Market and Services
Facts In 1999, Solvay Pharmaceuticals filed a New Drug Application (NDA) for a topical testosterone hormone drug, called Androgel. In 2003, Solvay obtained patent protection for it. Subsequently, the generic companies Actavis (before Watson Pharmaceuticals) and Paddock Laboratories filed an (...)

The US Supreme Court holds that reverse-payment patent settlements should be reviewed under the antitrust rule of reason (Actavis)
O’Melveny & Myers (Washington)
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O’Melveny & Myers (Los Angeles)
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O’Melveny & Myers (Los Angeles)
But Decision Raises as Many Questions as it Answers The Supreme Court yesterday held that it may be unlawful under the antitrust laws for a brand-name drug manufacturer to resolve patent litigation against an allegedly infringing generic drug maker by paying the generic to forestall market (...)

The US Supreme Court rules that a payment by a patentee to a generic manufacturer may constitute an infringement of antitrust law (Actavis)
Orrick, Herrington & Sutcliffe (San Francisco)
Why FTC v. Actavis Won’t Shift the Border Between IP and Antitrust Law* The Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc., No. 12-416, ___ U.S. ___ (2013), has generated a lot of commentary recently. Some articles have suggested that the decision may expose certain (...)

The US Supreme Court issues first ruling on antitrust legality of reverse-payment drug patent settlements (Actavis)
Rutgers University
On June 17, 2013, in FTC v. Actavis, the U.S. Supreme Court for the first time examined the antitrust legality of agreements by which brand-name drug companies pay generics to delay entering the market. Justice Stephen Breyer wrote the majority opinion for five Justices, concluding that these (...)

The UK OFT issues a statement of objections to four pharma manufacturers for anticompetitive agreements over the supply of paroxetine (GSK / GUK / Alpharma / IVAX)
Stanford University - Stanford Law School
UK OFT investigates GSK and generics manufacturers over pay for delay deals* On 19 April 2013 the UK Office of Fair Trading (“OFT”) issued a Statement of Objections to GlaxoSmithKline (“GSK”) and three generics manufacturers (Alpharma Limited, Generics UK Limited and Norton Healthcare Limited) (...)

The UK OFT issues statement of objections to four pharma companies alleging they acted to delay effective competition in the national supply of an antidepressant medicine (GSK / GUK / Alpharma / IVAX)
Blackstone Chambers
To fight or not to fight: pharmaceutical patent settlements* On 19 April 2013, the OFT announced that it had issued a Statement of Objections following its investigation into patent litigation settlement agreements (PLSAs) in the pharmaceutical sector. The underlying factual complaint related (...)

The US FTC asks the Eleventh Circuit to overturn a lower court’s decision to allow a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Watson Pharmaceuticals)
Vinson & Elkins (Washington)
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Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The US FTC files amicus curiae brief supporting generics’ claim in patent dispute (Actelion Pharms/Apotex)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files amicus curiae brief supporting generics’ claim in patent dispute* On 11 March 2013 the U.S. Federal Trade Commission (“FTC”) filed an amicus curiae brief in the case Actelion Pharms Ltd. V. Apotex Inc. which is being heard in the U.S. District Court for New Jersey supporting the (...)

The EU Commission sends SOs to two pharmaceutical companies over possible delayed entry of generic (Johnson & Johnson and Novartis)
Van Bael & Bellis
On 31 January 2013, the European Commission announced that it had sent a Statement of Objections (“SO”) to pharmaceutical companies Johnson & Johnson (“J&J”) and Novartis over suspicions that an agreement between their Dutch subsidiaries in relation to Fentanyl (a strong pain killer (...)

The US FTC releases a summary of its new report on pharma patent litigation finding an increase in "reverse payment" settlements based on expanded definition of "payments"
Jones Day (Washington)
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Jones Day (Washington)
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Jones Day (Chicago)
With the Supreme Court set to address the validity of "reverse payment" settlements of pharmaceutical patent litigation, the FTC released a summary of its new report, announcing that in 2012 drug companies entered "a record number" of such settlements. However, the underlying data and analysis (...)

The US Supreme Court grants certiorari to consider the legality of reverse payment settlements (Actavis)
Stanford University - Stanford Law School
U.S. Supreme Court grants certiorari to consider the legality of reverse payment settlements* On 7 December 2012 the U.S. Supreme Court granted a petition to consider whether reverse payment settlement agreements are per se lawful or presumptively anti-competitive. In the case (U.S. Federal (...)

The EU Commission sends statement of objections to pharmaceutical companies over “pay-for-delay” agreements (Lundbeck, Servier)
Van Bael & Bellis
On 25 July 2012, the European Commission announced that it had sent a formal Statement of Objections (“SO”) to Danish pharmaceutical company Lundbeck over its conclusion of so-called “pay-for-delay” agreements with four generic producers of citalopram, a antidepressant medicine. In its SO, (...)

The EU Commission sends SOs to more than a dozen companies in connection with investigations in the pharmaceutical sector (Perindopril)
Stanford University - Stanford Law School
European Commission issues Statements of Objections against several pharmaceutical companies* On 25 and 30 July 2012, in relation to the Citalopram case and the Perindopril case respectively, the European Commission sent statements of objections (“SOs”) to more than a dozen companies in (...)

The EU Commission sends SOs to more than a dozen companies in connection with investigations in the pharmaceutical sector (Citalopram)
Stanford University - Stanford Law School
European Commission issues Statements of Objections against several pharmaceutical companies* On 25 and 30 July 2012, in relation to the Citalopram case and the Perindopril case respectively, the European Commission sent statements of objections (“SOs”) to more than a dozen companies in (...)

A US Court of Appeals applies a quick look rule of reason and rejects scope of the patent test when considering whether pharma patent settlement violates the antitrust laws (Schering-Plough)
Hyman, Phelps & McNamara
In our post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s only been about three weeks since that (...)

A US Court of Appeals rejects the “scope of the patent” test in favor of a “quick look” rule of reason analysis when reviewing reverse payment settlements between patent holders and would be generic competitors in the pharmaceutical industry (Schering-Plough)
Vinson & Elkins (Dallas)
Citing the dire consequences for companies seeking to comply with antitrust law in the wake of a direct circuit split, major pharmaceutical makers are asking the Supreme Court to review a Third Circuit decision that declared settlement payments by brand-name pharmaceutical companies to (...)

The US Court of Appeals for the Third Circuit rejects Scope-of-Patent test in antitrust challenge to patent settlements (K-Dur)
Wolters Kluwer (Riverwoods)
Third Circuit Rejects Scope-of-Patent Test in Antitrust Challenge to K-Dur Patent Settlement* Reverse payments settlements between patent holders and would-be generic competitors in the pharmaceutical industry should be reviewed under a “quick look” rule of reason analysis based on the economic (...)

A US Court of Appeals holds that although reverse payment settlements between brand-name and generic pharmaceutical manufacturers are not illegal per se, they are presumptively unlawful under the rule of reason (Schering-Plough)
Arnold & Porter (Washington)
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Hooper Hathaway
On July 16, 2012, in an opinion authored by Judge Sloviter, the Third Circuit issued its decision in the K-Dur “reverse payments” case, holding that although such settlements are not illegal per se, they are presumptively unlawful under the rule of reason. In so doing it rejected the approach (...)

The US Court of Appeals for the 11th Circuit reaffirms that the “scope of the patent” test is the proper standard of antitrust review of the reverse payment settlements among pharmaceutical companies (Solvay/Watson/Paddock)
United First Partners
Introduction In FTC v. Watson Pharmaceuticals, Inc. (“Watson”), the Eleventh Circuit reaffirmed its long line of precedents and held that, absent sham litigation or fraud in obtaining the patent, the “scope of the patent” test should be used to evaluate antitrust challenges to the reverse payment (...)

A US Court of Appeals rejects the FTC’s latest “Pay-For-Delay” challenge (FTC v. Watson)
Mayer Brown (Washington)
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US Federal Trade Commission (FTC) (Washington)
On April 25, 2012, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s dismissal of the Federal Trade Commission’s (“FTC”) complaint against four pharmaceutical companies: Solvay Pharmaceuticals, Watson Pharmaceuticals, Par Pharmaceuticals, and Paddock Laboratories. The (...)

A US Court of Appeals rejects FTC’s approach to "pay-for-delay" settlement between brand name and generic drug companies as an unlawful agreement not to compete under S. 5 of the FTC Act (Watson Pharmaceuticals)
Wolters Kluwer (Riverwoods)
Eleventh Circuit Rejects FTC’s Approach to Pay-for-Delay Settlements as “Turducken Task”* The U.S. Court of Appeals in Atlanta rejected on April 25, 2012 the Federal Trade Commission’s challenge to a patent litigation settlement between brand name and generic drug companies as an unlawful (...)

The Italian Competition Authority fines pharma undertaking for abusing its dominant position in the market for products for the treatment of visual glaucoma (Pfizer)
Stanford University - Stanford Law School
Italian Competition Authority fines Pfizer for abuse of dominance relating to visual glaucoma drugs* On 11 January 2012 the Italian Competition Authority (“ICA”) issued a decision fining Pfizer Euro 10.6 million for abusing its dominant position in the market for products for that treat visual (...)

The EU Commission opens investigation against two pharmaceutical companies on account of patent settlement agreement (Cephalon / Teva)
Van Bael & Bellis
On 28 April 2011, the European Commission opened of its own motion formal competition proceedings against Cephalon, Inc. (“Cephalon”) and Teva Pharmaceutical Industries, Inc. (“Teva”) on account of a patent settlement agreement between the parties. Under the agreement, Teva undertook not to sell (...)

The US Supreme Court declines to review a Second Circuit ruling permitting a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Lousiana Wholesale Drug / Bayer)
Vinson & Elkins (Washington)
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Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The EU Commission publishes its second report on the monitoring of patent settlements in the pharmaceutical sector
Stanford University - Stanford Law School
European Commission report shows decrease of potentially problematic patent settlements* On 5 July 2010, the Commission published its second report on the monitoring of patent settlements in the pharmaceutical sector. The report shows that the number of patent settlements that may fall afoul (...)

A US Court of Appeals holds that reverse payment agreements between a patentee and a generic pharma manufacturers that do not exceed the scope of the patent are not illegal under the federal antitrust laws and refuses to conduct post hoc determination of patent validity (Bayer)
McDonnell Boehnen Hulbert & Berghoff
On April 29th, the U.S. Court of Appeals for the Second Circuit ruled that the "pay-for-delay" agreement between defendants Bayer AG and several generic drugmakers (including The Rugby Group, Watson Pharmaceuticals Inc., and Barr Laboratories Inc.) were not illegal under U.S. antitrust law and (...)

A US District Court allows the reverse payment suits to proceed finding that the agreements extended beyond the scope of the concerned patent (Provigil)
Stanford University - Stanford Law School
U.S. District Court allows Provigil reverse payment suits to proceed* On 29 March 2010 the U.S. District Court for the Eastern District of Pennsylvania rejected defendants’ motions to dismiss in suits concerning reverse payment settlements between the brand name manufacturer of the (...)

A US District Court dismisses antitrust claims on reverse payment on the pharma market (Androgel Antitrust Litigation)
Sheppard Mullin (Los Angeles)
FTC Gets Shut Down – Once Again – In Its Bid To Change How Courts View Reverse Payment Settlements* As previously reported on this blog, in January 2009, the Federal Trade Commission launched its latest challenge to the legality of reverse payment settlements in the pharmaceutical industry, this (...)

A US District Court grants defendants’ motions to dismiss antitrust claims brought by the FTC as regards reverse payments settlements and related commercial arrangements (Androgel)
Stanford University - Stanford Law School
U.S. District Court dismisses AndroGel reverse payment antitrust claims* On 22 February 2010 the U.S. District Court for the Northern District of Georgia (Atlanta Division) granted defendants’ motions to dismiss antitrust claims brought by the Federal Trade Commission (“FTC”) among others that (...)

A US District Court dismisses the FTC’s "pay-for-delay" antitrust lawsuit ruling that the contested settlements are not an unreasonable restraint of trade (Androgel Litigation)
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (New York)
On February 22, 2010, Judge Thomas W. Thrash, Jr. dismissed the Federal Trade Commission’s (FTC) antitrust lawsuit alleging that Solvay Pharmaceuticals (Solvay) conspired with generic drug makers Watson Pharmaceuticals (Watson) and Par Pharmaceuticals (Par) to delay generic competition for the (...)

The EU Commission monitors whether patent settlements concluded between pharmaceutical companies infringe EU antitrust rules
Morgan Lewis (London)
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Squire Patton Boggs (London)
On 12 January 2010, the European Commission sent an information request to a number of pharmaceutical companies, seeking copies of their patent settlement agreements, to check their compliance with EU antitrust rules (Official Press Release IP/10/12), as a follow up to its pharmaceutical sector (...)

The US DoJ files amicus brief on reverse payment settlements on the market for broad spectrum antimicrobial medicines (Arkansas Carpenters Health/Bayer, Hoechst, Watson)
Stanford University - Stanford Law School
U.S. DOJ files amicus brief on reverse payment settlements* On 6 July 2009 the U.S. Department of Justice filed an amicus brief in a reverse payment settlement case on appeal before the 2nd Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation). The filing is in response of an (...)

The EU Commission presents its preliminary report into the pharmaceutical sector
Linklaters (London)
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French Competition Authority (Paris)
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Linklaters (London)
The European Commission presented its Preliminary Report into the pharmaceutical sector (which runs to 426 pages) at a public hearing on 28 November. The deadline for comments on the Report is 31 January 2009. Click here for a copy of the Report, the Commission’s press release and the opening (...)

The US Federal Circuit dismisses antitrust claims against reverse payment agreement between pharmaceutical companies (Ciprofloxacin Hydrochloride)
ArbJournal
On 15 October 2008 the Federal Circuit affirmed the grant of summary judgment by the Court for the Eastern District of New York that patent settlement agreements («Agreements») entered into between Bayer AG and Bayer Corp (collectively «Bayer») and several manufacturers of generic drugs providing (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Tamoxifen Citrate)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Schering-Plough)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

The US Court of Appeals for the 11th Circuit holds that a reverse payment agreement between a brand-name pharmaceutical company and a generic would-be competitor should be analyzed under the “scope of the patent” test to determine antitrust liability (Abbott/Geneva/Zenith)
United First Partners
Introduction In Valley Drug Co. v. Geneva Pharm., Inc. (“Valley Drug”), the Eleventh Circuit adopted the “scope of the patent” test to evaluate validity of reverse payment agreements between a brand-name pharmaceutical manufacturer and generic would-be competitors. The court viewed the case in (...)

A US Court of Appeals holds that antitrust law is not implicated provided that the terms of “pay for delay” settlements between the brand name and generic pharma companies are within the scope of the patent (Valley Drug/Abbott Laboratories)
Hill, Kertscher & Wharton (Atlanta)
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Sutherland
A recent 11th Circuit case, Valley Drug Co. v. Geneva Pharmaceuticals, Inc., sheds light on the complex intersection of patent and antitrust law in the context of a settlement agreement between a name brand pharmaceutical manufacturer and two allegedly infringing generic manufacturers that (...)

A US Court of Appeals holds that a reverse payment agreement between a brand-name pharmaceutical manufacturer and a generic would-be competitor is a per se antitrust violation because the agreement exceeded the scope of the patent (Cardizem CD Antitrust Litigation)
United First Partners
Introduction In re Cardizem CD Antitrust Litigation (“Cardizem”) is one of the first in a long line of cases challenging the so-called reverse payment or pay-for-delay settlement agreements between the pharmaceutical companies. In Cardizem, the U.S. Court of Appeals for the Sixth Circuit held (...)

A US Federal Circuit Court finds that the district court exceeded its authority in shortening the statutory stay of entry by a generic competitor which was challenged by a pharmaceutical patent-holder manufacturer in a patent infringement suit (Andrx/Biovail)
Cabot (Boston)
Judges: Dyk (author), Bryson, and Linn In Andrx Pharmaceuticals, Inc. v. Biovail Corp., No. 01-1650 (Fed. Cir. Jan. 17, 2002), the Federal Circuit vacated and remanded a lower court’s order (1) shortening the statutory thirty-month delay of FDA approval of Andrx Pharmaceuticals, Inc.’s (“Andrx”) (...)

Dominance

The Canadian Competition Bureau issues draft IP enforcement guidelines that will have practical implications for the pharmaceutical industry
Davies Ward Phillips & Vineberg (Toronto)
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Davies Ward Phillips & Vineberg (Toronto)
Canada’s Updated Draft Intellectual Property Enforcement Guidelines and the Pharmaceutical Industry* I. INTRODUCTION In June 2015, Canada’s Competition Bureau released its updated draft of the Intellectual Property Enforcement Guidelines (“Draft IPEGs”) for public review and consultation. The (...)

The EU Commission fines pharmaceutical companies in pay-to-delay case (Servier)
Stanford University - Stanford Law School
European Commission fines pharmaceutical companies in pay-to-delay case* Last 9 July the European Commission (“Commission”) fined (see press releases here and here) French pharmaceutical company Servier and five generics manufacturers ( Niche/Unichem, Matrix (now part of Mylan), Teva, Krka and (...)

The EU Commission finds that the order sought and the enforcement of an injunction before a German Court on the basis of a smartphone standard essential patent constituted abuse of dominance (Motorola Mobility)
Stanford University - Stanford Law School
European Commission finds that Motorola Mobility misused standard essential patents* On 29 April 2014, the European Commission European held that it has adopted a decision which found that Motorola Mobility’s (“Motorola”) seeking and enforcement of an injunction against Apple before a German (...)

The EU Commission consults on commitments to license on FRAND terms regarding use of standard essential patents (Samsung SEPs)
Garrigues (Brussels)
Samsung offers commitments to appease DG Comp* The most important (antitrust-related) news last week was the European Commission’s announcement that it will market test a commitment proposal submitted by Samsung regarding the enforcement of its SEPs (Standard Essential Patents) related to (...)

The US Supreme Court reverses the judgment of the 11th circuit and leaves the structuring of the rule of reason antitrust litigation to the lower courts (Actavis)
Cleveland-Marshall School of Law
Just What on Earth Did Actavis Really Say? And Does It Mean Something for Section 1 More Broadly?* It’s going to be a strict, nearly-per-se quick look rule, folks, in more or less every reverse-payment case likely to be brought from here on out. Dollars-to-donuts. A few weeks have gone by, (...)

A US Court issues first analysis of an appropriate royalty that a patentee could obtain after promising to license its patent on reasonable and nondiscriminatory (RAND) terms (Microsoft / Motorola)
Rutgers University
On April 25, 2013, Judge James L. Robart of the U.S. District Court for the Western District of Washington offered the first analysis by a U.S. court of an appropriate royalty that a patentee could obtain after promising to license its patent on reasonable and nondiscriminatory (RAND) terms. (...)

The EU Commission sends a statement of objections to a mobile operator over alleged misuse of mobile phone standard essential patents (Samsung)
Van Bael & Bellis
On 21 December 2012, the European Commission announced that it had sent Samsung a Statement of Objections (“SO”) over its alleged misuse of mobile phone standard essential patents. In January 2012, the Commission had opened a formal investigation against Samsung Electronics following (...)

Procedures

The EU Commission publishes its 5th patent monitoring report
General Court of the European Union (Luxembourg)
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White & Case (Brussels)
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White & Case (London)
DG Competition of the European Commission just published its 5th patent monitoring report. It covers patent settlements entered into in 2013. Each year, the Commission claims that the report shows a “steady increase” of patent settlements in general, which supposedly would prove that the (...)

The US District Court for the Northern District of Georgia refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine, since such a conclusion would have contradicted the decision of the Supreme Court finding that a reverse payment settlement agreement should be subject to antitrust scrutinity (Actavis)
Sheppard Mullin (Los Angeles)
FTC v. Actavis on Remand: A New Chapter* District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine. In re AndroGel Antitrust Litigation (No. II), MDL No. 2084 (re Federal Trade Commission v. Actavis, Inc., No. 1:09-CV-955-TWT) (N.D. GA April 21, 2014). In (...)

A US District Court dismisses an antitrust class action against two pharma producers regarding an agreement to postpone the production of a generic epilepsy and bipolar disorder drug because no reverse payment with cash was involved to keep the rival off the market (GSK / Teva)
DLA Piper Weiss-Tessbach (Vienna)
U.S. District Court holds that Actavis requires monetary payments for antitrust scrutiny to be applicable* On January 24, 2014 U.S. District Judge William H. Walls dismissed an antitrust class action against GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceutical Industries Ltd. (“Teva”) regarding (...)

The New York State Office of AG Schneiderman announces a groundbreaking settlement with a patent assertion entity (MPHJ Technology Investments)
DLA Piper Weiss-Tessbach (Vienna)
New York Attorney General reaches agreement with “Patent Trolls” to bar deceptive practices* The prosecutor’s office announced that the New York attorney general (“NY AG”) Eric Schneiderman has reached an agreement with MPHJ Technology Investments LLC (“MPHJ”), a so-called patent troll, to stop (...)

The US DoJ and FTC testify at Senate Subcommittee Antitrust Oversight Hearing
Wolters Kluwer (Riverwoods)
Federal Antitrust Agency Heads Testify at Senate Subcommittee Antitrust Oversight Hearing* FTC Chairwoman Edith Ramirez and William J. Baer, Assistant Attorney General in charge of the Department of Justice Antitrust Division, testified before the Senate Judiciary Committee’s antitrust (...)

The French Competition Authority announces the launch of a pharma sector inquiry
JPTT & Partners
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White & Case (Paris)
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Novartis (Rueil-Malmaison)
On 26 February 2013, the French Competition Authority (“Autorité de la concurrence”) announced the launch of a pharma sector inquiry. The Autorité ’s main goal is to address the cost of prescription medicines for social security, the high prices of non-reimbursable medicines, and the low level of (...)

The US District Court for the Eastern District of Pennsylvania adopts "scope of patent" test for analyzing Hatch-Waxman patent settlements (Cephalon)
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On March 29, 2010, Judge Mitchell S. Goldberg upheld antitrust lawsuits filed by the Federal Trade Commission (FTC) and private plaintiffs against drug maker Cephalon, Inc. (Cephalon), alleging that Cephalon conspired with four generic drug manufacturers to delay generic competition for the (...)

Regulations

The US FTC issues a report on authorized generic drugs expressing concern that they are being used to delay generic competition
Gibson Dunn (New York)
U.S. FTC Scrutinizes Interplay Between Authorized Generics and Patent Settlements* The U.S. Federal Trade Commission has recently released two reports relating to the pharmaceutical industry. A significant theme in both reports is a concern that brand name pharmaceutical companies are using (...)

The EU Commission’s pharmaceuticals sector inquiry report signals future antitrust actions
Gibson Dunn (Hong Kong)
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Jones Day (Amsterdam)
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Jones Day (Frankfurt)
The pharmaceuticals sector in the European Union will remain under close antitrust scrutiny in the coming years. This is confirmed by the Communication the European Commission released yesterday in which it summarizes the main conclusions from its sector inquiry that started in January 2008. (...)

The French Competition Authority issues a favourable opinion regarding three derogating inter-professional agreements relative to the new rules on payment timeframes in the toy, DIY and watch making-jewellery sectors
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. Payment timeframes: The Conseil de la concurrence has issued a favourable opinion regarding the derogating agreements signed in the toy, DIY and watch making-jewellery sectors.* Referred to by the Minister of (...)

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