Pharma & Dominance

Dominance

The US FTC files an amicus brief challenging the abuse of the FDA’s "orange book" listing procedures which allow companies to automatically block the entry of generic drugs for 30 months (Jazz Pharmaceuticals / Avadel CNS Pharmaceuticals)
US Federal Trade Commission (FTC) (Washington)
FTC Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition* The Federal Trade Commission filed an amicus brief with the U.S. District Court for the District of Delaware in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals. The Brief (...)

The Spanish Competition Authority fines a pharmaceutical company €39M for filing unjustified lawsuits with the goal of delaying the entry of rivals into the market for female contraceptive rings (Merck Sharp & Dohme)
Spanish Competition Authority (CNMC) (Madrid)
The CNMC fines pharmaceutical company Merck Sharp and Dohme 39 million euros for abuse of a dominant position in the market for vaginal contraceptive rings* In 2017, the company took unjustified legal action against its competitor Insud Pharma under the pretext of protecting its patent. With (...)

The UK Competition Authority fines two pharmaceutical firms €70M for charging excessive prices to the National Health Service (Pfizer / Flynn)
Cleary Gottlieb Steen & Hamilton (London)
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Cleary Gottlieb Steen & Hamilton (London)
The UK Competition and Markets Authority (CMA) last week fined pharmaceutical companies Pfizer and Flynn £63 million and £6.7 million for engaging in excessive pricing. In the CMA’s view, the companies charged unfairly high prices for Phenytoin capsules, a genericised anti-epilepsy drug, in (...)

The UK Competition Authority fines two pharma companies £70M for overcharging the National Health Service (Pfizer / Flynn)
United Kingdom’s Competition Authority (CMA) (London)
£70 million in fines for pharma firms that overcharged NHS* After reassessing part of the case, the CMA has found that Pfizer and Flynn abused their dominant positions to overcharge the NHS for a life-saving epilepsy drug. Pharmaceutical companies Pfizer and Flynn fined £63 million and £6.7 (...)

The EU Court of Justice AG Kokott proposes that the Court should set aside the ruling of the General Court and declare that the pay-for-delay agreements concluded by a pharmaceutical firm constituted an abuse of dominance (Servier)
European Court of Justice (Luxembourg)
Marketing of perindopril: Advocate General Kokott proposes that the Court of Justice should rule that all agreements concluded by the Servier group with generic pharmaceutical companies constituted restrictions of competition by object and that it should set aside the General Court’s findings (...)

The French Supreme Court agrees with the Paris Court of Appeal’s decision reducing a €25M fine to €21M for abuse of dominance by obstructing the entrance of generic drugs onto the market (Janssen Cilag)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 1 June 2022, the French Supreme Court (Cour de cassation) upheld the judgment of the Paris Court of Appeal, which in turn largely upheld the 2017 decision of the French Competition Authority (FCA) to impose fines of EUR 25 million on Janssen Cilag and its parent company Johnson & Johnson (...)

The French Supreme Court rejects an appeal by a pharmaceutical company which alleged that a €21M fine imposed by the competition authority was erroneous (Janssen-Cilag)
Dechert (Paris)
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Dechert (Paris)
On 1 June 2022, the French Supreme Court (the “Supreme Court”) entirely dismissed the appeal of Janssen-Cilag (“Janssen”) and its parent company Johnson & Johnson against a judgment of the Paris Court of Appeal (the “Court of Appeal”) of 11 July 2019 in the Durogesic® case. However, this ruling (...)

The Italian Competition Authority fines a drug manufacturer €3.5M for charging excessive prices to the National Health Service for a life-saving drug (Leadiant)
Italian Competition Authority (Rome)
A524 - ICA fines Leadiant 3,5 million euros for abusing its dominant position* The Italian Competition Authority (ICA) found that since June 2017 Leadiant has charged the Italian NHS unfairly excessive prices for the sale of a life-saving drug. Similar proceedings were conducted by competition (...)

The Italian Competition Authority fines a pharmaceutical company for charging excessive prices for an orphan drug (Leadiant)
Giannino SI (Monserrato)
The Italian Competition Authority (ICA) has recently closed an Article 102 TFEU enquiry against a pharmaceutical company in the Leadiant case with an infringement decision. The ICA found that Leadiant, had abused its dominant position by charging highly disproportionate prices for a drug (...)

The Chinese State Administration for Market Regulation fines a national pharmaceutical company $1.4M for resale price maintenance (Geistlich Trading)
AnJie Law (Beijing)
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AnJie Law (Beijing)
Beijing AMR fines Geistlich Trading (Beijing) over monopoly agreement* On 28 February 2022, the State Administration for Market Regulation (SAMR) published an administrative penalty decision against Geistlich Trading (Beijing) Co Ltd for engaging in monopoly agreements of resale price (...)

The Dutch Competition Authority ceases an investigation into a pharma company after it promises to halt potentially abusive discounting of an arthritis drug (Pfizer)
Netherlands Authority for Consumers & Markets (ACM) (The Hague)
Drug manufacturer Pfizer to discontinue its steering pricing structure for Enbrel following discussions with ACM* Drug manufacturer Pfizer will no longer persuade hospitals in the Netherlands into purchasing anti-rheumatic drug Enbrel through its discount schemes. Pfizer has informed the (...)

The Italian Competition Authority closes its investigation into resale price maintenance in the market for probiotics following commitments from the alleged transgressor (SOFAR)
Portolano Cavallo (Milan)
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Portolano Cavallo (Milan)
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Portolano Cavallo (Milan)
In May 2021, the Italian Competition Authority (AGCM or ICA) launched an investigation into restrictions on resale prices that a pharmaceutical company, SOFAR, was alleged to have imposed upon its distribution network for a probiotic product (Enterolactis Plus). In Europe, agreements or (...)

The UK Competition Authority publishes its decision finding a pharmaceutical company guilty of excessive pricing on thyroid tablets (Advanz)
Toyota
On 15 December 2021, the UK Competition and Markets Authority (“CMA”) published the non-confidential version of its decision in Advanz Pharma, which provides further insight into its approach to dealing with excessive pricing. As reported earlier (See Michael Clancy, Samuel Hall, Peter L’Ecluse, (...)

The US FTC orders multiple pharmaceutical companies to provide up to $40M in damages for monopolizing the drug "Daraprim" and bans their executives from working in the sector (Vyera Pharmaceuticals / Martin Shkreli / Kevin Mulleady)
US Federal Trade Commission (FTC) (Washington)
FTC, States to Recoup Millions in Relief for Victims Fleeced by ‘Pharma Bro’ Scheme to Illegally Monopolize Life-Saving Drug Daraprim* ’Pharma Bro’ Associate Mulleady banned from pharma industry and corporate defendants to pay up to $40 million; Trial set to begin next week for ‘Pharma Bro’ Martin (...)

The Romanian Competition Authority opens an investigation into possible abuse of dominant position and restriction on market entry by a pharmaceutical company in the medicines market (Boehringer Ingelheim)
Romanian Competition Council (Bucharest)
The Competition council opened an investigation on medicine market* • Possible abuse of dominant position of Boehringer Ingelheim RCV Gmbh&CO. KG The Competition Council opened an investigation into a possible abuse of a dominant position of Boehringer Ingelheim RCV GmbH & Co. KG. KG, (...)

The Romanian Competition Authority opens an investigation into a pharmaceutical company’s alleged abusive behaviour on two distinct markets (Boehringer Ingelheim)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 6 December 2021, the Romanian competition authority announced that it conducted a dawn raid at the premises of Boehringer Ingelheim (BI) to investigate allegedly abusive conduct which targeted generic rivals of two of BI’s innovative medicines (see, attached press release in Romanian and (...)

The Lithuanian Competition Authority clears a merger in the healthcare sector on the condition that part of the healthcare business in the cities and districts of Kaunas and Šiauliai are sold (InMedica / INVL Baltic Sea Growth Fund / Litgaja / RP Pharma)
Lithuanian Competition Authority (Vilnius)
Merger in healthcare sector cleared subject to commitments* The Lithuanian competition authority Konkurencijos taryba has cleared the acquisition of joint control of InMedica and, indirectly, MediCA klinika, Kardiolita, Bendrosios medicinos praktika and Svalbono klinika by the investment fund (...)

The Italian Government approves the draft annual law for competition
White & Case (Milan)
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White & Case (Milan)
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White & Case (Milan)
After several delays, on November 4, 2021, the Italian Council of Ministers examined and finally approved the draft Annual Law for Competition ("Draft") pursuant to Article 47 of Law No. 99/2009. The Draft reflects most of the proposals sent to the Italian government by the Italian Competition (...)

The EU Commission carries out unannounced inspections at the premises of a pharmaceutical company active in animal health in Belgium due to suspected abuse of dominance
European Commission - DG COMP (Brussels)
Antitrust: Commission carries out unannounced inspections in the animal health sector in Belgium* The European Commission is conducting unannounced inspections at the premises of a pharmaceutical company active in animal health in Belgium. The Commission has concerns that the inspected (...)

The UK Competition Authority along with EU Member States cracks down on excessive pricing in the pharmaceutical sector (Pfizer / Flynn / Actavis)
White & Case (Brussels)
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White & Case (Brussels)
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White & Case (Brussels)
Competition authorities have been traditionally reluctant to pursue excessive pricing cases since many of them had failed on the facts. However, in recent years, there has been a resurgence of the topic in pharma-related cases. In particular, the national competition authorities have led the (...)

The UK Competition Authority finds that 2 pharmaceutical companies abused their dominant positions to overcharge the national health service for vital anti-epilepsy drugs (Pfizer / Flynn)
United Kingdom’s Competition Authority (CMA) (London)
CMA accuses pharma firms of illegal pricing* The CMA has provisionally found that Pfizer and Flynn abused their dominant positions to overcharge the NHS for vital anti-epilepsy drugs, after reassessing the case. Having gathered further evidence and after carefully assessing the facts, the (...)

The UK Competition Authority imposes fines totalling more than £101M on a pharmaceutical company for charging excessive and unfair prices for liothyronine tablets (Advanz)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 29 July 2021, the UK Competition and Markets Authority (“CMA”) imposed fines totalling more than £101 million on Advanz Pharma and previous owners, Cinven and HgCapital, for charging excessive and unfair prices for liothyronine tablets – a treatment for hypothyroidism (see Press Release). In (...)

The UK Competition Authority fines a pharmaceutical company for overinflating the price of thyroid tablets (Advanz)
United Kingdom’s Competition Authority (CMA) (London)
CMA fines pharma firm over pricing of crucial thyroid drug* The CMA has imposed over £100 million in fines after Advanz inflated the price of thyroid tablets, causing the NHS and patients to lose out. Advanz increased the price of thyroid tablet packs from £20 in 2009 to £248 in 2017 – an (...)

The Dutch Competition Authority fines a medicine supplier almost €20 million for excessive pricing of a metabolic disorder medicine (Leadiant)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 20 July 2021, the ACM announced that it had imposed a fine of € 19,569,500 on Leadiant for abusing its dominant position by charging excessive prices for chenodeoxycholic acid-Leadiant (“CDCA”), a medicine indicated for the treatment of patients suffering from cerebrotendinous xanthomatosis, a (...)

The Dutch Competition Authority fines a national drug manufacturer for excessive pricing (Leadiant)
Netherlands Authority for Consumers & Markets (ACM) (The Hague)
ACM imposes fine on drug manufacturer Leadiant for CDCA’s excessive price* The Netherlands Authority for Consumers and Markets (ACM) has established that drug manufacturer Leadiant charged far too high a price for its prescription drug CDCA-Leadiant. As such, Leadiant abused its dominant (...)

The Dutch Competition Authority imposes a fine totalling €20M on an orphan drug manufacturer for excessive pricing (Leadiant)
Bird & Bird (The Hague)
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Bird & Bird (The Hague)
Dutch competition authority ACM imposes EUR 20 million fine on orphan drug manufacturer Leadiant for excessive pricing* The Netherlands Authority for the Consumer and Markets’ (“ACM“) announced focus on drug price developments has finally come to a tangible enforcement result: a fine of almost (...)

The Dutch Competition Authority fines a medicine supplier on account of excessive pricing (Leadiant)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
The Dutch competition authority, Autoriteit Consument & Markt (ACM), announced on Tuesday that it imposed a fine of EUR 19,569,500 on Leadiant which was found guilty of an abuse of dominant position by charging excessive prices for chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated (...)

The UK Competition Appeal Tribunal confirms a pay-for-delay infringement decision but reduces the fines (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Van Bael & Bellis (Brussels)
On 10 May 2021, the UK’s Competition Appeal Tribunal (“CAT”) issued its final decision in GSK (Paroxetine) – the long-running saga concerning pay-for-delay patent settlement agreements between GSK and several generics. The CAT upheld the Competition and Markets Authority’s (“CMA”) finding of an (...)

The US Senate introduces Senator Hawley’s proposal for an important antitrust reform aimed at Big Tech, Big Banks, Big Telecoms, and Big Pharma
White & Case (New York)
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White & Case (Washington)
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Meta (Washington DC)
Sen. Hawley’s "Trust-Busting for the Twenty-First Century Act," introduced on April 12, 2021, takes aim at "Big Tech, Big Banks, Big Telecom, and Big Pharma" by proposing to curb mergers and acquisitions by large corporations and ease the way for prosecutors and private plaintiffs to prevail in (...)

The EU Court of Justice dismisses the appeals of several pharmaceutical companies involved in an agreement seeking to delay the marketing of the generic antidepressant citalopram (Lundbeck)
European Court of Justice (Luxembourg)
The Court of Justice dismisses the appeals of a number of manufacturers of medicines involved in an agreement seeking to delay the marketing of the genericantidepressant citalopram* The European Commission had imposed on them fines of almost € 150 million From the late 1970’s, the Danish (...)

The EU Commission opens a formal investigation into possible anticompetitive conduct of a global pharmaceutical company concerning a blockbuster multiple sclerosis medicine (Teva)
European Commission - DG COMP (Brussels)
Antitrust: Commission opens formal investigation into possible anticompetitive conduct of Teva in relation to a blockbuster multiple sclerosis medicine* The European Commission has opened a formal antitrust investigation to assess whether the pharmaceutical company Teva has illegally delayed (...)

The EU Commission investigates for the first time a case relating to divisional patent filing and litigation strategies in the pharmaceutical sector (Teva)
Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
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Herbert Smith Freehills (London)
On 4 March 2021 the EU Commission announced it has launched a formal investigation into possible anti-competitive conduct by pharmaceutical company Teva in relation to its blockbuster drug Copaxone, which is used in the treatment of multiple sclerosis. The patent for the active ingredient in (...)

The EU Commission accepts the commitment offered by a pharmaceutical company to reduce drug prices by 73% (Aspen)
Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
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Herbert Smith Freehills (London)
“When the price of a drug suddenly goes up by several hundred percent, this is something the Commission may look at” Commissioner Vestager said when opening a formal investigation into Aspen’s alleged excessive pricing conduct in May 2017. On 10 February 2021, the EU Commission (Commission) (...)

The EU Commission accepts commitments made by a pharmaceutical company to reduce prices for six off-patent cancer medicines by 73% addressing excessive pricing concerns (Aspen)
European Commission - DG COMP (Brussels)
Antitrust: Commission accepts commitments by Aspen to reduce prices for six off-patent cancer medicines by 73% addressing excessive pricing concerns* The European Commission has made commitments offered by Aspen legally binding under EU antitrust rules. Aspen has to reduce its prices in Europe (...)

The EU Commission accepts a commitment to reduce the price of six cancer medicines by 73% in an excessive pricing case in the pharmaceutical industry (Aspen)
Van Bael & Bellis (Brussels)
On 10 February 2021, the Commission announced that it had accepted a series of pricing and supply commitments from Aspen, thereby bringing an end to its investigation into whether Aspen had infringed Article 102 TFEU by charging excessive prices for six off-patent cancer medicines. Having (...)

The EU Commission accepts the commitment offered by a pharmaceutical company for excessive pricing (Aspen)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
In February 2021, the European Commission’s (“Commission”) long-running excessive pricing case against Aspen was brought to a close, with Aspen accepting a series of forward-looking pricing and supply commitments, but avoiding any fines or requirements to repay all of the higher prices charged (...)

The EU Commission accepts commitments by a drug manufacturer to reduce prices by 73% in an excessive pricing case (Aspen)
McDermott Will & Emery (Brussels)
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McDermott Will & Emery (Brussels)
On 10 February 2021, the EC concluded its first excessive pricing investigation in the healthcare sector by accepting commitments from Aspen Pharmacare Holdings Ltd and Aspen Pharma Ireland Limited (collectively, Aspen) (Decision C (2021) 72 final in Case AT.40394, Aspen). The decision (...)

The US FTC charges 2 pharmaceutical companies for the second time with preventing competition in the national market for oxymorphone (Endo / Impax)
US Federal Trade Commission (FTC) (Washington)
FTC Again Charges Endo and Impax with Illegally Preventing Competition in U.S. Market for Oxymorphone ER* The FTC is suing Endo Pharmaceuticals Inc., Endo International plc, Impax Laboratories, LLC, and Impax’s owner, Amneal Pharmaceuticals, Inc., alleging that a 2017 agreement between Endo and (...)

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