Pharmaceutical Companies

On July 9, 2024, the Federal Trade Commission (“FTC”) voted 4-1 (with Commissioner Melissa Holyoak dissenting) to release an Interim Staff Report (the “Interim Report”) entitled: Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. The Interim Report describes what FTC staff has uncovered to date during…

Continue Reading Federal Trade Commission asserts significant anticompetitive harms in Interim Staff Report on the pharmacy benefit manager industry

On 25 March 2021, the Court of Justice of the European Union (“CJEU”) dismissed the appeals by Lundbeck, Merck KGaA (and Generics UK), Arrow, Alpharma (and Xellia) and Ranbaxy, against the General Court’s (“GC”) judgment upholding the European Commission’s (“Commission”) 2013 pay-for-delay infringement decision.

Background

The case concerns the antidepressant containing the active pharmaceutical ingredient (“API”) citalopram.  Lundbeck’s patents for the API and two processes to produce it were protected in a number of European countries until 2003 (“Lundbeck’s original patents”).  Over time, Lundbeck developed other processes for the production of citalopram, in respect of which it obtained various patents (“Lundbeck’s new process patents”).

In 2002, Lundbeck entered into settlement agreements concerning potential launches of generic versions of citalopram with Generics UK (at the time an indirect wholly-owned subsidiary of Merck KGaA), Alpharma, Arrow and Ranbaxy.  Under the agreements, Lundbeck made payments to these producers of generic citalopram (“Other Providers”) in various forms (e.g., direct payments, purchase of generic citalopram stock for destruction, and guaranteed profits in a distribution agreement).  In exchange, the Other Providers agreed to cease or refrain from selling generic citalopram in the EEA as a whole or in specific Member States.

In 2013, the Commission adopted an infringement Decision against Lundbeck and each of the Other Providers, concluding that the agreements were “by object” restrictions of competition.
Continue Reading The CJEU’s Lundbeck judgment

Under Article 102 of the Treaty on the Functioning of the European Union (“TFEU”), an undertaking may abuse its dominant position by “directly or indirectly imposing unfair purchase or selling prices”.  The UK Court of Appeal recently provided guidance regarding the legal test to determine whether pricing is excessive and unfair.  In March, it dismissed the UK Competition and Markets Authority’s (“CMA”) appeal in the Phenytoin case.
Continue Reading The UK Court of Appeal Clarifies the Legal Test for Excessive Pricing

On 12 December 2018, the EU General Court (GC) delivered its judgment in the Servier reverse payment patent settlement case, the second GC judgment to date on reverse payment patent settlements (after the 2016 Lundbeck judgment).

The GC confirmed that such agreements fall within the scope of Article 101 of the Treaty on the Functioning of the European Union (TFEU) and may constitute a restriction of competition by object. The GC also confirmed that, to the extent that an infringement is a restriction by object, it is not necessary to analyse its effects. Finally, the GC annulled the fine imposed by the European Commission (Commission) because the Commission failed to establish that the market was limited to the perindopril molecule.Continue Reading EU Court’s Partial Annulment of the Decision in the Servier Reverse Payment Patent Settlement Case

On 29 January, Covington hosted its webinar on the ECJ’s Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato judgment.  Miranda Cole discussed the potential implications of this judgment for market definition, field of use licences and indication-based pricing.  The full presentation can be found here.

The Italian Council of State referred…
Continue Reading Hoffmann-La Roche – Some Broader Implications

The UK’s Competition and Markets Authority (the “CMA”) imposed a £84.2 million (€99.7 million) fine on Pfizer yesterday. In addition, the CMA also fined distributor Flynn Pharma £5.2 million (€6.1 million).  The CMA found that Pfizer and Flynn Pharma abused their dominant positions by charging excessive and unfair prices for phenytoin sodium capsules, drugs used to treat epilepsy, in the UK.  In addition to the fines, the CMA ordered both entities to reduce their respective prices within timeframes of between 30 working days and 4 months.

Continue Reading UK CMA Imposes Record Fine on Pfizer

In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on the Functioning of the European Union (“TFEU”) and art. L.420-2 of the French Commercial Code by denigrating generic competitors of its drug Plavix on the French clopidogrel market.
Continue Reading French Supreme Court upholds Sanofi’s generic denigration fine

The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine) by up to 1,500%.  Aspen had previously acquired the rights to commercialise these drugs, internally referred to as the “Cosmos” drugs, from GlaxoSmithKline.  Aspen achieved the price increases by adopting an aggressive negotiating strategy with the Agenzia Italiana del Farmaco, including threating to stop the supply of the medicines on the Italian market (at the time, Aspen was the only company supplying these medicines in Italy).  Aspen was able to achieve price increases of between 300% and 1,500% (over the prior price).

In its analysis, the AGCM first defined the national markets using ATC5 classifications. In light of Aspen’s position in markets defined this narrowly, it concluded that Aspen held a dominant position on the various markets.
Continue Reading Italy’s AGCM Fines Aspen EUR 5 Million for Excessive Pricing

In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union (“TFEU”) preclude the imposition of an obligation to pay a royalty for the use of a patented technology for the entire duration of a licence agreement, in the event that the patents protecting the technology are revoked.  The ECJ concluded that Article 101(1) TFEU does not preclude the imposition of a requirement to pay royalties, provided that the licensee is free to terminate the agreement by giving reasonable notice.
Continue Reading Court of Justice Rules That Genentech Must Pay Royalties to Sanofi

The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK.

The paroxetine patent was due to expire in 2001, and several companies including Generics UK Limited (“GUK”) and Alpharma Limited (“Alpharma”) were considering entering the market with generic versions of paroxetine.  After challenging the generic companies with allegations that their products would infringe its patents, GSK concluded agreements with GUK, Alpharma and Norton Healthcare Limited (formerly IVAX).  The companies agreed not to enter the UK paroxetine market between 2001 and 2004 in exchange for payments and other value transfers amounting to over £50 million.  The CMA found that this kept paroxetine prices high and deprived the National Health Service of the price reduction that would have resulted from earlier entry of generic competition.  When the generic paroxetine products finally entered in late 2003, prices dropped by over 70% in only two years.
Continue Reading CMA Fines GlaxoSmithKline and Several Generic Companies £45 million for Delaying Market Entry of Generic Paroxetine in the UK