Patent settlement agreements

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

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