This PharmaTech Talk post recaps the recent events with pay-for-delay deals. The FTC and DOJ are both on record as opposing these arrangments as anti-competitive. Several pharmacies and wholesalers have legally challenged their validity in an antitrust suit, and now 31 AG's from around the US have filed an amicus brief asking the Supreme Court to review these arrangments - specifically in a case involving Bayer and the generic producers Barr Pharmaceuticals and Watson Pharmaceuticals.
Interestingly, the EU has also cracked down on what they term "patent settlements". The European Commission is reviewing patent settlements from Big Pharma companies in 2009 - indicating that patent settlements are a concern because they may delay the market entry of cheaper generics.
According to the EU, its monitoring is beginning to pay off. It declared that only 10% f patent ssettlements in the period July 2008 to Dec 2009 were problematic as compared to 22% for the period Jan 2000 to June 2008. See Reuters.
The Pharmalot blog adds some further interest to this topic. It notes that in relation to a pending pay-for-delay suit -- involving Cephalon and the generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharamceuticals over copycat versions of Provigil -- 3 dozen other drug makers are suing to prevent the FTC from disclosing the contents of their pay-for-delay deals in response to a Cephalon petition to force FTC disclosure. Cephalon want the documents to challenge FTC conclusions that pay-for-delay deals are bad for consumers. The other drugmakers apparently fear this disclosure despite what Cephalon may think.
We may get to see the Man Behind the Curtain in these pay for delay deals.
Posted by Bruce Lehr Jan 20th 2011.