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Haunted: Teva’s $1.2 billion ‘pay-for-delay’ penalty; which companies will get hit next?
Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total payment of $1.2 billion as part of a ‘pay-for-delay’ settlement reached with the Federal Trade Commission (FTC) last week.  What exactly did Cephalon, for which Teva paid $6.8 billion, do so wrong? Isn’t ‘pay-for-delay’ common practice in the pharmaceutical industry?   First of all what is a pay-for-delay? ‘Pay for delay’ or reverse payment patent settlements, are agreements where the brand name drug manufacturer compensates generics, not to market the generic product for a specific period of time.  These settlements allow the brand manufacturers to extend their patent monopolies and according to an FTC study, these deals cost consumers and taxpayers $3.5 billion in higher drug costs every year.   What exactly happens and why is it a big deal now? Cephalon allegedly paid four generic drug companies (Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceuticals, and Barr Laboratories), over $300 million in total. In return the generics agreed to drop their patent challenges and forgo marketing of their generic versions of Cephalon’s blockbuster sleep-disorder drug Provigil, for six years, until April 2012.  An extended monopoly for Provigil, in the absence of generic competition, was “$4 billion in sales that no one expected”, the CEO of Cephalon reportedly said when the deal was struck.  While in Europe, regulators have been going after pay-for-delay cases for years, it was only as recently as 2013, in FTC v. Actavis, that the U.S. Supreme Court made clear that reverse payment patent settlements are subject to the same antitrust rules that govern general U.S. business conduct. The payment made by Teva will compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct, is the first positive outcome for the FTC after the Supreme Court ruling.   How common are ‘pay-for-delay’ settlements? Based on data provided by the FTC, for the past few years, more than 100 settlements are reached annually between brand and generic pharmaceutical companies. Over 30% of these settlements have the potential of being ‘pay-for-delay’ agreements.   Table// Potential pay-for-delay settlements reached between brand and generic companies:   Financial Year 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Final Settlements: between brand and generic companies 14 11 28 33 66 68 113 156 140 145 Involving First Generic Filing 8 5 11 16 29 32 49 54 43 41 Potential Pay-for-Delay: Involving First Generic Filing 2 9 11 13 15 26 18 23 13 Settlements 3 14 14 16 19 31 28 40 29   How severe are the penalties for ‘pay-for-delay’ settlements in Europe?  The European Commission has fined Johnson & Johnson (J&J) just under 10.8 million euros and Novartis 5.49 million euros, after discovering a ‘pay-for-delay’ deal on the painkiller Duragesic (fentanyl). The amount pales in comparison to the whopping €428m fine on Servier and several other companies (Niche/ Unichem; Matrix, which is now part of Mylan; Teva; Krka and Lupin) for conspiring to delay generics of the widely-used blood pressure drug Coversyl/ Aceon (perindopril).   In yet another settlement, agreements which operated in 2002 and 2003 between the Danish originator Lundbeck, and other generic companies, resulted in Euro 146 million in fines.   What should we expect in the future? Based on an FTC presentation made in September 2014, they highlighted 19 Cases to Watch, which has them targeting almost every major brand and generic pharmaceutical company. However, with the complexities involved, this list is continuously evolving: The cases (by name of the brand product) Actos, Adderall, Aggrenox, AndroGel, Cipro, Effexor, K-Dur, Lamictal, Lidoderm, Lipitor, Loestrin, Nexium, Niaspan, Opana, Provigil, Skelaxin, Solodyn, Wellbutrin.The brand companies involvedAbbvie, Abbott, AstraZeneca, Bayer, Besins, Biovail, Boehringer, Cephalon, Endo, GlaxoSmithKline, King, Medicis, Pfizer, Shire, Schering, Takeda, Warner Chilcott, Wyeth.The generic companies Actavis , Barr, Duramed, Dr. Reddy’s, HMR, Impax, Lupin, Mutual, Mylan, Par, Perrigo, Ranbaxy, Rugby, Sandoz, Teva, Upsher Smith.   Our view: Pharmaceutical companies, lawyers and the FTC will be busy for the coming few years, since there are a series of suits, which will be challenging settlements reached between brand and generic pharmaceutical companies.  While patents provide temporary monopolies to promote innovation, brand drug manufacturers will need to resort to more innovative ways of sustaining their profits. Click here and learn about the different strategies adopted in the United States to block generics?  

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#PharmaFlow by PHARMACOMPASS
04 Jun 2015