Legacy 2010 Schering-Plough Omeprasole Patent Suit (Branded As Prilosec® And As Zegerid® OTC) Against Par Pharma Nears Settlement?

Merck’s Prilosec®, acquired by Merck as part of the Schering-Plough bust up, or more precisely, the chemical compound omeprasole bi-carbonate, has been the subject of several different patent suits. [So too has been Santarus’ Zegerid® OTC — also an omeprasole bicarbonate. UPDATED 01.01.2014 @ 3 PM EST: Friendly commenter Bearwalk correctly points out that the Zegerid branded version was in-licensed to Schering-Plough Consumer Health — and so, is also (post November 2009) a Merck Consumer Health product. Thanks, for the able assist!] Most recently, Par Pharmaceuticals had filed an ANDA at FDA, back in 2010, to sell a generic version omeprasole ulcer treatment capsule — and has been selling its generic since July 2010.

Subsequently, the Federal Circuit reversed the New Jersey District court, here, and held that the invalidation of the patents for “obvious-ness” — was an incorrect decision. Now the case is back in New Jersey’s federal District Courts — on motion practice. The central goal of those proceedings is to try to figure out what — if any — payments will be made, by Par (or less probably, to Par) for these 2010 to 2013 generic ulcer drug sales. Sales of omeprasole in 2011 were around $200 million in the US.

Based upon a review of the United States District court filings in Cause No. 10-CV-04837, in Newark, New Jersey, it would seem that the Par omeprasole patent spat is nearing an agreed settlement. [Twice now, a judge-present settlement conference date — to settle all claims and counter claims — was postponed, for additional background discovery, by each side.]

I’ll have much, much more — when we know better what the most likely terms — governing the license/entrance of the Par generic version have turned out to be. [In any event, the payment to Merck is likely to be less than 10 per cent of the three years’ sales — or around a maximum of $60 million — and possibly quite a bit less than that.] Do stay tuned, with me. . . and Baby 2014!

Enjoy the bowl games — and the ice packs — for your heads (post champagne).


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