More Detail On Merck's Cozaar® "Shenanigans" -- Attempt To Stiff Teva Fails

This one failed -- as reported by Lexology (summarizing a McDermott Will lawyer's report) -- and Teva will have its 180 days' exclusivity on generic versions of Merck's Cozaar^® (as earlier reported, here):

. . . .Teva had filed Paragraph IV certifications against one patent listed in the Orange Book for Merck’s Cozaar® and Hyzaar® products. Rather than suing, Merck asked the FDA to delist the challenged patent. Already faced with two unrelated prior FDA rulings ordering forfeiture of the 180-day marketing exclusivity based on patent delisting, Teva challenged the FDA’s interpretation when it learned that Merck’s patent had been delisted. The district court granted summary judgment upholding the FDA’s interpretation.

On appeal, Teva argued that the declaratory judgment provisions added by the 2003 MMA amendments should be the only scenario in which the FDA may delist a challenged patent. Teva reasoned that nothing in the 2003 MMA amendments altered the essential incentive structure that Congress had set forth in the Hatch-Waxman statute. The court rejected Teva’s argument that declaratory judgment delistings are the only delistings permitted under the Hatch-Waxman Act. However, in ultimately ruling for Teva, the court read the statute as a whole, stating that all of the other forfeiture provisions required some participation by the generic drug maker and, therefore, the 2003 MMA amendments must not be read to mean that brand companies "should be newly able to delist challenged patents, thereby triggering a forfeiture event that deprives generic companies of the period of marketing exclusivity they otherwise deserve. . . ."

This sort of attempted gamesmanship seems beneath the dignity of the mission -- the mission is to save lives. Long ago, Merck made many times its investment back, on Cozaar/Hyzaar. And now, patients are overpaying for this medication -- millions of dollars, in the aggregate, for every day that Merck delays. That is simply wrong. Full-stop.