Tuesday, April 7, 2015

Yet Another New Round -- In Merck v. Apotex Patent Wars -- Over Nasonex®

Back in June of 2013, Apotex essentially won on appeal, as Merck was deemed not to have shown infringement in Apotex's formulation of Mometasone Furoate Hydrate, branded by legacy Schering-Plough, now Merck -- as Nasonex®. We covered that here, and here (in 2012), at the trial level as well.

It seems that Merck just filed a second piece of federal patent infringement litigation, in the federal District Court in Newark, NJ -- primarily because Kenilworth suspects that Apotex is preparing to sell a modified version of its generic here in the States, now, upon FDA approval of its ANDA. The modification -- Merck believes -- could be either to the bottle shape, or the chemical construct. We will have to see. But here is a bit from the just-filed complaint (a longish PDF file):

. . . .On information and belief, the mometasone furoate nasal spray product sold in Canada is packaged in bottles that differ from the HW9234 samples previously provided to Merck in the Previous Litigation. For example, Apotex represented to the Court in the Previous Litigation that although changes had been made to the size, configuration, and composition of bottles for its mometasone furoate nasal spray product, those changes were made for submissions to the Canadian regulatory authorities only: "For Canada, [Apotex] also committed to submit data for JK7465 & JK7468, which contain 140 metered doses as [opposed] to 120 metered doses (for US). These batches also packaged with the new shorter bottle and pump with addilene change, but not with the nitrile change. . . ."

On information and belief, the generic mometasone furoate nasal spray offered for sale by Apotex in Australia contains the same formulation and is packaged in the same bottle as the generic mometasone furoate offered for sale by Apotex in Canada. Visual inspection of the bottles confirms that both contain 140 metered doses, are of the same size and shape, and share the same distinctive seam running down the side of the bottles. See, e.g., Exhibit 5 (photographs of Apotex’s Canadian product) and Exhibit 6 (photographs of Apotex’s Australian product). . . .

On information and belief, Apotex will conform its U.S. mometasone furoate nasal spray product to its offerings elsewhere in the world in an effort to leverage lower production costs and maintain profits while offering its product at a substantially reduced price. Therefore, Apotex will seek to manufacture, use, offer for sale, and/or sell a product different than that which was the subject of the Previous Litigation. . . .

We will keep an eye on this, even as Nasonex sales are eroding, quarter by quarter, here in the US. This is still a materially important brand, for Merck.

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