Tuesday, June 11, 2013

Merck's Nasonex® Appeal Formally Denied Only One Week After Oral Arguments

I suppose speedy, and clear, decision making is a good thing, in judicial circles. And this legacy Schering-Plough patent fight -- about Nasonex®, has been brewing since December of 2009 -- a little over three and one half years. But this is very speeedy.

The order affirming Apotex's win, at the trial court level, is unusual in that oral arguments were held only last week. From my vantage point, that's a pretty strong suggestion that Merck -- claiming under legacy Schering-Plough patents -- had essentially no appealable case. While the basic legacy Schering-Plough patent was held valid, the US Court of Appeals for the Federal Circuit in Washington, DC just flatly agreed with Apotex -- that Apotex's formulation of the active ingredients in Nasonex, did not infringe the core Schering-Plough patent.

Here is my latest 2012 backgrounder, followed by a bit from Bloomberg on it -- do go read it all:
. . . .[My 2102 background, updated:] So, the core patent legacy Schering-Plough claimed was violated by Apotex's generic -- the '353 patent -- has been held not to read on Apotex's reformulation, by the federal appeals panel in DC. At the trial court level, the judge specifically cited other, additional chemical structures in the Apotex formulation -- each of which surround the claimed compound, and in Apotex's reformulation(s) of Nasonex, change its character appreciably. This, it seems, was the core reason for the opinion of non-infringement. . . .

[From Bloomberg, overnight:] Apotex didn’t infringe the patent, the U.S. Court of Appeals for the Federal Circuit in Washington said in a notice posted yesterday on its website. The court, without issuing a formal opinion, did affirm a lower court ruling that upheld the validity of the Merck patent.

The cases are Merck Sharp and Dohme Corp. v. Apotex Inc., 2012-1516,-1543, U.S. Court of Appeals for the Federal Circuit (Washington). . . .
With Apotex now soon likely clear to sell (I don't know if Apotex has cleared FDA on its generic applicaiton, yet) in the US, Merck's steady $1.26 billion a year revenue stream from the medication will shrink, in 2013 and beyond. Expect an appeal by Merck's patent lawyers, to the Supremes, and a fairly routine denial of cert, there. We will keep an eye on it, just the same.

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