Wednesday, February 19, 2014

More From The Caspofungin Acetate (I.V.) Generic Delay Wars -- Merck Sues AGAIN To Protect $620M In Cancidas® Annual Revenue

Well, as a Valentine's Day Card (albeit lacking all the usual hearts and flowers!), Merck filed suit on the Saint's day, in federal court in Delaware last Friday (the smallish complaint, as a PDF file here) -- against Xellia Pharmaceuticals, ApS -- to protect its Cancidas® interavenous antifungal franchise. That is the Merck branded name for caspofungin acetate, I.V. injectible -- as it is genericly known. And that is a reliable $620,000,000 stuffed into a few of Whitehouse Station's large black canvas duffel bags, every year. Okay -- some Condor Context® is again in order, here. So. . . here goes:

Back when I was very busy with other matters, circa early 2012, a fair bit of the Hatch-Waxman parts of the Cancidas patent suit history went unrecorded, here on my pages. So I have no links, as background, for the readers. To sum up, quickly though -- during late 2011 (Teva), and early 2012 (Sandoz), Merck settled two infringement suits (smallish PDF of a public record lawyers' letter) that it had earlier brought under the Hatch Waxman 30 month stay provisions, to keep generic versions of Cancidas off the market. While the so-called '300 patent was set to expire (before evergreening amendments, and provisional-updatings) in late 2012, there is still no generic on market in the US, to my knowledge.

The federal court records indicate that Merck settled with both Teva and Sandoz -- and it would seem to the casual observer that the length of time each agreed to stay off market with a generic exceeded the original '300 patent's life. So it is fair to allege that these were pay for delay settlements -- costing the US consumers and insurers perhaps $375 million a year (the reduction in pricing/margin likely from a generic entrant).

So, against that historical background -- two suits; two settlements (with terms held in confidence) -- we just learned that Merck has sued Xellia to keep it of the market for the Hatch-Waxman 30 month stay period. Thus, as even the ultra-conservative Dan Troy (then FDA's Chief Counsel) testified in 2003, when he was running FDA's legal shop:

. . . .Under FDA’s traditional interpretation of the Hatch-Waxman Amendments, multiple 30-month stays have been possible. Submission of newly issued patents after an ANDA application has been filed with FDA has required the appropriate certification and notice to the NDA holder and patent owner with the possibility of a 30-month stay if patent infringement litigation resulted. As a result, there have been a number of instances where there has been more than a single 30-month stay. These include paroxetine hydrochloride (Paxil) and gabapentin (Neurontin).

A recent review of FDA’s records indicates that of the 442 active ANDAs that contained paragraph IV certifications, only 17 have had multiple 30-month stays, representing 3.8 percent of all applications with patent challenges. However, we note that a significant number of these products have high dollar value annual sales, and we are aware of some instances where multiple stays have resulted in the delay of a generic drug approval for a number of years. . . .

Greater access to generic drugs will reduce health care costs because the price of generic drugs is typically much lower than the brand-name drug. Reducing expensive lawsuits over drug patents and making the approval process more efficient will also help to lower national health care costs by reducing the cost of bringing safe and effective generic drugs to market. . . .

The journey of Merck's Cancidas is in many respects like that of Paxil® and Neurontin® -- both impliedly criticized by then-FDA Chief Counsel Dan Troy. So -- Condor's Context? Buying off would-be competitors with secret settlements -- is the stuff of Sherman and Clayton Act claims, right? Right, but for the gerry-mandering of timelines, in FDA interference procedings. Even so, FTC has the right to subpoena or request those settlement agreements to make sure they are not collusive, or unduly injurious to otherwise lawful price competition.

And yet, here we are again -- over a decade later -- still seeing multiple shenanigan-laden paths to lengthening patents, and keeping the prices paid by US consumers (and/or their insurers) very high. We will follow this one herafter with a jaundiced eye. Be forewarned, dear readers. [I just think it's. . . mean. . . to bring suit on Valentie's Day, afterall. For shame, Merckies. Heh.]


Anonymous said...

"USA !!! USA !!!"

Go bobsledders!

Anonymous said...

If you check out sales of Cancidas in the US, they are very low - only a few million per year. Most of the $625 million is ex-US.