An Update, To One Of Our Mid-2015 Narratives: Bridion® Patent Extended, To At Least Mid-2026...

We've long-followed the tortured seven years' delayed path legacy Schering-Plough (under "Fast" Fed Hassan) inflicted upon itself (see this, as one of dozens of our prior entries, on it) to get legacy sugammadex (since branded as Bridion^®) through FDA approval. It has grown to be about a $1.4 billion per year franchise, in the OR. So -- bit by bit, it is making back the hundreds of millions spent to get it to market (though it remains unclear, on the available peer-reviewed clinical trial data, whether it actually improves clinical outcomes, coming out of surgery).

But overnight, Merck's been able -- that now owns the franchise (since 2010) -- to secure an additional three years of patent protection in federal court in New Jersey, to mid-2026 minimum (which is a feature of law that Congress passed, ostensibly to deal with occasionally very long lead times to secure FDA approvals -- for some drugs, for example, when the drug is shown safe -- but the clinical data is inconclusive, as to efficacy).

I do think this the right result, as Merck should be able to try to recoup what it and Schering-Plough spent to bring it to market -- so long as surgeons and anesthesiologists feel it is useful in the OR. . . (even though I do wonder whether it is the best use of limited insurance and public pay dollars). Here's Merck's presser -- and a bit from it:

. . .[T]he U.S. District Court for the District of New Jersey ruled in favor of the company and found that Merck correctly calculated the Patent Term Extension period for the primary patent related to Bridion® (sugammadex). Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs. . . .

“Merck’s science and technology was used to develop and launch Bridion, and we’re pleased that the Court recognized the validity of our full patent extension period granted by the Patent Office,” said Jennifer Zachary, executive vice president and general counsel, Merck. . . .

Now you know -- and that's it, for the power alley, today.

Grinning, as we prep stuff. . . now with eldest back home from London (most recently) -- to head on to the Pacific Northwest, by Saturday, and a meetup there with our other two grown great ones. . . grad school graduations, ahead! Then Colorado sunshine. . . Be excellent to one another. . . for we are all we've got. And, a great throwback, too -- for Thursday:



नमस्ते