As we noted last month, a very-able federal trial court judge, Sue L. Robinson, sitting in the district court of Delaware, has held the "New" Merck (and "Legacy" Schering-Plough) '291 patent on Temozolomide unenforceable for laches (or unreasonable delay), and/or inequitable conduct, before the USPTO, in the thirteen year process of getting the '291 patent issued on what became Temodar® -- legacy Schering-Plough's best-selling brain cancer drug.
At the time, New Merck said it would appeal the trial court's decision. It has begun to make the filings required to do so, as of February 3, 2010. In one of those filings, New Merck/Legacy Schering-Plough has suggested that Teva (as the party that ultimately acquired Barr Labs, the original potential generic entrant into the Temozolomide-as-brain-cancer-drug marketplace) should not be allowed to start selling the generic just as soon as FDA clears it, claiming "irreparable harm" will be inflicted on the Temodar brand -- and its goodwill. [Merck is offering to post what will likely be a large bond -- one that could easily go north of $200 million -- to secure this appeal-and-TRO/injunction manuever, if the appeals fail.]
Interesting. I wonder what harm a public record, duly entered federal court opinion, finding that legacy Schering-Plough deceived the patent authorities through "inequitable conduct" -- in order to gain a 32 year long monopoly on the brain cancer drug marketplace -- does to the Temodar® brand's "goodwill". [That is, of course, a rhetorical question.]
It seems as though Merck's lawyers didn't get the memo that the judge specifically found against them, at trial -- on the jaw-slacking grounds of arguably dishonest conduct, before the USPTO. 
To compound the oddity of these moving papers, New Merck's lawyers go on for almost two pages about how -- if the judge's ruling is upheld -- new uses for Temodar may never be discovered, and Schering salespeople will no longer be able to aggressively "educate" oncologists about the virtues of the drug. Again, this is puzzling, because while Temodar is a good drug -- it is simply silly to suggest that Merck's monopoly should continue (on into 32 years and counting, when the statute generally allows only 17 years), when its creators didn't "play by the rules" in creating that monopoly. [Full 50 page brief, in PDF format.]
Finally, it is truly baffling that Merck's lawyers think a federal appellate court jurist wouldn't ask him/herself "Gee, if Teva can sell the same compounded drug, here in the United States, won't Teva have some powerful motivation" to fully-"educate" oncologists -- about the proper use of Teva's Temozolomide product? I'd sure think so. But take a look at the moving paper excerpt at right (click the image, to enlarge it) -- while the brief is heavily redacted, this much is plain: New Merck would like to pretend that it hasn't already lost at trial.
These arguments are circular, in view of the trial court's explicit findings of fact. Generally speaking, trial court findings of fact are given significant deference on appeal. This is so, because the trial court judge observed live witnesses, and listened to their stories, and in some cases, questioned these witnesses herself. She was thus in a unique position to assess the credibilty of the factual witnesses. In contrast, on appeal, the jurists will learn all about the "facts of the case" from a cold, dead paper (or increasingly electronic) record. No live witnesses; no sweaty upper lips (or other "tells") of possible deception, or evasiveness.
In short, I think the appeal is unlikely to go Merck's way. [It is almost laughable that Merck's lawyers refer (at right) to an "early introduction" of the generic, to be sold by Barr/Teva -- when that "early introduction" would be almost a third of a century from when the '291 patent's life first began.] In any event, here is what an early Teva launch might mean to Merck:
. . . ."Teva's generic already has tentative approval, so it's certainly possible we will see it approved and launched within the next 48 hours," said Leerink Swann analyst Seamus Fernandez.
"Once you have a district court decision, and you already have tentative approval, that releases the FDA" to take action, Fernandez said.
Teva's less-costly medicine would likely batter sales of the Merck brand and depress Merck's earnings by 4 cents to 5 cents a share this year, and for several years to come, Fernandez said.
Sanford Bernstein analyst Aaron Gal said he expects Teva to launch its product in the second quarter and for it to have no competition from another generic until the third quarter. . . .
As ever, I'll keep you posted.
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