The Medicines Company Loses Patent Battle, Again
1 CommentBy Ed Silverman // March 23rd, 2010 // 6:16 am
There was a flurry of legal activity last week over the patent for Angiomax, an anti-coagulant drug which is sold by The Medicines Company. The little drugmaker caused a ruckus in Washington over the past couple of years due to an unusual battle - whether it was due a reprieve because it missed a basic, but crucial patent filing deadline by one day.
Background: In early 2001, MDCO applied for a standard extension to its patent, which would have been approved, except the company’s lawyers filed an application 61 days after initial FDA approval, missing the statutory deadline by one day. As a result, Angiomax’s protection is set to expire today instead of in late 2014, as the routine extension would have allowed.
MDCO calls this an administrative mistake and says the early patent expiration could cost it $1 billion as cheap generics arrive. And since 2002, the company has spent more than $13 million on lobbying - almost solely to get the missed deadline and its Angiomax patent extended. The effort even included drafting a bill that circulated on Capitol Hill, which twice passed the House, but not the Senate.
Last week, however, a federal judge ordered the USPTO to reconsider its rejection of the extension and told the patent office to keep the patent in force while it conducted its reconsideration (see here). But the victory didn’t last long. On Friday, the USPTO again denied the request to extend the life of the patent (see this). “Now I’m at war; this is very disconcerting,” Clive Meanwell, MDCO’s chief executive, tells The New York Times. “It’s not even polite, you know what I mean?”
However, the paper notes that the USPTO did honor the judge’s order to grant an interim patent extension while it reviews the file. So now, the patent will expire at the end of the day on May 23, instead of today. Ironically, the paper adds, the USPTO described this as a 60-day extension, although it’s really 61 days, which is the same mistake the company made nine years ago. The USPTO office corrected its mistake the next day.
Hat tip to the FDA Law blog
Condor
I am truly puzzled by The Medicines Comany CEO’s reaction.
The general rule in capitalist systems is that the law abhors a monopoly.
The second general rule in such systems is that when the government intervenes to create a monopoly at law for a company (by patent) — strict adherence to the rules on the part of the would-be monoploist ought to be expected.
He is, afterall, getting a “socialist/communist style” benefit.
He messed up. Now, rather than focusing on his lost monopoly profits ($1 B), why aren’t we all more focused on the notion that all Americans will receive a fairer (generic) price, on the drug?
No one may remotely-seriously contend that the company didn’t already make (many dozens of) times its original investment back.
The CEO’s lament sounds a little too much like Ken Lay’s wife (circa 2001), complaining on Fox News that “people don’t seem to understand — [choking sob] we’ve lost EVERYTHING! — all our houses. . . everything! [Sob.]”
Um, r-i-i-i-i-i-ght, Mr. CEO. Monopolists expect the government (as in the case of Temodar?) to be “polite” — when the monopolists screw up, by their very own admission?
Color me perplexed.
Namaste