The Medicines Company Win Its Patent Battle
3 CommentsBy Ed Silverman // August 3rd, 2010 // 4:32 pm
After years of litigation, The Medicines Company has won a bitter fight with the US Patent and Trademark Office when US District Court Judge Claude Hilton today ruled that the USPTO must consider a patent term extension for the Angiomax anti-coagulant. Unless the USPTO appeals, the decision ends a closely watched case over an unusual point - whether the drugmaker was due a reprieve because it missed a basic, but crucial patent filing deadline by just one day (read the opinion).
Here’s the background: In early 2001, the drugmaker applied for a standard extension to its patent, which would have been approved, except the MDCO’s lawyers filed an application 61 days after initial FDA approval, missing the statutory deadline by one day. As a result, Angiomax’s protection was set to expire last March instead of in late 2014, as the routine extension would have allowed (a back story can be found here).
MDCO argued this was an administrative mistake and the early patent expiration would cost it $1 billion as cheap generics arrive. And since 2002, the drugmaker 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, and one in the Senate (see here).
Last March, Hilton ordered the USPTO to reconsider its rejection of the extension and to keep the patent in force while it conducted its reconsideration (see here). But the USPTO again denied the request to extend the life of the patent, although the judge’s order to grant an interim patent extension while the file was reviewed was honored.
Christopher
Well, good for the Medicines Company (MDCO). I have to wonder though about when ‘rules is rules’. The deadline for filing was not secret and the company presumably employed people to monitor these things.
I think of advice given by a wise old type who said about being on time for a flight: “If the plane leaves at 3.00 and you are there at 3.01 you’re not going on vacation.” And yes, there are anomalies but we’re all grown up enough to get the point.
Rules is rules, but MDCO made it to the next stage.
Vic
Christopher,
You don’t have one key piece of information. I have been following this since the beginning and it turns out that the FDA had faxed the approval letter to MDCO on a Friday afternoon after normal MDCO business hours. Therefore the folks at MDCO did not find out about the approval until the following Monday which is where the entire debate began. Because of the wording of the legislation, the clock begins to tick upon _receipt_ of the approval. Therefore MDCO argued that it could not “receive” the approval until the next business day. This is a “routine” position for most federal agencies to take as well (documents received after close of normal business [typically about 4:30 PM Eastern time] are processed as though received the next business day). So, based on the fact that this is how the gov’t reads the requirements when THEY are on a deadline, it is not unreasonable for the industry to read the same terms in the same way when the industry is on the deadline.
Christopher
Vic,
That’s interesting and thank you, I did not know that. I still wonder though why, with so much at stake, MDCO’s people would not a) verify the deadline well before it became imminent; b) assume that the East Coast protocol of next day timing being OK (per your comment) was acceptable, again without confirming this; and c) wait until the very last day before filing. All these things suggest a rather loose approach which cost them ~$13m to fix and could have cost them much more in lost sales.
Lesson learned though perhaps?