Comments on: Generic Savings Vs. Patent Deadlines: A Reader Poll

By: Condor

Condor — Wed, 28 Oct 2009 21:46:15 +0000

I simply must note for the record, here that it may turn out that a simple secretarial delay, at Pepsi, in handing over a few papers to her boss, in the law department. . . just. . .

May end up costing Pepsi $1.2 billion, in Wisconsin.

Do we see Pepsi trying to lobby for a retroactive change in the law on default judgments in Wisconsin?

Nope.

Here endeth the sermon.

Namaste

By: pharmavet

pharmavet — Tue, 27 Oct 2009 15:51:34 +0000

Every law firm should know about the FDA’s policies on punctuality. I stayed up 48 hours straight to meet a pediatric extension deadline some years ago, and personally transported the application to Rockville and waited for it to get a receipt of the dated, time-stamped log-in. In fact, FDA is so strict that it has rules for ordering the receipt of ANDA’s that arrive on the same day. Absolutely no excuses here.

By: Former Pharma Marketing Director

Former Pharma Marketing Director — Tue, 27 Oct 2009 13:49:07 +0000

They missed the deadline, the law should not be changed to pander to their inadequacies as a law firm. How many other companies miss the deadline? Not many, so this one law would be favoritism for this one firm. They should have invested that 13 million dollars back into new drug research, where it would have had a better chance to generate revenue.

Hopefully if they see their 13 million dollar lobbying blitz isn’t going to get them what they want, other lobbyists will start to get the message. We can’t ask Doctors and others to stop taking the graft if the politicians can still taking it.

By: Condor

Condor — Tue, 27 Oct 2009 02:22:30 +0000

Yep — doc is right.

The law does (and should) abhor monopolies — so, to preserve their monopolies, the monopolists ought to be required to stay squarely within the strict letter of the law.

Said another way, the general presumption should be IN FAVOR of free, and open market competitions.

It is truly gag-worthy to see multi-billion dollar entities begging for “special extensions“, by legislative-fiat, of their already long-standing (prior-issued patent) monopolies. I really mean TMC NO ill, but this position is beyond the pale — in this particular environment, as a matter of health-care political policy.

“Oh — You made a mistake?” Deal wid’ it. Geez.

By: Doc

Doc — Tue, 27 Oct 2009 01:27:24 +0000

Would MDCO “let it slide” if a generic company brought out a generic for Angiomax 1 day early, before patent expiration?

Methinks not.

By: JP

JP — Tue, 27 Oct 2009 00:49:59 +0000

MDCO knows the game:

If I prove I was first to invent by one day I win (or filed the application one day earlier for Europe)

If I find art pre-dating their invention by one day I win.

If I file my ANDA lawsuit at 46 days instead of 45 after notice, I lose.

Patent term extensions are calculated to the day.

To cry “oh poor me” is pathetic but for the money understandable. If the 13 million in lobbying pays off shame on the politicians.

By: Christopher

Christopher — Tue, 27 Oct 2009 00:21:23 +0000

Lisa and I have agreed way too much. Who is changing:)

But really though, a day is important in so many walks of life.

If I get tickets for Eric Clapton at MSG and turn up a day late will he still be there siting on his stool waiting just for me? If I have a winning lottery ticket (right…) and hand it in a day late will I win? If I turn up a day later than my cruise ship leaves New York will they send me a boat to catch me up?

No. So why would a commercial enterprise like MDCO presume that their mistake should get extraordinary exemptions?

It should not. Those are the rules and tough if it doesn’t work. Sorry for MDCO which is a fine company, but they hire people to deal with this stuff.

By: Jackson Roe

Jackson Roe — Mon, 26 Oct 2009 22:47:01 +0000

I agree the Law Firm is the one at fault here. However, who provided the guidance to spend another $13million on lobbying to change current regulations? Again, some other lawyer. It is time for some attorneys to assume accountability, along with the manufacturers themselves.

By: Lisa Van Syckel

Lisa Van Syckel — Mon, 26 Oct 2009 20:20:24 +0000

OMG,.. Again, I agree with Christopher. Their Law Firm messed up on this one.

By: Nathan

Nathan — Mon, 26 Oct 2009 19:45:32 +0000

Smallvoice writes: “Hey, if someone is only a little over the limit for drunk driving let’s cut him some slack and not revoke his license..”

This is a flawed analogy - we aren’t talking about a legal issue. The company didn’t do anything wrong. Rather, they failed to file for a benefit by a particular date. Big difference.

It just seems to me that for a benefit that is in the range of $1 billion that some sort of a fine or a reduced benefit would be appropriate — not a complete loss of it. If I fail to file my income taxes on-time I don’t loose my ability to claim exemptions. Rather, I simply pay a penalty.

That said, I agree that it seems rather silly to create a law just to solve the problems of one company. However, it also seems silly that that there is no leeway here. Geez, 1 day late = $1 billion.