Generic Savings Vs. Patent Deadlines: A Reader Poll
23 CommentsBy Ed Silverman // October 26th, 2009 // 7:51 am
At a time when saving big bucks on health care is such a hot issue, should Congress alter patent laws to save a company a lot of money from generic competition because it missed a basic, but crucial filing deadline by one day? Tim Carney at The Washington Examiner raises the case of The Medicines Company, which makes Angiomax, an anti-coagulant drug that helps prevent a second heart attack.
In early 2001, MDCO applied for a standard extension to its patent, which would have been approved, except the company’s lawyers filed the application 61 days after initial FDA approval, missing the statutory deadline by one day. As a result, Angiomax’s protection is set to expire next year instead of in 2014, as the routine extension would have allowed. MDCO says the early patent expiration could cost it $1 billion as cheap generics arrive. So, Carney writes, since 2002 the company has spent more than $13 million on lobbying - almost solely to get the missed deadline and their Angiomax patent extended to 2014.
MDCO has drafted legislative language that is circulating Capitol Hill and it states the US Patent and Trademark Office “shall accept an application under this section that is filed not later than three business days after” the deadline for patent extensions. The bill is explicitly retroactive, he notes, and the current legislative language specifies this applies to “a drug that is intended for use in humans that is in the anticoagulant class of drugs.”
On fairness grounds, Carney writes, MDCO has a point: The company would have been entitled to the 56-week patent extension to make up for time lost while the FDA was still approving the drug. For being one day late, should the company really lose a billion dollars? But changing the law to keep generics off the market for a life-saving product is the opposite of seeking savings, he notes, adding that it seems the interest of generics coincides with President Obama’s broader agenda. [UPDATE: A loyal reader also notes that MDCO licensed the drug from Biogen and may face damages over the late filing - see pgs. 15 and 37 here].
Is MDCO’s argument - that this law is needed to encourage innovation - truly absurd, as Carney suggests? Should Democrats let MDCO suffer for filing a day late or should they say ‘no’ to a $13 million lobbying effort? What do you think?
Should The Medicines Company Get Its Way?
- No (61%, 104 Votes)
- Yes (39%, 66 Votes)
Total Voters: 170
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Hap
No. Let them sue their lawyers for the money. Next time, maybe their lawyers will remember how to read a calendar, or set an appropriate appointment in their computer program of choice, or maybe TMC will get some competent lawyers.
Would someone without $13M in lobbying donations get such sympathy, from say, the IRS? Probably not.
Justice in Michigan
Compared with the serious issues that concern exclusivity, this one is small indeed.
Obviously, there needs to be a deadline somewhere. To spend the additional time/money to change the law for one company seems nuts. The time lost from considering the more important issues about exclusivity seems even nutsier.
Condor
I am embarrassed for this company.
These are not secret laws — in fact, under our system, all laws must be public. This was a public deadline in 2001 — and there is no suggestion that the deadline is or was ambigious.
The lawyers who missed the deadline carry malpractice insurance for just this reason. Missing sucha a deadline is malpractive.
The idea of changing the law to protect essentially one company — and the Medicines Company’s profits through 2014 (while only barely Constitutional, in the first place) — should be unconscionable, as a matter of public policy. Especially so, in an environment where 44 million of us can’t afford/don’t have insurance for basic health care — and the majority of us are now seeking to make the law more equitable (with a strong public option). . . .
Someone should remind these folks that Bush/Cheney left office in January — and these “mighty blingin’ fabtacular corporate welfare-queen” deals (ought to have left the belt-way), with them.
Okay — I’ll go refill, now — but with some decaf, this time!
Namaste
Condor
Oh yeah. I know you can’t imagine why — but I voted “No” — in the poll.
Nathan
I suppose all of you unsympathetic complainers out there also think that a homeowner that is 1 day late on his tax bill should face immediate forclosure. That an unemployment application filed 1 day late should be inelligable for benifits. That an insurance premium submitted 1 day late should face policy termination.
Thank God that most human beings out there (including our politicians) have a bit more sympathy…
Justice in Michigan
If not clear, I’m for giving them the day. What seemed “nuts” was that it had to come through legislation.
But let’s say it was passed, and then a company was four days late. Nathan, would it then be OK to lower the axe? Why then?
What seems rational is not all/nothing, but perhaps some “lateness fine,” and then go forward.
smallvoice
The real danger here is the retroactive component of the proposed legislation MDCO is paying millions of dollars to get passed.
As another commenter remarked, why not prolong the request period for only 3 days? Is this a good reason to change the law? Hey, if someone is only a little over the limit for drunk driving let’s cut him some slack and not revoke his license– or better yet, retroactively up the limit so he wasn’t really driving drunk after all.
Laws are promulgated to establish standards and boundaries as well as the consequences for not complying. MDCO didn’t comply and as far as I can tell they have no good reason for non-compliance other than their lawyers screwed-up.
One of the effects of retroactively changing this law just to help MDCO make more money is to once again show how our system of lawmaking (and justice) is heavily biased to those with the money to “work” the system. It gives hope to all those other companies or deep-pocketed individuals who don’t operate within the law that a financial calculation can be made to show how putting money into retroactively changing laws is an economically viable course of action that may be preferrable to compliance.
Hap
I don’t think we (average citizen) would indeed receive such sympathy - the only reason we do, now, is because someone legislated it. My credit card company (or bank) would probably sell my home for late payments if it either made financial sense or were legal. Exceptions to patent for companies with lots of lobbying cash sounds too much like “socialism for the rich, capitalism for the poor” (or more accurately, “‘New Testament God’ for the rich and ‘Old Testament God’ for the poor”) for my taste.
You know what the dealines are - if you’re not smart enough to read (or not smart enough to hire lawyers to do so), than I’m not sure I should worry about your drugs. Maybe your patients should, though.
I think some sort of leeway would probably be OK, but even then it would be set in law. If you can’t read the rest of the law, why would you be able to read that part of it, and if you miss that deadline, what then?
Naysayer
NO WAY!
To those who are sympathetic and say give them the day…what about the poor schmuck that submitted, two days later, or perhaps 3 days late.
I read about this and some say its “The dog ate my homewoek” legislation. I tried that in elemnetary schools and you know what the answer was!
Condor
Nathan’s analogy is flawed primarily because it ignores the “informational advantage” a multinational public company, with multiple-billions in revenue, possesses — as compared to an individual home- buyer.
There is more to say here, but as I am on a cell-phone pecking this in, that is adequate to implode his argument.
Namaste
Condor
So sorry for the double post, but the other policy at work here is the American law’s general abhorrence of monopolies.
At patent is a monopoly-by-law. Thus very strict adherence to the law creating them ought to be required by all of us — if we really are capital market adherents.
Namaste
Christopher
‘Sympathy’ has been used more than once in comments made here but this case is not about pity or emotions - it’s about business. MDCO should not have missed the deadline and in doing so they screwed up. And note it is almost 8 years since this happened: this is not a new case (albeit it is a huge one for them).
PatAtty
I’m a pharma patent attorney, and I’ve done extensions both in-house and from an outside law firm. It’s really hard to see how this got fouled up other than just lack of care in the law firm, or possibly poor communication between the law firm and the client, because the short deadline is well-known. Extensions are not rocket science, and are mostly formal. We used to start assembling the request for extension almost as soon as the NDA was filed, making sure that regulatory was getting the chronology together; and then finishing it off as soon as the approval came through and regulatory could complete the chronology and we could check the final label against the patent claims.
Biogen probably has a complaint against MDCO, and MDCO probably one against the law firm, but I don’t see that we should make a change in law to fix someone’s mistake.
Nathan
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.
Lisa Van Syckel
OMG,.. Again, I agree with Christopher. Their Law Firm messed up on this one.
Jackson Roe
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.
Christopher
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.
JP
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.
Doc
Would MDCO “let it slide” if a generic company brought out a generic for Angiomax 1 day early, before patent expiration?
Methinks not.
Condor
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.
Former Pharma Marketing Director
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.
pharmavet
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.
Condor
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