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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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April 11, 2006

Ariad's Day in Court

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Posted by Derek

It's been a while since I wrote about Ariad and their suit against Eli Lilly, but the time has come again. Back in 2002, the company was granted (after sixteen years of prosecution) a patent with broad claims around the transcription factor NF-kappaB. I mentioned that one the other day as a good example of a protein that's involved in more things than human beings can keep track of, so you can imagine where these claims could take you.

In Ariad's case, they're planning on taking them to the bank. As I wrote at the time:

Ariad had a lawsuit fueled and on the pad, and as soon as their patent was issued, they launched. In fact, the Business Wire press release about the lawsuit went out before the one about the patent, which shows you where Ariad's priorities are. They claim that two of Lilly's biggest products, Evista for osteoporosis and Xigris for sepsis, both work through NF-kB (and there's little doubt that they do, at least partially.) Therefore they're demanding royalties, and pronto. Lilly had ignored Ariad's previous requests for a licensing deal, according to the Wall St. Journal, which moved them up to the exalted position of First Target. The other fifty companies can presumably expect the same treatment if they don't get on Ariad's good side.

And back in 2003, when the suit finally seemed to be cleared to go to trial, I wrote that it might get there during 2004, which shows you how much I overestimate our legal system. Or perhaps how I underestimate Lilly's legal team, which I'm sure has kept things spinning out as expensively as possible. After all, Ariad lost over fifty million dollars last year - perhaps Lilly were hoping they'd go out of business before things went to court.

Actually, that's not likely, since Ariad is merely the licensee. The assignees on the orginal patent are Harvard, MIT, and the Whitehead Institute, none of which will be going to be going out of business any time soon. I would very much like to know how much of their money is going into this fight, as opposed to Ariad's (more on this in a minute).

So here we go; arguments started this week. The implications, as I said back in those older posts, are potentially very large. Patenting big swaths of important biochemical pathway space has the potential to turn drug development into even more of an expensive nightmare than it already is. As this thorough overview in Science mentions, there are over 200 drugs that could plausibly be said to work (at least partially) through NF-kB signaling, from aspirin on up. You can add all sorts of development candidates for arthritis, cancer, diabetes and many other indications to that list. That article includes this interesting note:

Ariad's chances of winning, at first glance, appear small. "It's probably somewhat less than 20%," says Philip Nadeau, a biotech analyst at investment bank Cowen & Co., which counts Ariad among its clients. "These broad patents in general seem to be tough to defend when brought to court." But among the inventors on the NF-B patent are David Baltimore, now president of the California Institute of Technology in Pasadena, fellow Nobel laureate Phillip Sharp of MIT, and well-known Harvard molecular biologist Thomas Maniatis. Their very presence on the patent, and possibly in court, could be decisive. "You've got very prominent scientists who are the inventors," notes Rochelle Seide, a patent attorney with Arent Fox in New York. "That sells very well before a jury." (These inventors have not commented publicly on the patent or lawsuit and declined to do so for this story.)

And that's going to be interesting. Ariad would presumably like to have these luminaries in court, testifying on its behalf. Will they? These people surely know what the implications of an Ariad victory will be for industrial (and even academic) research. Do they really want this suit to succeed? I wish I knew.

A separate question is whether the institutions involved want it to succeed, and those answers might well be different. They all stand to gain some revenue from Lilly if Ariad wins - although, let's be honest, what's another few million or so to Harvard? Presumably there's even more money in the offing if Ariad starts to lean on everyone else, though. And since it's these sorts of institutions that discover more of these fundamental pathways, they might not be averse to a system that lets them profit from them - let the lesser outfits take their chances, eh? Pecunia non olet?

Lilly's defense seems as if it'll be that (first) their drugs were in development long before NFkB was even discovered, and (second) that, as in the Rochester/COX-2 ruling, that the identification of a biochemical pathway does not equal finding a drug that affects it. Those are both good arguments, and (like other observers) I expect Lilly to win. Of course, no matter what happens, there's going to be an appeal, so it could be years before we hear the last of this. (The Metabolite case that's been before the Supreme Court could well have a bearing on this, too. I'll have more on that in another post; I've been neglecting that one).

But along the way, it'll be interesting to see how the issue is reported. My fear is that the whole thing might end up being framed as a battle between disinterested, truth-seeking academic researchers and rapacious pharma drug peddlers. Let's hope not - there's only so much that my stomach can take.

Comments (22) + TrackBacks (1) | Category: Patents and IP


COMMENTS

1. Chemist on April 11, 2006 11:03 PM writes...

Give us a nerd post!! It's been too long since we heard you go off about...say, an ether peroxide accident in grad school.

Your patent posts are illuminating, but for my money, there's nothing better than hearing a working chemist curse his hindered base troubles..

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2. Jim Hu on April 12, 2006 9:30 AM writes...

I hadn't followed this case, but it sounds dreadful, and fits with my general dislike of patenting targets. I used to think of Ariad primarily for their academically interesting work on chemically induced dimerization based on the Crabtree and Schreiber approach (I published one paper exploring using different compounds to accomplish similar ends)...but it was never clear how they were going to make money off of that.

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3. mitosis03 on April 12, 2006 9:37 AM writes...

i have read some very interesting articles by you....i think however in the Lilly vs M.I.T. et al you would do well to read the legal documents...this is a "methods" case....not an existing pathway issue, Phil and Dave would not try to patent a pathway....your opinion of their wishes on the trial outcome is scary...where did you get that from?....but you know that don't you!....You would also do well to read Sidney Taurel's (familiar name to you?) strong support of patents and Intelectual Properties....He says they are what drive the indusrty and economy....he says is it our civic duty to protect them....

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4. peej on April 12, 2006 9:45 AM writes...

I still dont get patent issues. Wouldnt it just be simpler and clearer to have a patent on the specific molecular structure of a compound? It seems to me that challenges would go away then, and it would be very clear what was and was not under patent. Derek- you should probably answer this one in a blog post, since it seems so obvious but there must be issues surrounding it.

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5. Palo on April 12, 2006 10:07 AM writes...

It's funny to see how people can be on both sides of the patenting argument depending on which side their money rides.

The sight of a guardian of big pharma deep pockets taking shots at Harvard or MIT's millions is also delicious.

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6. Derek Lowe on April 12, 2006 10:19 AM writes...

Mitosis, I've read Ariad's patent, inasmuch as it's possible for a human to read it. There are over 200 claims in it, relating to just about every permutation of NF-kB utility that you can think of.

So it's true that they're not patenting the NF-kB pathway itself - just every possible use that mankind could ever find for it, in the broadest and most far-reaching senses that can get through the PTO. That, I guess, is a "methods" patent, and I still want it to go down in flames.

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7. Derek Lowe on April 12, 2006 10:23 AM writes...

Glad you're enjoying yourself, Palo; I aim to please. Fear not, though, if any big pharma company were crazy enough to try a stunt like this one, I'd take off after them, too.

There have been a few such things applied for or even issued (although I can't come up with an example as broad as this one). And I'm not happy about 'em. But Ariad is the first outfit I've seen that's ever tried to enforce one.

If perchance Ariad would win this case, and have it hold up on appeal - both very unlikely, I think - then you would indeed see everyone filing on such discoveries, and vigorously prosecuting them. And we'd all be the poorer.

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8. John on April 12, 2006 11:51 AM writes...

I am sick and tired of the large pharm companies taking the research of educational institutions and making a fortune. Now Lilly is trying to bully a small biotech company that evolved from educational research.

Why would we all be the poorer? Wouldn't a win by Ariad show the large pharms that they need to play fair?

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9. mitosis03 on April 12, 2006 12:09 PM writes...

Derek...you responded "as much as it is possible for a human to read it"...."i want it to go down in flames"...you now frame it as a methods trial whatever your broad opinion...problem is you framed your articles on the inference it was about pathways. That is not a trivial distinction!......curious that you couldn't understand it but concluded it "covered every possible use"..yikes...by the way i post on the Ariad message board you might want to read some of the posters there...

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10. Canuck Chemist on April 12, 2006 12:15 PM writes...

A patent is designed to cover an invention with a practical application, and not simply a discovery. My highly simplified analogy is that Edison shouldn't be denied the chance to profit from the light bulb by Thomson's evidence for the existence of the electron. How can we give patent rights to someone for something they didn't create but which already exists in nature? If one can patent a single natural protein, why not a collection of proteins and other bits and pieces? Should the discoverers of the HIV virus have been given patent rights and the chance to collect profits from the development of antiviral medicines? That's ridiculous. There is nothing preventing people in basic research from developing profitable (and patentable) applications to their discoveries, but to me that generally defeats the purpose of doing basic research. If anything the contributions of industry to basic research are underappreciated. Where would materials science be today without Bell labs, IBM, etc.?

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11. Palo on April 12, 2006 1:20 PM writes...

Derek,
I tend to agree with you on the merits of the patent.
My cynicism went along the lines of what mitosis pointed out. You have a tendency to ridicule and minimize the arguments that do not suit your opinion (or interests?). As mitosis points out, you did frame the issue on the grounds of "they are trying to patent a pathway", not the methods. When talking about gene patenting in the past, you seemed a lot more charitable in your opinion, even when gene patenting is as far upstream of drug development as the NF-kB pathway is, and with the same potential negative effect on drug discovery.

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12. JSinger on April 12, 2006 1:24 PM writes...

you now frame it as a methods trial whatever your broad opinion...problem is you framed your articles on the inference it was about pathways. That is not a trivial distinction!

I think the point is that the claims of the NF-kB patent are so broad and are being applied so broadly that it's effectively a pathway patent. The COX-2 guys at least had a clear idea of what they had and what hitting it could do, even if they still didn't have anything that constituted a real drug. Ariad is claiming rights to any treatment of any condition through any mechanism that could somehow be connected to a protein that's involved in nearly all signaling.

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13. Derek Lowe on April 12, 2006 1:25 PM writes...

Mitosis, you seem to think that saying "methods patent" will make me evaporate or something. Have you or have you not looked at the claims of Ariad's patents?

While we're on the subject, have you even read that Science article that I linked to? Lilly made and tested these compounds before NF-kB had even been discovered. These were targeted at the estrogen receptor and at protein kinase C. It was only after they'd made it to the final months of development that any role was found for NF-kB at all, and it's still anyone's guess as to whether that's part of their clinical profile.

So even your repeated invocations of "methods patent" don't seem, to my eye, to mean much. But on a broader level, I maintain that this patent is much worse, and in a different class, than the typical methods patent. I don't see how you can do anything that even brushes up against the inflammation pathways without, somehow, bumping into NF-kB. Does this mean that Ariad gets a piece of any and every drug that does?

You, apparently, say "Yes! Of course!". But ask the University of Rochester about that. Discovery of a biochemical pathway is not discovery of a drug. Many people do not believe that this statement is true, nor do they understand why it is. But it is.

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14. UndergradChemist on April 12, 2006 1:26 PM writes...

John, I don't know how you can possibly consider Lilly to be the aggressor in this case. That's like saying Bayer is technically "bullying" Ariad because they produced a drug (aspirin) decades ago that violates the patent just granted. Just because Ariad is smaller than Lilly doesn't mean that Ariad is in the right.

My friend works in the Maniatis lab, and I've been trying to get him to find out what the lab thinks about the Ariad patent/lawsuit, but he's too afraid of offending Maniatis to try.

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15. Derek Lowe on April 12, 2006 1:47 PM writes...

And by the way, Mitosis, I took your suggestion and had a look at the ARIA board on Yahoo. Not much of a signal-to-noise over there, is there?

For your information, no, I do not and have never worked for Eli Lilly. I don't know if my Wonder Drug Factory even got a letter from Ariad or not. We wouldn't be one of their major targets, as far as I can see.

I notice in one of your posts on the stock board, you say ". . .Ariad is also about curing cancer and has drugs in the pipeline!" Well, y'know, so do a lot of other companies. Should they all have to kiss Ariad's ring before they can proceed?

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16. mitosis03 on April 12, 2006 3:59 PM writes...

Derek...it is a methods trial and the court documents state two specific claims...i do not know all you know as Ariad and Lilly have kept that info very close to the vest...many have published on how little is known about the claims and counter claims by the parties involved...you however infer to know much more than what was issued to the public. Also as it is a methods case, limiting the amount of methods one can claim is not very Capital, it is quite socialist in fact...myself i would give everything away and work together to beat cancer but thats another story!...However you prefer to talk of wine, aspirin, whose on first , kissing rings and all "sorts" of curious phrases!...i do not know who will win and if Lilly did not use those methods specific to the claims than good for them may they win!! The comment about when the press release went out and priorities is revealing...there is no high ground here...stop looking for it!...Hope you liked the Ariad board...quite a crew...no hiding in the corner there! Do you play baseball?....i would rather have signal to noise than couched music!

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17. mitosis03 on April 12, 2006 5:48 PM writes...

by the way Derek i wish you would refrain from asking me a question and then answering it for me. What kind of reporting is that?...No i do not know or care what bumps into NFkB nor wouid expect it to be patented. Sorry for the pain the word "method" causes but thats what its about as far as the palintiff says!!....This case has two specific claims. You mentioned that your Wonder Drug Factory has not recieved a letter from Ariad yet? ..Are you using methods to regulate the NFkB pathway?....ugh!..i think i'll take an aspirin!

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18. annoyed on April 12, 2006 7:20 PM writes...

Mitosis,

You're broken english gives me a headache...speaking of aspirin.

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19. Petros on April 13, 2006 2:34 AM writes...

I'm with Derek on this one. I look at a lot of patents and the one central to this case is full of rambling claims for which there is little evidence presented to substantiate.

Ariad could well be out of business before the case is resolved. It's latest 10K shows liquid assets of around $81.5 million, an operating loss in 2005 of $57 million and income of only $1.3 million. Will a judgement come before Ariad runs out of money? And Lilly's appeal, if required, would certainly be after Ariad has run out of cash on its current figures.


(It was actually seeking info on this case when the suit was first filed that led me to find Derek's site.)

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20. Name Game on April 13, 2006 8:52 AM writes...

It is now clear that this board has the same type investor spinners found on the message boards. The tactics they use include posting names similar to other posters. In my case they tried subtleties like mitossis03, mitosiss03, mitosis_03 and so forth. Because this blog can not protect even the name mitosis03 i will no longer post under that name. It is clear those type investors post here and experience tells me those tactics may occur. Although that activity has not happened here yet, it is obvious those type are here and so i make this notice! -NOTICE- No posts under the name "mitosis03" or "similar" will be posted by me. i can be found on the Arriad or Lilly board et al. Any one who believes suspending opinion, engaging in dialogue and exploring are they way can post to me there . In that spirit we can discuss the pertinent issues to those companies! One last thing, Derek's comment about Ariad not sending his Wonder Drug Company a letter yet remains interesting! Farewell and Peace, Mito....EST would be 9:52 A.M......."at least do no harm"- Hippocrates

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21. name game on April 13, 2006 9:22 AM writes...

tried to post earlier...no matter...as it is obvious to me that investor type spinners roam this board and i am familiar with their tactics let it be known i will no longer post here under the name mitosis03....nor any similar name will be posted by me. The spinners use those name game tactics to confuse. By the way the last spinner toally skewed Ariads financial situation and their ability to raise funds. Prospective partner for phase three as phase two has been completed ....not surprised by the smoke!

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22. Same Old Game on April 13, 2006 10:26 AM writes...

Mitosis03 seems to get some enjoyment for getting under people's skin.

http://www.the-scientist.com/article/display/15238/

Mr. Lowe was right about the "Not much of a signal-to-noise over there, is there?" comment. One can plainly see if a poster is not kissing "Ariad's ring" on the board they are categorized as either being from Lilly or just basher. The "multiple names" is funny since the poster has been implied in using other alias to post.

Ariad has failed in the past, AP1903 (and the 20% workforce reduction) and the "10X better than Gleevec" '464' yet people like the poster enjoy posting about other companies failures and issues while ignoring their own company.

Ariad can raise funds … anyone need a shelf or two or three?

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Es ist wahr, mal wieder eine kleine Pause im Blogging, aber das Leben hatte mich in seinem festen Griff. Aufgeweckt hat mich diese Geschichte: Ariad's Day in Court In der Derek Lowe von In the Pipeline ber das Gerichtsverfahren Ariad vs. Eli Lil... [Read More]

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