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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 25, 2006

A Shot Across the Bow

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Posted by Derek

The Ariad-Lilly suit that I spoke about here earlier this month is continuing along, with no news to report. But there is an interesting development: Amgen, surely one of the companies contacted by Ariad about infringement of their NF-kB patent, has decided to play offense. They've filed suit against Ariad in the US District Court in Delaware, seeking a declaratory judgement that Ariad's patent is invalid and that Amgen hasn't infringed any part of it. Interestingly, there's no press release about this to be had from Amgen. Ariad is the source of all the information on this - it's much more of a material event for them, so they're under greater regulatory pressure to disclose the news.

Such rulings can be sought when one party feels what the law terms a "reasonable apprehension" of legal action by another, and I'm sure that Ariad's letter would be enough to meet that requirement.

Meanwhile, according to the U.S. Patent Office's "Official Gazette", there's been a re-examination request filed for Ariad's original patent, as of last December. The applicant is listed as Bawa Biotechnology Consulting, which would be Raj Bawa's firm. They're well-known for doing biotech freedom-to-operate and infringement work, and I would assume that they're being paid by Lilly. Or maybe Amgen. Heck, maybe even someone else - there are enough people mad at Ariad that it's hard to narrow the list down.

My opinion hasn't changed: I think that Ariad deserves to lose this case, and that they will. If their patent goes down in flames, taking all others of its sort with it, that'll be even better.

Comments (30) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. Litigator on April 26, 2006 10:51 AM writes...

Derek
Your post is filled with generalities and is not accurate! Bizjournal.com et al have summarized Amgens suit filing and quote Amgens 'David Polk'....Ariads releases were mandatory for Ariad and not as you infer the only source of information here!. Next is the use of this very general term upstream as used in Biology mixed with very general ideas about upstream in patent law!....that needs very serious examination, reduction and focus before one could comment on what you are trying to say. The leap between upstream in a specific bilogical event and methods to regulate them in specific ways is one thing. Its application to specific patent protection and law is someting else. Specific not broad is certainly the operative term here! If the patent is not specific, your explanation of that certainly isn't either. Do you have access to all the visuals and exhibits given with the patent?... Telling us the patent is too general is not proof! Elaborate or cease! As we speak
Lilly puts foward the defense that the patent is covering only a biological process with no method, regulation or other discovery. Lilly has been firm on this. Lilly also claims prior discovery, and that is clearly their position! Give Lilly credit for the clarity on this! On the other hand Derek your ever changing position could actually imply all regulations techs like the Hedge Hog regulation Amgen licensed from Curis is invalid...imply we said not compare! That would require specifics!

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2. Palo on April 26, 2006 11:17 AM writes...

I mostly agree that a broad patent like Ariad's might be bad because of the far reaching implications. But I have to disagree with Derek on his characterizing the patent as quasi ridiculous. The re-examination request filed for Ariad's original patent that Derek mentions was asked by Ely Lilly, was not initiated by USPTO. It took the U.S. Patent Office 16 years of revision to grant that patent, what are the chances that it is as superfluous as Derek suggests? (on the other hand, it really shows that it was controversial). Also, if it is so much off reality, why did other companies (like Bristol-Myers Squibb) reach agreements with Ariad on that same patent?

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3. Cryptic Ned on April 26, 2006 11:44 AM writes...

Derek, did you add all those randomly placed exclamation points to comment #1 to make it seem even more ridiculous, or did Litigator put them in himself?

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4. Derek Lowe on April 26, 2006 11:58 AM writes...

No, I did not edit Litigator's comment! He just writes like that! Who knows why!

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5. Derek Lowe on April 26, 2006 12:03 PM writes...

It's true that an issued patent is assumed to be valid (until someone re-litigates it, that is). But the PTO has granted so many insane patents over the years that I don't give the issued claims much credit past that strict legal interpretation.

I'm not talking about bozo ideas like the cat-laser-pointer exercise method, or the (in)famous "swinging on a swing" patent. I mean physical impossibilities (as far as we know) like warp drives, faster-than-light radios, methods for reincarnation, and so on. The patent office grants all kinds of invalid stuff, sad to say.

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6. Tim's Brother on April 26, 2006 12:08 PM writes...

"Do you have access to all the visuals and exhibits given with the patent?..." - Litigator

Why yes, we all do! Thanks, USPTO!

http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6,410,516.PN.&OS=PN/6,410,516&RS=PN/6,410,516

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7. Litigator on April 26, 2006 12:14 PM writes...

All we have are generalized reports on law issues. It leads to conclusions. Foe one, many patents take years in the patent office for many different reasons...that is the problem with the reporting..so we take many different occurences never giving the specific reasons for the occurences. Then we can write any story we want....that is why the Warren Commissions early conclusion and subsequent revisions are just as far fetched as any movies...no one gives the "connecting specifics" only threads streeeetching across gaps!..So we assume Ariad sent a letter to Amgen ..does any one have proof? And if we do prove it, does that really mean Amgen used the letter as a way to sue to pre-empt a suit. And if thats true and Ariads patents are invalid then why not go to the patent office. Of course Lilly and others have already done so. Now we assume one of the others may have been paid by Lilly. That assumption was spent on the need to tell us how many dislike the patent. This goes on ad naseum. Law is very complex and so are upstream musings!? Yet these inferences go on to support another inference and so on!...Not a sound legal methodology!....A little honesty and clarity may help us all in these important matters, they deserve better than drawing lines in the sand and hurling generalizations around!

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8. litigator on April 26, 2006 12:30 PM writes...

We saw that posters here used the tactics of attacking the poster as a way of not answering the simple questions...there was a poster here who used the telegraph form of ....word....word....word....dot dot dot... we belive it means "stop" in the telegraph lingo. It has some effect in electronic doings...we were amazed how that annoyed and invited subterfuge.....old legal trick...just....a.....gambit....not quite as vapid as talking to oneself however!.......see......it...really works.....one poster was fuming at the poor guy, but it actually drew attention to his questions. Some left unanswered. Very easy to answer questions were left alone. He also used the small "i" ...boh these techniques are becoming popular in the blog world...must be an E.E. Cummings thing!....I "i" like it ...it has effect here! Maybe he was onto something......STOP!...Maybe now some will reread our posts for what they say not how they say it. Only in America!

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9. Derek Lowe on April 26, 2006 12:52 PM writes...

Litigator, since you bring that technique up, I believe that you must be talking about "Mitosis03", who commented several times on the "Ariad's Day in Court" post that's linked to in today's entry. He was a great user of ellipsis (the three-dots technique you're referring to).

Could it be a coincidence that you're posting from the exact same IP address?

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10. SRC on April 26, 2006 1:43 PM writes...

Am I the only one that after reading certain posts above feels rather like that cat must feel after chasing the laser pointer playing on a wall?

Just wondered.

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11. D..L on April 26, 2006 1:56 PM writes...

so Derek no sense posting here as you will edit what you want, of course that is so easily remedied but we do not feel you are capable of honest discourse and we are not here to judge you. Only wanted honest info flow and discussion of tech and patent doings. Please try some specific accuracy in your methods especially if you are going to regulate NFkB or use any other "method" to make a drug. People depend on it! Yes this IP is used by many but that really has nothing to do with with our open and honest discussions. In fact you know keeping that info close is used for the safety of posters over the "waste" parts of the internet. Your IP announcement says much! In fact your responses and actions may be useful in another exhange. Thank You

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12. Palo on April 26, 2006 2:11 PM writes...

Derek, checking out a poster's IP address to use in minute style arguments doesn't seem like you...

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13. Derek Lowe on April 26, 2006 2:54 PM writes...

At least I post - and only post - under my own name here. I don't like playing IP address games, but I dislike even more someone's coy references to their own comments under another name.

Mitosis03/Litigator/Name Game, you've been unable to convince me, under any of your aliases, that you understand very much about either molecular biology or patent law. Now, it's possible to know those subjects and still disagree about Ariad v. Lilly, but in those cases the disagreement has at least a chance of being a learning experience for both sides. You may, in fact, have reasons for arguing Ariad's side other than owning their stock and wanting it to rise, but they haven't been noticeable.

What I've had from you are rambling comments about honesty, about red herrings like whether Amgen really sent a letter to Ariad (when the source for that information is a press release about Ariad's own web site, about the Warren Commission and who knows what else, all laced with semi-random uses of the words "specific", "broad", and (of course) "method", which shows up about three times per paragraph.

Whoops, I forgot: I've also had accusations from you that I work for Lilly, which five minute's work would show you is not the case, along with some implications that I would step in and edit your comments. Just for the record, I've deleted comments at request of their authors a few times, but I've never altered a word of an existing one. People who remember WBurke's screeds here can attest to that; if anyone's comments deserved the red pencil, those were the ones.

No, there have been plenty worse. You're still welcome to stick around. I'd rather you pick one name and stay with it, but your writing style is a pretty good indicator all on its own. You're still easier to deal with than some of your fellow ARIA bulls on the Yahoo message board, one of whom opined today that I look like an alcoholic in the pay of some hedge fund.

Just lay off the incoherent threats, if possible, and try to make sure that your comments have a readily expressible take-home message - if possible.

Here's mine: I believe that Ariad's '516 patent is far too broadly written as granted. I do not believe that many of its claims are well enabled. I believe that the USPTO made a mistake in granting it, an outcome which would be far from unheard of.

Although others have tried, and sometimes succeeded, in patenting such large swaths of cell-biology space, Ariad's attempt to enforce these claims sets what I believe is a dangerous and counter-productive precedent. Should they prevail, I believe that this could set off a tragedy-of-the-commons outcome in molecular biology IP, and I believe that this would hinder the practice of research and the biotech industry more than it would help it. I want them to lose, and I don't want anyone else to do what they are doing.

I am not saying these things because I work for or receive any compensation from Eli Lilly, because I don't. Nor do I own any shares in the company, other than what would be in my mutual funds - the bulk of which position is Vanguard's S&P 500 index fund. I have no position in Ariad stock or options. I do not stand to profit in any way from a decision in favor of Lilly (or one in favor of Ariad, for that matter).

Are we clear?

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14. Harry on April 26, 2006 3:11 PM writes...

Bravo, Derek!

I'd like to know if Mitosis/Litigator/Name game is using some sort of random phrase generator to produce these incoherent screeds. I doubt very seriously if someone who writes in such a disorganized fashion is a litigator of any sort.

And no, before I'm accused- I do not nor have I ever worked for Lilly (or any other pharma company for that matter).

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15. Palo on April 26, 2006 3:51 PM writes...

See, you didn't need your Big Brother powers to say all that. Did you?

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16. Derek Lowe on April 26, 2006 3:58 PM writes...

Well, it does keep me from having to say it over and over to a swarm of allegedly different individuals.

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17. srp on April 26, 2006 4:13 PM writes...

I think Derek is being uncommonly civil in the face of these dissociative ravings. I also think anyone using sock-puppet tactics deserves to be IP-exposed. So if you see a comment from "srplover" saying "srp is wonderful and all his enemies should perish," a little sleuthing to expose the deception would not be amiss.

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18. Nom De Plume on April 26, 2006 7:55 PM writes...

Derek, Mitosis 03 is well known to all on the Ariad and other message boards. In fact he sometimes goes to annual stockholder meetings for Ariad and others and always invites fekllow posters to meet him there! We met him there and spoke! Just another investor relaying nd questioning info as how I took him. Many of us from certain backrounds and areas found IP's that are very secure on a potential internet. Further even if we were Mito and all the ptojected nom de plumes it does not retract from your ill informed posts! So you stoop to shoot the messanger. Bravo! Even the president of the United Staes must stand naked sometime!

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19. Plume de Name on April 26, 2006 7:58 PM writes...

Harry and Derek are you guys using methods too regulate NF kB together? Sounds so , how do we say, cozy!

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20. Siamesecat on April 26, 2006 8:09 PM writes...

Now Now Derek, such a tirade. Did the pointing out of your ill researched post make you a bit muffy. Have some warm milk. Yes in the cyber age with all these cyber cafes many of us post from the same IP's. We actually bump elbows between the poetry readings and cappacino. Try a cyber cafe to post one day it is quite refreshing! Or find a secure one that you can share. Please keep your children from singing your songs it is so weak!

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21. Harry on April 26, 2006 9:11 PM writes...

NDP- you apparently have some sort of reading and/or comprehension deficiency.

If you had actually bothered to read my post you would know that (I repeat- and I'm typing very slowly for your benefit) I DO NOT and HAVE NEVER worked for ANY pharma company.

My company does custom synthesis on a gram- to multi kilo scale. We do not regulate, modulate, moderate, agitate or any other-ate your pet "method" Nf KB. Oh yes, some !! ... !!! .... !! to make you feel comfy.

To everyone else- I apologize to you if the asperity in my reply is annoying. I will henceforth refrain from feeding the troll.

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22. assumer on April 27, 2006 10:52 AM writes...

So we have no working knowledge of NfKB.
Yet we know all about it? Then we claim on the Ariad web site we can find that Ariad contacted Amgen in a letter. From that we assume that the letter is the legal wedge Amgen used in the suit. So we assume Bawa's firm is being paid by Lilly? Think I will ask the Lilly folks. So we Assumed all the info was released only by Ariad. So this IP I used here is used by many but we assume it is some other poster and that makes all your other assunptions correct. You want assumptions? Actually the MIT/Harvard patent is secretly combined with the swing chain and cat laser patent. Harvard et al are using the combined technology to beat Nasa in their attempts to blow up the moon. Didn't you know? Oh the pending tragedy! Any one posting to this site should know that if Derek disagrees with you he will post unpublished info about one of your choices of computer sites! Nasty little Derry will make his usual authoratative assumptions about that!! You will also do well to research Dereks info, it is a current tradgedy! Science found the cat watching the wall doesn't know the image on the wall is being produced by a remote machine! The cat thinks the image represents a reality in itself. The images posted here are being produced by Derek Lowe, find out if there is a mathing reality outside of Dereks brain cells. Do your own research! No hope for specifics from Derek!

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23. Dr Snowboard on April 27, 2006 11:49 AM writes...

I think WBurke was more educated and erudite than these guys...yawn.

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24. SRC on April 27, 2006 1:25 PM writes...

Uh...is Thorazine off-patent yet?

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25. Harry on April 27, 2006 1:38 PM writes...

THESE guys? I think maybe "their" name is really Sybil.

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26. srp on April 27, 2006 2:18 PM writes...

The trolls here are certainly...different. Full-bodied, but with a nutty flavor.

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27. Harry on April 27, 2006 3:48 PM writes...

Actually- I find their writing style reminiscent of the survivors/attorneys/partners of the important and rich folks who met an untimely end in Nigeria/Ghana/Ivory Coast, etc. Said persons having access to large sums of money left in inconvient circumstances and who want to give me a large portion of said funds in return for my help, banking information and a modest fee (to cover bribes and other facilitation).

On the other hand- the charitable folks described above generally have a better command of English spelling, punctuation and composition. Also- their correspondence actually has a point to it.

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28. ip person on April 28, 2006 12:31 AM writes...

Here goes:
Patent in suit has 203 claims. Claim 1 recites:

1. A method for inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-.kappa.KB, the method comprising reducing NF-.kappa.KB activity in the cell such that expression of said gene is inhibited.

http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=4&f=G&l=50&co1=AND&d=PTXT&s1=dna&s2=baltimore.INNM.&OS=dna+AND+IN/baltimore&RS=dna+AND+IN/baltimore
(Link to USPTO.gov patent)

The priority alleged goes back to 1980's, but, somewhere along the line the PTO in the re-exam has held (I think) that there's no support in the 1988 application for the claimed invention.

There's three issued patents in re-exam, and sort of a hash of a process, but it looks to me like the end result will be that the PTO will take this on and not stay pending the outcome of the litigation.

Now, some fed. judges do stay litigations pending the PTO results, some don't. I would think that the litigation would be stayed (not dismissed) pending the PTO determination.

Curcumin goes to the nfkb effects --
http://www.annalsnyas.org/cgi/content/abstract/1030/1/578?maxtoshow=&HITS=&hits=&RESULTFORMAT=1&andorexacttitle=and&andorexacttitleabs=and&fulltext=curcumin+nuclear&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT
Since this is an inherent effect, there is no prior art date relevant - it's always happened.

So you can see how the broad claims are imo a stretch.

Ariad's patent person I think was also the patent person for Genetics Institute when GI v Amgen was raging on. there the strategy was to get a probe to the EPO gene, and publish a plan to clone up the whole thing (remember pre-PCR) -- looks like same patent strategy here -- stretch out a wish list as far as you can, and then ambush the people who actually have something which contributes to humanity. IMO. No offense to the inventors who we all love, it really looks to me like some schmarty patent lawyer who talked the BOD into this kind of thing.

IMO, my opinion, from a quick scan of the file wrappers.

IP person

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29. dr. ewa on April 28, 2006 4:06 PM writes...

Derek's argument is lost in Politics. Obvious Derek is chomping at the bit to cast his vote for Hillary Rotten Clinton. As a Scientist I wonder why Derek the English Major/Writer is so anti Capitalism ? I wish more M.D.s and Lawyers would become writers, maybe then we'd get some meat with the story, not only Political cry baby rants like Derek's.

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30. Dave on May 1, 2006 9:41 PM writes...

Ariad's going down and going down hard on this one.

Bad patent, worse company.

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