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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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September 5, 2006

Ariad's Patent Eviscerated

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Posted by Derek

A correspondent has alerted me that the US Patent Office's re-examination of Ariad's huge NF-kB patent is complete. And 160 of its 203 claims have been rejected. This includes, I believe, all of the ones that Ariad used to make its recent case against Eli Lilly (#s 80, 95, 144, and 145). For example, it appears that only six of the first fifty claims are still standing.

You can find all the details here at the USPTO's PAIR site. (That 66-page "Re-exam Non-Final Action" is where the good stuff is). It appears that most of the claims have been dismissed due to over-broad functional language. There's a statement in there that most of the claims are "purely functional":

"With respect to claim 1 it is noted that the sole method step is function i.e. reducing NF-kB activity. Accordingly, the claims would encompass any in vitro or in vivo, natural (indirect) or man-made (direct) means of reducing NF-kB activity. Indeed, most of the method steps recited in the Baltimore patent are purely functional. . ."

This is an argument over the "means-plus-function" section of US patent law, 35 U.S.C. section 112, paragraph 6 if you want to get right down to it, which has been the subject of many a lawsuit. Here's a good discussion of the topic, and here's the Patent Office's take on it for its examiners, if you want to feel a throbbing sensation in your temples. Basically, I think the problem is that the patent is claiming a function (inhibition of NF-kB signaling) without specifying the means by which it is to be carried out.

And there's that nasty problem of prior art. The examiner notes a paper from the Journal of Biological Chemistry (265, 8339) which "teaches the reduction of NF-kB activity in induced cells". This reference, the office action goes on to state, expressly anticipates a large swath of the patent's claims right there. It makes for interesting reading, this re-exam, and I certainly don't have time to dig into all 66 pages of it tonight. But it'll be interesting to hear what Ariad (and its stock boosters) have to say in the morning. There's nothing on their web site tonight. . .

Update, September 6: Still nothing from the company on this - wouldn't an office action on a key piece of intellectual property qualify as a material event? One that affects ongoing litigation? Dated August 2, yet?

Comments (8) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. IP Person on September 5, 2006 10:08 PM writes...

Whoa, page 45: Drinking red wind is invalidating prior art to most of the claims.

The printed publications include the King James version of the Bible (1611), and the French paradox (how come the French drink so much but are healthy? Vin rouge, n'est ce pas? Le dernier cri.)

I smell some really bored patent lawyers sitting around maybe with a bottle of red wine, saying, "hey, about that Ariad re-exam..."


Permalink to Comment

2. some guy on September 6, 2006 1:52 AM writes...

I believe you left an italic tag open in your post. Everything on the page from the beginning of the quote is in italics.

I do enjoy reading the site though.

Permalink to Comment

3. Petros on September 6, 2006 1:53 AM writes...

Let's hope the appeal judges don't hold contray to this re-examination.
But to get both the King James Bible and Goodman & Gilamn cited as invalidiating prior art!.


THe last page of the 66 sumamrises which claims are regarded as invalid and appears to lay waste to even more than 153 of the claims on one or more grounds.


But the emergence of this submarine patent, from various cips, highlted what was wrong with the old US system of only publishing patents after grant rather than on filing as elswheer. The PCT equivalent survived with many few, much less all embracing, claims possibly as a consequence.


Permalink to Comment

4. Fred Cohen on September 6, 2006 8:35 AM writes...

Thanks so much for alerting your readers to this important update. This is a very important patent case for the industry. I was dumbfounded when I read of the jury verdict. I later regrouped enough to author a blog post in late June (http://pharmaweblog.com/blog/2006/06/28/lilly-keeps-fighting-says-biotech-patent-is-too-broad/), where I discussed some of the key issues to be determined during Lilly's appeal of the verdict (my understanding is that Claims 7 and 9, which were also disallowed by re-examination, were to be key to the appeal). Undoubtedly, this patent re-examination will be an important determinant of the eventual outcome of this lawsuit. Perhaps a patent attorney can fill us in on how this will is likely to play out in court.

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5. Dave on September 6, 2006 10:10 PM writes...

So where are the Ariad loyalists now?

Permalink to Comment

6. Derek Lowe on September 7, 2006 5:51 AM writes...

A few of them, anyway, are spending their time calling me a fraud over on the Yahoo message board. But for the most part, the silence is impressive. Kind of like Ariad's, actually.

Permalink to Comment

7. LNT on September 7, 2006 9:21 AM writes...

It's funny that Ariad's stock price didn't drop early August... Surely this is on the investor's radar screens... Or maybe investors had already built in a NF-kB defeat into the current stock price.

Permalink to Comment

8. LNT on September 7, 2006 9:21 AM writes...

It's funny that Ariad's stock price didn't drop early August... Surely this is on the investor's radar screens... Or maybe investors had already built in a NF-kB defeat into the current stock price.

Permalink to Comment

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