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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 7, 2006

Inherently Obvious - It's Obviously Inherent

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Posted by Derek

Note: This is part 2 of tonight's Ariad-fest. Part 1 is below.

The Ariad reexamination itself makes for entertaining reading, if you have a sufficiently geeky worldview, which I do. I was incorrect in my first look at this the other night, when I thought that the rejections were largely on means-plus-function grounds. All of the claim rejections are based on 35 U.S.C. 102, which is good ol' prior art, and 35 U.S.C. 103, which is obviousness. If something has been publicly described, you can't patent it. The bulk of the document is a case-by-case recitation of the various publications which anticipated the patent's claims or rendered them obvious.

By my count, there are fifty-three of them cited. Since the patent's claims are written in the pounding, repetitive, unbalanced-washing-machine style favored by many attorneys, most of these citations turn around and invalidate great swaths of them, over and over. Not only are there the expected papers from the primary literature, but various textbooks and reference handbooks (the PDR, Goodman and Gilman) make an appearance as well.

The actions and literature descriptions of the mechanisms of cyclosporin, glucocorticoids, various antibiotics, and many other substances are adduced. My favorite section is on pages 46-49, on the effect of substances such as resveratrol, found in grapes and in red wine. (More on resveratrol here and here). The examiner cites the King James Bible as invalidating prior art, along with several more conventional citations, and points out that:

"In short, any time someone, over the last several hundred or thousand years, drank even a moderate amount of red wine with food containing significant fats (e.g., the typical French diet) they were reducing NF-kB acitivity (and concomitant NF-kB mediated gene expression) that had been induced by the fat content in the food."

And as the official Manual of Patent Examining Procedure makes clear, something old doesn't become patentable just because you've finally discovered the scientific reason for its effects. If the use or property you're trying to claim is inherent in the prior art, it's unpatentable. As long as the inherent characteristic necessarily flows from the prior art, and is not just one of many other possibilities, the claim can be rejected. Once this happens, the burden of proof is on the applicant to show that there's a difference that isn't obvious. That will be Ariad's only recourse at the USPTO, which is why they're also going outside and petitioning the US District Court.

From my perspective, they're not going to have an easy time of it. The rejection of the NF-kB claims seems pretty comprehensive, and it's hard for me to think of arguments that would refute enough of the examiner's contentions to matter. Left unspoken in the office action is the clear inference that the original patent should never have been granted in the first place, which is what I thought back in 2002. Looking back, that post seems downright psychic, if I do say so myself.

Comments (10) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. Fred Cohen on September 8, 2006 8:17 AM writes...

Once again...great job on an important topic!

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2. Chrispy on September 8, 2006 2:23 PM writes...

Derek,

It seems you scooped most everyone on this.

I still don't know why their stock hasn't taken a Serious Dive on the news...

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3. LNT on September 8, 2006 2:50 PM writes...

It's interesting to look at Ariad's stock price over the past 3 days. It's lost about 15% of it's value since Derek made his first post about Ariad on the 5th. During the same time, the NASDAQ has lost only 1% of its value.

Derek, you may have single-handedly sliced about 15% off the valuation of Ariad! (about $40 million less market cap since Wednesday)

Way to go! ;->

Permalink to Comment

4. rbird676@yahoo.com on September 8, 2006 3:04 PM writes...

What is the basis on which Ariad wishes to prevent the PTO from reviewing its patent by court action? It seems like reviewing the validity of a questioned patent would be precisely their job - if anyone has the legal and technical expertise to do so, it would be the PTO. If they shouldn't have that authority who should? I assume Ariad thinks the courts (or no one) should be able to review a patent, but I can't see why anyone else would think so.

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5. Hap on September 8, 2006 3:05 PM writes...

Sorry about the above. (#4)

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6. DSL on September 8, 2006 5:25 PM writes...

I agree. Great job. As I recall didn't you short this stock? I hope you did, this kind of legwork deserves a payback.

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7. Chrispy on September 9, 2006 2:31 PM writes...


Regarding shorting ARIA:

With a Bid value at 4.03 and an Ask at 7.27, doesn't this creat a dangerous situation if you sell short and the stock goes up a bit; you have to cover your shorts with stock almost twice the value?

I don't mean to hijack this thread, but as a scientist I thought it my civic duty to short this lame-o company. Perhaps someone out there more savvy in these matters than myself knows?

Good for you, Derek, for voting with your dollars long ago!

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8. Derek Lowe on September 10, 2006 9:34 PM writes...

That bid and ask is the sort of quote you get on thinly traded NASDAQ stocks after hours. It'll collapse to something more reasonable once the trading day starts

But there's always a danger in going short. Of course, there's always a danger in going long, too, but if you're totally wrong in that direction, all you can lose is your entire initial investment. If you're short and stubborn, you can lose more than that.

That said, at any given time there are probably more opportunities to be found on the short side than the long, just because far fewer people are looking for them. But you can find yourself lined up against a lot of really crazy people.

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9. Chrispy on September 12, 2006 2:31 PM writes...

Another blow to Ariad:

Just off the AP wire this morning...

Amgen's Ariad Lawsuit to Move Forward
Tuesday September 12, 8:56 am ET
Judge Denies Ariad's Motion to Dismiss Lawsuit Filed Against It by Amgen


CAMBRIDGE, Mass. (AP) -- Ariad Pharmaceuticals Inc., a developer of drugs to treat cancer, said Tuesday a federal court denied its motion to dismiss a lawsuit filed against it by biotechnology company Amgen Inc.
Amgen is seeking a declaratory judgment that its arthritis treatments Enbrel and Kineret do not infringe on Ariad's patent covering treatment using cell-signaling activity, and that the patent is invalid.

The U.S. District Court for the District of Delaware did not dismiss the suit, filed in April, and the case will now move forward.

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10. mitotic phase on September 13, 2006 6:58 AM writes...

You say it’s another blow to Ariad yet on the company message board on Yahoo, that is read by the company probably hourly,the message board self-anointed pundits are already calling the continuation a victory for Ariad. The case is different IMO since Ariad must prove this time that Amgen did infringe instead of Lilly defending that they didn’t. At least in Delaware Ariad and the yahooers won’t have apparent inside information into the proceedings.

Ariad claims it gives free use of their questionable patent but that is only until something useful is discovered then they want paid or else they will take them to court. It’s actually not a bad way for a cash strapped company to get others to do the research and they reap the profits. The company and the childlike yahooers like to boast about all the colleges, universities and institutions that have free use of Ariad technology, currently over 900 (again right up until something profitable is discovered then they want paid). Yet nothing has EVER been discovered in all these years speaks volume of the material they are using. But isn’t it nice that your tax dollars are possibly paying for Ariad’s research to be done at these colleges, universities and other institutions.

Has anyone attempted to patent mTOR yet? Would not surprise me to read that Ariad has attempted it.

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