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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: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

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August 26, 2009

Ariad's Patent Rises From the Grave to Smite the Living

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Posted by Derek

Ariad's trek through the legal system has not yet ended! This story has been running for years now - I think the original lawsuit was filed in 2002. Back in the spring, a decision by the Court of Appeals for the Federal Circuit reversed a Massachusetts District Court ruling in Ariad v. Eli Lilly. That decision invalidated a lot of Ariad's key patent claims regarding the Nf-kB signaling pathway, and some of us thought (well, I did) that this would be the end of the story.

But no, Ariad filed a petition in June (PDF) for a rehearing, and that has now been granted. So this fall, the decision will be revisited. It looks like this time, though, the question will not be decided so much on the science and history of Nf-kB, but on a question of patentability.

There are several requirements to get a patent, of course, novelty and utility being the first big ones. You also have to have a complete written description of the invention, and (if you want your claims to stand up) you're going to want to enable them - that is, actually show that you can do what you say, and prove that you have. For pharmaceuticals, that means you need to make real compounds, show physical data for them sufficient to prove that you've made them, and (if you're claiming their effects) show that they do what you're claiming they can do.

The Ariad v. Eli Lilly decision in April turned on written description. Basically, the court held that the company had not described any molecules that could do the vast numbers of things the claims staked out. There was a 1997 case (also, oddly enough, involving Lilly) that raised the standard in that area, and the famous University of Rochester v. G. D. Searle case (COX-2 inhibitors) was decided by applying the same standard. There's been a lot of controversy about the 1997 ruling, though, with many people complaining that the court sort of superglued a tougher written description requirement onto the existing patent law. Ariad has invited the CAFC to take this opportunity to clear things up. That's probably a good thing, since this issue was going to have to be resolved at some point, but it pains me to see Ariad's ridiculous patent case be the means for this.

Personally, I think that Ariad's claims could be tossed by considering the enablement requirement, rather than just written description. (If you think that they didn't do a sufficient job of describing what they wanted to claim, you should see how they reduced it to practice). Here's a post that agrees with that view, and goes into much more detail. It appears, though, that the courts haven't yet come up with a good way to use enablement to chop humungous patent claims down to size. Perhaps this will eventually happen, and the whole written-description era will come to seem like a detour.

I suppose we'll be returning to this issue something this coming winter. Until then, Ariad's patent walks the earth still.

Comments (6) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. Lucifer on August 26, 2009 8:34 AM writes...

Our system encourages rent-seeking behavior over real innovation, lawyers over scientists, legal sophism over objective scientific research..

What can I say?

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2. alig on August 26, 2009 8:58 AM writes...

How many claims are left in this patent? I know when the patent office revisited this patent they threw out most of the claims (as substances modifying Nf-kB signaling had been reported previously, the first examples being in the Bible "drink the wine and be well"). I know Ariad appealed that ruling as well, but I haven't heard about any change there. I am just curious what still remains of the patent for the court to litigate?

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3. Petros on August 26, 2009 9:40 AM writes...

Well in Europe the granted patent (EP-00407411) issued with just 15 claims and expired on the 1 March 2009. A stark contrast to the 203 claims in the originally issued US patent

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4. Pat Pending on August 26, 2009 5:09 PM writes...

Petros, you need to understand that the EPO charges 200 euro for each claim over 15 which tends to encourage brevity but the EPO will also allow you to do thing such as a multiply dependent claim that depends on another multiply dependent claim and will only charge you for two claims unlike the USPTO which will not allow a multiply dependent claim to depend on another multiply dependent claim and which surcharges you for a multiply dependent claim as well as counting within the multiply dependent claim to surcharge you for excess claims if you are in excess of 21 claims

Permalink to Comment

5. Petros on August 27, 2009 3:48 AM writes...

Pat Pending

That wasn't the point, the EPO threw out most of the original claims.

Permalink to Comment

6. Vader on August 27, 2009 3:47 PM writes...

I believe the correct paraphrase is "Ariad's Patent Rises From the Grave to Feast on the Brains of the Living."

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