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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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« Merck versus the New England Journal | Main | If It's Not One Thing. . . »

January 24, 2006

The Examiner Finally Snaps

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Posted by Derek

PCT (Patent Cooperation Treaty) applications are published with an "International Search Report" appendix document. This is done by one of the larger patent offices from the countries in the PCT, and is a preliminary assessment of the patentability of the claims in the application. The searchers try to identify other documents in the patent or open literature that might bear on their novelty or scope.

It would be difficult to pay me sufficiently to do this for a living. I've been involved in many in-house patentability and claim-writing discussions, and they can be agonizingly tedious and frustrating. That's why I've never been able to understand how some pharmaceutical applications are written. They start off with chemical claims whose first generic structure seems to take in the vast reaches of interstellar space. Then the next fifty or sixty claims narrow this down in gratingly tiny steps to oh, about the edge of the Kuiper belt. Then comes a recitation of six hundred and seventy-eight specific names of compounds that are specifically claimed, and on and on.

I have trouble imagining how anyone can go to such pains, and I have trouble imagining why they bother. After all, if you don't enable these claims (patent-speak for "show that you actually made something that fits that description"), they're not worth all that much if it comes down to a fight. And I've seen many claims that couldn't be fully enabled short of putting five hundred people to work on them full-time for about ten years.

For those of you with access to patent images, try the generic structure in US6214850 on for size. It's very concise, as these things go, but rapidly expands like some sort of mutant fungus. For a wordier example, try WO2002042272. This jewel has 139 pages of claims in it, and the number of R-groups that show up in its laughable generic structures goes up into the hundreds.

The whole purpose seems to be to confuse and irritate anyone who tries to read the claims - and to be fair, that's very likely just that the purpose is, since that makes it harder for someone else to figure out what the real subject of these hay-bale-sized applications actually is. But the poor souls at the search agencies are paid to do that, and every so often they lose it. I just came across a search report which starts out with this cri de coeur:

"In these claims, the numerous variables and their voluminous, complex meanings and their seemingly endless permutations, makes it virtually impossible to determine the full scope and complete meaning of the claimed subject matter. . .it is impossible to carry out a meaningful search on same."

Comments (13) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. dlib on January 24, 2006 11:00 PM writes...

Remember, if these ever see the light of a courtroom the results wil be decided by laypeople ( although it could be practically decided in the Markman hearing before a jury hears it ). I saw a precedent by the first circuit court of appeals that
berated the use of "gobledy gook"(sp?) in biotech patents and oral arguements.

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2. Jake McGuire on January 25, 2006 2:34 AM writes...

You don't have to actually make an invention to enable it, just provide enough information that someone "skilled in the art" could make it.

I think that there's a fascinating economics paper in here somewhere on the various ways that the incentives within the patent system are all screwed up. In fairness, it's a pretty difficult problem to design a system that is useful to the little guy while simultaneously robust against hundreds of millions of dollars of amoral lawyering, but one would hope that we could come up with something better than what we've got now.

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3. Philip on January 25, 2006 7:31 AM writes...

If you're interested, there is a nice patent web site where even the unwashed masses can get access to patent images in .pdf format at

http://www.freepatentsonline.com/

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4. Konrad Koehler on January 25, 2006 7:54 AM writes...

I agree that the way patents are written is boring. But (as I am sure that you are aware) there is a legitimate reason for starting with broad claims and progressively narrowing them down to the level of individual compounds. The idea is that if the broader claims are not allowed, these can be removed leaving intact the narrower claims.

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5. LNT on January 25, 2006 8:39 AM writes...

I'm curious to see if you guys think that "patentable chemical space" will be mostly used up durring our career lives? Certainly we'll never run out of new molecules to make -- but it seems to me that in another 10 years, the "composition of matter" patent may be a thing of the past. Every patent "claims" untold millions (or billions) of various permutations of a given scaffold. How long can this go on before every concievable molecule falls under somebody's patent?

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6. Derek Lowe on January 25, 2006 8:55 AM writes...

Konrad's right; these things are written in the telescoping style so that your really important claims are behind layers of legal firewall, much of which goes down during the patent prosecution.

But I can't figure out why (in some of these cases) there have to be quite so many layers of the onion, and why the initial claims start out so absurdly broad. The person writing them knows that they're not going to issue, and the person examining them knows that they're not going to, either.

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7. Canuck Chemist on January 25, 2006 9:34 AM writes...

The issue of a lack of patentable chemical space is a valid one, however it's my understanding that a chemical structure must have a specific application in order to be patentable. This means that old molecules (and chemical space) can be patented with new indications in mind-- which is exactly what everyone tries to do to squeeze as much juice as they can out of known blockbuster molecules.

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8. Anonymous on January 25, 2006 11:06 AM writes...

Canuck- if something has been reported anywhere in the literature for any purpose, you can only get a "use" patent. This means you have exclusive right to selling that material for indication X. However, if someone else sells it for any other purpose (indication Y, or as a preservative, or whatever), there is nothing to stop the market from buying it at the cheaper price, so any patent you have is likely impossible to enforce.

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9. markm on January 25, 2006 11:52 AM writes...

"But I can't figure out why (in some of these cases) there have to be quite so many layers of the onion, and why the initial claims start out so absurdly broad. The person writing them knows that they're not going to issue, and the person examining them knows that they're not going to, either."

There's no penalty for overbroad claims, so lawyers think they might as well claim everything they can think of. When misbehavior is free and occasionally profitable, many more people will misbehave. However, overbroad claims in too many patents will cripple the search system. The examiners can't keep up, nor does the patent office have the legal budget to handle too many applicants suing them for trimming back their claims. My suggestion is to award a bounty of $20,000 per claim plus expenses, paid by the patent applicant, for anyone who takes a patent to court and overturns or narrows it.

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10. dlib on January 25, 2006 12:08 PM writes...

Well there can be a penalty for overbroad claims if they get narrowed during prosecution.
Derek, you should read up on the FESTO decision by the supreme court. It has real bearing on this topic.

Cheers,

dlib

Permalink to Comment

11. Derek Lowe on January 25, 2006 1:24 PM writes...

I wrote about the Festo decision back in 2002, but it hasn't had as much effect in the drug industry as I thought it might. For one thing, I thought that we were all supposed to write claims more carefully, in order not to have to alter them so much during patent prosecution, but that doesn't seem to have taken hold. I think everyone is waiting for another court case or two to clarify the Supreme Court ruling, and who knows how long that'll be. . .

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12. JXH on January 25, 2006 5:35 PM writes...

Regarding the "lack of patentable chemical space," it's not as signifiant an issue as it might initially seem. I suppose it is conceivable that considering all the broad genus claims in all the issued patents, a large of chunk of all compounds with, say, 50 to 100 atoms may have been indeed been claimed in these patents.

However, just because a particular compound (i.e. a "species") falls within a claimed genus, it doesn't mean that the particular compound can not later be claimed in another patent. In fact, the issue isn't whether the compound was ever claimed, but rather, whether it was ever "disclosed." Disclosure can take many forms: journal article, ACS symposium seminar, etc. And anything discussed in a patent is also considered to be "disclosed."

As I said above, if a particular genus is disclosed/claimed in a patent, it doesn't necessarily knock out a species. The smaller the genus, and the more it resembles a particular species, the more likely it is that the particular species is sufficiently disclosed, and not eligible to be claimed later on in a patent. And naming a particular compound in patent or showing its structure is generally deemed to be disclosure sufficient enough to prevent later patenting of that species. However, the behemothic genus claims to which Derek makes reference are so broad that it is unlikely that a court or the PTO would say that they disclose any particular compound within the genus.

Apologies for the long post. It's a confusing area of the law, and entire tomes could be/have been written about it.

Permalink to Comment

13. SRC on January 25, 2006 6:41 PM writes...

JXH hits the nail on the head. Risibly broad claims in fact serve little purpose, other than to indicate that whoever drafted the application lacks judgment (and/or suffers from galloping insecurity).

Imagine trying to parse any of those claims for a district court judge (probably a political science major; smart guys, but with zero relevant background). Good luck.

Now imagine trying to lead a jury of 12 ordinary citizens (average education: high school) through this riveting prose to explain how someone infringes. That would be well worth the price of admission.

For this reason, as a practical matter the claims are indefensible.

The worst part is that if someone finds one of the myriad claimed compounds has some particular utility, he can claim it separately in a selection patent, as JXH points out. If that someone is one of the present inventors, he'll have to overcome his own patent as prior art against his subsequent application.

Moral: if you don't have the goods, don't quack like this.

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