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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: Twitter: Dereklowe

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May 2, 2007

Obvious Ain't Obvious No More

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Posted by Derek

The Supreme Court doesn't take too many patent cases, but when they rule on one, it's news. This week they handed down a decision in KSR v. Teleflex, and most pharma/biotech readers can be forgiven if their immediate reaction is "Who they?"

But you'll hear about them, all right. This case turned on the definition of obviousness, which is Section 103(a) for lovers of patent law. The standard, ever since the Graham decision many years ago, has been that a patent claim can't be rejected on obviousness grounds unless there's some "TSM" (teaching, suggestion, or motivation) in the prior art, something that would have lead a person of ordinary skill in the art to take that step. (Update - not quite. I've conflated the original Graham stuff with later decisions - see below). That's the sort of thinking behind this earlier post, for example, and it's the way we've all thought about drug patents.

You see where this is headed. The Supreme Court has (by a 9-0 vote) redefined this criterion. (Interested fanatics can get the full decision here). Here's a key section that gets across the spirit of the thing:

". . .Helpful insights, however, need not become rigid and mandatory formulas. If it is so applied, the TSM test is incompatible with this Court’s precedents. The diversity of inventive pursuits and of modern technology counsels against confining the obviousness analysis by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasizing the importance of published articles and the explicit content of issued patents. In many fields there may be little discussion of obvious techniques or combinations, and market demand, rather than scientific literature, may often drive design trends. Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, for patents combining previously known elements, deprive prior inventions of their value or utility."

In other words, the Graham tests are history. (Update - not so fast! TSM was a construct of the CAFC, the Court of Appeals for the Federal Circuit, in an attempt to come up with an mechanism to apply the Graham decision). What replaces them? There's language in the ruling about "predictable" combinations of the prior art as opposed to "real innovation", but in the end, this is going to have to be thrashed out by years of lawsuits. If this had been a legislative act instead of a judicial ruling, it would be called the "Intellectual Property Lawyer's Perpetual Employment Act of 2007". Here's a post on the ruling from PatentBaristas (who also have an excellent roundup of other takes here).

What will this mean for pharma? Eventually (and this will take a while), it looks to me like it's going to be harder to do the sort of patent-extending moves with formulations, enantiomers, and such that we've seen so much of. Some of these are surely going to end up on the wrong side of the new obviousness line, when it gets drawn. That's going to be the biggest effect, I'd say, and overall, I'm not going to be sorry to see some of that stuff go.

I know that this ruling is going to be seen as a blow to the drug companies, and financially, that's what it's going to be. But in the long run, I think we're better off without incentives to dink and tweak existing drugs to extend their patent lives. It's profitable, and given our success rate in the clinic, we could use the money. But without the temptation to do this kind of thing, which is basically a moral hazard, we'll be forced to work on more substantial things. If some of these modifications really are an advance, then presumably they'll fall on the protected side of the patentability line, so we won't miss out on the really good stuff. The now-with-the-great-taste-of-fish innovations, though, I think we're better off without. It's not going to be easy to give them up, but hey, it's not an easy industry.

Comments (4) + TrackBacks (0) | Category: Patents and IP


1. DerekF on May 2, 2007 12:08 PM writes...

Actually Graham was not TSM: Graham said "establish scope and content of the prior art, the differences between the prior art and the claims, and the level of ordinary skill in the pertinent art" (plus the so-called "secondary factors"). TSM was created by the Federal Circuit in an attempt to make the Graham test more readily usable. The problem for the patent applicant/attorney is that the PTO examiner is both the advocate for obviousness of the claim (the attorney for the other side, if you will) and the judge of the merits of his/her own and the applicant's arguments; unlike the situation in infringement proceedings where the judge/jury are neutral. Without some readily articulable and applicable test for obviousness, life becomes more complicated, and we will see many more patentability appeals (and perhaps fewer patents) - until a new test, approved by the Supremes, emerges.

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2. Derek Lowe on May 2, 2007 12:14 PM writes...

Thanks for the clarification - you can tell that I'm not a true lawyer at heart. I'd always thought that TSM was Graham, and I suspect that there are others like me. So it was a creation of the Federal Circuit, eh? Would you see this latest ruling as the Supreme Court trying to shake up the CAFC a bit and show them who's boss?

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3. LNT on May 3, 2007 10:50 AM writes...

Medicinal chemists really need additional training in these matters. Here's a case that was hotly debated in a previous project: we designed inhibitors of enzyme "X" based on inhibitors reported in a competitor's patent. We were able to get around thier patent by simply replacing a core phenyl ring with a thiophene. (everything else held constant) This sounds "obvious to someone skilled in the art", doesn't it? However, the synthesis of this beast was far from obvious. We couldn't use any of the previously established methodology for the synthesis of the thiophene analog. So we applied for a patent assuming that the combination of the unique synthesis and some unique biological properties (again, "nonobvious") of the thiophene would allow us a patent position.

Any opinions here? It would be very helpful to have all new medicinal chemists take a 2-3 day class in patent law so that we could be a little more familiar with these issues and the terminology involved in discussing these issues with lawyers.

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4. DerekF on May 3, 2007 12:10 PM writes...

Do I see the KSR decision as the Supremes trying to shake up the Federal Circuit? No, not really - everyone knows where the ultimate power resides. There's been a lot of commentary in the patent law blogs on KSR, as you might expect, with little consensus. I see KSR more as a "bad facts" case - I (and a lot of people, though surely there are those on the other side) see the "invention" of the case as obvious, and that the FedCir just got it wrong as they sometimes have done. I think TSM is a good test, better than Graham, which is too general for everyday application (patent prosecution in particular), but I think the FedCir was too dogmatic about it in their KSR decision. Certainly they back-tracked noticeably on TSM once the Supremes agreed to take the case; but the Supremes did not reject TSM wholesale, just the somewhat rigid application they saw in the FedCir decision.

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