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« Second Circuit Denies En Banc Reconsideration in Cipro® Case | Main | Biotech/Pharma Docket »

September 08, 2010


Man the docs are so slow here lately.

BTW, Don, Kev, do either of you have any feelings on the new weight loss drug that is coming out? Will it get approved in your opinion? Maybe you guys aren't familiar with it and I've forgotten the name, so if that be the case nm.

Dear 6:

"Slow?" What do you mean?

A drug that would truly control weight would be a boon.

Thanks for the comment.

Slow man, PO and the rest had you beat on this article by like a week.

But yeah man, there's 3 drugs that were for weight control going through testing, my buddy was investing in the "safest" of them through their companies stock. The first drug already failed to get approval. We'll see about the next 2. 2nd one is due out on the 15th. Might want to look into it.

The "teaching points" on the lead compound cases are totally divorced from what the cases actually hold, and attempt to avoid the rule established in those cases prima facie obviousness for compound cases starts with the reasoned identification of the lead compound based on what the reference says followed by showing why it would have been obvious to modify the obvious lead to get the obvious compound. Nowhere in Eisai does it say that "ANY known compound may serve as a lead compound", neither does Procter and Gamble say anywhere that "it is not necessary to select a single compound as a 'lead compound'". Neither do any of the cases say (as do the new guidelines) that even a totally inactive compound is fine as a lead compound.

It seems that the twisting of the holding in these cases is to make it easier for examiners to carry on rejecting compound claims for obviousness using nonsense hindsight reasoning. Typical rejections are those where examiner searches the structure and finds an insignificant compound in a reference (its only significance is that it is structurally similar to the claimed compounds, not anything the reference teaches), and then asserts the claimed compounds would have been obvious because they include a homolog/positional isomer (or whatever) of the compound the examiner has found by searching for similar compounds. The rejection is often accompanied by a string cite of cases per se obviousness cases (Henze and the like), about half of which were decided even before the Patent Act was passed and all of were completely discredited by Ochiai in 1995 (stating that "reliance on per se rules of obviousness is legally incorrect and must cease.")

Fifteen years later, it has not ceased, but is alive and well, and the Patent Office is still encouraging the same kinds of nonsense rejections with twisted "teaching points" that ignore what the cases actually say - that the prior art has to make both the selection of the lead compound and its modification to the claimed compound obvious. Instead, the Patent Office is telling examiners not to worry that the reference would not have made the particular compound obvious ("any compound" is OK as a lead), or that that the compound the examiner found as being similar to the claimed compounds would not have been an obvious lead based on the reference (it is OK to have as many leads as you like in a reference - they don't even need to be active - did we mention that ANY compound can be a lead?). It will be business as usual, and examiners should go ahead and keep making the same per se obviousness rejections, ignoring Takeda, Eisai, and P&G in the same way that Ochiai has been ignored.

Anonymous, I hear you, but I'm not surprised. I think it's just business as usual for the USPTO, which as often as not seems to reinterpret court decisions in a manner it finds convenient, then records that (incorrect) reinterpretation in the MPEP as gospel for all examiners to follow.

"which as often as not seems to reinterpret court decisions in a manner it finds convenient, then records that (incorrect) reinterpretation in the MPEP as gospel for all examiners to follow. "

What is the problem with that? Is the executive branch not free to interpret their judicial brethern's proclamations how they please?

Seeing nothing wrong in disregarding the law is about par for USPTO rejections.

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