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« In re Omeprazole Patent Litigation (Fed. Cir. 2008) | Main | Director Answers House Subcommittee's Questions »

June 12, 2008

Comments

If kubin didn't claim 80% identity limited only to "conservative" substitutions as defined in the specification then I don't know why you think the court will be able to provide substantive guidance on this issue assuming the examiner had ample objective evidence to support the position that making any deletion/sub/insertion up to 80% non-identity without distubing biological fxn was unpredictable.

Dear Anonex:

You hit on one of the fundamental paradoxes: how can something be predictable enough to be obvious yet unpredictable enough to have written description issues? (And I know this problem cuts both ways.) I think you also hit the nail on the head regarding the PTO position, that written description requires you to identify all the substitutions by species and position. Which is totally different from chemical practice, where not only do you have a plurality of species at each R position, but permutations of these without invoking written description issues. Despite the increased complexity of proteins that might justify this differential treatment, the PTO position also covers Ile -> Val substitutions where the sidechain differs by a methylene group.

So the court may have the opportunity to set some standards - even if those standards track the Guidelines, the Board will be precluded from ignoring them as they did in Kubin. And that would be a positive result.

Thanks for the comment.

Kevin - I have a copy of BIO's brief - but any way you can post the Amgen brief?

"the statute clearly states that '[p]atentability shall not be negatived by the manner in which the invention was made.' "

The statute may "clearly state" the quoted lanaguage but the precise intent and scope of that language is far from clear. I'd say it ranks up there with the worst writing in any of the patent statutes.

My personal opinion is that the prohibition is far more limited than Amgen would like to believe. In particular, the prohibition does not prevent one from considering *any* evidence of how easy it is to make (or "discover") inventions like the alleged invention when one is determining the level of expectation of success.

Arguably, evidence that it was *in fact* easy to make the invention would bolster a finding that the *expectation* of success was reasonable.

Dear You're:

To keep things straight, that was BIO's point, not Amgen's. But a knowledge of the history behind the phrase, which is in BIO's brief in part, is informative.

In the 1952 Patent Act, the intention was to codify the concept of obviousness, which was a Supreme Court doctrine not found in the prior statute. Since the Court had recited numerous dicta, including inchoate concepts like "flash of genius" that the practical-minded men drafting the statute realized would be impossible to interpret equitably, they included the sentence that so vexes you.

The sentence, properly interpreted, forms a very good shield against exactly the kind of mischief the Board engaged in. The question is not whether an invention is hard to make, or elegant, or requires genius, it is whether the skilled worker would have been able to achieve the invention using the ordinary skill in the art. The CAFC has properly said that, in an instance where the complete polypeptide sequence is known, it may be trivial to make ANY nucleotide sequence encoding the protein. But in Kubin, nothing was known other than that there was a protein. Now, in order to clone it successfully, it had to be a protein that was expressed in the cells from which the mRNA was obtained, and at an abundance that would produce clones at a frequency that could be detected, and then there is the inherent uncertainty of cloning a related gene that doesn't have the required function. All this speaks to the CAFC's point in Deuel, that without some guidance in the art cloning a new gene is not obvious merely because conventional cloning methods are used to do it (and Amgen argues that the methods they used were not conventional).

And as to whether it was "easy" to make an invention, here is a story about exploration in the 15th century. Portuguese sailors would sail down the coast of Africa only until the North Star dipped below the horizon, for fear of not having a way to navigate home. It was only as the result of a storm that blew a ship past that point that later sailors knew how to navigate in the new waters. For these later sailors, the earlier, ignorant ones must have looked a little silly. And like them, those of us living in the world where the inventor has made his invention may think it easy, or obvious to do. It usually isn't (but that's hindsight reasoning for you).

Thanks for the comment.

"they included the sentence that so vexes you"

Thanks for the comment.

"But in Kubin, nothing was known other than that there was a protein."

Actually there was a whole heck of lot more known that that, which is the Board's point. Apparently you're vexed, too.

Thank you for your comment.

Dear You're:

Not vexed, just curious about why the Board thinks the generic teaching of how to obtain a gene makes obvious the gene itself. It is understandable that they don't understand the difficulties involved, and they miss an important point about instances where cloning a gene would be obvious. But they have drawn the line in the wrong place using the wrong analysis, and with any luck the CAFC will tell them that.

Thanks for the comment.

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