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« CLE's on KSR Int'l Co. v. Teleflex, Inc. | Main | Conference & CLE Calendar »

May 04, 2007

Comments

"For known antigens for which there are no antibodies known in the prior art, it may be "obvious to try" to obtain an antibody, but it is certainly not predictable either that an antibody can be obtained, or that said antibody will have a particular minimum affinity for its cognate antigen. Thus, since one characteristic property of any antibody (including both polyclonal antisera and monoclonal antibodies) is its affinity, including in the definition of a claimed antibody an affinity minimum is one way to show non-obviousness."

Unless the antigen is especially non-immunogenic or otherwise resistant to the creation or screening of antibodies, especially in the age of phage display, I don't see how such limitations will show nonobviousness. On threshold affinity or avidity limitations, again unless you show that there is something special about your threshold (like it is really difficult to do this unless you had insight to a technical fix). I think this was true before KSR, but the case just underscores this.

I hope you are not saying that one wouldn't be motivated to make an antibody to a known antigen without more, are you? The dicta in KSR goes directly against this, I think.

It depends on the scope of the claim. A claim to "an antibody produced by the hybridoma identified by ATCC No. X" will be non-obvious because it is limited to the specifically-deposited antibody. If the claim is to be more broad, it would need to have at least a threshold affinity, analogous to the limitations in In re Wands. The fact is that there is no way to know a priori whether something will produce a particular antibody or one having a non-trivial affinity. And the point is the "reasonable expectation of success" prong of the test - which the Court in a backhanded way reaffirmed.

The problem would be if we went back to the old DNA claim calculus, that the protein existed, thus there was a motivation to isolate the gene encoding the protein, and since the Maniatis manual told the skilled worker how to clone genes, a gene for a known protein was obvious. The CAFC said, no because it wasn't obvious that it would be THIS gene (the one you cloned) and this opened up the money for funding the genomics revolution. (And if you think private funding for Celera didn't spur the public HGP efforts to get the thing done quickly, you weren't paying attention.)

Applied to the antibody example, if the position becomes that the existence of a protein, the fact that having an antibody for that protein is good to have, and antibody technology is reliable thus antibodies are obvious, there will be no motivation to invest in antibody drugs. If this is the case, there won't be money for the next Herceptin, and maybe the Supremes are comfortable with that kind of world but I'm not.

Obviousness is all about line-drawing, and factored into where the line is drawn has to be the consequences on the purpose of the patent system - providing a way to protect technology long enough for investment in the technology to make sense. If we go down the "everything is obvious" road again in biotechnology maybe this time we won't be lucky enough to recover.

Thanks for the comment.

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