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« Court Report | Main | House Slips Pay-For-Delay Provision into Appropriations Bill »

July 06, 2010

Comments

Do we know when these cases are scheduled to be reviewed by the CAFC?

Kevin,

A very concise but thorough analysis of what is now a muddled mess. I would suggest getting a Ouija board or maybe consulting the Oracle of Delphi to figure out what the Federal Circuit is going to do with the process/method claims in AMP, Classen and Prometheus in view of the pronouncements from our Judicial Mount Olympus. About the only thing I think is safe to say (with tongue in cheek) is that Sweet's basis for invalidating Myriad's method/process claims (MoT) isn't going to pass muster with the Federal Circuit now that our Judicial Mount Olympus has hurled its thunderbolts and smitten MoT as not the exclusive test.

Which gets me back to why 35 USC 101 is a lousy way to screen out the patent claim chaff from the wheat. After Bilski, we still have no clear and objective test for determining patent-eligible subject matter under 35 USC 101, certainly not from our Judicial Mount Olympus. Instead as Michael Risch has suggested and which I completely agree with, use 35 USC 112 as the initial screen for patent claims. The Bilski claims would have flunked 35 USC 112 under both paragraphs 1 and 2, and we would have avoided all this muddled rhetorical nonsense from our Judicial Mount Olympus that wouldn't know patent-eligible subject matter if it hit them square in the face.

This may be an unsophisticated analysis, but I have been using it as a rough rule of thumb: if the entire method could be performed mentally (assuming one had enough processing capability ;) ) then it is suspect in my mind. For example, adding some sort of limitation in claim 1 of the '999 patent regarding the physical step required to "analyze" (e.g., using a nucletode probe or primer) would clearly solve the problem. It poses a challenge in terms of covering all of the possible technological solutions, but should pass muster as patent eligible. If no such steps are included, then the claim requires more scrutiny IMHO. Admitedly not a test that works well for the non-biotech arts though, but perhaps there is an equivalent solution there.

Kevin,

Why would a previously unknown SNP be different from a previously unknown mutation?

who takes away the patents to research MYGN no incentive for personalized medicine and judges must take this responsibility: put their money to continue the search.
intelligents or bandits?

I don't think you can draw a line between known and unknown laws of nature, etc., in view of the quote from Benson (quoted in Bilski) that "phenomena of nature, though just discovered . . . " are not patentable under 101.

Dear Courtney:

Good point; I was unclear. What I meant to say with regard to the statement:
"the presence of a specific mutation at a specific position in the nucleotide sequence of the BRCA1 or BRCA2 gene"
in the context of a method claim is that the method of detecting this specific mutation for this specific purpose was not known. In Bilski, the method of hedging risk was known, and the application of it to commodities trading was straightforward.

I recognize that the method of detecting mutations associated with disease is also known, but the specific application of that method to detecting a risk for breast cancer by detecting the BRCA1 and BRCA2 polymorphisms was not, and the application to the general method is not straightforward (you need to have identified the mutation).

I recognize that one way of looking at this is that the mutation is a phenomenon of nature that was always there, but I think the Court's precedent supports the view that "phenomenon of nature" in the patent eligibility preclusive context is related to general phenomenon - the law of gravity or electromagnetism. Specific application of natural priciples is the only basis for any invention - "nature is all we have," after all.

Thanks for the comment.

Dear Ken:

Obviously my day for being opaque. What I intended to convey was the contrast between claiming an application of a natural phenomenon (detecting a SNP for predicting a risk for a disease) and claiming the SNP itself - "a DNA fragment encoding residues xxx-yyy of SEQ ID NO. Z, wherein residue ### is (a mutant form)." Any mutation fits this bill.

Thank for the comment.

Dear Question:

I don't think the court has set the briefing schedul for the AMP case yet, but we can expect the case to be fully briefed by the fall, with argument scheduled thereafter. Same should be true for Prometheus and Classsen.

When the cases are briefed and argued does not reliably predict when the decisions are rendered; it is possible the Federal Circuit could "talk amongst themselves" and issue all three on the same day in 2011.

Thanks for the comment.

Dear Sunny:

I look at it similarly: if the claim could be practiced using only a computer, then it is overbroad for failing to recite any affirmative step in the "real" world. If you clone a gene and have it in a test tube, you have an invention. If you isolate and sequence DNA to detect a mutation, you have an invention. If your invention encompasses methods for extracting sequences from a database and comparing them, there had better be some software or other element of the claim that changes it from merely using genetic information, because the information per se isn't patenable. But a method for determining subpopulations of individuals at particular risk for a disease may be; it just isn't a biotech invention (so my ability to intelligently opine on it is much lower).

Thanks for the comment.

"in the context of a method claim is that the method of detecting this specific mutation for this specific purpose was not known."

Then the "not known" part is irrelevant for your analysis. Either the claim preempts an abstract idea or not.

At first glance I thought as you do Kev, but the more I look at the claim it appears to be nothing more than the abstract idea then had some post solution activity added on to limit it to the specific field of BRAC1 detection.

This is a tough call for me, not because the application of the abstract idea preemption test is hard, but because of my lack of a thorough understanding of the subject matter at hand and specifically what would be considered "post solution activity" in this art.

"and the application to the general method is not straightforward (you need to have identified the mutation)."

That is most likely irrelevant to the inquiry.

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