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« Life Sciences Venture Funding up 37% in Second Quarter | Main | AMP v. USPTO: Judge Moore's Concurring Opinion »

August 01, 2011

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Listed below are links to weblogs that reference Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2011):

Comments

Kevin,

Nice review of Lourie's opinion. This is definitely one Lourie's better opinions compared to Ariad and especially Prometheus which are very obliquely (and in my opinion, confusingly) written.

Your comments on footnote 6 in Lourie's opinion are interesting. I especially share your puzzlement as to why Lourie characterized In re Bergy as no longer binding precedent in the Federal Circuit. In fact, Sweet, the district judge in this case, treated Bergy as if it was still binding precedent. This is yet another instance where what Lourie says mystifies me.

The court's opinion is not only fractured, it's half-witted. It's half-witted because it only gets half of the way to an intelligent IP policy for molecular diagnostics. It upheld the patentability of isolated DNA, which it clearly should have, based on well-reasoned case law and 30 years of practice. However, by attempting to jam the method claims into the Bilski framework (which has its own problems, even when limited to software), the court missed the forest for the trees.

Those who support the patentability of such claims need to put aside the tortured legal analysis – analysis equivalent to the medieval debate of how many angels can dance on the head of a pin – and emphasize the broader policy. Does it really make sense, in terms of the goals of the patent system, to hold that these kinds of diagnostic claims are not patentable? Clearly, they are based in technology. (See Article 1 Section 8 of the Constitution.) Clearly, they represent an extremely useful advance in the field of personal medicine. I realize that case law says that abstract ideas are not patentable. However, mental steps are not necessarily the same as abstract ideas. These claims represented the application of technology to a real world problem, which provided an extremely useful real-world result. That should be enough.

"Does it really make sense, in terms of the goals of the patent system, to hold that these kinds of diagnostic claims are not patentable?"

Yes. Issuing patents on abstractions, facts, and/or mental processes is bad policy.

"I realize that case law says that abstract ideas are not patentable. However, mental steps are not necessarily the same as abstract ideas."

They are both ineligible for patenting, and rightly so. That's what matters.

I have a quick question Kev, how does the mRNA know how to leave the introns out?

In other words how does the mRNA know the difference between introns and exons?


One other question if you don't mind. Could the pre-RNA fragment in the picuture be termed "an isolated gene"?

"the court missed the forest for the trees. "

For the record Geoff (can I call you NWPA v2.0?), I agree that the court missed the forest for the trees. Specifically, it focused on whether or not the claim was itself directed to a chemical (the tree), and forgot to analyze what the claim actually preempts in a Bilski style analysis. It is for that reason that I believe ACLU still has a wonderful opportunity higher up the chain.

"Clearly, they are based in technology."

Making a diagnosis is based in technology? L O to the L? LO^L?

"These claims represented the application of technology to a real world problem, which provided an extremely useful real-world result. "

The application of what technology? The "technology" of making a "diagnostic"? You realize that a diagnostic is not "technology" right?

"In contrast, a portion of a native DNA molecule -- an isolated DNA -- has a markedly different chemical nature from the native DNA. It is, therefore, patentable subject matter.""

One of my favorite parts of the decision. According to this, apparently all one needs do is take a leaf from a tree and then chop the stem of the leaf off half-way. Wallah! Patenable! Leaves don't occur naturally with their stems chopped halfway off!

Let's consult the Magic Microscope(TM). It knows all, it sees all.

I guarantee that if I filed a composition claim tomorrow that included within its scope a fallen leaf or even a "chopped off" leaf, it would never, ever be rejected under 101 by the USPTO.

As an argument for ineligibility of an isolated composition under 101, the leaf analogy is the least compelling argument out there.

"According to this, apparently all one needs do is take a leaf from a tree and then chop the stem of the leaf off half-way. Wallah!"

It's a baseball bat for a fetus.

Dear 6:

To answer your question (to the best of my understanding of how this has been worked out):

Certain protein factors interact with the portion of the chromosome (generally) adjacent to the "gene," meaning the expanse of chromosomal DNA defining the exons that encode a protein and any introns that may be positioned in between separated exons. This configuration permits an enzyme, RNA polymerase II, to transcribe the gene into a single-stranded RNA molecule, having a "cap" at the 5' end; the opposite end has a string of A residues that are added enzymatically after the RNA is produced (i.e., they are not in the chromosomal DNA).

This RNA is then processed by enzymes in the cell nucleus that recognize subsequences at the margins of the introns and "splice" the exons together in the proper frame for translation by ribosomes (which are in the cytoplasm; the rest of this happens in the cell nucleus). While not everything is understood, there are mutations in these subsequences in the beta-globin genes that cause diseases called thallosemias (sp?) due to mistakes in this splicing process. Once the RNA has been properly and completely spliced, it is called an mRNA, is transported to the cytoplasm and proteins made using it. Discussion of this process is beyond the scope of the question.

Since all this happens in the cell, in no way could it be considered "isolated," and in any event it is RNA not DNA - single-stranded vs. double-stranded, ribose sugar vs. deoxyrobose sugar, uridine vs. thymidine bases, capped vs. uncapped, etc.

"I guarantee that if I filed a composition claim tomorrow that included within its scope a fallen leaf or even a "chopped off" leaf, it would never, ever be rejected under 101 by the USPTO."

Really? Because I may or may not be a person who rejects and I may or may not be able to assure you that I would reject such under 101.

"It's a baseball bat for a fetus."

Lulz.

I am not sure I get what was transformative about the Prometheus claims. The problematic machine-or-transformation test aside, these tests, namely, the ones in Prometheus v Mayo, AMT v USPTO and Classen v Biogen, all rely on one essential stage, that of comparing one set of values to another. In Prometheus, it was achieved by first administering a drug (in order to get the second set of values to be compared) followed by the determining step; In AMT, one was by a straightforward comparing (determining step); and the other was by “growing”; “determining” and then “comparing”. Interestingly, the Federal Court in AMT glossed over the fact that in Prometheus, the “determining” step also involved comparing, and was not considered as a separate step. In Classen, the steps were similar to those in Prometheus.

If the Federal Court is to be believed, the essential difference between Prometheus and AMT was that the steps of “administering” and “determining” result in transformations, thereby satisfying the machine-or-transformation test. The Federal Circuit’s analysis in respect of ‘Methods of “Comparing” or “Analysing” Sequences’ reflect my approach to this issue. The methods claim a “phenomena of nature’ and are mental processes, both of which are unpatentable. The confusion, it seems to me, lies in a misunderstanding of what the invention is. The inventive concept in a majority of these types of claims is that a correlation between two values provides information. In Prometheus, the information was necessary to determine an optimized dosage regime for that patient; in Classen, the information was necessary to determine which regime was less likely to cause a disorder. Neither of these claims are diagnostic methods; they merely enable the physician to determine an optimum course of treatment. In AMT, the information gathered determined whether the patient had cancer or was predisposed to it. This was a classic diagnostic method, as was the claims in Lab Corp v Metabolite (a method detecting vitamin deficiency). I doubt very much that it makes a material difference for the purposes of the analysis whether the claims are diagnostic methods or merely part of the treatment regime for the patient.

In any event, the central point made in Prometheus (2008) and (2010) remain. It boils down to this: the insertion in a claim of a step which provides one set of values to be compared (by, for example, administering a drug), makes that step transformative. As the Court in Bilski v Kappos noted, the Information age may very well require different, and perhaps a more sophisticated, approach to patent eligibility. In relation to process claims, where a thing is being created, then, surely, the machine-or-transformation test is appropriate. However, where the process claim relates to information that it generates, as the examples above show (rather than a “thing” being created), then there is nothing to be transformed. It is this failure to appreciate that the “inventive concept” in such claims is really to the method of getting the “information”; whereas the machine-or-transformation test is appropriate where a “thing” is being created using a process. The analogy is not the same. The end product from the claimed process, the “thing”, must be transformed under the test; but, in medical patent claims, there is nothing to transform as the “thing”, the object of the claimed method, does not come till the end. This possible distinction has been troubling me for some time now, so any comments are welcomed.

Kevin,

As I read the majority and concurrence, it's not the "being in the cell" that suffices for isolation, but rather the separation of the gene sequence from adjacent nucleotides. Can you show me where the court's idea of isolation is linked to "being in a cell"

best,
David

Dear David:

Sorry for the confusion; I was responding to 6, insofar as he was asking whether production of mRNA is "isolation." It seems to me that both the majority and the concurrence start from the premise that we are talking about the patent-eligibility of something in a test tube; no one believes that any of Myriad's claims (or anyone else's) cover the DNA in the cell (indeed, an isolated DNA claim is not infringed if the DNA is transferred into another cell unless the patentee has a separate claim for the recombinant cell).

Thanks for the comment.

Kev thanks for the breakdown. I had drafted a response but idk where it went. In any event, the summary over at PO by D on the matter was very easily read and understood (although this could be because I took the time to look up everything before he laid it out and then he just laid it out again in very simple terms).

Bottom line after I understand the whole issue is that I still find fault with the practical effect that such claims have in so far as they effectively preempt practically all practical applications of the genetic information. I know there are folks that say that there are other uses that are not covered, but I just don't know if having limited the claims to not cover those will rise above adding insignificant post solution activity or limiting yourself to the specific field of use. But idk, we'll see what the USSC has to say shortly I imagine.

"I am not sure I get what was transformative about the Prometheus claims."

That's because there was nothing transformative about them. You didn't miss anything, the Fed's made something up, and they're likely to get reversed. Just another year at the patent protectionist federal circuit.

"no one believes that any of Myriad's claims (or anyone else's) cover the DNA in the cell"

Not if you read the popular press, who STILL claim that someone else is owning your DNA.

"Not if you read the popular press, who STILL claim that someone else is owning your DNA."

Is owning the sequence of your DNA that much different? Mmmmm, idk.

Kevin,

Case in point: 6's response.

Skeptical,

I totally concur with your last point. Mind you, you'll be labeled as an "elitist" but who cares?

Although a bit of trepidation is likely in order (no matter on what end of the spectrum you tend to fall), I look forward to reading what the SCOTUS has to say when the esteemed Justices opine on gene patents. Particularly since Myriad presents a bit of a chicken-and-egg question -- that is thus perhaps not scientifically, definitively solvable -- policy considerations will probably weigh heavily in their ultimate determination. Which also makes one wonder to what extent the Court's new political makeup will affect the case's outcome.
http://www.GeneralPatent.com/blog/

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