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August 14, 2013


Kevin: "The question that will need to be addressed is whether these claims recite diagnostic method claims that remain patent eligible under the Court's Mayo v. Prometheus Labs. decision"

The Federal Circuit's claim construction would seem to be rather problematic for the patentee and the denial of a preliminary injunction would still be a very reasonable choice. The only steps in the method claim are these two:

1) amplifying a paternally inherited nucleic acid from [a pregnant woman's] serum or plasma sample and

2) detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

Given the broad construction of the terms "amplifying" and "paternally inherited nucleic acid", there seems to be little doubt that step (1) is old, i.e., serum from pregnant women was subjected to PCR prior to the discovery by the inventors (circa 1997) that the serum contained small amounts of fetal DNA.

Step (2) can be practiced by merely recognizing that some of the amplified DNA from step (1) is of fetal origin.

The issue in Prometheus, then, is front and center in Sequenom's claims. It would seem that having discovered that fetal DNA exists in PCR-detectable levels in the serum of pregnant women, Sequenom sought to prevent anyone else from exploiting that fact or recognizing that fact in its only relevant practical context (I haven't checked the prosecution history but I gather from the summary above that they tried repeatedly to obtain claims broader than the very broad claims that ultimately issued). The Supreme Court has left no doubt that attempts to use the patent system to retain control of facts -- particularly facts about biology -- must be checked.

If the issue remains elusive to you (or anyone else) consider the following:

1. A method comprising:
determining if a sequence of DNA in the serum of a pregnant woman comprises SEQ ID NO:1.

2. The method of claim 1, where the sequence is obtained using any sequencing method known in the art.

Claim 1 is undeniably ineligible in view of Prometheus (and the Federal Circuit's decision in Myriad, applying Prometheus to Myriad's method claims). Claim 2, of course, adds nothing to claim 1 that would save it.

The analysis and conclusion remains unchanged, of course, if instead of a specific sequence (BRCA1) being detected, we substitute a generic description of a class of undefined sequences (e.g., "fetal DNA of paternal origin"). And that non-distinguishing difference appears to be the only difference between Sequenom's claim and the method claims of Prometheus and Myriad that have been deemed ineligible.

I say "appears" because it might be the case, in fact, that serum from a pregnant woman was never subjected to PCR amplification before the filing of this application. That seems highly unlikely but, if true, it would turn the first step in the claim from an "old step" into a new step and would thus mitigate the Prometheus issue. Of course, if that first step was indeed new and non-obvious, one wonders why Sequenom bothered to include the subsequent "detecting" step ...

Dear Jorma:

I suspect the "detecting" part of the claim was included for utility purposes - a method for amplifying fetal DNA in maternal blood has to actually do something, and detecting it provides a utility that satisfies the other requirements of Section 101.

I agree that the patent eligibility of the claim will depend on whether detecting fetal DNA in maternal blood was "new" when the patent application was filed. I do think that we (and the Court) need to be careful with broad pronouncements of reducing patent eligibility of diagnostic method claims. Claims that overreach (like the Myriad claims struck down by the district court) are one thing, but a broad preclusion is bad policy, for at least this reason: as our understanding of molecular biology of disease having a genetic component becomes more extensive the opportunity to "hide the ball" by not disclosing the basis of the diagnosis will increase. Non-disclosure is worse for everyone that patenting diagnostic methods, a fact the Court does not appear to appreciate.

Thanks for the comment.

Patent eligibility and patentability ('newness') are different things. This was emphasized by the Prometheus Court in no uncertain terms.

Good points, Kevin. I disagree wiht a couple aspects:

You wrote: "I suspect the "detecting" part of the claim was included for utility purposes - a method for amplifying fetal DNA in maternal blood has to actually do something"

I don't think the utility requirement is that burdensome (for lack of a better word). A bona fide new method for amplifying fetal DNA in maternal blood does actually "do something" -- it amplifies fetal DNA in maternal blood, which could be useful for any number of reasons.

Your observation does highlight a recurring problem with broad claims to discoveries of natural phenomenon: if your claim is so broad that another party using old tools can become an infringer merely be detecting the phenomenon you described first, the claim is at very high risk of being ineligible. It's easy to understand why this is the case if you consider situations where "looking trhough a microscope" is the only step in the claim and the "new" element is the identification of the importance of what you are looking at, or the counting of some pre-existing material that "correlates" with some likelihood of disease, or the identification of where to point the microscope. I believe such claims are ineligible. I also don't see a policy reason for distinguishing between the use of a microscope or any other old methodology. Do you?

"as our understanding of molecular biology of disease having a genetic component becomes more extensive the opportunity to "hide the ball" by not disclosing the basis of the diagnosis will increase. Non-disclosure is worse for everyone that patenting diagnostic methods, a fact the Court does not appear to appreciate"

I think that's debatable (and we will surely be debating the issues for a long, long time!). First, valuable genetic information is going to be obtained and made public more quickly than ever because (1) sequence information is going to become easier to obtain (in part, with the help of worthy patents on new methods of obtaining that information); (2) because the ever-shrinking cost of computer storage and processing is going to make it easier to analyze the information about sequences; and (3) because the pressure to make that information available to everyone (doctors and patients, especially) is going to be enormous. The ball may be "hidden" for short periods of time but those times will likely be extremely short, at least with respect to any "balls" that matter. Take the alleged discovery in this case, for instance, i.e., the discovery that fetal DNA exists in detectable quantitities in the serum of pregnant women. Let's say that the discoverers knew that they could not get a patent so broad that it prevented others from making the discovery independently. How could that discovery possibly have been hidden from the public for any substantial length of time?

As for "non-disclosure being worse than patents on diagnostic methods", that would certainly depend on the methods being claimed. Given the increasing ease of obtaining medical information (sequence information in particular) and processing that information to identify *some* correlation between *some* sequence and *some* condition (whether it be classified as a "disease" or not), it doesn't seem prudent to give the "discoverers" of such "correlations" 20 years of exclusivity whereby people are prevented from using old, publicly available (or, in some cases, patent ineligible) methods to obtain the information themselves.

So there is no confusion on this key point, I do not disagree that patents can successfully promote progress in any useful art, including the medical arts. I do think it's important to recognize, however, that the progress that is promoted by worthy patents (on, say, new methods of gathering information) may not itself always be patent-able or deemed practical to patent (either for statutory reasons or any other reason). That would certainly apply to information about disease correlations and genetics obtained, in part, through the aid of new sequencing methodologies (which will continue to progress, with the help of patents).

Skeptical: "Patent eligibility and patentability ('newness') are different things."

Indeed they are. However, the claims we are discusssing here, just like the claims that were found ineligible in Prometheus, involve only two steps. The Supreme Court made clear that in these sorts of claims, at least, where one step is old and conventional and the other step is ineligible subject matter (e.g., the recitation of a natural phenomenon or correlation or some other ineligible step), the claim is very likely to be ineligible.

The bottom line is that whether eligibility and "newness" are different things, the analysis for determining patent ineligibility under Prometheus requires determining what steps, if any, are "old and conventional." If you know a way of performing the Prometheus analysis without addressing the "newness" of any claim element, you should tell everybody about it.

I see at Patently-O that Jorma Narrone has been linked with the entity formally known as Malcolm Mooney.

While I asked a similar question before, that question went unanswered.

Jorma Narrone, have you posted on this or other blogs using any (or all) of the following pseudonyms (or derivations thereof):
Malcolm Mooney,
Keeping It Real,
Vivika M., or
Friend of the Court?

Will I get an honest and straightforward answer?

I remain...

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