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December 20, 2010

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Listed below are links to weblogs that reference Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010):

Comments

Nice to see the CAFC is keeping the door wide open for the patent-eligibility of diagnostic methods. But the question of validity under 102, 103 and 112 wasn't before the CAFC. Do you know if Mayo pleaded on these grounds so that these questions will be heard on remand before the district court? If determining the levels of 6-thioguanine or 6-methylmercaptopurine in the blood after administration of the listed drugs was known in the art, that would leave the "wherein" clauses as the basis for patentability - but those clauses don't actually recite a step. It will be interesting to see how this case plays out.

Good stuff by the CAFC. SIlver lining (for people like me) is that the panel seems to characterize the claims as treatment methods, thus giving the court some wiggle room for later distinguishing claims like this and claims where there is no administration of a therapeutic prior to the assay (most diagnostic claims). Big winners are not diagnostic companies, but pharma companies. CAFC has just given pharma a road map for protecting old drugs. Man I love these judges!

Dear Gary:

Agreed - the interesting decisions will be Classen (where there is no express requirement for an immunization step, just that the patient be immunized), and Myriad (if it reaches the merits), since those are classic diagnostic method claims.

Thanks for the comment.

Dear Dan:

I would think it malpractice not to include defenses based on invalidity under one of the statutory sections, unless such an allegation fails Rule 11 (unlikely). So when it goes back the district court may be receptive to such arguments.

I agree with Gary, however, that this decision doesn't give much comfort to pure diagnostic method patent holders, since there is usually no treatment step in those claims (and the ones that might have them might also have Muniauction problems enforcing them).

Thanks for the comment.

It seems that pure diagnostic method patents can seek refuge in the determining-deemed-transformation, although I don't fully understand the line drawn between "mere data-gathering" versus "transformative determination."

That the explanation is couched in terms of "insignificant extra-solution activity" versus "central to the claims" seem more like a conclusion bootstraped into the logic than a coherent explanation itself.

Kevin,

Lourie's decision is not quite as "tortured" as the original, but I still see too much trying to "pigeon hole" methods like these into the "transformation" prong of the "machine or transformation" test. The patent-eligibility of Prometheus' method shouldn't even be in question. If the Federal Circuit would start with 35 USC 112 as others has suggested to screen claims like these, it would become evident that the Prometheus method is a "real world" drug dosage calibration method directed to a specific drug/metabolite. (In view of Prometheus, there's no question in my mind that the method in Metabolite is likewise patent-eligible)

Classen will be an interesting, especially as the Federal Circuit panel is a different one. The quesiton will be which side of the patent-eligibility equation the Classen method falls on: the patent-eligible Prometheus side or the patent-ineligible Grams side. BTW, the Grams method is eerily similar in format to the Bilski method.

Kevin,
Very in depth coverage, as usual.

Classen will be the key. It's hard to imagine a way to test vaccines w/o performing the steps in Classen. While that may set up an easy 102, you could also easily argue this is exactly what SCOTUS meant when it talked about "wholly preempting" tue use of an idea.

Kevin writes "The implications of this decision may be significantly limited by the Court's emphasis on the "treatment" steps as being transformative and thus almost by-definition patent-eligible"

Except that not all the claims required "treatment" steps (see claim 46). The Court goes out of its way, in fact, to state that the treatment steps are not necessary for 101 eligibility. All that is required is that the step of "determining" the levels of the metabolite is "transformative" and "related" to the "purpose" of the claim. Never mind that if one practices only the steps recited in the claim, one "transforms" precisely nothing that wasn't transformed in exactly the same way by the prior art.

This is one of the most poorly reasoned cases in recent memory (even worse than earlier CAFC decision in the same case).

"one "transforms" precisely nothing that wasn't transformed in exactly the same way by the prior art."

SRtbSD,

Not passing any judgment on the claim itself, but your analysis appears to be dissecting the parts of the claim, rather than looking at the claim as a whole. Transformation is simply not required in every element, but merely some element, and then, even not in the non-prior art element.

It appears that you are conflating issues.

Skeptical "your analysis appears to be dissecting the parts of the claim, rather than looking at the claim as a whole."

Yes, I'm "dissecting" the claim and also reading the specification to determine what the invention is, i.e., what exactly is covered by this claim and what activities will be precluded by the claim? The invention of claim 46 is not a new method of measuring thioguanine in a subject. If you follow the claimed steps "as a whole", there are precisely zero transformations of matter that are new relative to the prior art, whether the steps (a single step, actually) are looked at individually or combined. All that is new here is a tacked on mental step of interpreting the results in a specified way. The only *relevant* transformation for 101 purposes the transformation of someone's brain such that it contains new information about a "need" to proceed in a certain manner. But the claimed method doesn't achieve *that* transformation. The specification achieved that transformation when it was published.

Or, if you prefer, the claim is simply anticipated/obvious because it can't be the case that tacking on a mental step at the end of an old claim suffices to lift the claim above the prior art. So which is it, "Skeptical"? It's time to "pass judgment on the claim." I look forward to your answer.

"Transformation is simply not required in every element, but merely some element, and then, even not in the non-prior art element."

Yes, that is what Lourie is saying and I think the Supreme Court will shortly be explaining to him why that simple-minded, strict test is wrong. They sort of indicated as much in Bilski, didn't they?

All:

I think something we need to remember is the question is not whether this claim is patentable - it may well be that other sections of the statute (102, 103, 112) are capable of "shooting down" such a claim (and there is language in Bilski to the effect that courts are better off using those sections rather than 101). This is because 101 merely creates a threshold as to what is patent-eligible, and it a very blunt tool at that. You can read Bilski, Chakrabarty, and several other Supreme Court cases to mean that the Court would rather err on the side of being too inclusive on eligibility provided that the other sections of the statute (including the utility requirement of 101) were applied strictly. And there is a good policy argument to be made that this is the better course, since it minimizes the risk that a new technology (from the "Information Age" or otherwise) be precluded from patent-eligiblity just because it is "new" (like biotechnology once was). Indeed, Judge Rich said in Bergy, in making this distinction, that there were many things that were patent-eligible that were, nonetheless, not patentable. Perhaps that is the way it should be.

Thanks for the comments.

Kevin,

Your reply is on target, thus this is not the time to "pass judgment" on the claim, no matter how much SRtbSD wants to engage in such a discussion. That would simply be off track from the direction that CAFC is guiding the patent world. It's time to realize that 101 is a threshold question, a welcome mat to a wide open door. Once inside the door, then the rigors of 102/103/112 will play out.

SRtbSD,

I am skeptical about your intentions. Your eagerness you engage in a "THIS-patent-is-bad" discussion misses the most important point of the story. As to Bilski somehow indicating that Lourie is wrong in the dissection of claim analysis, I would say that the opposite is quite true. It is indeed quite clear that the Diehr view on claim dissection was strongly pronounced in Bilski (there is no "sort-of"). Do you have a personal problem with this Diehr holding?

The true distinction between Prometheus and Grams is that Grams claimed a general method of diagnostic testing (i.e., do a test to determine whether there is any undefined "abnormality," then use any undefined algorithm to determine the cause of the abnormality). What a ridiculous claim! If ever anyone claimed an abstract principle, Grams did.

In this way Grams is indeed much closer to Bilski than anything else. I just wish the CAFC had emphasized this part of the facts in Grams because I believe this is the true reason Grams's claim was patent-ineligible.

I agree that Classen will be interesting in shedding more light on the outer limits of patent-eligibility since Prometheus was pretty solidly patent-eligible. I'll need to look at the Classen claims again, but I seem to remember not being very impressed. Only slightly better (i.e. more specific) than Grams.

Skeptical "I am skeptical about your intentions."

I'm skeptical about your intentions, too, and also Kevin's. Of course, that is irrelevant but now we're all on the record about our skepticism. For the record, I have no skin in the game other than a general loathing for the "think-about-the-result-of-an-old-method" claim format used by Prometheus (for the reasons provided above, among others). My own clients who invent diagnostic methods have been advised not to rely on such claims for years, for reasons that are obvious (to me, at least).

"It is indeed quite clear that the Diehr view on claim dissection was strongly pronounced in Bilski (there is no "sort-of")."

Please cite the passage from Bilski which says that under no circumstances can any claim element be ignored for 101 purposes, regardless of how tangential that element is to the actual contribution of the inventor to the art. Put another way, is it your belief that Bilski holds that ANY "transformative" or non-mental step preceding a novel mental step is sufficient to render a claim eligible under 101? That certainly seems to be what you are implying. Please clarify.

Skeptical: "It's time to realize that 101 is a threshold question, a welcome mat to a wide open door. Once inside the door, then the rigors of 102/103/112 will play out."

I find the apparent unwillingness of you or Kevin to address the 102/103 issues very ... interesting, particularly given the well-recognized tensions regarding the application of 101 versus these statutes. With respect to claim 46, knowing that the prior art taught that determining 6-MP levels can be used to evaluate clinical efficacy and tolerance (admitted in the patent itself), how can claim 46 not be obvious or anticipated when it recites no other step except determining those levels? I'm very curious about your answer. All the highly educated, scientifically trained attorneys I know who have considered the issue arrive at the same conclusion: the claim is DOA. I know at least Kevin has a decent education. Why so reluctant to address the issue, Kevin? Do you find it uninteresting?

Dear Shot:

The answer is much more pedestrian and less nefarious that you might think. The court was asked to review one question - do these claims satisfy Section 101/subject matter requirements. That's pretty much it. It may well be that there are many reasons why other portions of the statute would invalidate the claims, and on remand I suspect Mayo will present that evidence. But the district court did not find these claims invalid on any ground other than non-statutory subject matter, so that's all the opinion says.

It isn't a question of whether the 102/103/112 issues are interesting or not. They may be interesting to you, or to me, but they are irrelevant to the decision the court made. That is a pretty conventional (and useful) conservation of judicial resources, and frankly it might violate the case-or-controversy provisions of the court's jurisdiction were it to opine prematurely on the 102/103/112 aspects of these claims (as well as raise due process concerns for the patentee). So rather than speculate on whether these claims are valid or not under Sections 102, 103, or 112, the court (and the post) focused on the question at hand - do these claims recite statutory subject matter? There is more than enough time to get to the other grounds/bases for invalidity.

Thanks for the comment.

Kevin, are you unable to explain to me how it is possible that adding a mental step to an old method can result in a patentable claim? Or are you simply refusing to do so? If the latter, care to explain why? As I noted, it is a very interesting question and just the sort of thing that a patent blog such as this one would be expected to tackle with glee. Your silence on the issue is odd, to say the least. It's a remarkably straightforward set of facts, after all. One need not make any assumptions.

"That is a pretty conventional (and useful) conservation of judicial resources, and frankly it might violate the case-or-controversy provisions of the court's jurisdiction were it to opine prematurely on the 102/103/112 aspects of these claims (as well as raise due process concerns for the patentee)."

The Federal Circuit routinely opines on 102, 103 and/or 112 aspects of claims that it has construed before sending them down to the district court. You know, those cases about "being careful what you wish for" and the like. The Federal Circuit's reluctance to address the issue in this case remains striking, albeit a tad less striking than your own reluctance (and Skeptical's). I could of course speculate regarding "bias" here but I'l leave that to others.

Shot:

Now, you're too smart to really not get what I'm saying -look at the last paragraph of your comment: "The Federal Circuit routinely opines on 102, 103 and/or 112 aspects of claims that it has construed before sending them down to the district court." Yes, because that's what they are reviewing in the context of claim construction.

We could speculate all day on whether these claims are patentable - but that isn't the question. The question is whether they are patent-eligible. I don't think the court's reluctance to opine on patentability is striking at all - I think they understand the issue.

For the record, I call them like I see them, biased or not.

Of course, if you want to talk about policy, then we have two competing policies, it seems to me. You can take the position that making these types of claims patentable is wrong, for all the reason that you have espoused in your comments. It is a defensible position, but one that looks at the question from the point of view of whether the applicants "deserves" or "has earned" the patent grant. Fair enough.

The other position is the public interest position - what is the consequence of making these types of claims not patentable? One easily imagined one is non-disclosure - I figure out the correlation and don't tell anyone about it. I just open my shop and say "I can predict whether you are getting enough of drug X" (or "Are likely to get cancer" or "Are likely to get Alzheimer's"). And I charge all that the market will bear for as long as I can until someone else figures it out, too. Could be 5 days, 5 months, 5-, 50- or 500 years later. Can't say - but what we can say is that for all the time greater than 20 years the public has not benefited - either from my disclosure of the test or the follow-on inventions that stem from my observation.

So there are pros and cons to each position. Ultimately, I think non-disclosure is worse than over-patenting, but that's my choice - my bias, if you will. I can defend that position. Beside spite or orneriness, can you?

All the joys and blessings of the holiday season to you.

The outcome of the Classen patent litigation should add further nuance to this line of cases. I look forward to learning details of that case's decision.
http://www.generalpatent.com/media/videos/patent-suits

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