Source: https://patentlyo.com/patent/2012/04/guest-post-prometheus-v-mayo-a-european-view.html
Timestamp: 2019-02-21 03:28:09
Document Index: 313556281

Matched Legal Cases: ['art. 52', '§101', '§102', '§103', '§112', '§101', '§102', 'Art 52']

Guest Post: Prometheus v Mayo – A European view | Patently-O
Guest Post: Prometheus v Mayo – A European view
April 3, 2012 PatentAbstract Idea, anticipation, obviousness, Subject Matter EligibilityDennis Crouch
Guest post by Paul Cole, European Patent Attorney, Lucas & Co.
How is the Prometheus invention viewed by the EPO, and what are the differences between the reasoning of EPO appeal boards and of the US Supreme Court concerning patent eligibility?
An indication is that the EPO granted EP-B-1114403 (Seidman) which corresponds to US 6355623 and has a main claim that reads:
The above claim is not an outlier. The forward references of the '633 patent include US 7524851, whose equivalent EP-B-1695092 has a main claim that reads:
A method for monitoring azathioprine therapy in an individual, said method comprising
measuring the level of 6-thioguanosine diphosphate and 6-thioguanosine triphosphate in a sample from said individual, and
calculating a concentration ratio of 6-thioguanosine triphosphate to 6-thioguanosine triphosphate and 6-thioguanosine diphosphate,
wherein a concentration ratio greater than 0.85 is indicative of superior clinical responsiveness to azathioprine therapy, and wherein a concentration ratio less than 0.85 is indicative of inferior clinical responsiveness to azathioprine therapy.
In a communication dated 26 October 2007 and available in the EPO's online file the Examining Division decided that the '851 claim was novel and inventive based on the technical effect of improved therapeutic efficiency. In accordance with EPO practice, from that effect a technical problem based on the Seidman disclosure as starting point could be reconstructed which was to provide an improved method of monitoring azopurine therapy.
If the '403 patent had been challenged e.g. in an opposition the EPO would have been bound to follow established case law and hold that the claimed method was patent-eligible firstly because it is carried out on a sample from the subject and secondly because an in vitro measurement is made, see the Enlarged Appeal Board decision in G 3/08 PRESIDENT'S REFERENCE in which the long-standing practice of the Appeal Boards was approved. An argument that the "wherein" features should be disregarded for assessment of novelty or inventive step taking into account the exclusions under art. 52 EPC as a mere discovery or mere presentation of information would have been likely to fail because, as seen above, improvement in therapeutic efficiency is treated at least at first instance as a technical effect.
The CAFC in its opinion on remand of 17 December 2010 reasoned in broadly similar terms to what would be expected from an EPO Appeal Board dealing with patent-eligibility. It held that treatment and optimization formed part of an inherently patent-eligible treatment protocol (opinion, page 20) and continued:
We agree with the district court that the final "wherein" clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole. The data that the administering and determining steps provide for use in the mental steps are obtained by steps well within the realm of patentable subject matter; the addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm.
As to the overall significance of the "wherein" clauses in the context of the claim as a whole, the CAFC appears to have accepted that they helped define a technical result (opinion at pp.22-23):
Although the wherein clauses describe the mental processes used to determine the need to change the dosage levels of the drugs, each asserted claim as a whole is drawn to patentable subject matter. Although a physician is not required to make any upward or downward adjustment in dosage during the "warning" step, the prior steps provide useful information for possible dosage adjustments to the method of treatment using thiopurine drugs for a particular subject. Viewing the treatment methods as a whole, Prometheus has claimed therapeutic methods that determine the optimal dosage level for a course of treatment. In other words, when asked the critical question, "What did the applicant invent?," Grams, 888 F.2d at 839 (citation omitted), the answer is a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.
From a European standpoint the key ruling of the Supreme Court is that the reasoning of the CAFC and the EPO Appeal Boards should not be followed. Its reasons are set out in the slip opinion pp. 20-21:
Third, the Government argues that virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable application sufficient to satisfy §101's demands… The Government does not necessarily believe that claims that (like the claims before us) extend just minimally beyond a law of nature should receive patents. But in its view, other statutory provisions—those that insist that a claimed process be novel, 35 U. S. C. §102, that it not be "obvious in light of prior art," §103, and that it be "full[y], clear[ly], concise[ly], and exact[ly]" described, §112—can perform this screening function.
This approach, however, would make the "law of nature" exception to §101 patentability a dead letter …
What role would laws of nature, including newly discovered (and "novel") laws of nature, play in the Government's suggested "novelty" inquiry? Intuitively, one would suppose that a newly discovered law of nature is novel. The Government, however, suggests in effect that the novelty of a component law of nature may be disregarded when evaluating the novelty of the whole… But §§102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections. Cf. Diehr, 450 U. S., at 188 (patent claims "must be considered as a whole").
If the CAFC/EPO approach is to be abandoned, what is the alternative? The rule followed by the Supreme Court is that the claimed combination of features must amount to significantly more than the natural law itself and that limiting the law to a particular technological environment or adding insignificant post-solution activity does not suffice. The Court was aware of the need for caution and warns in its opinion:
In effect the Mayo rule corresponds to the "contribution approach" suggested at first instance in the UK in Merrill Lynch's Application [1988] R.P.C. 1 which was to consider whether the inventive contribution resided only in excluded matter. That approach also has its difficulties and it was rejected by the UK Court of Appeal in Genentech's patent [1989] R.P.C. 147 where it was observed that:
Such a conclusion, when applied to a discovery, would seem to mean that the application of the discovery is only patentable if the application is itself novel and not obvious, altogether apart from the novelty of the discovery. That would have a very drastic effect on the patenting of new drugs and medicinal or microbiological processes.
The Supreme Court acknowledges that the rule ought not to be interpreted to cover newly discovered first or subsequent medical indications for a known substance (slip opinion at page 18):
Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.
Such a conclusion is consistent with the arguments of Robert Sachs in Part III of his Guest Post, where he singles out relative terminology and conclusory statements. A question expressed as "doing significantly more" or "adding enough" is a matter of degree rather than of kind, and provides no unequivocal forward guidance. Indeed the Supreme Court accepted the limitations of its guidance (slip opinion at page 24) where it said:
In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another.
Perhaps the wisest course is to take the opinion at its word and accept that beyond disapproving the CAFC/EPO approach Mayo makes no new rule and does nothing positive to explain what is patent-eligible and what is not.
Paul Cole wrote more on the topic in a recent guest post on Warren Woessner's blog Patents4Life.
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141 thoughts on “Guest Post: Prometheus v Mayo – A European view”
Is the question “patentable” or “patent-eligible?”
(and yes, it matters very much)
I agree with you. I would qualify slightly. ‘adjusting’ would also need to lead to an action which was new overall. If it had been previously done to give the drug, measure its concentration and then change the dose to a particular value, if the granted claim covered doing such a change, it would be invalid. That there is now a better rationale for doing this cannot, to my mind, make the procedure new.
Lolz at MaxDrei. That’s what you get for pontificating onthe virturees of the EP system, when the very thing you are pontificating about is embedded in the US system (and you are too dense to realize it).
Look, I haven’t the time or the inclination to bother any more. You can Google “Appeal Procedure at the EPO” and read for yourself that there is no Binding Precedent. Or read T_1099/06, ref 31 in the Google piece. You might also want to read:
link to ipeg.eu
My point is that over the last 30 years the EPO’s DG3, thanks to plenty of bouncing around, has done an excellent job of laying down a coherent body of substantive patent law of claim validity so that, by now, we know with some certainty what is “technical” under the EPC.
You think it is unfortunate that you cannot opine on European patent law. Is that what you really think? If it bothers you that much, you can do something about it.
“There simply is no court sitting atop the EBA”
Sounds like your EBA is equivalent to SCOTUS, except slower.
“no national Supreme Court in Europe can reverse the EBA”
So you do have binding precedent then.
That’s all right Newbe. Bounce is indeed a phenomenon at the EPO. But the bounces/iterations get ever-smaller. Every English lawyer says Binding Precedent is imperative for legal certainty. But every English lawyer founders on the fact that after 30 years of supreming, and many thousands of iterations, the Enlarged Board of Appeal of the EPO has brought ever-greater legal certainty to the substantive law of patentability in Europe. Must I say it again: no national Supreme Court in Europe can reverse the EBA, which stands supreme and learns from its mistakes. There simply is no court sitting atop the EBA.
Look at the current annual supplement of the White Book. Find me something new on the substantive law of the EPC on eligibility, enablement, novelty or obviousness. You can’t. It’s already all done and dusted and the national jurisdictions are stuck with it.
Unfortunately I cannot opine on EP law as that is outside of my knowledge comfort zone, and I was looking towards MM’s integration of the historical US law on mental steps into his perpetual (half-baked?) example. So point one is off-track of what I am looking for.
That being said, though, I don’t think you are correct in your characterization of “ever greater clarity.” Without a binding precedent doctrine, you are all but guaranteed not to have a greater and greater clarity, but rather a continuous fracturing and bounce effect. I think you assume that there is some natural evolution and distillation of legal theory, but I am afraid that is not an assumption that has merit. Law simply does not coalesce on its own like that. There are too many people with different agendas tugging and pulling in too many different directions. While “one single half-baked SCOTUS decision” can cause havoc, it is unabashedly more focused than the multi-divergent national renditions that the EP is likely to produce. So point two I would disagree with you on basic principles.
Thanks Ned, Max
I deliberately didn’t express a view. I was curious to see whether there would be any dispute about the validity of my generalization and whether it would alter anyone’s existing view of the matter. Me, I don’t think either of these types of claim can be patentable in the US or EP, unless they recite an action contingent on the rating/determination. In EP, you might then have a patentable invention if, for example, adjusting Y on the basis of the particular range X was new and non-obvious and provided some advantage (e.g. more efficient quality control in a manufacturing process. Adjusting the dosage of a drug would be an unpatentable medical treatment in EP).
What are “rating” and “determining” Hagbard? They are mental acts, aren’t they? If one is but the other not, please explain why. Are you saying that this sort of mental act is properly patentable?
Ned the EU has 27 Member States, but the European Patent Organisation has 40, and rising. The EPO is NOT an EU institution. What do you mean by ” current EC policy” please.
The issue where to draw the line on patent-eligibility is a problem world-wide, even for those able to think clearly.
1. Article 52 of the European Patent Convention announces mental acts as ineligible, which implies that mental acts as such lack technical character. In in vitro test has technical character but one that is new only by virtue of a mental act ought not to survive Article 56, obviousness.
2. The EPO does not do Binding Precedent. What is meant by “technical” emerges with ever-greater clarity from the flow of 1000+ decisions coming out of DG3 each year (rather than one single half-baked SCOTUS decision). Those wanting to know what is meant by “technical” need to keep up with their reading of the EPO caselaw. Order your copy of the White Book, and its annual supplements, from the EPO website. Not expensive.
Hagbard, you make a distinction without a difference.
The old process measure and reports X.
The correlation is a relationship that is pure information. It is a law of nature. It may be reported in a physicians handbook.
The act of comparing X to the published correlation is a mental step.
1) Information cannot be patented.
2) Natural Laws cannot be patented.
3) Mental steps performed on information produced by old processes cannot and should not be patented.
There is a problem in the European Community just as much as there is a problem in the US. Clear thinking is one of the things that seem to be absent from current EC policy on this topic.
Does “rating” something effect a “transformation?”
Is “rating” anything anything other than abstract?
determining a need to increase a parameter Y of the known process if X less than a,
determining a need to decrease a parameter Y of the known process if X greater than b
post got mangled, end of US version should read:
determining a need to increase a parameter Y of the known process if Xb
It seems to me that the respective EP and US claims can fairly be generalized as follows:
A method of rating the quality of the outcome of a known process, comprising:
measuring parameter X of the subject of the process (measurement of X being previously known in the context of the known process); and
rating the outcome as satisfactory if the value of X is in the range a < X < b US A method of optimizing a known process, comprising: measuring parameter X of the subject of the process (measurement of X being previously known in the context of the known process); and determining a need to increase a parameter Y of the known process if Xb
Would be interested to know if this affects anyone’s existing opinion of the cases.
To be clear MM, you have evaded any discussion on this on at least the following posts:
link to patentlyo.com (thread name changed as filter prevents unadultered link)
Mr. 6 chimed in with something to the effect that “regulars” often do this type of thing, but I find it self-defeating to continuously preach something without backing that position up with proper legal citation. I do not proscribe to the view that if you repeat something often enough, it must be true.
I don’t know about that. There does not seem to be anything per se to exclude mental processes from being “technical.”
Would you by chance be finally willing to discuss case law on the subject MM?
It’s been several threads removed, but I still have not seen Maxdrei’s definition for “technical.”
However you define the term “technical,” a “technical” solution to a problem certainly does not include a solution achieved entirely by a mental process.
How about it Maxdrei? Anyone else?
So, tim, you need to think “technical character” for eligibility at the EPO and “technical features solving a technical problem” as a basis of recognition of non-obviousness.
A computer has technical character. So, as here, does an in vitro test.
Me, I’m having difficulty recognising “is considered” as a technical feature. I was hoping that Paul Cole would enlighten me on that issue.
Well. ‘considering’ is a mental act. ‘being considered’ probably implies a mental act, though it’s not very clear by whom. My view, having looked at the EPO claim (thanks for the link, Paul) is that the EPO got it wrong, too (incredible!). My (very limited) understanding of how these things are dealt with by the EPO in computing inventions is that hardware (or physical process steps) make a proposal potentially patentable, but ‘non-technical’ restrictions (such as mental steps) do not confer novelty. I’m with Ned Heller.
So, Paul, many thanks again, and I have now skimmed through the EPO file in your EP 1695192 patent. Link:
I found out that the non-obvious step was to measure both of TGTP and TGDP. That strikes me as “technical” means by which an objective technical problem is seen to be solved.
While “considering” might well solve the objective technical problem in Prom’s invention, I’m still wondering whether “considering” is a technical means to solve that problem (and therefore whether it counts, at the EPO, to establish non-obviousness).
But national courts in Europe don’t do EPO Problem and Solution obviousness. So what would happen to Prom’s claim in Europe, if ever its validity were to be attacked, strikes me as anybody’s guess.
Not Paul Cole says:
So much for your ASSiduous behaviour.
Now I see that EP patent number Paul, right in the middle of your original posting. Thanks, and sorry about that.
There may be a few further postings, but before this falls off he page, so to speak, may I take this opportunity to offer sincere thanks to readers for some interesting comments.
I am not sure what this was in reply to so cannot answer it.
EP-B-1695092. It is not in the patent family of the patent in issue but is a wholly different invention by a different applicant. But essentially the same claim format was approved, which is the whole point.
Could be – though I haven’t looked (do you have a link?). I don’t put it beyond the bounds of possibility that the EPO might have got it wrong, too…
how about the glycerine example? If it is distinguished from the situation in Mayo, what is the distinction?
What is “the glycerine example”?
Where, precisely does the present rule end
I don’t know, Paul. Where, “precisely”, does “inventive step” end? Does the lack of one’s ability to articulate the “precise” end mean that the approach is “unworkable”? Of course not. The bottom line is the Supreme Court’s approach is “highly workable,” provided you understand the approach and are not critiquing one of the ridiculous strawmen that certain commenters have proposed.
My eyes are particularly weak today Paul. Yes, I know you got the number right. Yes, I reviewed the Saidman family before I asked you what is the 092 patent. I just can’t see an ‘092 patent in the Saidman family list.
I’m reading the post as assiduously as I can Paul but I still don’t know what the ‘092 patent is. Sorry.
If you do not recognize the 092 patent you obviously have not read the post. And the number is correct (I have checked).
As you know you should be able to go from the esp@cenet entry to the patent family. And you can also get the family from Delphion if your firm subscribes to that
…is the link to the Seidman patent family. One EPO member but loads and loads of USPTO members. Does that say something to us about the relative commercial importance of the two jurisdictions?
Paul what ‘092 European patent please?
Apologies – should be 1115403. Here is a link
link to worldwide.espacenet.com
The file history is not so interesting compared to the 092 European patent
tim, I tried for a Link but I think Paul Cole got the EP publication number wrong. Paul?
As Charlie Brown says: “Now that I know that, what do I do?”. My view is that claims should tell you what to do, not what to think. They should recite physical things or actions. If you’ve invented litmus paper, you can claim it as a thing. If litmus paper is known, and also that it turns red or blue sometimes, but nobody understands why, I don’t think you should have a patent for the explanation. You can have a patent for specified new uses to which the explanation leads you.
MaxD, would you happen to have a handy link to the EU claim? I’m sure it wouldn’t be too difficult to find, only tedious!
Paul, thanks for the information about European procedure.
Regarding the US patents, it seems common in many US patents for patent attorneys to include explanations of what is going on in whereby clauses. But it remains critical that the underlying process steps themselves constitute novel subject matter for the claim to be patentable. What Prometheus teaches us is that if everything is old in terms of the physical process steps and the only novelty left is in the information produced, and their is no specific physical output from the claim whatsoever other than the prior art outputs, the claim probably is invalid under section 101, and may be invalid as well under section 102.
It is not actually sorting dosage regimes but of sorting blood samples. What you get is three indications: too low, OK and too high. A claim to a method of testing whether a thiopurine is being administered at a correct dosage by separating red blood cells from a blood sample, analysing the red blood cells for thiopurine metabolites and observing whether the amount of metabolites fell within a specified range would not be out of line with the diamond testing claim. In hindsight there are forms of claim whcih could have been less provocative to non-specialised judges.
Hi Paul, the fitness for patenting, of new, non-obvious and useful ways to sort sheep from goats (or natural from synthetic diamonds, or excessive lashers from moderate lashers, or one class of object from another) is less controversial or problematic, I should have thought, than claims like the Prom claim.
Is sorting dosage regimes into good ones and bad ones just as patentable as sorting one class of object from another? I wonder.
Ned: Many thanks for your continuing interest on this topic.
First so far as Europe is concerned:
(a) undoubtedly a patentable subject matter evaluation is made at the search stage and if nothing of a patentable character is found then a nul search report will be issued.
(b) the final decision to grant or refuse is made at substantive examination. The power of decision is reserved to the 3-member examining division and is exercised at the substantive examination stafe. If the difference between the invention and the prior art is in a feature excluded under a. 52 then that may arise after search and during substantive examination.
As a result of this posting I am conducting further research as to how this kind of test is dealt with under the normal practice of the USPTO and the EPO.
For example, I found US 6163960 having a main claim reading:
I also found US 6331708 has a main claim reading
I am not sure whether these are the best readily found examples or whether there are better ones, and am in the middle of investigating. But certainly in the diamond testing case the whereby clause is similar to that in Mayo, although arguably better expressed. It would seem that the USPTO has a practice of admitting whereby clauses of the general kind found in Mayo, although I need to check the file wrappers to see the extent to which whereby-type clauses were relied on during prosecution.
What if A makes litmus paper and discloses that it has acid/base sensitivity. B works out which is which. Is B’s interpretation a technical feature? The two patents that are mentioned above provide an indication that it might be.
Paul, there is something you still may still not getting, but it may be the result of the way you examine patent applications in Europe. Let me explain.
Take the litmus test, I think the novelty must be in the use of the paper for the purpose of a test. That is patentable. The paper is, after all, transformed by the tested material.
If however, the paper had been used for this purposed before and the claim ending in something like in Prometheus where a test of red indicated the need to do X and blue indicated a need to do Y, then the claim varies from the prior art only in the information. It is not a claim for an industrial process, but for information.
The problem the EPO has, as Max pointed out before, is that it determines 101 issues at the search stage before the novel subject matter is finally ascertained. Therefore, it might be impossible for the EPO to preliminarily determine whether the point of novelty in the claim lies in subject matter that is otherwise unpatentable, and the rest of the claim that ostensibly might be directed to patentable subject matter in reality adds nothing of substance, but rather amounts to data gathering or insignificant extra solution activity.
All this argues to me is that the examiner in the EPO must reserve the question of 101 subject matter to after a determination of the novelty of the physical elements/transformations.
Very interesting comment and not straightforward. Put litmus paper into a solution. If red, it is considered acid; if blue basic. If that a mental act, an observation or what? But without the interpretation the test is meaningless.
All very fine and dandy, tim, but just look at the in vitro test claim issued by the EPO, and in particular its “is considered” language. Now consider, is “considered” tantamount to a mental act?
In Europe you can patent inventions, but not discoveries. In USA you can patent both inventions and discoveries, but not ‘laws of nature’. That must be because ‘laws of nature’ are not new. They are implicitly old (they don’t change over time – when worked out, they are only new information). One of several mistakes made by the Supreme Court was to assume, implicitly, that the exclusion of ‘laws of nature’ added something substantial to the exclusion of things that are old.
Is a ‘correlation’ patentable? Presumably only as a process. But a ‘correlation’ is primarily a mental process. Are mental processes patentable in USA?
According to Eliot
Can it confer novelty to do an old deed for a new reason?
It was not rejected because it was not the law, it was rejected because more was needed says:
“and is arguably an ”
It was admitted that the claim was not a natural law itself.
Quite directly, there must be more.
I suspect that there is a difference between a law of nature and gravity.
Apples fell from trees to the ground before one fell on the head of Isaac Newton (reputedly). But Newton’s treatment of the law of gravity was a human expression of that law, which it must be said maps well to canon balls and the motion of the planets and many other phenomena.
In the present case we could say that the natural law is that there is a risk of metabolites building up in blood cells and their precursors, and that this can give rise to harmful side-effects. But the observation that a particular range of metabolite level in blood cells is therapeutic and that regions outside that range are ineffective or harmful is a human observation and is arguably an expression of the natural law, not the natural law itself.
No shortage of that – look at the thread wherein we “make” nature infringe our patents.
In some sense, all inventions may be said to be laws of nature. A gear would not turn absent natural physical properties such as momentum and energy. We could say that the use of the gear also is no more than a law of nature.
There is no such thing as a law of nature. People do experiments and make observations. They propose “laws” to describe the results of their observations. The laws thus made are human laws, not natural laws. Newton’s “law” of gravity was primarily a method that proved useful to predict the flight of canon balls. To ascribe this law to nature is an example of human grandiosity.
Max, liability is imposed on the architect because he is the one responsible in the end. Ditto the inducer.
The real problem with Prometheus style claims is that publishing information by itself should not be enough to cause infringement; but in this case, it is. This is why this case is bizarre.
It really makes one wonder how the patent office could've granted these claims in the first place and how the Federal Circuit twice confirmed them. The patent is on new information, in this case a law of nature. Simple knowledge of the new information apparently will make infringers of anybody who is currently practicing medicine and who treats patients suffering the particular disease. Ask anybody on the street whether this should be possible, and I would bet they would uniformly say that should not be possible. But it happened.
The 9-0 reversal by the Supreme Court was more than just a reversal of the Federal Circuit on a issue where there was substantial debate among the lower court/courts. The Supreme Court was sending a message, a strong message to the Federal Circuit that it was, let us put it this way, way out there in its jurisprudence on this issue.
I am going to predict that the unanimous Supreme Court opinion will be studied in Europe and will have an effect.
What “hook” might that be Ned? I don’t see the connection. You and I are drifting ever further from the point. I’m a European patent attorney, not a bricklayer, builder, surveyor, site manager, civil engineer, cement supplier, architect or copyright lawyer.
What happens when an architect supplies plans, the building is built and it promptly falls down? Is the architect off the hook?
“I think a good case could be made that the supplier of such information is at least an inducer.”
Perhaps one day you will get the chance to follow your hunch. People were imagining similar thoughts when EPO “use” claims were new. Nothing’s happened yet though. I’m not a litigator but I’m sceptical that the tort of “inducing infringement” even exists in Europe.
Where, precisely does the present rule end, and where can it be (ab?)used? For example, how about the glycerine example? If it is distinguished from the situation in Mayo, what is the distinction?
Max, I am not following you. There is direct infringement by anyone who administers the prior art mendicant, tests for metabolites and who has "knowledge" of the correlation. Anyone who provides the doctor who receive the test results the patented, critical knowledge has provided the critical "component" of the patented method. I think a good case could be made that the supplier of such information is at least an inducer.
Thus, unless there is some law to the contrary, I think I could successfully sue a publisher who supplies the publication to doctors; and the measure the damages would be based on the number of administration/test performed by the doctors.
In all of this, there would have to no proof whatsoever that the doctors who recieved the information actually did anything different whatsoever.
So, in pertinent fact, the patent covers the information, direct infringement occurs when a doctor performs the prior art method with the knowledge of the correlations, and the publisher induces infringement by providing the doctors with the knowledge of the correlations.
These are patents on the information in reality. Why the EPO should not recognize this is a wonder.
Publisher inducing infringement? No. There is primary infringement and there is indirect infringement, but no indirect infringement without there being an act of primary infringement to base it on. I’m confident that the scope of the indirect infringement provision isn’t wide enough to catch a mere publisher of information.
Max, in your opinion, could the publisher of a book that described the patented (in Germany) correlations be successfullly sued in Germany for inducing infringement? If not, why not?
Could the publisher defend on the basis that the correlations are described in the patent and therefor are information in the public domain?
Thumbs At The Ready says:
“Let me know if you are having difficulty understanding this, Paul. It’s not very complicated. I can walk you through the analysis in more detail if it isn’t clear. ”
PC The reason why the player + disc is non-patentable is that the player is old, the disc per se is old, and the only novelty is in non-eligible subject matter. The proper objection is s.102, NOT s.101. However, s.101 is not nullified because it defines the kind of added feature which can be taken into account under the patent system, and a novel cinematic performance is not a qualifying kind of added feature. Similarly a computer loaded with software for carrying out Bilski’s trading method is patent-eligible but is not novel because the only novelty is in the software which implements an abstract non-eligible idea. That approach is what is used in the EPO, and contrary to what is asserted by the Supreme Court has turned out to be highly workable
The 101 approach is also “highly workable”, Paul.
The reason the Supreme Court didn’t accept the 102/103 approach to dealing with Prometheus’ claim is (1) they would have had to create a rule from scratch saying that mental steps and/or ineligible subject matter must be ignored when analyzing claims under 102/103; and (2) any such rule would have been motivated by the EXACT SAME CONSIDERATIONS that motivate the rule under 101, i.e., unless you ignore those ineligible elements when considering validity, you risk granting claims which are effectively claims to the ineligible subject matter.
In other words, you get the same result either way so the Court decides to simply rely on 101 directly.
Let me know if you are having difficulty understanding this, Paul. It’s not very complicated. I can walk you through the analysis in more detail if it isn’t clear.
You should also realize that the Prometheus Zombies (“P-Zombies”) who are whining right now about the decision would be no less apoplectic if the Court had created the “ignore ineligible subject matter for 102/103 purposes” rule. You can bet your life on that.
Sorry, I did not intend that my “re-dosing” means that the dose changes, just that the re-dose is set having regard to the correlation. See my exchange below with MM, where I understand him to say that including such a re-dosing step is not enough, in itself, to save the claim from ineligibility. I also think the extra step ought not to make the decisive difference.
In Europe, one of the ineligible items in Art 52 EPC is indeed “the presentation of information”. But only that item “as such” and here it is more than “as such”.
Thanks. Progress I think. I like your point about reciting in the claim a relationship between the dosage levels required, after the metabolite level has been ascertained. Without that, the doctor can get to an optimum dosage level only by trial and error.
Your “book” is not available till after the date of the claim. Your book enables more effective treatment. Your book ensures that the dosage remains within the band that is optimal for treatment of the disease. Your book solves the problem how to ensure that the patient is always on the optimal dose. I think the patent system should find a way to deliver a time-limited exclusive right to the one who solved that technical problem.
At the outset I was with you. Then I followed Paul Cole. Now I’m wavering. I’m an engineer not a chemist. I’m curious. I’m learning.
Max, what I don't get about your post is your assumption that one must actually adjust the dosage to infringe. I have said before and I will say it again now, that I don't believe the Supreme Court would have held these claims invalid if the claims required the adjustment of the dosage.
Implicit in your assumption is that the adjustment of the dosage step is inherent in the form of the claim in Europe based upon some implied limitations or constructions of the claim. The question is whether the EPO would grant the claims when only thing new is the information and there is no requirement to do anything with the information. The information itself can be published in a book, in a table, in a computer program that can be looked up by the doctor just before he adjusts the dosage. It could be anywhere. The correlations are set. They are information. They can be reduced to writing. They can be etched in stone for all time.
So construed, it is my understanding that even in Europe one cannot patent information. But that is all that is happening here in United States with the Prometheus claims. Because nothing is done with the correlations, they are simply information that could be published in a book, or written in stone or anything. Once the doctor knows of the correlations, he is an infringer regardless of whether or not he adjusts any dosage whatsoever.
This is the vice of the claims. One these claims are allowed, anybody reading the patent, anybody reading of the correlations in the medical text, any doctor who tells another doctor of the correlations, becomes an infringer or potentially an inducer. We are patenting information. This cannot be right.
Pointless, the test is the same test as it has always been. It will produce the same results as they have always produced. I don't see how you can say that the test produces anything new.
The reason why the player + disc is non-patentable is that the player is old, the disc per se is old, and the only novelty is in non-eligible subject matter. The proper objection is s.102, NOT s.101.
MD It’s your incessant use of the weasel word “effectively” that troubles me MM.
It’s not a “weasel” word, MD. It’s a synonym for another phrase, “For all practical purposes”.
Take the present case. The steps are 1) dose 2) get metabolite levels 3) think 4) carry on dosing. As far as I can make out, a claim to all four survives 101 but a claim to just the first three does not. But, effectively, they protect the same contribution to the art.
I would argue that if the prior art includes dosing, measuring and re-dosing and the claim does not specifically recite the dosing levels in the dosing step (not the thinking step), then the claim remains ineligible, for the reasons I’ve given.
1. A method of optimizing brainstorming, comprising
thinking [new, non-obvious thought], wherein if thinking [new, non-obvious thought] does not lead to desired result,
This is ineligible in spite of the subsequent transforming step.
I think we should argue about what sort of contributions to the art are fit for patenting and which sort are not
That is exactly what we are arguing about. Comparing numbers on a patient’s chart to numbers in a book so you can more effectively treat the patient with old drugs is not a conribution that is fit for patenting.
List of the Vocal Minority says:
Don’t forget the lapdog Ned.
Except it is admitted that the parameter was heretofor monitored.
You have to understand that the posters here are too dense to distinguish between 101 and 102/103, unless it’s for their favored art. Every other art should just be eliminated by whatever means anyone sees fit.
Once you accept that, it’s much easier to read the non-sensical comments here from the likes of MM and 6.
You’ll make a good PTO lifer, 6. With any luck, you’ll never need the real world.
Easy. Monitoring a parameter heretofore not monitored to determine the effectiveness of the drug.
“we are not asked to consider THAT aspect of the claim, but simply whether it is patent eligible”
Yeah. OK, “the claim” and “it” it is. But nevertheless, I should still like to know whether a correlation claim that is skilfully drafted in the light of Prometheus will survive 101 analysis and, if so, on what logic?
That is what most of the respectable patent bar has been saying all along.
It is only the fringe (but vocal) element that delights in the conflation of What-Ev. THat is, until that same shoddy logic is trained on items in their own backyard, and then precision is required in claims, and “effectively” becomes a verbotten word.
This decision is about patent eligibility. Not novelty. Not obviousness. Not enablement. Not claim scope (except insofar as claim construction is relevant to s.101). Not infringement. Is it too much to ask that we should concentrate our minds on the actual issue before the Court?
If you want to criticise the claim considered by the Supreme Court, it is virtually non-infringible. A pharmacist dispenses the thiopurine medicament to the patient. A practice nurse takes a blood sample. A lab in California or elsewhere does the chromatography. The physician in charge of the patient interprets the results. On what basis are they joint tortfeasors?
But that is NOT the point: we are not asked to consider THAT aspect of the claim, but simply whether it is patent eligible.
This posting has not asserted that new, non-obvious and enabled drug correlations are patentable AND enforceable, just that they may be patentable, and that the test applied by the Supremes is not a good a basis for deciding eligibility. It is not in dispute that if you require enforceability you need to claim competently.
Ned, can we set aside the minutiae of claim drafting form (your “ends in a wherein clause” point) and instead discuss the substance of correlation inventions. Is that substance patentable?
Take the doctor who is ignorant of the correlation numbers. She 1) doses 2) monitors metabolite 3) thinks and 4) carries on dosing. No infringement.
Then the Prometheus numbers are revealed to her. She continues steps 1 through 4, but is she now infringing? The Prometheus advocate told the court she was, but is that determinative of the issue? First, Prom has to prove it. Then, Prom has to bring the court to an inclination to give it the relief it seeks.
It seems to me that all those who assert that new, non-obvious and enabled drug correlations are patentable and enforceable, just so long as you claim them competently, are missing the point that, even when the subject matter is competently claimed, and the claim gets through to issue, it is a mental act that makes an accused process an infringing process.
In Europe, the EPO worries about validity, and leaves national infringement courts in each EPC sovereign Member State to worry about infringement issues. Those courts cannot dictate to the EPO on matters of validity. Instead, they have to do the best they can with the claims that are held not invalid by the EPO. Many in Europe suppose that bifurcation of infringement and validity under a new pan-EU patent right would be a disaster. With cases like Prometheus to discuss, I’m now not so sure.
I have been thinking about the various comments onthe way to work this morning.
Essentially s.101 defines the kind of subject matter that might be patented. By analogy, the JACS will publish new papers relating to chemical synthesis but not papers about gardening. The Economist does not publish papers in pure mathematics. So the role of s.101, like a.52 EPC is simply to define the type of subject matter that can be patented. Other provisions deal with clarity, enablement, claim scope, novelty, inventive step etc.
Why can’t we patent a DVD player characterised in that it is loaded with a particular new film? There is no dispute that the DVD player is a technical product and qualifies for patent protection. US and European patent attorneys would not differ on that point. Ther DVD player does not cease to be a qualifying product simply because it has been loaded with the DVD, and if you so believe you would have the absurdity of oscillating patent eligibility – it is eligible when empty but non-elegible when loaded with the DVD. Your children can have lots of fun switching the player between eligible and non-eligible states by taking the empty player, putting the disc in it and taking it out again.
The reason why the player + disc is non-patentable is that the player is old, the disc per se is old, and the only novelty is in non-eligible subject matter. The proper objection is s.102, NOT s.101. However, s.101 is not nullified because it defines the kind of added feature which can be taken into account under the patent system, and a novel cinematic performance is not a qualifying kind of added feature. Similarly a computer loaded with software for carrying out Bilski’s trading method is patent-eligible but is not novel because the only novelty is in the software which implements an abstract non-eligible idea. That approach is what is used in the EPO, and contrary to what is asserted by the Supreme Court has turned out to be highly workable. But the decision is taken on the grounds of lack of novelty or lack of inventive step, NOT on the grounds of lack of qualifying subject-matter.
So is the interpretation a qualifying technical feature of the test or a mere law of nature as the Supremes allege? Its purpose is to achieve a clinical benefit and that kind of benefit has traditionally been taken as a sign of patent-eligibility. The benefit arises not in the fields of literature, entertainment or business trading but in the field of clinical medicine. That should be sufficient for patent-eligibility and that is what the EPO has demmonstrated is its belief.
If you want to destroy this patent, 102 or 103 are the right tools, not 101.
It’s your incessant use of the weasel word “effectively” that troubles me MM. Of course patents are effectively (to use your word) exclusive rights on knowledge. That’s always been so. Exclusive rights in return for disclosure of information. Take the present case. The steps are 1) dose 2) get metabolite levels 3) think 4) carry on dosing. As far as I can make out, a claim to all four survives 101 but a claim to just the first three does not. But, effectively, they protect the same contribution to the art. I think we should argue about what sort of contributions to the art are fit for patenting and which sort are not (rather than which sort of claim formulation can jump all the hurdles). I think it more interesting to argue whether a contribution that is a correlation is patentable than about exactly how poor were the claim-drafting skills of those representing the discoverers of this particular correlation.
“The test produces the same number it has always produced because the test is the same test.”
Not really. The test will give you a whole spectrum of numbers because that’s what happens in real life. One dosage to one person simply won’t give you the same result as another dosage to another person. That’s why the “information” is new and useful. The body metabolizes and there are all types of variables – weight, sleep, other foods, exercise, general health, etc.
The point is not what “the” test gives you, it is what to do with what the test gives you.
NutraSleet?
Fallacy’s point is that it is a fallacy to think that just because steps are old, they cannot be patented (with or without a new thought).
Many patents are just that – old steps put together. The point is that the “point of novelty” is a sham for 101 purposes.
And guess what? Even writing every method step down in a book doesn’t change the fact that some combination of those old, written in a book method steps can still give you a new patent.
Fallacy, I have no idea what you are talking about. It is a given that all the physical steps are old and the only thing new is the correlation. The tests produce the same number they have always produced. What to do with the test results is what is new, and that can be printed in a book.
Pointless, but that is the correlation. It can be printed in a table, in book, anywhere. The correlation is invariant and does not depend upon the test results.
The test produces a metabolite level number. The test produces the same number it has always produced because the test is the same test.
What to do with that number depends upon the correlation. For that, one looks up the number in a table or book to find out what one should do with the test result. Alternatively, one could simply remember the correlation.
But regardless, what is being claimed is a correlation that is pure information.
We should not be able to patent information from a patent law point of view. But certainly, people have 1st Amendment rights to read, and once information is in the public domain, it is there forever.
So, pointless, there is a problem here and you simply do not get it.
“They might be anticipated. If the steps are arranged in a different order, they might be obvious. The case law is pretty clear.‘
And they might earn a patent.
You forgot that third path.
And it’s not easy to do that, given that the great majority of patents are but combinations of things already “out there.”
Not Hans Blix says:
Even nicer from the Sockie Man himself.
What about (method) claims that have no individually new steps?
They might be anticipated. If the steps are arranged in a different order, they might be obvious. The case law is pretty clear.
What about (any type) claim that has no individually new elements?
They might be anticipated. If the parts are arranged in a different order, they might be obvious. The case law is pretty clear.
The point of novelty is a fallacy for 101 analysis.
Except for this 9-0 decision that you are apparently unable to understand.
“Let me know if you need help understanding why this is the case, Paul.”
I can think of a certain Newbie who has asked for your understanding MM and even provided case law with which you can explain yourself grounded in a real legal analysis.
You seem to have an opinion about the ___, or at least an interpretation of the ___, and you seemed very willing to share it with everyone. Now all of a sudden you are unwilling to discuss your opinion (and the logical extensions of it) when Newbie and others bring out the case law?
Funny how silent you get when that comes up (silent after your usual meaningless expletive-laden outburst subsides that is).
“As such, every act up to the wherein clause was previously done before and people doing only those acts have a right to continue.”
What about (method) claims that have no individually new steps? What about (any type) claim that has no individually new elements?
“Paul, what to do when metabolites are at level X can be printed in a book.”
Why is this nonsense post here? Anything can be printed in a book. What a pointless statement by Ned Heller.
“What’s not new about a new way to monitor the effectiveness of a given drug?”
What IS new about the way to monitor the effectiveness of a given drug as stated in the claim?
MD Remember when you and I used to argue about EPO “use” claims?
No. That’s because we never “argued”, MD. You simply refused to acknowledge the indisputable fact that the “use” claims are a silly end-around the EP “prohibition” against claiming methods of treating humans.
It doesn’t look to me like you tried to answer the question I asked. You answered a different question.
You … told us it would all end in tears because nobody would know who was infringing and who was merely practising the prior art.
I never said any such thing about EP use claims, MD, and I’m baffled as to why you would claim otherwise.
I don’t see pharma kicking up any fuss. Do you?
I have no idea why you believe “use” claims are relevant to the issue we’re discussing, MD. Moreoever, I don’t want to know. I’d rather that you try (again) to answer the question I asked. Here it is:
What appears to be happening is that the “technical effect” of an invention has been expanded to include the use, within one’s brain, of otherwise unpatentable facts. I’m not sure how you can argue that this isn’t effectively a patent on the knowledge itself (at least with respect to those practicing the prior art). Do you want to try?
PC I agree with everything you say, but how is the Mayo rule of nature avoided.
Because “the Mayo rule” isn’t relevant to claims reciting novel, non-obvious transforming uses of old compositions, Paul.
Is this really that difficult? I suppose it is, if you are trying your best to remain ignorant about the claims at issue in Prometheus and why they were found ineligible. That certainly seems to be exactly what you are doing, Paul. Chicken little, etc.
“And if you don’t reward those who conduct surveys, the work does not get done and the useful arts do not progress. ”
Oh, so the petitioners trying to get a grant to do this work and which were prohibited by the patent would never have tried to get their grant and do this work? Remind yourself of the factual situation on the ground before spouting this nonsense eh Paul?
Nice analogy Paul. I wonder if you think Joseph’s method of interpreting dreams should likewise have been patentable subject matter? Perhaps you see in his method some sort of “technical result”?
“These folk are no better than that charlatan Joseph.”
Easy broseph. Joseph had God on his side.
And to be clear Paul, as soon as those nice doctors can come up with an invention, they may have a patent for it.
“No special reward for them, ”
Is not saving lives special enough of a reward? I swear to go d, did they stop telling people to not be a doctor if their goal was to be rich?
“Thanks to them thiopurine drugs are now safer to use.”
Petitioners say the dosage levels that should be observed are different from those taught by Prom anyway.
I agree with everything you say, but how is the Mayo rule of nature avoided. It is a rule of nature that nitroglycerine relieves angina, isn’t it? Then putting the compound into tablets or a syrup is trivial.
Re the author’ question about the U.S. patentability of the unexpected discovery that the explosive nitroglycerin could be used as a heart medicine, and the proposed claims for that, that is not the Prometheus invention situation and need not just be claimed that way. An exemplary article in IDEA on pharmecutical patenting states the widely accepted view that:
“New uses for known compounds are also patentable; the compound itself, however, belongs to the prior
art.” [Citing In re Thuau, 135 F.2d 344, 346 (C.C.P.A. 1943.]
“[BUT]The new use must have utility, must be novel as to the use directed, unobvious in light of the prior art, and sufficiently disclosed so as to both enable and indicate possession of the invention at the time of filing.”
Remember when you and I used to argue about EPO “use” claims? Novelty of purpose and all that. Use of fuel additive X to reduce friction, when the prior art included use of the same additive to inhibit fuel-caused corrosion of engine parts? You (like the patent litigation community in England) told us it would all end in tears because nobody would know who was infringing and who was merely practising the prior art. Well, it hasn’t caused any tears yet. The patent owner carries the burden of proof. The infringement judges are coping with it. I don’t see pharma kicking up any fuss. Do you?
All goes to show that self-sufficient patent culture one side of the Atlantic is one thing, and on the other side another, and elements of one don’t necessarily sit easily with elements of the other.
PC: The prosecutuon files are open to inspection online. So you can see for yourself what the Examining Division said.
I can also see for myself what YOU wrote, Paul (quoted in my immediately preceding comment), which is why I’m asking YOU to address it.
You seem to have an opinion about the EP Examining Decision, or at least an interpretation of the decision, and you seemed very willing to share it with everyone. Now all of a sudden you are unwilling to discuss your opinion (and the logical extensions of it)?
Paul, when one infringes simply by publishing the correlations in a book, you have to begin to admit that there is a problem.
Night, I disagree. I think they recognize the inventive contribution, but object to the form of the claim. Had the claim ended in a physical act of adjusting the dosage and still the SC would have objected to the claim, then you would indeed have a point.
Paul The law of nature is that people respond differently and metabolites build up. The identified range is in a specific context and is a human creation.
So why not simply allow the following claims to be granted:
“A method of thinking about [otherwise unpatentable fact] in [a specific context]?”
Why not? That’s effectively what’s being claimed. For all practical purposes, there is no difference between the above claim and the claims you seem to be advocating for.
I am by no means sure that the whereby clauses in the US can be unequicocally equated with a law of nature either.
Well, let me help you out, Paul. In the US, a claim in the following form:
“A method, comprising [prior art step(s)], whereby [result of old step(s) implies newly discovered, patent-ineligible fact]”
is ineligible because it effectively claims ineligible subject matter (call it a “law of nature”, abstraction, or purely mental process … doesn’t matter).
Let me know if you need help understanding why this is the case, Paul.
There is absolutely no need for me to confirm anything. The prosecutuon files are open to inspection online. So you can see for yourself what the Examining Division said.
The point of novelty was well apparent to the EPO in the counterpart to the Prometheus patent and in the later patent that I found. But the EPO decided that the new interpretation was sufficient cause and was a technical feature. That was very clear from the posting.
I am by no means sure that the whereby clauses in the US can be unequicocally equated with a law of nature either. If you wished to develop a contrary argument, there is much scope for doing so. The law of nature is that people respond differently and metabolites build up. The identified range is in a specific context and is a human creation.
And I think we must agree to differ. I support the CAFC and the EPO. You support the Supremes. In the PRESIDENT’S REFERENCE decision the Enlarged Appeal Board pointed out how workable the EPO approach is and how many decisions of the Appeal Boards have adopted it. The application of the rule presents difficulties but the rule is clear.
Ned, I think there is an implicit judgement that they don’t think this invention is much.
MD, I’ll ask you the same question I asked Paul:
In the EP, can I now claim “a method of interpreting data” comprising “looking at data, wherein if X >Y, then Z?
That seems to be what you’re suggesting. Is the word “monitoring” critical?
Paul, what to do when metabolites are at level X can be printed in a book.
I do not think that it is constructive or helpful to rubbish the claim drafting at this time. In hindsight we would all say that we could have done a better job
That’s nice, Paul.
Give us a all a fxxxing break already.
Paul, 6 explained all this beautifully, as does Malcolm. The central problem with the wherein clause is that it was the point of novelty. As such, every act up to the wherein clause was previously done before and people doing only those acts have a right to continue.
Now, consider that all those previous acts result in a blood test number stating the level of metabolites, and futher consider the doctor or patient knows what to do with the number because he or she has read about the requirement to do Y when the number is X. Does the doctor or patient infringe simply by reading the report?
That was the theory of infringement in court in Prometheus.
Now, it seems appareent, does it not, that this form of patent makes knowledge an infringement?
But the same is not true if a physical ACT is required in response to the knowledge.
In the case of a discovery of a new drug or use, the drug is a physical embodiment. It must be made, sold or used to infringe. The same issues are not involved.
This really is not rocket science Paul. Perhaps Breyer was inarticulate or long winded. But, in the US, the requirement of doing something new that is physical, or of producing a new machine, a new article or new composition, has long been the law.
Now, it seems that producing new information is also proscribed in the EPC. But why you cannot see that this is what you are doing if all the physical steps are old and the claim ends in information, the kind produced by the prior art, but what to do about the information could be read in a text book, is beyond me.
On the face of the document there may be an argument under 35 USC 103 since some analysis had been carried out and the survey conducted by the inventors was arguably obvious to try.
Are we talking about the Prometheus claims in the US? Of course they are obvious (if not anticipated). They cover recognizing a need to administer more drug when zero metabolite is detected.
Get your head of the sand, Paul.
The whole point is that the EPO regarded the interpretation from the patient data in the specification as technical in nature, and sufficient to justify patentability.
So I can claim “a method of interpreting data” comprising “looking at data, wherein if X >Y, then Z?”
That seems to be what you’re suggesting Paul.
This Time The Egyptians Win says:
“And as I have said, the claims were on message”
And as I have said, they were not.
The facts include the claims (whether or not any adjudication on 103 has been completed). Sticking your head in the (Egyptian) sands and clamoring for a patent in spite of “the facts before us” is quite different than merely saying the Court got it wrong on the 101 question.
So where does that leave us? I know that the equities lie in leaving the good doctors without a patent.
Taking affront at my “arrogance” to mask your plight is a shallow and base move.
I am not surprised you jumped at the chance.
Night, I think Breyer is talking about “doing more” in terms of applying the LoN to produce a specific result. He is not talking about obviousness.
Max, patient taking drug X gets a blood test and sees the reported level of metabolites as a number. The drug is old. The test is old. The report is old.
Has he infringed a claim that ends in one of these wherein clauses?
Add to this that he has read in a medical text that if the result is Y, one needs to do Z.
Is he an infringer?
6, nice series of posts.
“Try Again” contemptuously writes
“We” are not debating anything. “You” are being shown the folly of your post
These arrogant words just ended our conversation.
I do not think that it is constructive or helpful to rubbish the claim drafting at this time. In hindsight we would all say that we could have done a better job. But a lot of effort went into that specification and it shows. And as I have said, the claims were on message.
At the moment we are only looking at section 101. In relation to that and what is said in the patent the Pharaoh analogy is apt to show where the equities lie. If a section 103 case is made out, perceptions could change. But until that happens we have to take the facts as they are set out before us.
This Time The Eqyptians Win says:
“Much could be said about the claims, but this is not the occasion.”
On the contrary, you have made it the occasion.
You preach that they deserve a patent.
I can agree with you that the decision was flawed, that 101 was not the right tool.
But that will not change the fact that your preaching is just as flawed.
What Mayo does as far as its patent efforts is quite besides the point.
Much could be said about the claims, but this is not the occasion. If you construe it properly, however, the claim analysed by the Supremes arguably qualifies under section 101 (the CAFC thought so) and is on message.
On the face of the document there may be an argument under 35 USC 103 since some analysis had been carried out and the survey conducted by the inventors was arguably obvious to try. But that ws not the case before the court, at least at this stage in the litigation. And if you don’t reward those who conduct surveys, the work does not get done and the useful arts do not progress. The UK patents court came to this sensible (and pragmatic) conclusion about 30 years ago.
On the face of the patent nobody knew how to interpret the test until Seidman and Theoret did their work. The practical consequence was that thiopurine drugs became safer and doctors became more willing to use them. If that is disputed, it has not become apparent from anything I have seen.
Possibly next time Mayo will come up with a useful test that they want to patent???
“Are we debating ways of monitoring or ways of determining?”
“We” are not debating anything. “You” are being shown the folly of your post.
“We” are also not asking patients anything as that is quite besides the point that your post was bogus.
Are we debating ways of monitoring or ways of determining? Should we ask the grateful patients whether it matters to them, whether we use the old or the new way of “monitoring” the success or failure of the drug treatment regime which they are enduring (or suffering)?
Beautiful, nice and touching.
Drs. Seidman and Theoret deserve a humanitarian award.
They do not deserve a patent (at least not one for the claims provided). What they wrapped it up in was already common knowledge. Their bad. The fact that the Court butchered the legal analysis is our bad.
Satire as a legitimate form of protest is no match for a basic factual and legal assessment (in fact, no match for the paltry incorrect Court assessment).
MaxDrei is "WAY" too dense says:
In exactly what “way” are you determining where those metabolite levels fall?
Is that “way” in any way different (in and of itself) than known prior art “ways?”
When I determine whether the metabolite level falls between 230 and 400, am I not “monitoring” the thiopurine therapy? If nobody up to now has monitored thiopurine therapy in that way, am i not doing it in a new way?
Once upon a time there was a man called Joseph living in Egypt.
Pharaoh had a problem. He dreamed had two dreams, one about fat cows/lean cows and the other about fat ears of grain/withered ears. Although Pharaoh had experienced such a dream, and it had happened twice, nobody could interpret it. There was nothing new about the dreams. If Joseph had not intervened, Pharaoh would probably have carried on having dreams, just as before, and they would have done no good for him or anyone else. Joseph had the insight to determine the meaning. Pharaoh rewarded him by putting him in charge of all Egypt, and he saved the lives of his family members, many Egyptians and many people in surrounding countries. Or so the Bible tells us.
Some millennia later along came Ernest Seidman. He was a doctor working in Canada. He wanted to make thiopurine drugs more available to people with Crohn’s disease and ulcerative colitis. In order to improve his treatments he teamed up with Yves Theoret who was a research biochemist. There was a test for thiopurine metabolites, but it seems that nobody know how to interpret it, any more than people knew how to interpret Pharaoh’s dreams. Without knowing how to use the metabolite test it was not possible to administer the drugs safely and many doctors were frightened to use them. Dr Seidman and Dr Theoret worked out the interpretation. Of course their achievement was less world-shaking than that of Joseph, but they have saved a lot of patients from nasty side-effects and in a few vulnerable cases they may have saved lives. Thanks to them thiopurine drugs are now safer to use.
But that’s not enough for a patent, says Justice Breyer. These folk are no better than that charlatan Joseph. Just like him they had an abstract idea, but wrapping it up in a test involving blood samples and chromatography makes no difference. Such ideas should be the common currency of everyone. Certainly the people who figured out the interpretation (or their licensees) should not have a patent. No special reward for them, any more than there should have been a special reward for Joseph. That chap Pharaoh must have been a mug!
(P.S. Satire is a legitimate form of protest.)
They found a heretofore unknown correlation between a drug and a metabolite and claimed monitoring the metabolite to determine the proper dosage of the drug for a given patient.
What’s not new about a new way to monitor the effectiveness of a given drug?
“Might it be that there are different dictionary definitions of “way” and “monitor””
Mayhaps you can explain yourself MaxDrei instead of asking someone else to explain what you meant.
As I read Columbo’s remark, Prom’s claim had nothing to do with any such “new inventive or better” way to monitor as the claim used any and all way(s) to monitor. It just did not matter the way chosen to monitor, as it was merely the result of any such way to monitor that was captured in the wherein clause.
The claim lacked what you stated in your post, or to put it bluntly, your post misses the mark.
So unless your dictionary definitions of “way” and “monitor” include addding something completely different to your sentence, you may just want to say something different.
Thanks for taking the time to write it up Paul.
So now even the Brits are getting in on panning the Supreme Court. Good, they’ve earned it for this poorly reasoned, ill conceived swipe at patents in general.
Sorry. Not following you there Columbo. Might it be that there are different dictionary definitions of “way” and “monitor”, and the ones you choose to rely upon are narrower?
I agree with you on “important” but not on “little”. So, can you perhaps explain? I would be grateful, and perhaps EPO readers too.
“allow claims like Prom’s, that provide a new, inventive and better way to monitor”
Except Prom’s did not provide a new inventive and better way to monitor.
A little point, but surely important.
I’m grateful to Paul Cole for looking into the EPO file and finding out that:
“In a communication dated 26 October 2007 and available in the EPO’s online file the Examining Division decided that the ‘851 claim was novel and inventive based on the technical effect of improved therapeutic efficiency. In accordance with EPO practice, from that effect a technical problem based on the Seidman disclosure as starting point could be reconstructed which was to provide an improved method of monitoring azopurine therapy.”
This is how the EPO handled obviousness. Nevertheless it is relevant in that it accommodates MM’s criticism, that the claim should be found ineligible because it is in the form of “old steps + new thought”.
When the claim is directed to a useful process, the focus of its examination in the PTO should be dwelling on matters of technological obviousness, sufficiency of technical disclosure and whether the scope of the claim is commensurate with the reach of the disclosure and the magnitude of the contribution to useful arts.
Some still think that claims to Molecule X should be allowed only when limited to a specific use, but these days they are in a minority. If you, Supreme Court, are going to allow claims to Molecule X per se, then so too should you allow claims like Prom’s, that provide a new, inventive and better way to monitor drug therapy.
I’m (not) sorry that I took TBL’s advice prior to even reading his advice.
All I had to do was read 6’s first line about prior art and note that conflation is never good.
A prior art argument simply is not proper under 101.
6 continues to confuse the fact that many are not upset with the nonobtainment of a patent for Prometheus, as they are upset with the Supreme Court reasoning, or lack thereof.
The EPO reasoning is interesting, but far less so than the continuing 101 morass perpetuated with the decision.
“Just remember that you created this. ”
Lulz, I think you have that backwards my good man.
“The whole point is that the EPO regarded the interpretation from the patient data in the specification as technical in nature”
Well, their bad. Not much more to say on that topic. But perhaps they could tell us what is “technical” about interpretatin’ on data. Just so we can have an lol. Or maybe you could do it in their stead. Remember, just for lols not really for srs.
“and sufficient to justify patentability.”
Well, over the prior art perhaps, if we grant this “technical” hogwash in the first instance. But this is a discussion about subject matter eligibility in the US. So, maybe we could just stay on topic a bit.
“And they did it again with the second patent”
Did you know that the USPTO has a whole legion of examiners that misapply the law, on purpose? I wonder if there is another legion across the pond?
“One reason is that the EPO attaches incredible weight to new and useful technical results reported in experiments, and such were to be found in both patents.”
There is none in the world that places more weight on new and useful “technical results” reported in experiments. Unfortunately I see no technical results in either patent. Perhaps if you had line nums. But I think I see what you are thinking is a “technical result” in the patents. I see no new result, and even if I did it would be divorced from technicality.
But all that is neither here nor there, let us mosey on over to your hypo.
“(1) A pharmaceutical composition comprising nitroglycerine and a pharmaceutically acceptable diluent or excipient.”
Ok, so, yeah, probably invalid IF we consider that a natural lawl (which is something I am unable to speak on). And even though you say “modern” claims typically take this form I’m less than convinced that they do all the time. Although they may well have and it is irrelevant to our discussion.
Although, note that I cannot say for certain that it is invalid, perhaps there are other ways to take advantage of this “natural lawl”, even if we presume it to be such, which are not covered. And in which case, the claim probably passes 101. The applicant will get his chance to respond.
“There is no invention in selecting the diluent or excipient and making tablets – how to do that was well-known in the nineteenth century”
There probably is invention in actually making a diluent or excipient or making tablets that have nitro in them tho right? That’s the whole gist of this.
“And it is unreasonable to confine the invention to a particular species of diluent and tablet.”
Tell it to the USSC brosensky. Or tell them the activity of nitro is not a natural lawl. When they say “yeah ok, you get past 101” then don’t act amazed.
“Are you seriously suggested that because the glycerine was formulated with lactose, that is all Dr Murrell invented?”
Well I didn’t say that yet, but since you’re making me aware of it now, perhaps that is the case. If that is historically what happened then I bet if we asked Dr. Murrell then that is what he would tell us he invented. Only a lawlyer probably thinks otherwise.
I’m curious, did what’s his name that supposedly invented this treatment patent this back in the day? Oh, he didn’t? I wonder why not? Was there no patent lawls then? Because I thought there were. Perhaps he’s just a do gooder?
“Composition claims of this type have been commonplace for at least 60 years to my personal knowledge, and probably long before that, and have been accepted throughout the world. ”
If you say so. I seem to recall the inventor of the polio vaccine asking “could you patent the sun?” Or something like that when he made his “invention”.
“So the reasoning of the Supreme Court impugns pharmaceutical practice which is internationally accepted, has been so for many decades and is the settled expectation of the industry.”
Well, to be honest, if we accept this “activity” as a “natural lawl” the the USSC reasoning probably did impugn this practice from the get go, it’s just lawlyers have been so busy ignoring them for the last 50 years not many people noticed.
Listen though, that PRESUMES that we consider what you stated to be a lawl of nature. I’m not really sure if that is true. In Prom, we were looking at a correlation and the way it was recited in the claim was as a mental step. That’s a different nugget entirely from “activity” of nitro being considered a lawl of nature and then invalidating claims to an actual novel tangible composition. Imo I certainly could probably get your claim 1 allowed and I would do it simply by not considering that a lawl of nature and arguing forcefully for that. Ez peasy brosey.
>>”doing significantly more” or “adding enough” is a matter >>of degree rather than of kind,
Ned, this is the flash of genius in different clothes. The SCOTUS seems to have a tendency to decide that inventions are not worth a patent. I think this emerges from their massive egos and untrained minds. They simply do not and apparently do not care to understand hindsight. J. Rich harped on this over and over again that this was the key to understanding patent law. The longer I have been in this field the more I agree with this. Understanding hindsight makes a person humble and forces the person to build a case against a patent carefully based on the evidence at the time of the invention.
Paul, you’re a bright guy, a capable patent attorney, and a regular reader of this blog. By now you should know better than to read 6’s comments, let alone respond to them, and forget about the idea that he’s ever attended a hearing at the EPO, an office in which he’s not good enough to be file clerk.
@6: Firstly the EPO will have been well aware of the prior art. If you have ever attended a hearing at the EPO you will know that the Examiners go through the specification as filed with a fine toothcomb, and overlook NOTHING. By the time you get to as hearing they know more about the invention than you do (because they have more time). If you have seen a European examiner’s marked-up copy of the specification it is AWSOME the detail they go into.
So the European examiner who granted the application was well aware that the thiopurine drugs had been administered before (they were introduced in the 1960’s to suppress immune rejection in heart and kidney transplants), that they had been used for Crohn’s and colitis, that it was known what the metabolites were and how to measure them and that some measurements had been made. The whole point is that the EPO regarded the interpretation from the patient data in the specification as technical in nature, and sufficient to justify patentability. And they did it again with the second patent. One reason is that the EPO attaches incredible weight to new and useful technical results reported in experiments, and such were to be found in both patents.
The hypothetical Murrell claims might be (in modern form):
(1) A pharmaceutical composition comprising nitroglycerine and a pharmaceutically acceptable diluent or excipient.
(2) The composition of claim 1, wherein the diluent comprises lactose (for example: there are others which are equivalent).
(3) The composition of claim 1 in the form of tablets.
(4) (for US) A method of treating angina or another cardiac condition, which comprises administering to a patient affected with such condition a therapeutically effective amount of nitroglycerine.
(5) (for EPO – purpose-related product claim) Nitroglycerine for use in the treatment of angina and other cardiac conditions.
There is no invention in selecting the diluent or excipient and making tablets – how to do that was well-known in the nineteenth century. And it is unreasonable to confine the invention to a particular species of diluent and tablet. Are you seriously suggested that because the glycerine was formulated with lactose, that is all Dr Murrell invented? Composition claims of this type have been commonplace for at least 60 years to my personal knowledge, and probably long before that, and have been accepted throughout the world. So the reasoning of the Supreme Court impugns pharmaceutical practice which is internationally accepted, has been so for many decades and is the settled expectation of the industry.
“improvement in therapeutic efficiency is treated at least at first instance as a technical effect.”
First let me say nice post Paul. Second let me say that you seem to have forgotten the prior art in this case. Remember bro, everything in the American claim (and as a potentially irrelevant aside: also perhaps in the EU claim) is old save for the “wherein”. And the “wherein” has no “technical effect”. There is no improvement in therapeutic efficiency. People had been giving these doses already. The only thing new is that people are supposedly recognizing now, for the first time, that a certain amount of this stuff indicates a need to up or lower the dosage.
All the claim you showed us was an indication that the EPO fed up on finding prior art. But, nice try.
“As to the overall significance of the “wherein” clauses in the context of the claim as a whole, the CAFC appears to have accepted that they helped define a technical result ”
Nah bro, all they did was say that there was no technical result achieved and then go on to blather about how there totally is a technical result if we look downstream from the invention. Well, guess wut? We don’t look downstream. If you people in EU wish to, too bad for you.
“In effect the Mayo rule corresponds to the “contribution approach” suggested at first instance in the UK in Merrill Lynch’s Application [1988] R.P.C. 1 which was to consider whether the inventive contribution resided only in excluded matter. ”
Nah bro, you’re thinking about the wrong “contribution”. They court is talking about the “contribution” made by the other limitations in the claim to affect the scope and preemptive effect of the claim. The “contribution” at issue in the EU court ruling is a different kind of contribution, namely the inventive “contribution” over the prior art. These two decisions are worlds apart my friend.
But keep trying, eventually you’ll get it.
“what logic new drugs escape the rule in Mayo”
Pretty simple logic. They’re typically for a novel, non-obvious composition o matter.
“Suppose Dr Murrell had claimed a pharmaceutical composition for the treatment of angina or other heart conditions comprising nitroglycerin and a pharmaceutically acceptable carrier or diluent. ”
Sounds like a good invention, passes 101 np. That is, presuming you mean she claimed a specific pharmaceutically acceptable carrier or diluent. If she didn’t, then of course there may well be a problem.
“The anti-angina activity of nitroglycerin could be regarded as a mere phenomenon of nature “though just discovered”, the reference to treatment of cardiac disorder could be a mere limitation to a particular technological environment and formulation into tablets or other forms for convenient administration to the patient could be regarded as an insignificant post-solution activity since the incorporation of active ingredients into tablets or other dosage forms was well known long before 1878″
All very true, but you’re overlooking ONE BIG OL THING BRO. Presuming like I said above, that she claimed only specific pharmaceutically acceptable carrier or diluent then she’s good to go because other people can make their own pharmaceutically acceptable carrier or diluent and design around. She is thus not attempting to preempt all uses of the “natural law” (even if we could say it was one) that nitrog has anti-a activities. If she isn’t claiming a specific pharmaceutically acceptable carrier or diluent in these claims then of course we may have an issue. Claim what you invent and no more. P e r i o d.
You have to remember Paul, we in the US aren’t just going around designating this and that as post solution or a field of use limitation for giggles bro. We’re doing it to see if the claim is indeed an attempt to patent the the whole of some judicially excepted subject matter. If the answer to that question is plainly no from the get go then there is no need to bring the dog and pony show of post solution activity and field of use limitations out.
“Indeed, blocking further development was an objection raised in the 1790’s to James Watt’s patent for a steam engine. ”
I read his claims, he was pretty safe. Although some tard authors of a recent paper thought that he was running scared at the thought that he may have overclaimed and didn’t want it litigated.
“It might be said that the hypothetical Murrell claim ”
Why don’t you just write out this hypo claim Paul and we’ll analyze it together.
The EPO EBA referral was a mistake, since you generally do not answer to core questions if the whole procedure was not acceptable in the first place.
The summary of the referral should have stop at the first check, which was “does this referral is deemed acceptable”?
Furthermore, this referral was done within the patent church.