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:
An in vitro method for determining efficacy of treatment of a subject having an immune-mediated gastrointestinal disorder or a non-inflammatory bowel disease (non-IBD) autoimmune disease by administration of a 6-mercaptopurine drug, comprising
determining in vitro a level of 6-thioguanine in a sample from said subject having said immune-mediated gastrointestinal disorder or said non-inflammatory bowel disease (non-IBD) autoimmune disease,
wherein said treatment is considered efficient if the level of 6-thioguanine is in the range of about 230 pmol per 8×108 red blood cells to about 400 pmol per 8×108 red blood cells.
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:
The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.
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.
It is, however, less than clear by what logic new drugs escape the rule in Mayo but the Prometheus test is caught by that rule. For example, nitroglycerin was first synthesized in 1847 and was used as an explosive. In 1878 it was introduced as a treatment for angina by Dr William Murrell. 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. 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. The pharmaceutical composition claim which is in standard form for a first medical indication would block research into further formulations and further medical indications for nitroglycerin. Indeed, blocking further development was an objection raised in the 1790's to James Watt's patent for a steam engine. It might be said that the hypothetical Murrell claim confines the reach of what has been discovered to the particular application of pharmaceuticals but it might equally be said that the Prometheus claim confines the reach of what has discovered to the particular application of a blood test for metabolites of drugs of a particular family. If there is a distinction, arguably it is no more than pragmatism.
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.
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).
Don’t go away mad, just go away.
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.
Not sure what point you are trying to make MaxDrei.
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.
Thanks MaxDrei.
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.
Who would expect anything else?
Two points:
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.
Of this:
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?
try again:
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:
EP
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
link to patentlyo.com
link to patentlyo.com (thread name changed as filter prevents unadultered link)
link to patentlyo.com
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.
It’s been several threads removed, but I still have not seen Maxdrei’s definition for “technical.”
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:
link to register.epo.org
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.
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
link to register.epo.org
…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:
A method of testing steering wheel lash for acceptability in a vehicle having a steering wheel, the method comprising:
securing a steering angle fixture to the steering wheel, said steering angle fixture having an indicator for indicating whether the steering wheel has been moved a predetermined angle;
moving the steering wheel to a first rotational position, recording the steer ahead angle at the first rotational position, said steer ahead angle at the first rotational position being a first steer ahead angle, and setting the steering angle fixture at a predetermined fixture position;
moving the steering wheel to a second rotational position at which the indicator indicates that the steering wheel has been moved the predetermined angle, and recording the steer ahead angle at the second rotational position, said steer ahead angle at the second rotational position being a second steer ahead angle;
indicating that the vehicle has excessive steering wheel lash if the difference between the first and second steer ahead angles is less than a predetermined amount.
I also found US 6331708 has a main claim reading
A method of testing whether a diamond has had a layer of synthetic diamond deposited thereon, comprising:
directing a beam of ultraviolet radiation towards a face of the diamond, so as to form a pattern of beams of radiation due to refraction and reflection of the irradiating radiation, and
observing the pattern of beams of radiation substantially of wavelength substantially in the range of 230 nm to 320 nm
whereby if the reflected and refracted beams are weak or unobservable, it is indicated that said face is formed of natural diamond, and if said pattern is complex, it is indicated that said face is at least partly formed of synthetic diamond.
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
“The last temptation is the greatest treason:
To do the right deed for the wrong reason”
Can it confer novelty to do an old deed for a new reason?
“and is arguably an ”
It was argued.
It was admitted that the claim was not a natural law itself.
It was not enough.
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?
Sent from iPhone
Ned, you write:
“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?
Your thoughts.
“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. ”
I want to see the easy and not very complicated part that this squares with the existing 101 precedence that you promised several days ago.
THAT’S the real issue.
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.
The zombie that will not die.
Too funny.
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.
Consider:
1. A method of optimizing brainstorming, comprising
drinking a cup of coffee,
thinking [new, non-obvious thought], wherein if thinking [new, non-obvious thought] does not lead to desired result,
drinking more coffee.
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.
+1
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.
Paul you write:
“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?
Paul,
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.
“‘Once the rockets are up, who cares where they come down? That’s not my department’, says Wernher von Braun.”
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.
Touche!
NutraSleet?
Ned,
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.
Just imagine that!
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.