Prior art: Erlotinib will work to treat NSCLC (non-small cell lung cancer).
Later Patent: Giving Erlotinib to treat NSCLC.
Federal Circuit upholds patent – holding that prior art was speculation that did not provide "reasonable expectation of success."https://t.co/2QlU6FQYsi pic.twitter.com/y0d3MUq0DV
— Dennis Crouch (@patentlyo) October 4, 2019
… and another conversation cut incredibly short (after the purposeful misnomers and mischaracterizations are cleared away).
I do wonder if Ben picks up on just who was the one with the ‘mierda de toro’ on this topic (hint: that would be Ben).
xtian,
Be advised that anon will repeatedly refuse to explicitly explain the link between clinical trials and then come at you with ‘mierda de toro’ like:
“”You accuse me of “You appear to be using some sort of utility analysis which considers both the positives and negatives of an invention.” and then YOU set your arguments to this edict.”
anon,
Assuming you antagonism to pharm patents is based on more than an inferiority complex rooted in being passed up by better law firms who practice pharm prosecution, I invite you to explain:
1) How does a drug with positive effects failing a drug trial due to side effects demonstrate that the drug has NO utility.
2) Why you are only considering the side effects of pharm inventions (i.e., why wouldn’t Ford’s refusal to use an improved engine because it doesn’t meet their safety standards demonstrate that the engine has NO utility”)?
3) why do you think you know better than the drafter of the 1952 act on this subject?
“Knowledge of the pharmacological activity of any compound is obviously beneficial to the public. It is inherently faster and easier to combat illnesses and alleviate symptoms when the medical profession is armed with an arsenal of chemicals having known pharmacological activities. Since it is crucial to provide researches with an incentive to disclose pharmacological activities in as many compounds as possible, we conclude that adequate proof of any such activity constitutes a showing of practical utility.” Nelson v. Bowler, written by Judge Rich.
Activity isn’t “approved by the FDA”. Activity in Nelson was shown based on rodent based data.
Ben,
As with other aspects of 101 that have received “revisions,” the aspect of “any” utility is one that should be revisited — ESPECIALLY in the context of which my points are provided: that is, that the speculative EARLY claimed utility is not actually possessed at the time of filing for MANY (note: not necessarily all) Pharma patents.
As has been my point all along, if the claims are appropriately limited to the actual utility that was present at the time of filing (AND we are not ‘sanctioning’ Research Projects just because ‘Pharma’), then I have no beef and my view aligns with Judge Rich (albeit admittedly in a tightly constrained interpretation).
Ben,
In context from that same Nelson v. Bowler case (emphasis added):
“The board correctly stated that evidence of any utility is sufficient since the counts do not recite any particular utility.” (626 F. 2d 853 page 3, column 1, lines 1-3, citing Blicke v. Treves 241 F. 2d 718 (1957).
I kindly ask you to note my consistent position in regards to recitations of particular utility.
Putting aside your childish accusations and your refusal to answer the questions that were FIRST put to you,…
Your 1) is a misnomer to the discussion point. It is NOT a matter of “no utility” as it is a matter of the claimed utility.
Your 2) is AlSO a misnomer as the discussion point is explicitly on the facts here of Pharma claimed utility, as well as your strawman of “there be some utility,” so no problem with a mere research suggestion and lack of actual claimed utility at the filing date.”
You seem to want to hold a different conversation than the current one, branching into areas that I have not discussed (with “theories” that are not mine) and then you get testy when I point out that you have wandered off into other discussions.
Your 3) has a valid point (in what Rich may say), but I would want to see the context before giving your OVERSTATEMENT that my view makes me “think I know better than the architect.”
… and again note in the extended conversation that I am NOT against any or all Pharma patents — but instead aim my chagrin at the CLAIMS that are not supported with possession at the time of filing.
As I have noted – you want to claim some utility? (along your Judge Rich lines) Fine. No problem. Claim the utility that you possess at the time of your filing. But don’t try for utility that you don’t possess at the time of filing.
I have difficulties understanding how the “predictability in the art” sheds some light on the obviousness on any particular invention. For example, in this case, the 99.5% failure rate of drug testing is only loosely related to the claimed invention. I don’t see how this percentage excludes the testing of drugs that have nothing to do with the claimed drug and the treatment of ailments that have nothing to do with the treatment recited in the claim.
Ask Judge Newman to explain it.
I should like to hear from somebody who knows something about how obviousness in such cases is handled in Europe, how it contrasts with obviousness in the USA, and whether the Federal Circuit can borrow anything useful from the European way of thinking.
As Atari Man observes, such obviousness issues have been a “theme” in pharma patents for “at least a decade”. It seems to me half a lifetime ago, that Europe started to wrestle with the notions of “reasonable expectation” as opposed to an “understandable hope to succeed” and, as a result. planted centre stage the over-arching notion of “plausibility”.
Does plausibility play a role, in the USA? And, if so, how do courts in the USA cope with evidence of what was “plausible” at the date of the claim in suit?
MaxDrei,
Care to venture as to “plausible” and that 99.5% “not success” rate?
How many can you estimate of the US patents in Pharma are filed prior to actually possessing the noted utility that is so strikingly absent?
Do you think that Pharma should have a different “gift” just because that art field is involved with human life?
(note that the George Carlin Filter has already been tripped and snagged a comment).
Hard to answer your questions, anon. For me, the “plausible” test strikes the right balance between i) granting to inventors a scope of protection that is “fair” in relation to their contribution to the art, ii) granting to the public a degree of protection from unjustified exclusive patent rights granted to others, and iii) promoting progress in the useful arts (as opposed to inhibiting it).
This is just my 2 cents, reliant upon 80 x 6 months experience in the patents space.
So you cannot tell if a 99.5%
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is indicative of plausibility…?
What is a difference between plausible and implausible for you?
To me? No different from any other dictionary reader.
Your Task: in the case in dispute, assess the evidence adduced by the opposing sides and judge, on a “more likely than not” standard, through the eyes of the notional skilled person, whether any particular assertion relied upon by patentee (or applicant) is or is not “plausible”. Judges in the patents courts of Europe do this on an everyday basis. Which part of that task is beyond your capabilities, Judge Anon?
You attempt to spin this back to me when it is you that admits difficulties with a Pharma
F
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rate greater than 99%.
Unglaublich.
Anon,
Thinking though the standard you espouse, but looking at it from a going forward perspective, not hindsight. Lets say that human data is needed. OK.
Most patents covering the compound that make up the pharmaceutical drug are filed well before human trials. As a result, these composition of matter patents typically only confer on average 7-10 years of exclusivity that the drug is on the market. Meaning, the 20 year patent term is chewed up during the FDA clinical trial process. NB. composition of matter patents have about a 95% success rate of being held valid and infringed by the generics.
IF, in your scenario, the composition of matter patent could only be filed after there is human clinical trial evidence, this would occur after a phase II trial. Because the patent would be filed much later in the development cycle of the drug, this would “save” about 6-8 years of lost patent term on the composition of matter patent. Thus, the compound may enjoy 13-18 years of patent term thereby keeping generics off the market for a longer time.
“Most patents covering the compound that make up the pharmaceutical drug are filed well before human trials.”
Full stop.
You appear to want this as some type of “must have,” when for ALL other art fields, actual possession remains required AT the time of filing.
Now, if you understand (accept/acknowledge/integrate) that facet, we can turn to the issue of “time under patent.”
Of course, IF you have the (required) actual possession prior to filing, then any actual time for clearance (through the rest of the FDA gauntlet – remembering now that the beginning part of that gauntlet is NOT under patent term), than the OTHER laws on the books may do well to compensate for that time (and in fact, in view of the latest thread and the ruminations under what as intended by Congress in 1984), a later patent START date makes even more sense.
One of the principal faults is the mere presumption that Pharma patents don’t have to oblige the actual possession factor because “Pharma.”
I “get” that “hey, we are talking about human life” MAY make it desirable to have special recompense for safety and efficacy, but I do NOT “get” why people are turning a blind eye as to HOW the current system treats a foundational aspect — and in a very real sense, funds “research projects.”
Note that it “gets even worse” when you take a step back and listen to Big Pharma try to justify the truly 0b scene profit margins on approved drugs (because they have to recoup money spent on non-approved drugs).
The WHOLE of it is that the Pharma industry has ‘sold’ the notion that it is “special” and normal patent rules need not apply. Normal rules like actually having possession at the time of filing.
Let’s talk about possession and your hang-up with Pharma patents.
Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc.
If my spec shows how to make a compound, and the spec also includes in vitro tests showing said compound to have XYZ antagonism, I have satisfied the test for “possession” of a claim to the compound. Thus a claim to a novel compound with this utility demonstrated and a way to make it disclosed in the spec doesn’t need human clinical trial data for the inventor to be in possession of said compound.
Now a claim to treating a human disease with said compound in which the XYZ antagonism is just one aspect of the idiopathy of the disease is a different story. I would tend to agree with you that more data, even human data, may be necessary to show that the inventor was in possession of the invention (a method to treat a disease with the compound).
Building on this, what this case pronounces is that pronouncements of future, potential uses of a known compound, like “this compound may be good for diseases x, y, z, and A, B, C and diseases 1, 2, and 3” without actual data to support the compound works in those diseases cannot form the basis for an obviousness rejection. At most, these statements are invitations to experiment with the compound, which is not a basis to find a claim obvious.
Balance that with the failure rate in the specific disease implicated by the method of treatment claimed, these prior art blanket statements should carry little, if any, weight in an obviousness determination.
You share possession as if “possession of the invention” in some 103 sense is the only aspect.
It is not.
You must possess all aspects of a patent at the time of filing.
That includes the notion of utility. Remember: patents are NOT awarded for research projects.
The notion of constructive reduction to practice does NOT change that — AND in particular with both the recent expert AND the facts of this case, it should be clear that constructive reduction to practice is NOT obtained with a filing which is nothing more than a research plan.
With your wording of “in my spec,” I “get” that you have “something,” and that THAT “something” may include in vitro data.
THAT does NOT mean that you the same “something” as would be confirmed with in vivo data.
CLEARLY, a 99.5%
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rate shows that.
Outside of that, and to your other point of what may serve as proper material for a 103 rejection, I have not taken exception to. Do NOT take my arguments on possession as somehow being the opposite takeaway in the 103 sense that would not jibe with the 101 sense that I am discussing.
As you yourself note: mere invitations to experiment simply are that: mere invitations. Such do not serve as EITHER 103 art, nor as ACTUAL POSSESSION for particular claims.
If Pharma wanted to file early (before they posses the HUMAN version, they are fully capable of filing for NON-HUMAN items. But do not give some “free pass” from the one to the other.
Of course, Pharma wants the patent on the second (HUMAN) item, but they should not be filing early, and in speculative “invitation to experiment” mode or time frame.
This has been a theme in pharma patents for at least a decade…
Prior art shows something similar? Well, it’s an “unpredictable art”. Something almost identical isn’t good enough, because it may have wildly different properties (remember Proctor v. Teva?). Why, our formulation can cure you and the prior art might kill you, so it’s totally different!
Infringer shows something similar? It’s totally the same! We have prophetic examples! Sure, we didn’t know whether this particular formulation would kill you or cure you, but they’re essentially the same.
Does PHOSITA consider science fiction?
(That is, a specific genera of fiction — mind you, the question here is NOT to elements of the fiction that in and of themselves are not fiction; and thus may separately be considered, with or course its own proper support)
Don’t know about the USA but under the EPC the skilled person assessing obviousness is deemed to be aware of the state of the art, which Art 54 of the Statute defines as:
“everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.”
link to epo.org
There is plenty of case law in Europe to tell us what “made available” and “public” means, in this context. But any conventionally published printed paper science fiction novel, whatever its language, surely is. However, what that book makes available, if anything, to the skilled person is debatable.
The EPO way of addressing obviousness makes just as short shrift of science fiction as it does of published patent applications. Indeed, in terms of the useful technical teaching that any given publication imparts to the reader, for example the reader interested in “tuning” a power train, some would assert that there isn’t that much difference betweeen these two areas of literature.
Is something really debatable when you also profess to be able to make short shrift of it?
That sounds like the opposite of debatable.
It also sounds like you beating up on a strawman to advocate for some EPO way.
Would not ALL jurisdictions be able to dismiss a genre of fiction? Any “science” in that genre — if desired to be used for patent purposes — should be able to be supplied apart from the fiction and stand on its own, eh?
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