Patent claims treatment of DISEASE-X by administering 100mg of DRUG-Y. Specification has no EVIDENCE that treatment actually works, no reduction to practice, and only speculative examples.
How should the claim be rejected? (Choose the best answer).
— Dennis Crouch (@patentlyo) March 16, 2022
I wrote today about a claim requiring a dosage be "therapeutically effective."
Survey: All patent claims include an implied "effectiveness" limitation — otherwise the claim would lack utility under Section 101.
— Dennis Crouch (@patentlyo) March 16, 2022
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March 18, 2022 at 9:16 am
I have to wonder about those 57 Tw1ts who view that claims need not (even) implicitly have utility.
Any of you want to posit your legal reasoning?
I don’t know who is advocating for “no utility.” That’s preposterous. What some in this thread are confusing is a claim to an “ineffective treatment,” which is neither utility, enablement, or FDA clinical efficacy.
1) Clinical efficacy is an FDA standard used to approve new treatments. link to fda.gov..pdf
2) Enablement: MPEP 2164. Does the specification contain sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
3) utility: MEO 2107 under the utility guidelines. Do the claims require specific utility, and would one of ordinary skill in the art in view of the disclosure and any other evidence of record that is probative of the applicant’s specific utility.
Valid patents can meet 3, 2 and 1. They can also meet just 3 and 2, but not 1. Invalid patents can meet 3, but not 1 and 2. However, there is no case where you have a valid patent that meets 2 but not 3.
By definition, if the claims of a patent WANT 3, 2, AND 1, but drop out on 1), such is INVALID.
I have no beef with applications that have — at the time of filing — possession of EACH of 3, 2, and 1.
Those are not the ones in the cross-hairs here.
Visit again the list from the FDA of items that
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(and want) that 1.
Anon,
Is clinically and statistically significant efficacy the standard for enablement or is an “effect” (think patient reported outcomes) shown in 1 person sufficient for enablement?
All depends on the claim.
If Pharma wants a claim that does not cover actual human use under FDA approval, they can draft such a claim (with the concomitant LACK of an enforceable patent over any one else making product that DOES meet FDA levels.
Do you really think Big Pharma has such as their aim?
At least a 101 under Brenner and enablement under cases like Corona Cord Tire. Maybe WD too. Patents on drugs should not be issuing without some reasonable likelihood of their working – ie will be shown effective in therapeutic use.
The difference in treatment vis-a-vis mechanical inventions is justified by the nature of drugs. Their actual use is essentially identical – make into pill/injection and administer – so the utility of any drug is not apparent from its nature. For a mechanical invention, POSAs can more often judge the utility of the purported advance from the invention itself.
The downside of the current regime of mostly letting pharmaceutical companies get patents for inventions of speculative utility is one of preemption and misaligned incentives. Other drug companies are dissuaded by over broad early patents, and the real activity we want to incentivize, like the choice to invest in advancing a drug especially to Phase 2 and beyond, are not deemed significant enough patenting events because of flimsy early patents.
“Hypothetically, if we grant someone a monopoly over an ineffective treatment, is there any harm?”
Hypothetically, if someone cares more about making a client happy with a worthless patent than potentially restricting future innovators, does that make them a Defender of Innovation, or, a Parasite on Applicants?
What potential restriction on future innovators are you seeing in the proposed NO value patent?
If there IS a restriction, does this not mean that there WAS at least some value?
Ben – you missed this logical point in the question being asked.
“proposed NO value patent”
We all know it isn’t “no value”. It costs $$$ to invalidate, and even if nobody really wants to go through the trouble it can still be a part of a gigantic portfolio that, together, is basically unassailable.
It costs $$$ to invalidate
Why bother invalidating a patent that has no value?
it can still be a part of a gigantic portfolio that, together, is basically unassailable
And the problem is?
“Why bother invalidating a patent that has no value?”
Uh because of this new thing called the courts and their definitely not-a-thugs sheriff/bailiff force? Derp aherpa?
“And the problem is?”
Uh the whole point to this convo is that we’re talking about patents that should be invalidated on art/112/101 etc. Derpa herpa. Try to keep up old timer.
Your telling someone else to “keep up,” while you plod ahead — in the wrong direction — is amusing.
That you also insert a baseless ageism (you have no clue as to the relative age of Wt) is you being you, 6. When you have a weak position, rather than address substantive points, out come the insults and the ISMs.
Uh because of this new thing called the courts and their definitely not-a-thugs sheriff/bailiff force? Derp aherpa?
That is a nice, meaningless response. I asked a specific question, and I get nonsense in return.
Uh the whole point to this convo is that we’re talking about patents that should be invalidated on art/112/101 etc.
Then answer the question posed — Why bother invalidating a patent that has no value?
If you have no answer, then say so.
“That is a nice, meaningless response. ”
You do know that what gives patents, in general, any “value” is the courts enforcing them (along with their definitely not a thug force of gun weilders) correct? If they do this with patents that are actually, under the law, invalid, then this is IlLigiTiMaTe. The whole conversation is about IlLigiTiMaTe patents. How tar ded are you that you didn’t read Ben’s original post to be addressing such?
“Then answer the question posed — Why bother invalidating a patent that has no value?”
Because of the same reason I just stated ta rd. Because the courts will “give it value”, IlLigiTiMaTeLy, so you can better understand since you are a ta rd. Je sus. Just tar ds in this thread. They’re tiny little babies.
Wow 6, you keep on missing the point here (and you keep on calling others “ta rd” while exhibiting that trait).
6,
Your statement echoes the error of Ben:
We all know it isn’t “no value”. I We all know it isn’t “no value”.
IF the situation is that there iS some value, then the asserted premise does not apply.
You cannot HAVE the premise without there being in fact NO value.
“IF the situation is that there iS some value, then the asserted premise does not apply.”
Bro, they mean no legitimate value. Not that the government cannot artificially create faux illegitimate value. That’s the whole critique. And you know it. Stop pulling our leg.
“You cannot HAVE the premise without there being in fact NO value.”
You can have “dur premise” when the argument is not that there is “derpa no illegitimate value” but the argument is instead that there is no “legitimate value”. Re re.
6 congrats – you have managed to say absolutely nothing with your:
“You can have “dur premise” when the argument is not that there is “derpa no illegitimate value” but the argument is instead that there is no “legitimate value”. Re re.”
And at the same time — again — miss the concept of “NO value” at point.
Your “create faux illegitimate value” is a non sequitur. Point blank: you have value or you do not have value.
No one is saying anything about “legitimate” value (whatever you think that might entail).
“you have value or you do not have value”
There’s a difference between legit value and illegitimate value re re. Mobsters and their work “have value” but it is illegitimate. Invalid patents that are issued “have value” but it is illegitimate. Re re.
“No one is saying anything about “legitimate” value (whatever you think that might entail).”
Yes, they are re re. Your inability to understand what ben is going on and on about ad infinitum thinking he’s just spouting bs is a sign of your tar dation. Ta rd.
As usual 6, when you descend into your “dur dur” lingo, you are the one to whom such lingo applies.
My statements here remain correct – your odd “illegitimate” notion is just not at point.
Re: “if we grant someone a monopoly over an ineffective treatment, is there any harm?”
For more than 150 years large numbers of the public have been mislead into buying “quack” medical cures advertised as patented, by falsely assuming that if it was granted a patent it must be efficacious.
For details on the enormous size and different tactics of the whole quack medicine industry in general, see the recent book: “Quackonomics” “The Cost of Unscientific Health Care in the U.S.” by Ethan L. Welch, M.D.”
Paul,
This is a legitimate point — and also echoes my longstanding views on how Pharma “pulls a fast one” by NOT possessing the claimed efficacy at time of filing – as witnessed by the high FDA drop out rates.
Below we see the (repeated) excuses — but as I have met those statements in the past, they are ONLY excuses and do NOT vouch for suspension of patent rules “because this is Pharma.”
Hypothetically, if someone cares more about making a client happy with a worthless patent than potentially restricting future innovators, does that make them a Defender of Innovation, or, a Parasite on Applicants?
Parasite on Applicants? Your anti-patent (or anti-patent attorney) bent is showing. Biotech companies are far more sophisticated than you.
Drug development is a gamble. The odds of a particular composition being commercially viable are slim, and it can take untold years to make a determination as the drug’s viability. However, if patent protection is to be obtained, the application must be filed years before that determination is made.
By way of example, if 10 patent applications are filed in year 1, perhaps by year 5 there will be 7 of those 10 that have issued and by year 12, a determination can be made that just 1 of those 7 issued patents is commercially viable. What happens to the other 6 issued patents? The answer is probably nothing. They sit there doing nothing. If they aren’t infringed, then who really cares if the USPTO granted those patents? The USPTO grants tens of thousands of patents on things (in the non-biotech world) that will never be commercialized. Are we going to go back and try to invalidate those patents? To what end would we do so?
Regardless, biotech companies know this calculus and part of it entails attempting to obtain patents on drugs that aren’t commercially viable.
Specification has no EVIDENCE that treatment actually works, no reduction to practice, and only speculative examples
EVIDENCE that treatment actually works is not required. The filing of an application is constructive reduction to practice.
If I design a new type of hull for an oil supertanker, am I required to actually build one to show that it provides the benefits that I purport for it? The answer is NO. Working models are not required, which is essentially what this question is directed to.
I will add that because of the development timelines mentioned by WT and the forced publication (by the FDA of clinical trials) the average time of patent exclusivity that covers a drug product (even considering PTA and PTE) is somewhere between 12-16 years.
link to scholar.harvard.edu
The interplay between FDA and patent law is such that companies are forced to file their applications early in the development timeline of a new drug. Pharma companies do not have the luxury to wait until NDA approval, or even NDA filing to file the patents.
This is unlike other arts. And yes, pharma is special, like it nor not.
That “12-16” figure depends heavily on the data exclusivity. I have not seen any studies, but based on experience I doubt that most drugs see more than 8 market years of actual patent exclusivity. And that number is going gradually down, now that large pharma (i.e., the sort with actual manufacturing capacity and channels of distribution) is doing less and less R&D, and relying more and more on acquiring small pharma innovators to expand the large pharma pipelines.
No – Pharma is NOT special when it comes to actual possession at time of filing.
THAT is the crux of the issue.
Pharma is not special in that regard you point out. But pharma is special as it is the only industry that is forced to publicly disclose its invention prior to (in your opinion) it being ready for patenting.
Following this thought – would you then agree that the clinical trial disclosures are not novelty destroying, relying on the experimental use section under City of Elizabeth v. American Nicholson Pavement Co. (U.S. 1877)?
Such that pharma would be allowed to file a method of treatment patent once the phase II results are analyzed, even though the method of treatment may be publicly available on CT.gov?
I would be good with that!
xtian,
Absolutely — as I have myself previously advanced the “experimental/not-ready-for-patenting position.
This would also remove the (rather weak) excuse of “well someone else will file [their own not-yet-possessed] application.
And better yet, no patent law even need be changed.
Precisely because Pharma is a “special” case, it might well make sense to amend §112(a) to require that all applications asserting a medical utility must have animal data in the application for enablement to be admitted. Because this rule would apply to all applicants equally, no one filer would be able to steal a march on another by filing early. Also, because the rule would be stated in terms of enablement, that would mean that someone who files without animal data would—by definition—be providing a non-enabling disclosure, which could not, therefore, constitute blocking prior art to the filer who first arrives with animal data in the application.
That’s just it Greg — Congress has NOT written the patent laws to give Pharma any such “special” status (leastwise on the points being discussed here).
Congress has written many laws that make Pharma special, e.g., Hatch-Waxman Act. What other industry can use a patented invention and not be sued for infringement just because the product is getting approval by another government agency? I am speaking about generic drug approval, of course.
tian,
That is a bit of a non-sequitur to the notion of the current set of patent laws at point.
Even more so, this makes my point, as one can (and should) surmise that if Congress wanted Pharma to be special with THIS set of patent laws, Congress knows how to do that.
They have not done that.
I would postulate that pharma hasn’t historically had to lobby congress to make itself special until this decision. We may now see that change.
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March 18, 2022 at 10:24 am
The better question is should Pharma either lobby so or be granted what it would lobby for.
My answer to both is NO.
I would go even further and note that there is a certain level of coddling of Pharma that perpetuates an abysmal track record of development.
Rather than coddling, Pharma — and everyone else — would be better off with more competition, and innovation itself aimed at the development process.
Greg, it’s your field, not mine, but I’m sceptical about your assertion that “animal data Y/N” is all it takes to guarantee that:
“…no one filer would be able to steal a march on another by filing early”
In fact, I’m not convinced of that at all, given how easy it is, all over the world, these days, to generate something spurious that is presented as “data”.
How much “animal data” would be enough, to constitute “enablement”? And even if there is enough such data to enable something, does the enablement extend throughout the ambit of the claim in view? I’m dubious that your “animal data” test will do anything at all to stop marches being stolen.
I prefer a different test, one more incisive but more flexible, namely the one that has evolved over these past 40 years at the EPO, namely, does the disclosure in the patent application as filed render it “plausible” that the claimed subject matter performs in the way pleaded by the Applicant/Owner. I grant you though, it’s going to be data in some shape or form, drawn from one source or another, that will be needed, to establish any level of plausibility.
In reality, how much difficulty would you have, in house, to reach (with the help of your experts) an opinion whether what some competitor’s patent application is asserting is or is not plausible? Do tell.
How much “animal data” would be enough, to constitute “enablement”?
That would still be a case-by-case question. I am not suggesting that my proposed statutory amendment would solve all hard questions. Animal data would become necessary, but not sufficient by themselves. All I am really saying is that a constructive reduction to practice should not be enough for claims with medical utility—an actual reduction to practice (pre-filing) should be required. Once that becomes a statutory requirement, then no one would have cause to fear the time it takes to run the animal trials.
Let’s just all be grown-ups here and recognize WHY Pharma — being sooo unpredictable — may be especially prone to what Greg would suggest.
For MOST ALL other innovation, constructive reduction to practice is more than adequate.
“The filing of an application is constructive reduction to practice.”
Wrong. It might be, or it might not be a “constructive reduction to practice.” Depends on the disclosure.
This is the whole point: absent an actual reduction to practice, there may not be a conception of the invention in the unpredictable arts.
Filing a biological method of treatment application without any experimental data in the specification is … really not a good idea.
Lol — because this unpredictability is a sign of being “grown-up,” eh Malcolm?
All drug candidates are at least useful enough to try them and see what happens. That is at least some utility. So why not a claim like “treating COVID by administering a horse feed bag of horse corn just to see if it has any effect?” That would have utility in ruling it out, or ruling it in.
The reality it that the PTO is not the FDA and does not have such resources.
Re: “How should the claim be rejected?” Is that a question of what we personally or ideally think should happen, or, how we expect that the PTO should act on it?
Nice non sequitur, Paul.
The issue is not “does the USPTO have the same level of funds/capabilities as the FDA.”
The issue is on the applicants.
This reminds me of my past comments drawing attention to the (very specific) problem with Big Pharma, who are apt to file applications LACKING POSSESSION of the claimed advance — as can easily be seen with the number of Pharma items DROPPING OUT of the FDA trials.
Not necessarily. There are a lot of reasons why drug candidates don’t advance in clinical trials. For example, it could be a simple business decision that a company makes in that they wouldn’t make enough money with the drug if it was approved. Also, maybe the drug was effective in treating a specific condition but the side effects were too serious. Maybe a company decided to put their limited resources toward one project instead of another.
There are definitely cases where companies submit applications where that are wishful thinking, and that is definitely a problem. However, the clinical trial failure rate doesn’t correlate with that at all.
Dvan,
To the extent that those other reasons may apply, those are not situations in which lack of possession is at point, and thus not germane to the point at hand.
And there is most definitely a correlation between dropped FDA cases and lack of possession — notwithstanding any amount of “other reasons.”
We have had this discussion before. This case is a perfect example where Biogen HAD TO FILE before the clinical trials, because the FDA REQUIRES clinical trial disclosure on ct.gov.
This is the major issue not addressed in the opinion. Pharma is impacted by FDA rules that require disclosure at a time where some would say “you haven’t yet shown utility.”
What is the balance? No clinical trial disclosure?
The “balance” is to follow that rules that apply equally to all.
You must have possession at time of filing.
>The “balance” is to follow that rules that apply equally to all.
OTOH, most other arts don’t require that you predict what will be the final, commercial embodiment at filing i.e., the best mode can change after filing (and even that low standard has been relaxed further)
I’m not a chem guy, but the trouble here seems to be a catch-22 between “you need to know the exact therapeutic dose at filing” and “you can’t gather the evidence necessary to determine that dose w/o creating a bar date.” If that’s accurate, a reasonable balance might be to permit mouse/computer models, etc. to support a fairly broad range. The final human trial dose just has to be more-or-less within that range.
And, if there is some magic synergy about a particular dose, then de facto allow CIP practice.
OC,
You’ve conflated things.
I am talking about Claims — claims that Pharma wants to have granted that will cover products that meet FDA standards but must be possessed at time of filing.
This IS something that applies to all art units.
Your notion of “final commercial embodiment” appears to only obfuscate the legal point.
For Pharma, any final commercial embodiment that is outside of the claims (as possessed at time of filing) is meaningless.
Or to think of this another way, at filing, one must possess the entire gamut of the claim — including any particular embodiment that in the future would pass FDA scrutiny.
But we have MANY examples of Pharma patents that
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this; whose claims — explicitly depending for their utility — are NOT possessed at time of filing, and this lack comes to light only later.
This presents an endemic problem in that Pharma routinely files on items that they do not possess.
You see excuses such as “but this is Pharma,” or “but actual development and verification is in the public” as if those somehow waive laws that ARE followed by all art units.
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