by Dennis Crouch
The Federal Circuit recently affirmed a district court decision in United Therapeutics Corp. v. Liquidia Technologies, Inc., providing guidance on enablement, written description, and claim construction for method claims. The case involved patents covering treating pulmonary hypertension with treprostinil.
United Therapeutics sued Liquidia for infringing two patents covering the treatment of pulmonary hypertension using the drug treprostinil (US10716793) and a purified form of the drug itself (US9593066). The patentee won on the treatment patent but lost on composition patent, with the district court holding that the broader composition claims were anticipated while the narrower claims were not infringed. Both sides appealed, and the Federal Circuit affirmed on all grounds.
Enablement/Written Description of Unclaimed Variants
A key issue is whether the claims lack enablement and written description. The treatment claims are directed to “treating pulmonary hypertension,” and the defendant argued that the claim was unduly broad in its swath. In particular, the specification provides guidance only for certain types of pulmonary hypertension. No disclosure is given for how to treat Group 2 Pulmonary Venous Hypertension.
The Federal Circuit rejected this argument:
Liquidia essentially asks us to treat Group 2 PH as a claimed species within a larger genus (i.e., all five groups of pulmonary hypertension). But analogizing a subset of patients having a variant of a particular disease to traditional genus and species claims is inapt. It would be incorrect to fractionate a disease or condition that a method of treatment claim is directed to, and to require a separate disclosure in the specification for each individual variant of the condition (here, an individual group of pulmonary hypertension patients) in order to satisfy the enablement and written description provisions of 35 U.S.C. § 112, unless these variants are specified in the claims.
Slip Op. This decision provides important guidance for drafting and prosecuting method claims, making clear that the specification does not need to address every possible disease subtype or non-responsive patient population to satisfy 35 USC 112, as long as those limitations are not captured in the claims. Specifications need not address every disease subtype or patient population, as long as not expressly captured in the claims. It will be interesting though to see how this precedent sits along side the recent focus on “full scope” disclosure.
The court also dug into the details to find that the treatment improved Group 2 PH hemodynamics (the studied marker of improvement) even if it also increased mortality of those patients. That death problem “may be an issue for the FDA. But our focus is on the claimed invention. And on this record, with the district court’s claim construction, the claims are adequately enabled.”
Claim Construction and Safety/Efficacy Limitations
As mentioned, the claims are directed to “[a] method of treating pulmonary hypertension comprising administering … a therapeutically effective single event dose …” The accused infringer argued that this language should be construed to require a showing of both safety and efficacy. On appeal though the appellate panel agreed with the district court that “therapeutically effective” had been particularly defined in the specification is improving hemodynamic values and the preamble language of treating PH “does not import any additional efficacy limitations or any safety limitations.” Again, the court washed its hands of any safety or efficacy concerns: “Questions of safety and efficacy in patent law have long fallen under the purview of the FDA. . . We decline to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations.”
Product-by-Process Claims
Some of the composition claims were directed to a product (treprostinil) prepared by a particular process (alkylation and hydrolysis). When judging this type of product-by-process claim for anticipation purposes, courts ignore the process limitation. The question becomes simply whether the prior art discloses the claimed product even if created by some different or not disclosed process. “As these claims are product claims, they are anticipated by a disclosure of the same product irrespective of the processes by which they are made.” Slip Op. Here, the defendant had provided such a references.
Affirmed.
Off-Topic:
I received an Office Action with only non-statutory obviousness-type double patenting rejections in a pre-AIA application (grandparent application was filed pre-AIA). In the comparison chart, the Examiner cited, for example, three separate claims from the prior issued patent (two separate independent claims (1 is a system claim and the other is a method claim) and 1 dependent claim) against a single independent system claim of the current application. The Examiner provided no explanation of how they were applying the prior patent claims against the independent claim of the current application.
I’ve been practicing a good number of years but I’ve never seen multiple independent claims of differing types applied against an independent claim. It has always been a single patent claim matched up against an allegedly “patentably indistinct” single claim of the pending application. I can understand a dependent claim being cited (with the independent claim from which it depends there to show the incorporated features) against a independent application claim but use of multiple claims (without explanation of how they are being applied to the application claim) is new to me.
Helpful feedback would be appreciated.
Can the method items distinct from the system items (or vice versa) be “added” together to reach (or make obvious) your child claim?
Is a terminal disclaimer not on the table (this may not be worth the time fussing about it)?
Yes, a terminal disclaimer is on the table, and I agree that it is a simple solution. Case law suggests that the filing of a terminal disclaimer is not an admission of the propriety of the rejection, but case law changes. If the nonstatutory obviousness-type dp rejection was improperly made, I’d rather have that on record for the prosecution history.
The patent method claims being cited are directed to something different than the system claimed in the application. The method claims include an independent claim and a dependent claim that depends from that independent claim so I don’t really have an issue with “adding” the independent and dependent method claims together but the Examiner is citing another independent system claim, and it’s not clear if the Examiner citing the system claim as rendering the application claim obvious, and also citing the “combined” independent and dependent method claims as separately rendering the application claim obvious.
If obviousness-type double patenting is still bound by a KSR obviousness inquiry, then the Examiner needs to provide their reasoning with a rational underpinning. There’s nothing here. I’d compare to a situation where an Examiner is saying that something is obvious over a single reference but not providing any explanation as to how.
“ Yes, a terminal disclaimer is on the table, and I agree that it is a simple solution. Case law suggests that the filing of a terminal disclaimer is not an admission of the propriety of the rejection, but case law changes.”
[eye roll]
If you can see an OTDP rejection yourself, then why would you not file the terminal disclaimer? What’s the point of getting into the weeds of whether the Examiner is doing it right?
“If you can see an OTDP rejection yourself, ”
I never said I did. Too me, the Examiner just threw a few claims against the wall to see if something stuck.
35 U.S.C. §101 says that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…” (emphasis added). You are supposed to get one patent for one invention. If there are multiple different ways to claim that invention, then you are supposed to put all of those different claims into the one patent.
It is, of course, quite common for folks to put some claims in one patent, and then some more, patentably indistinct claims to the same invention in a second patent. If you put some claims in one patent, and then some others in a separate patent, you deserve an ODP rejection. As an act of grace, the U.S. allows one to resolve this violation of the “one invention, one patent” rule with a terminal disclaimer, which turns the multiple, separate patents into a single, legally operative unit (all expire at the same time and can only be asserted when they are all owned in common).
Did you get a restriction requirement in a previous app? Is this a DIV or a CON? If you got the restriction requirement in the earlier case and filed this grandchild app as a DIV, then you should argue the §121 safe-harbor.
If you just filed a CON to keep the family alive, however, then that fact alone is enough to establish the prima facie rejection. A separate argument about patentable distinctness between the present claims and the grandparent claims is not necessary, because your client should have put all of the relevant claims in your first application. If they did not do that, it is on them. The public should not be made to pay the price for your client’s laziness/negligence.
“If you just filed a CON to keep the family alive, however, then that fact alone is enough to establish the prima facie rejection.”
That’s amazingly wr0ng legal advice.
While I would not [eye roll] you, I would ask if Malcolm’s assertion fits.
That is, can you ‘see’ a legitimate basis (whether or not the examiner properly did their job)?
I am all for making examiners actually do their jobs (especially when they clearly are making
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up, but if you could (quickly) do their job in this instance and make a colorable position, then the ‘easy’ path here is likely the better one.
I do not see the level of risk too high at all as to the suppositions of accepting terminal disclaimers changing any time soon. Do you have a scenario that you can imagine that would raise that risk?
No, the Examiner is using claims directed to an apple to reject claims directed to an orange.
From the sounds of it, it looks like you are left with arguing an improper rejection. I would aim for a direct lack of establishing a prima facie case. Of course, this does carry a risk of putting more into the prosecution history than your client may like (which draws back to the less-than-savory “letting the examiner get away with shoddy work” terminal disclaimer).
Exactly.
The shoddy quality of work by the Examiner is unacceptable, but the even shoddier supervision by the Examiner’s SPE is even more unacceptable.
Perhaps then two phone calls.
Of course, the first must go to the examiner (in large part because that’s the first question the SPE’s going to ask).
I would be point-blank: there is no way this rejection approaches a good-faith full action because it does not come close to establishing a prima facie case; therefore, the examiner can sua sponte issue a full action, or face a second non-final (no-count, quality ding).
If the examiner won’t budge, kindly explain to the supervisor the ding to the supervisor with an loss of appeal on this simple matter.
I generally do try to work with examiners, but I also have no problem cutting the games down.
One might simply explain to the examiner that this is just not a case that the client wants to mess around (lots of different supporting rationale are available).
“Perhaps then two phone calls”
Exactly what I had in mind. Let’s see how productive the first call is.
Apples and oranges are both common, commercially grown fruits.
pretty sure the context here does not reach to the larger arena of mere commercial fruits (but you be you)
Computers don’t care if a sequence of ones and zeroes represents an apple, an orange, available real estate, or a lottery ticket number. The bits are processed according to the instructions provided and that’s that. But this is a fact not everybody is willing to admit for some mysterious reason.
Just how many logical fallacies do you want to stuff in one response?
Examiner: “This reference describes a truck bed holding a 1000 pound load, exactly as in your claim.”
Derp: “Irrelevant! The truck in the reference is holding oranges while my claim recited a load of apples!”
Move the goal posts back, and try to follow the context as provided.
Or are you still trying to reformat your computer hard drive with a Britney Spears CD (because it’s just 1’s and 0’s and the computer does not care)
Helpful feedback would be appreciated.
From MPEP 804(II)(B)(3):
A nonstatutory double patenting rejection, if not based on an anticipation rationale or an “unjustified timewise extension” rationale, is “analogous to [a failure to meet] the nonobviousness requirement of 35 U.S.C. 103” except that the patent disclosure principally underlying the double patenting rejection is not considered prior art. In re Braithwaite, 379 F.2d 594, 154 USPQ 29 (CCPA 1967).
…
In view of the similarities, the factual inquiries set forth in Graham v.John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 should be considered when making a nonstatutory double patenting analysis based on “obviousness.” See MPEP § 2141 for guidelines for determining obviousness.
In other words, the Examiner should make something comparable to a regular 103 obviousness rejection. If the Examiner has not, then argue that the Examiner has failed to establish a prima facie case of obviousness and work from there. You may also want to preemptively argue for the nonobviousness of the combination, but the point is that the Examiner has not done what he/she was supposed to do.
How the hell does this opinion not cite to, apply, nor reference this year’s S.C. Amgen case? Amgen directly addresses the “full scope” question. There the Court held, I think, that the full breath of the claims must be enabled. They didn’t ask whether any particular expressly claimed species is enabled, but rather the full claimed genius irrespective of whether the claims also expressly included limitations to the species. I really didn’t like the Amgen decision, but I think the Federal Circuit should have applied it’s holding here or at least distinguished the cases.
I agree that it is a little odd to decide a case that raises a scope of enablement issue and not mention Amgen. I think that one can properly distinguish Amgen here, but it is strange not even to mention Amgen. Otherwise, I have three thoughts (worth exactly as much as you have paid for them) about this case:
1) I am glad to see the CAFC reaffirm In re Anthony, 414 F.2d 1383, 1395 (C.C.P.A. 1969), et seq. post Amgen. The idea that it is for the FDA—not the patent system—to decide “safe and effective” is a good rule. The patent system exists to “promote… the Useful Arts.” No company is going to invest the funds necessary to establish safety and efficacy unless they know in advance that they have patent exclusivity. The cost of a phase III trial is just too high to make it worthwhile to deploy that capital unless you know that you can recoup it in an exclusive market if you succeed. If you made it a pre-requisite to establish “safe & effective” before you can get a patent, you would have a chicken-or-egg problem, the end result of which would be that there would be much less new drug discovery work done. That is not consistent with the goal of promoting this useful art.
2) When I first read the case, I thought that I would have come down differently than the CAFC on the scope of enablement question here. The longer than I reflect on it, however, the more I see that Judge Lourie’s opinion gets it right. It is possible for a drug company to test a meaningful variety of species within a chemical genus, so if they fail to do so, it is on them. Anyone who has participated in a phase III trial, however, knows how hard it is to recruit patients. If you made it a requirement to test every possible sub-population of patients before drafting your method of treatment claim, you would be back in that chicken-or-egg problem mentioned in #1 above. This opinion serves the goal of promoting the useful arts better than a more woodenly literal Amgen holding would have.
3) I was struck that the district court found that “claims 1–3 of U.S. Patent 9,593,066 (“the ’066 patent”) are invalid as anticipated, but are otherwise infringed… .” I do not know that I have ever seen a court find claims to be invalid but still infringed. Has anyone else seen that before? I think that this is the right way to think about it (although obviously the Court in Commil USA v. Cisco Sys., 575 U.S. 632, 644 (2015) disagreed when it wrote that “an invalid patent cannot be infringed…”), but one does not see this perspective often expressed in a judicial opinion.
Nice to see how Greg (who asserts that he cannot he see my posts) has picked up an article (other”w”ise) that focuses on Zeihan.
Of course, his musings on the patent side are entirely self-serving to the Big Pharma mode.
While a patent may only be living or dead legally, it does seem that anticipation is a special kind of death compared to obviousness, ineligibility, or lack of enablement/description.
In the latter, the claims were imperfect and thus could never be infringed, even if they were out of the public domain, while with anticipation, the claims may be perfected but for the fact that someone else got there first, putting them in the public domain.
It may not be quite logical, but it seems possible to infringe an anticipated claim…
Two thoughts.
First, a claim that is invalid cannot be infringed. Yes, of course.
Second, a District Court is only human and can get wrong its holding that the claim is invalid (even while it gets right its hoding that the accused embodiment falls within the scope of the claim, correctly construed. So for the court to say “Invalid but otherwise infringed” merely recognises the reality that its decision on validity might get reversed on appeal.
I am amazed that this has not always been the right way for a DC to write its decision. It is a bit like an English court writing “But in case I’m wrong on this validity issue I will go on anyway to consider the infringement issue”.
Thanks, Max, for your thoughtful reply. I certainly agree with you that it is a good thing for a district court to decide both infringement and validity, so that there will not be a need for remand if the invalidity is overturned on appeal.
Even more fundamentally, however, I think that it is conceptually better to treat infringement and validity as totally separate issues—the way that the Germans do. By analogy, if the Canadian ambassador unprovokedly stabs me in broad daylight at a Dodgers’ game, should the police list “natural causes” on my death certificate? No, they should write “murder.”
It is true that it is a murder that can never be prosecuted, but the murder did happen. In the same way, if a claim is infringed, then it is infringed. It is possible that this infringed claim is unenforceable, but that really should not affect the infringement analysis—just the liability.
Over-politeness masks (not to mention another hidden Yglesias Kool-aid imbibing) the issue that US courts may not give advisory opinions, and if the matter is found invalid, the court may well not be at liberty to afford a conjecture that IF the claims were instead actually valid, THEN infringement would be determined.
There seems to be a general trend away from the Foundational view that the US government was meant to be of limited powers, and if a first issue settles the matter, then wading into additional matters is to be avoided.
Greg’s article’s author literally thinks the japanese do not want to take over china and that fiat money is not necessary for bubbles. Lelz.
“I predict, we will not find our world shattered into a pastiche of isolated regional economies, separated by oceans full of pirates and marauding neocolonialist empires.”
But imagine how fun it would be if we did bros! Though yes, the pax Americana will likely prevail against the pirates and would be neocolonialist empires. Sadly.
“But there’s the possibility that U.S. hegemony could simply be replaced by a hegemony guaranteed by a coalition of states — the U.S. plus India, Europe, Japan, South Korea, the UK, and so on.”
Dude doesn’t know what hegemony means. Lelz. And he unironically thinks that india is going to dominate anyone or anything in the next little while lol.
“China, the only state capable of overthrowing U.S. power by force ”
Talk about a WHOPPER! The ccp overthrow US power by force? They can’t even take over Taiwan, 15 miles (in some places less) from their own shores! ROFL.
“For example, he places a lot of emphasis on the preeminence of U.S. naval power. But naval power can change very quickly. China has been engaged in a massive buildup in recent years. Its navy overtook the U.S.’ in terms of number of ships almost a decade ago. ”
What a ta rd, “muh ships n sheet”, the US navy dominates the world not because of merely its number of ships, but because of A. it’s global network of bases and logistics (absolutely rofl dominant there) as well as alliances and agreements backing them, and B. it’s type of ships and how it operates them (more carriers than the rest of the world combined, subs etc. etc. all operated correctly instead of like tar ds), and a few other odds and ends.
“China’s navy is certainly already powerful enough to crush international piracy, which Zeihan predicts will be a major force in disrupting international trade after America’s withdrawal. ”
Not even close to correct. They require basing agreements/bases all around the world like the US has to do that. And they can’t get them, and haven’t even tried to get them for the most part (got their first one a few years back iirc). Again, it’s not just the ships, it’s where and how they’re operated.
“but China’s navy is now almost certainly even more powerful than Japan’s, and the gap grows every day.”
Dude literally thinks china’s navy is “out on patrol” far from china. In reality, it isn’t.
Anyway, he’s probably right about the book tho. No collapse 🙁
Meh, this boils down to “I don’t like what Zeihan says so I’m going to ignore it and give my own uninformed opinion” from the likes of Yglesias.
That alone is just not that noteworthy.
What’s noteworthy for the context here of THIS blog is just how insipid Greg is in his over-imbibing of the Kool Aid of such Sprint Left narrative drafters as the likes of Yglesias and Drum.
Greg has zero ability or inclination to do any of his own legwork in understanding most of anything.
Greg’s article’s author literally thinks… that fiat money is not necessary for bubbles.
Right. He thinks that because it is true. There is no more compelling evidence for the proposition that “X is possible” than to observe X happening.
The Dutch tulip mania occurred in a world without fiat currency. All of those Dutch tulip contracts were denominated in guilders (i.e., silver coins). There is no possible currency less “fiat” than silver coins.
Evidently, then, it is possible to have bubbles without fiat currency. The fact that it happened means that it is verifiably possible.
Why would anyone think that “fiat currency” is necessary for a bubble? That makes no sense.
“Yes I do know you can’t have bubbles without fiat”
link to youtube.com
Wtf?
DC: “ It will be interesting though to see how this precedent sits along side the recent focus on “full scope” disclosure.”
Care to make a prediction? I predict that this decision will end up in the dustbin at least in those circumstances where the species that are not enabled were known in the art at the time of filing and/or where the defendant is practicing the non-enabled species.
“the specification does not need to address every possible disease subtype or non-responsive patient population to satisfy 35 USC 112”
This is just a context-specific restatement of the settled law that enablement doesn’t require perfection across the scope of the claims. A claim to improved peanut butter can be fully enabled in spite of the fact that some people are deadly allergic to it.
“just a context-specific restatement of the settled law that enablement doesn’t require perfection across the scope of the claims”
That “settled law” is not so settled anymore given the new “full scope” requirement, now is it?
Did that new “full scope” address this type of non-full scope?
(Asking for a friend)
The new “full scope” requirement is also not a requirement for perfection. See my original comment for an example of nuance (that isn’t even very nuanced). Read it carefully. Take a few deep breaths. Then get a life.
You did not answer my questions.
Maybe you should delete that ‘take a deep breath’ thing.
> in those circumstances where the species that are not enabled were known in the art at the time of filing
Are you endorsing the “new use of a known…composition of matter” claims (vs. new “use of a know…manufacture” claims)?
I don’t follow your question but even more confusing is how the question relates to the quote or anything else I wrote …?
And, in the face of the odd continuing aversion:
Before Lourie, Dyk, and Stoll (Lourie)
As to:
“therapeutically effective single event dose …
that “therapeutically effective” had been particularly defined in the specification is improving hemodynamic values and the preamble language of treating PH “does not import any additional efficacy limitations or any safety limitations.” Again, the court washed its hands of any safety or efficacy concerns: “Questions of safety and efficacy in patent law have long fallen under the purview of the FDA. . . We decline to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations.”
First, since this item requires FDA approval to HAVE utility, the dodge by the court is — itself — inapt.
Second, the same sense of utility is a requirement and IS in the claim and is NOT “additional.”
The creep of 1984 continues… piling nonsense on nonsense.
Let’s not go too far. If a drug is delisted by the FDA, do all of its patents instantaneously become invalid? If it is relisted, do they magically now qualify as patentable? If a drug is available in one country, but banned in another, is it simultaneously efficacious and non-efficacious (visions of Schroedinger’s cat…). The FDA is political, and it seems “problematic” to apply standards that may have nothing to do with merit to the enablement issue.
I’d be willing to bet that the FDA’s errors lean almost entirely on the side of approving drugs that have not been shown effective–and in fact are not effective. This is a real problem for cancer drugs approved on the basis of surrogate endpoints. And that’s to say nothing of the well-acknowledged fact that even gold-standard RCTs have inherent biases toward showing an effect from treatment.
All that is to say, we should think of the FDA’s efficacy criterion as the floor, not the ceiling, of showing pharmaceutical utility.
Most common reason for FDA to remove a drug’s approval is safety, not efficacy.
The point of my comment was that showing efficacy (AKA pharmaceutical utility) to the FDA is not an overwhelmingly high burden, as some people in the patent world seem to think. In fact, as I allude to above, that burden should probably be more rigorous than it is.
My comment was in response to anon. I agree with you. If most people truly understood that the FDA routinely approves drugs that have statistical efficacy of no more than 30%, the would be hearings on the Hill!!
And yet, xtian, you are well aware that my running ‘beef’ with Pharma patents is that the claims as written reflect utility NOT possessed at the time of filing as reflected with the huge numbers of items that
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FDA process.
This emphasis then of, ‘gee, even a large portion that are deemed to pass really do not meet their claims” only emphasizes (and not detracts from) my position.
Were you intending to bolster my view?
I m well aware of your beef with pharma arts…However, if one patient was treated successfully, does that not support the claim? Why would I have to prove it works for all humans?
Is there an analogy with a different art? chemical arts? Why is pharma held to a different standard of utility?
Does the claim explicitly spell out that one human that it actually does have utility for?
Yeah, thought not.
“Is there an analogy with a different art? chemical arts? Why is pharma held to a different standard of utility?”
That’s MY point: your view allows Pharma to be held to a different standard of utility.
Not to put Greg’s words in your mouth, but above he ALSO attempts to have that different standard (because, gee, it costs too much to actually possess what is required to be possessed at the time of filing and all
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Don’t confuse “utility” under 101 with enablement under 112 and/or “pharmaceutical utility” per the FDA. Vastly different standards for each.
Please Malcolm…
“Pharmaceutical utility…”
Sorry but no – patent law has but one utility.
… although I should note here the opposite of Malcolm’s typical “whatever” in his NOT conflating 101 and 112.
(it’s such a grown-up thing to do)
If either safety or efficacy is not there, then the claimed utility is also not there.
Claim 1. A method of treating pulmonary hypertension comprising administering by inhalation to a human suffering from pulmonary hypertension a therapeutically effective single event dose of a formulation comprising treprostinil or a pharmaceutically acceptable salt thereof with an inhalation device, wherein the therapeutically effective single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths.
First – nowhere is it claimed the drug is “safe” according to FDA standards. The drug is a method to treat hypertension. Treatment is not defined as acceptable according to FDA standards. I submit that utility for treatment is found when one patient gets better, regardless of how may other patients did not.
On safety – If the drug causes someone’s gums to bleeds but alleviates the hypertension, the FDA may pull the drug off the market for safety reasons. However that has nothing to do with how efficacious the drug is. There are no claim limitations that require it to be “safe.”
Oncology drugs are some of the most harmful drugs. they are designed to kill cells – the antithesis of safety. Yet, oncology drugs are approved and patented.
Your submission does not fly.
You seem to not to want to reflect that a Person Having Ordinary Skill In The Art brings along the necessary implied facts as to both safety and efficacy in the claim term of, “a therapeutically effective.”
If one wants that claim term to ONLY apply to a subset, then they are free to provide a more limiting claim.
As to, “Oncology drugs are some of the most harmful drugs. they are designed to kill cells – the antithesis of safety.” – no – you do not get to treat “kill” so haphazardly, as in the instance of oncology, that self-same “In The Art does the distinguishing.
From the FDA’s wesbite that I cannot link…
““Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a particular use outweigh the potential risks”
… and this advances which point exactly?
Person Having Ordinary Skill In The Art brings along the necessary implied facts as to both safety and efficacy in the claim term of, “a therapeutically effective.
The fact that the FDA uses a subjective balancing test is not consistent with your statement above that safety and efficacy is inherent in the knowledge of a PHOSITA.
Your assertion has no backing.
FDA is merely setting the required standard – and one that EVERY Person Having Ordinary Skill In The Art would all equally have to meet.
Your use of “subjective” is simply misleading.
What happens when a Dr. prescribes a drug off label to treat a new disease in a patient? Would that not be sufficient evidence for utility?
All the more evidence that the FDA approval process has no place in patentability consideration.
But, what about the problem of fraudulent/erroneous “scientific” publications. Its time to get rid of In re Antor, and require vetting of “references” before they are considered prima facie evidence. While not every reference is suspect, the presumption of operability is a “big lie”, every bit as bad as the other one(s).
While it might be true that the USPTO does not have the resources to verify the references it cites, neither do applicants. The burden of rejection is on the USPTO, and with GPT now feeding the monster, we must impose filters to prevent “hallucinations” from becoming truth.
+1
Depends on the facts, but normally they don’t prescribe off-label unless the indication is very similar to one for which the drug has already been approved, or a very similar drug has already been approved for the off-label indication, etc. It inherently rests on efficacy studies.
I am skeptical that we can speak meaningfully about what “normally” happens in instances of off-label prescriptions. I do not know that we have any reliable way of measuring what is “normal” and what is “abnormal” in such circumstances.
John Maynard Keynes…
The irony that I have quoted him to Greg (about Greg’s “sensitivities”)
In a theoretical sense, FDA approval is not required for practical utility. Merely treating patients in a clinical trial is actual utility, whether the drug can be marketed or not.
Also, must the FDA be the US FDA?
I would disagree.
The terms of art for a Person Having Ordinary Skill In The Art do NOT reflect your notion of ‘practical utility.’
THIS is the beef with the requirement to possess utility AT THE TIME OF FILING when so many items with filings
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FDA trials.