Federal Circuit Says Amgen’s Repatha® Patent Claims Require ‘Undue Experimentation’ to Practice

By Eileen McDermott
February 13, 2021

“What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.” – CAFC

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation. Judge Lourie authored the opinion.  Amgen v. Sanofi (CAFC, Feb. 11, 2020)

This is the second time Amgen’s U.S. Patents No. 8,829,165 (the “’165 patent”) and No. 8,859,741 (the “’741 patent”) have been on appeal to the CAFC. The patents describe antibodies that work to lower low-density lipoprotein (LDL) cholesterol levels. The CAFC explained:

The ’165 and ’741 patents share a common written description and the specification discloses amino acid sequences for twenty-six antibodies, including the antibody (designated as “21B12”) with the generic name of evolocumab, marketed by Amgen as Repatha®…. The claimed antibodies are defined by their function: binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction.

In the 2017 appeal, a jury determined that the patents were not invalid for lack of enablement and written description and Sanofi appealed. The CAFC found that the district court had erred in its evidentiary rulings and jury instructions and remanded for a new trial. On remand, the district court eventually granted JMOL for lack of enablement, and Amgen file the present appeal.

The Wands Factors

Amgen specifically asked the CAFC to reverse the district court’s decision holding ’165 patent claims 19 and 29 and ’741 patent claim 7 invalid for lack of enablement, arguing that the court’s analysis of the “Wands factors” was improper. In In re Wands the Federal Circuit said that “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” The factual considerations that have come to be known as the Wands factors are:

(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and
(8) the breadth of the claims.

These factors are applied once it has been shown that some experimentation is necessary to practice the patented claim in order to determine “whether the amount of that experimentation is either ‘undue’ or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out.”

Amgen argued that “no undue experimentation is required to obtain antibodies fully within the scope of the claims” and pointed to expert testimony showing that “a person of skill in the art can make all antibodies within the scope of the claims by following a roadmap using anchor antibodies and well-known screening techniques as described in the specification or by making conservative amino acid substitutions in the twenty-six examples.” The court further summarized Amgen’s argument:

Amgen argues that the court erred by focusing on the effort required to discover and make every embodiment of the claims…while failing to recognize that Sanofi could not identify any antibody that cannot be made by following the specification’s teachings…. Amgen contends that the embodiments in the patent are structurally representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure/function correlation establishing enablement.

But Sanfoi said that “there are millions of antibody candidates within the scope of the claims, the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the claims requires substantial trial and error,” explained the CAFC.

The Facts Control

In its discussion of the Wands case, in which the claims at issue were found to be fully enabled by the specification, the CAFC explained that, while it has become the “go-to” case for guidance on enablement and also involved antibody claims, it “did not proclaim that all broad claims to antibodies are necessarily enabled. Facts control and, in this court, so does the standard of review.” Instead, the CAFC agreed with the district court that Amgen’s claims were more analogous to the facts of cases like Wyeth & Cordis Corp. v. Abbott Laboratories; Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.; and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., in which the CAFC found the claims at issue invalid for lack of enablement. The opinion added:

What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short. In particular, it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.

Ultimately, said the court, the claims at issue are composition claims “defined, not by structure, but by meeting functional limitations” and the specification failed to enable the claims without undue experimentation. Furthermore, the invention “is in an unpredictable field of science with respect to satisfying the full scope of the functional limitations,” and lastly, as the opinion previously described, Amgen’s contention that affirming the district court would overrule Wands is incorrect, as “Wands was based on the facts of that case and the evidence presented there.”

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The Author

Eileen McDermott

Eileen McDermott is the Editor-in-Chief of IPWatchdog.com. Eileen is a veteran IP and legal journalist, and no stranger to the intellectual property world, having held editorial and managerial positions at several publications and industry organizations. She has acted as editorial consultant for the International Trademark Association (INTA), chiefly overseeing the editorial process for the Association’s twice-monthly newsletter, the INTA Bulletin. Eileen has also served as a freelance editor for the World Intellectual Property Organization (WIPO); as senior consulting editor for the Intellectual Property Owners Association (IPO) from 2015 to 2017; as Managing Editor and Editor-in-Chief at INTA from 2013 to 2016; and was Americas Editor for Managing Intellectual Property magazine from 2007 to 2013.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 46 Comments comments. Join the discussion.

  1. Anon February 13, 2021 7:24 pm

    … to tie this into another article, would the outcome change if AI were to be involved (thereby not only possibly reversing what would be considered ‘undue’ – but perhaps going “full circle” and placing this back in the invalid zone, but for the different reason of being obvious?)

  2. Model 101 February 14, 2021 8:45 am

    The jury said valid…the CAFC said invalid…cmon!

    More functional claim mumbo jumbo.

    More crook stuff!

  3. Pro Say February 14, 2021 10:42 am

    “Facts control . . .”

    Sure they do.

    Whenever it suits our ultimate ends. See, e.g. our eligibility jurisIMprudence.

  4. BP February 14, 2021 2:21 pm

    The first case, Amgen, Inc. v. Sanofi, 872 F.3d 1367 (Fed Cir 2017) appeared fine – until the USPTO got a hold of it and twisted it into a memo that has been misapplied by examiners to reject any claim reciting an antibody. The first case addressed what was required under “written description” for functional claiming an antibody by reciting what it binds to (antigen).

    The current case now reiterates that the Fed Cir simply doesn’t like broad antibody claims (you think it could have done this back in 2017 rather than piecemeal!).

    How will the USPTO use this second piecemeal decision to confound prosecution and waste applicants’ $$$ to the benefit of infringers?

    Like the 35 USC 101 mess, the lack of clarity for claiming antibodies as to 35 USC 112 has also sent many applications haplessly to the grave (i.e., written under one “standard” where the courts decided to promulgate another “standard”). Worse yet is the utter failure of the courts to consider development timelines/huge investments for such technology (and how applicant’s own prior art in an 18 month window can destroy value).

    Maybe the Fed Cir should also write the USPTO memo with strict instructions as to implementation during examination because, as shown time and time again, the USPTO is grossly incapable of writing or implementing a fair memo (think lifers like Hirshfeld that can’t even write a cogent petition decision). In the “gap” between Fed Cir and USPTO, the USPTO injects its own anti-patent bias, which is furthered by the anti-patent TC directors, SPEs and examiners to screw applicants.

    We see compounding corruption in a trickle down manner.

    SCt, Fed Cir and USPTO are all to blame in their gross dereliction of their constitutional duties. They care little for invention, innovation or RoI, which, in turn, delivers monopolies and infringers, i.e., criminals.

  5. B February 14, 2021 4:41 pm

    From the opinion: “Turning to the specific Wands factors, we agree with the district court that the scope of the claims is broad.
    While in and of itself this does not close the analysis, the district court properly considered that these claims were indisputably broad. The parties dispute the exact number of embodiments falling within the claims. However, we are not concerned simply with the number of embodiments but also with their functional breadth. Regardless of the exact number of embodiments, it is clear that the claims are far broader in functional . . . . Further, the use of broad functional claim limitations raises
    the bar for enablement, a bar that the district court found
    was not met.”

    I wonder why there’s no discussion of 112(f)?

    Isn’t 112(f) the go-to section when one wishes to interpret the scope of purely functional claim language?

    I may be wrong, but this opinion appears to be a total stinker

  6. BP February 14, 2021 6:30 pm

    @5 “a total stinker” yes and a delayed one too (to inflict as much damage to pending applications and issued patents as possible).

    The Fed Cir gleefully sends more patent applications to the graveyard while giving infringers ammunition to confound and increase the expense of litigation for patentees.

    Another tick toward midnight on the patent doomsday clock.

    One standard for the “unpredictable” arts (i.e., picture claim at best, after years of costly research, clinical studies where some live and some die, etc.) and another standard for the “predictable” arts (i.e., those that are obvious and conventional, unworthy of patent protection).

    The Fed Cir is steering patents down the road to monopoly rule and efficient infringement because, in the eyes of ignorants, either the technology/industry is too complex and they can’t understand it (bye-bye under 112) or they “think” they understand it as being obvious and conventional (bye-bye under 103 and/or 101, they’re the same thing, right?).

  7. Anon February 15, 2021 7:46 am

    B @5,

    One reason you do not see that is because the courts are too busy attempting to rewrite the law in the area that you point out.

    Consider: there are worlds of difference between a PURELY functional claim, an exacting picture claim, and the vast and wide world between.

    35 USC 112(f) was provided as a helpful OPTION to applicants to engage in the choice of a PURELY functional claim.

    Claims that are not purely functional, but instead, may adapt some wording that includes the sounding of functionality, NEED NOT be deemed to fail 35 USC 112(a) or (b), nor do they NEED to invoke 35 USC 112(f) to survive.

    The “problem” is NOT as the courts desire to paint things: that applicants are somehow ‘being shady’ and using words that happen to have aspects of functionality.

    The “problem” is that the world itself is now well into the Kondratiev Fifth Wave of innovation, and it is innovation itself that inhabits the spheres of being implemented in software, and as it happens, such is best described by words having aspects of functionality.

    What you are actually seeing are the reflected of the anti-patent Supreme Court who simply do not like patents, and do not like (especially) patents for software and business methods.

    Once that critical point is put front and center, a lot of the noise — across most all areas of innovation (to which the Fifth Wave has washed over) — can be properly identified and dealt with.

  8. TFCFM February 15, 2021 10:48 am

    BP@#4: “Like the 35 USC 101 mess, the lack of clarity for claiming antibodies as to 35 USC 112 has also sent many applications haplessly to the grave (i.e., written under one “standard” where the courts decided to promulgate another “standard”).

    Maybe, but not for applications written by anyone with a shred of sense in the last couple of decades. Already in Regents U. Ca. v Lilly (1997), the handwriting was on the wall: claiming a generic type of molecule and a function is not permissible.

    Even though the USPTO kept allowing “any-and-every antibody that binds with X” (later “any-and-every antibody that binds with X with an affinity of at least Y” and still later “any-and-every antibody that binds with X with an affinity of at least Y and exhibits functionality Z” ) for a while, no one (again, with any sense) believed that these claims would hold up under $-backed legal scrutiny (that is challenge by a party which cares enough to pursue an appeal).

    For well over a decade, and probably for more than two, sensible biotech practitioners attempting to recite or claim a molecule focus on describing WHAT THE MOLECULE IS, rather than merely what it does. If you can’t tell the reader of your patent or application what the molecule is, you haven’t described it. As you note, when the description of the molecule is 1990’s-generic, such claims can sometimes be disposed of as “abstract,” too — but most practitioners have wised up too much to even try such nonsense any more.

  9. Pro Say February 15, 2021 10:50 am

    Anon, BP, and B: Big +1s

    On this President’s Day, what would our distinguished past leaders have to say about what SCOTUS and the CAFC have done to American innovation?

    What would they say about a Congress that refuses to take back the Constitutional reins to restore American innovation?

    What would they say?

  10. Frank Coppa February 15, 2021 12:14 pm

    Nicely-done summary, Eileen

  11. Anon February 15, 2021 1:02 pm

    TFCFM’s lament reminds me — we have an ethical duty to rigorously pursue our client’s rights (even pushing back against anti-patent encroachment of the type that TFCFM sees as ‘writing on the wall).

    The easy route of ‘maximum’ picture claiming is simply not — under any view — rigorous protection of our client’s interests.

    Another indicator that TFCFM is not a registered patent attorney, leastwise one who prosecutes patents and obtains rights for clients.

    At ‘best’ (and I use that term loosely), he is a litigator that may (once upon a time) obtained registration with the patent office.

    Those who seek protection simply do not carry the attitude that TFCFM consistently displays.

  12. BP February 15, 2021 2:41 pm

    @8 & @11, TFCFM seems to read it wrong. Why? Not sure.

    And please, decorum to other posters: “anyone with a shred of sense”???

    As stated, part of the problem is the trickle down, when the USPTO issues a memo (as it did for the 2017 case) and the examiners ensnare applications as to antibodies that do claim structure (TFCFM seems to have missed this point).

    And, TFCFM, it seems like you may not be aware of the reason why the term “unpredictable” arts exists, or its impact on actual research (and where research is performed, state interests and how that may impact inventorship/ownership along with possible incentives for some to disclose).

    Maybe you have worked on antibody technologies where trial results span 5 years or more and involve patients that are “mobile” and may move from hospital to hospital, doctor to doctor?

    I would welcome TFCFM’s strategy for something other than a picture claim that will be published and stand as prior art against what may possibly be more broadly claimed at year 5 of a trial?

    Do you file with a broad description and claim narrowly (picture claim) and hope you have enough trial data to support the claim? And then try to introduce post-filing evidence years later for enablement of claims in a broader continuation application (hoping structure exists in the original filing)?

    I’m not trying to be snappy to TFCFM, just trying to unpack the comment and understand your “shred of sense”.

    And the main gripe was – how the USPTO uses the memos to ensnare claims written “with a shred of sense” that do recite sufficient structure.

  13. Model 101 February 15, 2021 9:14 pm

    Pro say,@9

    Answer…tar and feather them all and then to the gallows with’em

  14. B February 16, 2021 10:02 am

    @ Anon “One reason you do not see that is because the courts are too busy attempting to rewrite the law in the area that you point out.”

    I just find it amazing that, after Taranto wrote out 112(f) in Investpic v. SAP America, the rest of the delinquents on Madison Place are still reading 112(f) out of the Patent Law.

    So far as I know I’m the only one who has raised the issue b/f the courts

    https://www.supremecourt.gov/DocketPDF/18/18-1199/96395/20190415015752247_Investpic_Amicus_filing.pdf

  15. B February 16, 2021 10:36 am

    @ Pro Say “On this President’s Day, what would our distinguished past leaders have to say about what SCOTUS and the CAFC have done to American innovation?”

    A full half of these “leaders” are just pro-government tools who believe that government in any form can do no wrong. Further, when you get 9-0 opinions from the SCOTUS on an issue, one can’t even blame the political appointees of the party you don’t like.

  16. TFCFM February 16, 2021 10:39 am

    BP@#12: “I would welcome TFCFM’s strategy for something other than a picture claim that will be published and stand as prior art against what may possibly be more broadly claimed at year 5 of a trial? Do you file with a broad description and claim narrowly (picture claim) and hope you have enough trial data to support the claim? And then try to introduce post-filing evidence years later for enablement of claims in a broader continuation application (hoping structure exists in the original filing)?

    As an initial matter, one thing is clear: What one does NOT do is disclose narrowly and claim broadly at element boundaries that specify what is novel and non-obvious about a claimed invention (“…anything and everything that performs the same function as the inventive part of my technology.”) That is a downright invitation for an invalidity/non-patentability finding grounded on insufficiency-of-disclosure and/or claiming-abstract-subject-matter. This fundamental principle applies to all technologies, whether it’s antibodies, computer software, chemicals, manufacturing methods, or electrical circuits.

    (Not so when the identity of the element is not critical to a claimed invention. Where an antibody, for example, is not central to the invention — such as when it simply associates a tag with a target — looser description and broader claiming are both permissible and appropriate. After all, when it genuinely doesn’t matter which of a near-infinite number of potential-antibody tags your target, the description can be equally loose. That is not the case in this dispute.)

    When, as here, you have invented an antibody (or, as with Amgen, 26 different antibodies) which have a particular function, that function being critically dependent on structure, what you want to claim is the antibody-with-that-function. So which of the near-infinite-number of antibodies and antibody-like-molecules are the ones that have that function? If that is the class you wish to claim, that is the class that you have to describe. So how to do so?

    1. You have one (or 26) examples that you can “picture claim.” Your mind is not as limited as some commenters’, however, and you’re willing to think, so you want to claim more broadly.

    2. Assume there are some significant number of non-disclosed molecules (in addition to the one or 26 that you’ve disclosed) that will exhibit the function you want to claim. Which are they? Obviously, there’s no existing list (either in the art or in your head) or else you wouldn’t have bothered inventing any.

    3. For most antibody-like-molecules, the relevant function will be intimately tied with the “binding site” (using simplified term so that non-biotechs can follow us), so you know that
    a) this part is going to be important to claim pretty specifically and
    b) other parts of your molecule can be described less-stringently (but don’t just punt and claim “anything-and-everything” on these parts, either).

    4. Turning to the “non-binding-site” parts of your molecule, you may have some significant leeway here (depending on your technology), but a least think what these parts CANNOT be and describe/exclude-from-your-claim at least those impermissible aspects. (Your binding site covalently linked to the tail of an African elephant is going to preclude most injectable uses, for example, but may be fine if your molecule simply needs to be fixed to a support; if the latter, give at least some descriptional attention to what the relevant characteristics of the support are.) This part of the molecule appears to be of minimal relevance in this dispute.

    5. Turning to the “binding” end of your antibody-like-molecule, remember what your specification has to do: teach a skilled artisan what the class of molecules that you want to claim are (“written description” of the molecules in the class and of the metes-and-bounds of the class) and how to make and use those molecules. Let’s assume away “how to make and use” and presume that you’ve described that sufficiently in your spec. (Let’s also ignore best mode.) How to describe the class and the molecules in it?

    6. If you’ve disclosed only a single molecule and its binding site, you’re likely out of luck. As you well know if you’re writing antibody-type applications, antibodies with very different binding sites can bind at or near the same “target site” (again, being loose for the point of readability), and can do so with the same affinity or with a higher or lower affinity. Also, seemingly minor changes in a binding site can dramatically affect function.

    There may be some very limited variations in your single binding site structure that can be predicted to not-destroy operability. As with any other claimed feature, if you can demonstrate that a skilled artisan can readily determine those variations, you should be able to claim them (but expect to have to convince the examiner to the extent you vary from your disclosed binding site structure). Rather than hoping the art supports you, consider “building in” to your specification the art-based disclosures and arguments that you would use to support claim scope broader than exactly-the-binding-site-you-disclosed.

    This is, of course, a fairly limited scope — but this is only fair because your disclosure (one binding site “plus prior art-predictable variations”) is fairly limited.

    7. If you disclose multiple operable (i.e., “your-disclosed-function”) antibody-like molecules:
    a) you can do #6 for each, obviously; and
    b) to the extent that your multiple examples reliably predict operability for non-disclosed embodiments, you should be able to claim those not-disclosed-but-predictably-operable embodiments as well.

    (For simple-example, if you disclose four operable embodiments that are identical, but for the chemical group at one binding site location, and the groups at that location in your four examples are -hydrogen, -methyl, -propyl, and -butyl, it will usually be predictable that an -ethyl group at that location will be operable too, even though you haven’t disclosed it.)

    Such “predictive” disclosures of operable molecules will likely be data-intensive and difficult to make. That, however, is simply a consequence of disclosing only discrete molecules and limited current capacity to predict other operable molecules from them. FWIW, anyone who wanted to evade your patent claims by predicting other operable molecules from the discrete examples you have disclosed would face the same difficulties, which is why this is an eminently fair limitation on the scope of your claims. If you haven’t disclosed such “other operable molecules” well enough to put others in possession of them, you shouldn’t be able to claim them.

    Recognize that even when it is possible to “connect the dots” between disclosed molecules to include non-disclosed alternatives, your dots will likely never be so numerous as to predictably encompass all possible operable molecules (because there may be some unlike any operable molecule you’ve disclosed). Thus, “any and every operable molecule” claims are, and should be, vanishingly rare.

    In short, you can claim what you can disclose, including both molecules-actually-disclosed and reliably-predictably-operable-molecules-that-are-not-explicitly-disclosed. “Description” of this latter class of molecules, however, requires more than expression of a wish-that-you-knew-what-they-are.

    (Note: Obviously, any given antibody-like-technology is going to have its peculiarities, and I haven’t tried to address each of these here for the sake of readability.)

  17. B February 16, 2021 10:48 am

    @ TFCFM ” If you can’t tell the reader of your patent or application what the molecule is, you haven’t described it.”

    I’d love to say you’re wrong, and in 2008 I could have rightly mocked you. There was a time when scientific theory wasn’t around to describe what was being patented. Thus, for over 100 years product-by-process claims were used. You should read Judge Newman’s quasi-treatise on product-by-process claims. See, e.g., Abbott Labs. v. Sandoz, Inc (CAFC 2009)

  18. BP February 16, 2021 12:16 pm

    TFCFM @16, thank you for taking the time. I think fitting the ideal into the real timeframes/timelines is a tricky part, especially where lab/clinical data (and/or molecule making) may be coming from a state university (e.g., research/teaching hospital, etc.) and where trials may take many years. Enablement for “unpredictable” arts may raise some questions as to inventorship. I think back to the laser, where I know someone that was incredibly skilled (a true genius) that sped development tremendously (maybe by a couple of years) – undoubtedly a problem solver. At some point, for the “unpredictable” arts, arguments may possibly be made that the person or people that “enabled” may be an inventor or inventors and, as we know, working with universities, especially state universities in states with laws pertaining to ownership of IP by the state, can complicate matters. How to fit the ideal as to the spec for 112/103 into the real timeframes/timelines while preserving/optimizing the client’s rights?

  19. Anon February 16, 2021 3:07 pm

    B,

    Thank you for your link. Love the Giles Rich references.

  20. Anon February 16, 2021 4:13 pm

    BP,

    Did you want to throw in there one of my Pharma bug-a-boos?

    Possession of the claimed utility at the time of filing.

    (consider, for example, just how many items wash out of that “does this actually work” phase — on items long submitted to the patent office)

    The phrase “you don’t get a patent for a research plan” comes to mind…

    (No matter how exacting a picture claim, you – the Royal You – don’t possess something at the time of filing if it takes years of actual testing to prove out the utility of the claims)

    Is this not every bit a problem as the topic under discussion?

  21. TFCFM February 17, 2021 12:09 pm

    BP@#18: “How to fit the ideal as to the spec for 112/103 into the real timeframes/timelines while preserving/optimizing the client’s rights?

    IMO, we’re not so far off from the “optimal” for real time frames now. In this dispute, the patentee disclosed, apparently, 26 antibodies that “work.” The accused infringer invented another one that, again apparently, was not very similar to the 26 disclosed by the patentee. There appears to be no credible argument that a skilled artisan in this field could have taken the 26 antibodies disclosed by the patentee, applied whatever predictive-type methods are available for predicting additional operative antibodies, and come up with the accused infringer’s antibody. It therefore seems eminently fair that the patentee’s patent should not include within its scope the accused infringer’s antibody, given that the patent neither discloses it or teaches a skilled artisan enough to make it.

    By analogy, if I were the first to invent a mousetrap that has a spring element operably linked to a trigger and to a bopping-element that bops the mouse when the trigger is triggered, my contraption should be patentable to me (assuming all criteria satisfied), but should not extend to every mousetrap that has a very different spring element operably linked in a very different manner to a very different trigger and likewise operably linked in another very different manner to an very different type of mouse-bopping element. I have neither invented nor disclosed every possible type of spring/trigger/bopper mousetrap that can be made, and my patent for the first one should appropriately be limited to what I disclosed and “some-sort-of-fair” equivalents of what I disclosed. Rube Goldberg and his mousetraps ought not to require my permission merely because their multitudinous pieces may include each of a spring, a trigger, and a bopper in very different configurations.

    IMO, the mess that has developed around patenting antibodies stems from the fact that antibodies are conceptually simple (“they’re just molecules that stick to specific things”), but are in actuality extremely diverse. Think “mousetrap” and consider how many mousetrap patents exist, despite the fact that they all seem to fall into a small number of categories (traps that kill, poison, or capture the mouse).

  22. Anon February 17, 2021 2:47 pm

    TFCFM, how detailed must one ‘get’ to avoid the very “very different” [fill in the claim element here]?

    You seem to be completely unaware of the very basic claim drafting notion known as Ladders of Abstraction.

    It’s as if – for you – the only ‘invention’ one has EVER ‘actually invented’ would be that SINGULAR exacting picture claim.

    In your last post, would you then ‘demand’ 26 different claims to the 26 different structures that (apparently) have no way of having an over-arching (one step up the Ladder) manner of description?

    Do you realize that MOST ALL other fields of innovation operate very differently than your particular mindset (and have, well, like forever)?

  23. Xtian February 18, 2021 9:06 am

    Anon @20. I would love to discuss letting pharma wait until clinical trial results were in hand to file the patent application!! Imagine only filing your composition of matter patent when phase three results were in hand!! The result would be that composition of matter patents would provide exclusivity for almost the entire time the pharmaceutical product was on the market. (typically composition of matter patent term is about 12 years from launch of a pharmaceutical product).

    However, FDA requires publication of all clinical trials, which include details such as the active ingredient, route of administration, diseased patient population, dosing regime, etc. so pharma is forced to disclose the invention prior to “seeing if it works” as you say. If you eliminate the publication requirement and keep clinical trials secret, I am all on board!!!

  24. TFCFM February 18, 2021 9:46 am

    Anon@#22: “how detailed must one ‘get’ to avoid the very “very different” [fill in the claim element here]?

    You seem to be completely unaware of the very basic claim drafting notion known as Ladders of Abstraction.“.

    Whether considered for obviousness or sufficiency-of-disclosure purposes, the question of “how close is close enough?” (or “how close is TOO close?”) is an eminently fact- and technology-specific question. Nonetheless, in this dispute it seems clear (in fact, undisputed) that the 26 embodiments disclosed by the patentee did nothing whatsoever to teach a skilled artisan how to make the infringing embodiment. Those 26 disclosed antibodies may well have taught skilled artisans to make non-disclosed antibodies that were “close enough” (see above) to themselves. However, to the extent the accused embodiment was not one of those “close enough” versions (and it appears both undisputed and indisputable that it was not one of them), the patent ought not to cover that embodiment, meaning that the proper result occurred here.

    You have now several times in our conversations invoked “Ladders of Abstraction” as if it were some magical talisman that trumps the patent statute and over two centuries of US patent law jurisprudence. IF (big if) it is more than a mere slogan to disguise your lack-of-any-better-excuse, please explain why calling “Ladders of Abstraction” should relieve a patent applicant or patentee of the need to comply with our patent laws and jurisprudence.

  25. Anon February 18, 2021 10:04 am

    TFCFM,

    You have now several times in our conversations invoked “Ladders of Abstraction” as if it were some magical talisman that trumps the patent statute and over two centuries of US patent law jurisprudence

    Not so.

    At all.

    I have invoked the concept because it is a concept used by every active practitioner that I personally know, and one that you seem completely oblivious to.

    There is NO “trumps the patent stature and over two centuries of US patent law jurisprudence” in the plain fact of the existence and application of the principle.

    Quite to the contrary, the principle is evidence of the understanding of those very things — in the practical application of our craft. Your retort then is nothing but chicanery, as you ASSume your position and ask me to prove that such should be allowed. You ask proof for a position never taken, and which is not in accord with the principle — evidence that you do NOT understand the principle.

    It is statements like this from you that tarnish the image that you try to evoke. You are NOT a practitioner, active in obtaining patent protection for clients, are you?

  26. Anon February 18, 2021 10:13 am

    Xtian,

    You may need to be careful, as we are on the brink of having an actual conversation ( 😉 ).

    I DO hear what you are saying, and frankly, I am not impressed by the actual physical product needs of the pharma industry.

    In part, this is because patents are NOT any type of “positive right” thing that gives you the affirmative right to make a product and put that product into the marketplace.

    Thus, whether or not a product IS in the marketplace is an item entirely divorceable from patent protection.

    On top of that, whether or not another agency requires anything is just NOT the province of patent law. Leastwise, when it comes to the universal aspects (and believe me, I am a strong advocate for making nearly ALL aspects to be universal aspects, as I am extremely cognizant of the effects of “divide and conquer” when it comes to innovation protection law.

    Additionally, I do hear you on the “effective life” argument, but is there not already a number of “Pharma-specific” laws that help alleviate that effect?

    But returning to the immediate point: patents are NOT meant for study plans, and IF indeed Pharma is ONLY doing such (whether or not a different government element ‘forces’ filing prior to actual possession), THEN all such patents should be recognized as failing to meet one of the universal requirements for innovation protection. As it is, there is NO current such “excuse” for any area of innovation to get a pass on possession at time of filing. None.

  27. BP February 18, 2021 3:05 pm

    @21 TFCFM, thanks again, for smaller entities, the timeline/timeframe tends to be a bit more problematic I believe as to ownership, momentum, etc.

    As to “but are in actuality extremely diverse”, agreed. If you have a target that’s sterically hindered, overall structure can be determinative. Logically, a ping pong ball sized antibody is likely worthless yet may not be excluded under the old antibody-by-antigen claim style.

  28. xtian February 19, 2021 9:00 am

    @Anon26 I would agree that all aspects of patent law should be universal across technologies. I do think, however, your view of dismissing the external requirements of another agency is myopic. Pharma may be the only technology space where the development of a product is forced to be made public (i.e., forced publication by FDA). If pharma were allowed to keep that development secret, patent law could be universally applied.

    I’d also agree (because I think you raised the hatch-Waxman “benefit” to pharma in previous threads) that Hatch-Waxman scheme (FDA exclusivity and the technical act of infringement by a generic filing their ANDA) should be eliminated as well to keep us on par with the other technologies under patent law. I don’t think our society has an appetite for that!

  29. TFCFM February 19, 2021 9:20 am

    BP@#27: “the timeline/timeframe tends to be a bit more problematic I believe as to ownership, momentum, etc.

    I’m not sure that I fully understand what you mean by this. I’m guessing that you mean that it will (usually, at least) be extremely time-consuming and a lot of hard work to prepare a patent application that sufficiently describes a broad category of antibodies (especially including significant non-disclosed embodiments) that share a function, and that “smaller entities” will have a difficult time devoting the time and resources to doing so. I don’t disagree at all.

    However, I don’t think that this is an unfair outcome. In all technical fields, the “basic deal” is that a patent granted to an inventor is supposed to give the inventor a limited exclusive right to practice WHAT (S)HE HAS INVENTED in exchange for the inventor disclosing the information necessary to practice the claimed invention to the public. Where one has disclosed only a small scope of subject matter, there is nothing unfair about granting limited exclusive rights which have a correspondingly small scope.

    It is for this reason that I feel that when the identity/structure of an antibody is at the “crux of the invention” (everyone cringe, even though we all know what I’m talking about), the scope that the antibody-reciting patent claim should have depends critically upon the scope of antibodies that are sufficiently disclosed that the public can thereafter practice the invention throughout its claimed scope.

    Looked at another way, the maxim from Brenner v Manson also seems applicable: “A patent is not a hunting license…”

    “Smaller entities” may be practically less-able to produce encyclopedic, data-heavy specifications of the sort that will often be necessary to support broad antibody-centric claims. However broadly-teaching a tome they prepare should (and, under current law, must) determine how correspondingly-broad a patent grant they should receive.

  30. TFCFM February 19, 2021 9:24 am

    TFCFM@# 21: “You have now several times in our conversations invoked ‘Ladders of Abstraction’…

    Anon@#27: “I have invoked the concept because it is a concept used by every active practitioner that I personally know…

    Regardless, you over-estimate my mind-reading powers. I can think of several concepts to which the generic label “Ladders of Abstraction” might reasonably be applied. I have no idea — and cannot convince you to disclose to us — which, if any, of those concepts you associate with the phrase.

    Get back to me if you decide to ever say what you mean, instead of invoking magical catch-phrases.

  31. Anon February 19, 2021 9:50 am

    xtian,

    I concur that I am applying a bit of myopia in regards to the effects of government agency indications.

    Let those other government agencies fix their own messes.

    I do not believe that just because another government agency wants something, that the effect should rippled through the patent-sphere.

    THAT is an open invitation to ‘divide and conquer’ corruption of the innovation protection dominion.

    I also agree with you that there are other questions to be entertained (in relation to whether or not our society has an appetite for any particular OTHER agency changes).

    As to patents — and more particularly, to innovation (its history and protection) — that is my bailiwick.

  32. Anon February 19, 2021 9:54 am

    …and xtian, since we appear to have established an understanding, let me invite you back to my first post here (Post 1), and invite your comments as to the application** of AI on the legal principles indicated (which include just what ‘undue’ becomes when AI takes over the experimentation, as well as what implications that also may engender for obviousness considerations).

    **this is quite separate from the other AI considerations that I am fond of pursuing – that of the impact beyond ‘mere use,’ and the notion of AI becoming the Devisor.

  33. Anon February 19, 2021 3:56 pm

    TFCFM,

    I can think of several concepts to which the generic label “Ladders of Abstraction” might reasonably be applied.

    It’s not an invocation of a magical catchphrase, and the fact that you merely can think of several concepts only shows that you are not a practitioner.

    But I would be interested in what these “several concepts” are (to you).

  34. Anon February 20, 2021 10:04 am

    Regardless, you over-estimate my mind-reading powers.

    I call BS on your false statement.

    You take as a given (and it is not) that my statement implicates “mind-reading powers.”

    My statement does no such thing.

    You then assert that an action on my part is a cause of your dilemma.

    This is false across the board.
    There is NO ‘over-estimation’ on my part.
    Your dilemma is identified as your own words betraying the fact that you are NOT what you would want to intimate that you are.

    When (if ever) have you been a practicing attorney, using a USPTO registration number, and obtaining patent rights for a client (outside of excessively narrow exacting picture claims)?

    Your parlor tricks of putting up fallacies while avoiding the points being put to you may impress your non-attorney friends.

    They impress no one on a blog with the express purpose of discussing patent law.

  35. TFCFM February 22, 2021 9:48 am

    I note that you still decline to say what you mean.

    If you’d like to translate “Ladders of Abstraction” into something meaningful, I’d be happy to share my thoughts on whatever meaning the phrase might have in the context of this discussion.

  36. Xtian February 22, 2021 10:27 am

    Anon@32 I haven’t put much thought into this aspect, but here’s how I see it: Undue experimentation has always evolved as technologies have advanced. advances in computation and automation make burdensome repetitious tasks, now routine. If use of AI is just like these advancements, then use of said AI is not undue experimentation. I would caveat that with the fact that the AI cannot be proprietary to one user. It must be available to all to use to become routine experimentation.

  37. Anon February 22, 2021 11:51 am

    TFCFM,

    Your note is false.

    Further, I am calling on you to share what you only hinted at. The ball is in your court.

  38. Anon February 22, 2021 12:02 pm

    Thanks Xtian,

    There are a few wrinkles for any “use of” AI. Your reply about some “must be available to all” is a new one. I am not sure that one can really insert that (leastwise, other than to say that anyone with enough money could obtain the “use of”).

    The known presence though — regardless of any actual widespread capability (whether or not ‘proprietary’ – let’s hold that thought for a second) may well be enough to affect the calculus on the legal determinations.

    Joe Blow certainly may not have all the money in the world and cannot compete with Big Pharma (right now), but the lack created by wealth disparity does NOT change the calculus of “undue” or “obvious,” now does it?

    The lid on Pandora’s box certainly seems askew with the notion of just how much (including, if one ventured into the DABUS assertions, but turns the focus there towards the ‘traditional’ non-predictable** arts) of any non-human effort is ‘undue.’

    ** “non-predictable” as a term of art in and of itself may be gutted, as the ‘one’ doing the predicting may not be a human predicting.

  39. TFCFM February 23, 2021 9:44 am

    Anon: “I am calling on you to share what you only hinted at.”

    I did not “hint,” but rather stated explicitly, that I do not know what you mean by the phrase “Ladders of Abstraction,” and asked you to say what you mean. You have, as ever, declined to explain yourself.

    If you were doing anything but throwing up gibberish to obscure your ignorance, you’d have explained by now. No one is fooled.

  40. Anon February 23, 2021 12:34 pm

    TFCAM,

    Again you deflect.

    I did not “hint,” but rather stated explicitly” – this is NOT in relation to your wanting what I put to you as well known among actual practitioners, but instead is related to YOUR assertion of:

    I can think of several concepts to which the generic label “Ladders of Abstraction” might reasonably be applied.” at your post of 30.

    To say that you “can think of” BUT NEVER ACTUALLY SHARE is – as I put it – “hinting.”

    I called on you to do more than your nebulous hinting because you sharing this would reveal that you ARE NOT an active practitioner.

    As I said, the ball is in your court.

    No one is fooled.

    Indeed – but not how you are trying to spin it. As I also said (see at least my post at 34), your reply is built on falsehood.

    That may suffice to impress your non-attorney friends, but here, actual practicing attorneys note your deflection and call you out on it.

  41. TFCFM February 24, 2021 12:33 pm

    It seems to me that if you had a point remotely worth considering, you wouldn’t seek to hide it behind meaningless jargon and decline to explain the intended meaning of the jargon if asked.

    I can only conclude that you have no point worth considering.

  42. Anon February 24, 2021 1:23 pm

    TFCFM,

    Again, your spin is false. The accusation of “hiding” is simply not proper.

    You’ve now tried at least three times to deflect.

    And again, your non-responsiveness may impress your non-attorney friends, but it does not impress here.

    Why don’t you just admit that you were speaking out of your arse when you hinted that you could think of several concepts?

  43. TFCFM February 25, 2021 11:51 am

    Well, the doctrine of “Bullfrogs With Stopwatches” (well known by all “real” patent practitioners, obviously) trumps your no-less-convincing doctrine of “Ladders of Abstraction.”

    So there.

    (Nonetheless, if you had any point worth considering, you’d make it in idiomatic English, rather than hiding behind jargon you refuse to explain.)

  44. Anon February 25, 2021 12:22 pm

    Again – the ball is in your court.

    You hinted at something.

    I called on you to ‘validate’ that hint.

    You went into full deflection mode.

    Feel free to admit that you do not know what the phrase means.

    Here. Let me set the example:

    I do not know what the phrase “Bullfrogs with Stopwatches” means.

    See how easy that it?

    Of course, I am sure that you realize that the phrase that I put to you IS a recognized term of art and your admission says more than you are willing to be honest about.

    Your gamesmanship already says that though. As noted, your parlor trucks may impress your non-attorney friends. They do not impress here.

  45. TFCFM February 26, 2021 11:20 am

    Anon@#44: “Feel free to admit that you do not know what the phrase means.

    I have done precisely that:

    TFCFM@#30: “ can think of several concepts to which the generic label “Ladders of Abstraction” might reasonably be applied. I have no idea — and cannot convince you to disclose to us — which, if any, of those concepts you associate with the phrase.

    Put up or shut up:

    What do you mean by “Ladders of Abstraction”?

    Extra points if you explain how the phrase relates to the issues discussed here.

  46. Anon February 26, 2021 11:27 am

    Lol – put up or shut up yourself.

    What are these “several concepts” that you hint at? That you can “think of?”

    Clearly, you don’t want to share this because clearly, you recognize that the term I use is a recognized term of art and you don’t understand it because you are not an active practitioner that serves to protect innovation.

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