Kevin Collins: An Initial Comment on King Pharmaceuticals: The Printed Matter Doctrine as a Structural Doctrine and Its Implications for Prometheus Laboratories

Kevin Collins has written a new Patently-O Patent Law Journal essay discussing the recent decision in King Pharmaceuticals. [Read the full essay]

On August 2, 2010, the Federal Circuit affirmed the district court’s summary judgment of patent invalidity in King Pharmaceuticals, Inc. v. Eon Labs, Inc. King Pharmaceuticals is most notable for its extension of the printed matter doctrine from objects claims that recite written texts as limitations to method claims that recite speech acts as limitations.

This Essay proceeds in three parts. Part I summarizes the King Pharmaceuticals opinion. Part II argues that the opinion was correctly decided, and it offers an original thesis about the role that the printed matter doctrine should play to enforce patentees’ disclosure obligations and preserve the deep structure of the Patent Act. Assuming that King Pharmaceuticals was correctly decided, Part III addresses the necessary next step in the continuing refinement of the printed matter doctrine. The Federal Circuit must explain why claims like the claim at issue in Prometheus Laboratories v. Mayo Collaborative Services are novel.

Cite as Kevin Emerson Collins, An Initial Comment on King Pharmaceuticals: The Printed Matter Doctrine as a Structural Doctrine and Its Implications for Prometheus Laboratories, 2010 Patently-O Patent L.J. 111 at /media/docs/2011/10/Collins.KingPharma.pdf.

Kevin Collins is a professor of law at Washington University in St. Louis.

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

95 thoughts on “Kevin Collins: An Initial Comment on King Pharmaceuticals: The Printed Matter Doctrine as a Structural Doctrine and Its Implications for Prometheus Laboratories

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  3. However, amici cannot frame the issues presented or develop the factual record, so that layer of protection is limited.

    That’s true, but the Circuit has the power to remand for additional findings of fact. Or to make the facts up as it goes along, apparently. The real goal of an amicus brief is to get the Circuit to state the appropriate rule, regardless of how the outcome of the case is dictated by its particular facts.

    Even if the case is settled on remand, you still get your precedential rule.

    so the position of the PTO should not be maximally against patentability.

    It’s not, is it? Only the crazy people here think it is.

    What Ned and I are suggesting, as far as I can understand from Ned’s posts, is that when there is sufficient doubt as to the validity in law of a claim (or especially a common claim format), the PTO should make a good-faith rejection based on that doubt, and not allow that claim without either a compelling legal argument from the applicant or a statement from the Federal Circuit (which will eventually get a hold of it anyway) that such claims are patentable.

    Procedurally speaking, what happened in Beauregard was the worst possible outcome. The case went just high enough to change PTO policy, and stopped just short of establishing any legal foundation for that policy.

  4. Anon,

    Q: How do you know that Ned is wrong?

    A1: It’s his name at the bottom of the post.
    A2: Ned is never wrong, well, at least in IMHO-Ned Law Land.
    A3: Well you try keeping all those meds in order.
    A4: Well the Office should keep on pushing the limits of law. Like with Inequitable Conduct (which at least doesn’t have the messy legislative side).

  5. IANAE,
    That is generally true. However, amici cannot frame the issues presented or develop the factual record, so that layer of protection is limited. I doubt there is a big risk there anyway, since how many parties are really going to spend the time and money to look like they are trying but set themselves up to lose, risking that they might win? That particular part of my point was probably weak to begin with.

    I would be on more solid philosophical ground to state that the position of the law is not maximally against patentability, so the position of the PTO should not be maximally against patentability.

  6. Common Sense -these claims were clearly anticipated and obvious, and a 101 defense was not going to change the truth. It was good business for King to play the patent system

  7. Ned,
    I generally agree that, once they’ve decided a particular issue and they are going to see it again going forward, they should push that issue to a resolution. Even then, there are any number of reasons they may want to let a particular case go – for example where the facts of it are unique enough that’s the resolution of that case will not provide much guidance for them. I just wouldn’t go with you so far as to make the blanket duty statement.

    Their job is to implement the law, and sometimes that means they need to push a little and figure out what the law really is. But it’s also consistent with their job to sometimes let things go.

  8. Anon, OK then. In your opinion, should the Commissioner have simply begin granting Beauregard claims when IBM asked him to grant them or, if in doubt about their patentability under existing law, should it have taken the issue to the Federal Circuit?

  9. Ned,

    You are mistaken – the Office has no duty to bring anything to the courts. Their duty is to apply the law, to examine patents according to what the law is. They are neither legislative (drafting the law), nor primarily judicial (deciding what the law means). There is some bastardization (given the lack of true separation of powers)of the judicial in the BPAI, but that’s a topic for another time.

    Having agendas about developing novel legal issues gets the Office in trouble. One key example: the claims and continuations rule fiasco. How many examiners could have been hired and properly trained for what the Office spent pursuing that power trip?

  10. That would leave the status of patent law to be sabotaged by those that would make less than a maximum argument for patentability on the other side.

    Perhaps, but any important patentability-related issue that gets as high as the Federal Circuit will inevitably attract amicus briefs like moths to a flame. And if it doesn’t get that high, it’s probably not precedential anyway.

  11. Steve, on novel legal issues raised by applicants, the Office has a duty to bring the issue to the courts.

    IBM came up with Beauregard. I can assure you they were not happy campers when the PTO abandoned its case just prior to having the Feds come out with it holding.

  12. Ned,
    It can’t be the duty of the office to take a maximum position against patentability in all cases. That would leave the status of patent law to be sabotaged by those that would make less than a maximum argument for patentability on the other side.

    The correct duty of the patent office, and any other government agency, is to take a consistent position on the meaning of the patent laws, updated as best they can according to updated statutes, rules, and cases. Occasionally, the position might also be updated in view of changing national priorities, budget constraints, etc. There is no correct bias that the patent office or any government agency should have.

  13. The Office failed its public duty in Beauregard by withdrawing the case

    Or maybe Ned, it was a nonstarter given existing case law.

    Since you be so swell at getting case law cites, I’ll let you get this (hint: it’s an older case that has been recently discussed)

    Ah yes, more words of yours about me that you will be eating.

  14. ping, the Office owes a duty to the public to take the maximum legal position supportable against patentability so that the applicant may appeal to the courts and have novel legal issues decided by the courts. The Office failed its public duty in Beauregard by withdrawing the case. All those article of manufacture patents are now issued with “uncertain” legal merit. What a waste of time and resources if the courts ultimately decided such claims are not patentable.

    Your characterization of what happened in Beauregard as good is unfortunate.

  15. sniifff

    that ripe smell is the old whine in, well, old wineskins. Put it this way – even the Office smelled what a loser it had in the Beauregard case and backed away.

    Aza I said:”Ya telling me the last time this “difficult” trifecta came around was Beauregard?

    Oh wait – it was the USPTO itself that turned tail and said “Our bad – that way is OK”, wasn’t it?

    I’ve heard of some weak excuses – and seen some for weaker cases make it up the judicial ladder. And typically it takes two sides to have a court dispute, and Iza bet that at least one side would be willing to risk creating the precedent that destroys the rest of a portfolio.

    Thata be my scholarly me quoting me quota.

  16. A (not)

    Malcolm is correct that beauregard claims are ripe for the picking

    LOL – like the basic argument that the Office recognized back then has changed at all – NOT.

  17. Ah, so. Beauregard. Just send the patient a computer encoded media that operates to load a program that displays the required message.

    Problem solved. ….

    Really?

  18. A: Helluva precedent.

    Indeed. It’s all the authority Beauregard claims currently have to stand on.

    It is, however, precedent for the BPAI objecting to Beauregard claims, which (if you follow the conversation above) is the only point I was trying to make. That, and the fact that the Federal Circuit didn’t also uphold the rejection is no indication the Federal Circuit likes them at all.

    A: Some defendant will persuade a judge that those claims don’t recite any corresponding structure and thus should be construed under 112P6.

    That has to be the fall-back position, assuming the patent in suit doesn’t have corresponding structure that would make the claim valid and infringed. Still, printed matter kills the claim dead if the argument succeeds, and it’s not hard to find analogies. This case, for example.

    SteveW: Someday, the Fed Circuit will wake up and realize that what they intended by the printed matter doctrine was actually one of the canons of statutory interpretation – give full meaning to apparently competing statutes.

    I don’t think they’re concerned about competing statutes, since nothing stops people from getting protection under multiple statutes for the same product.

    What really concerns them is whether writing stuff on a prior art article can make it patentable, particularly when it’s a transparent attempt to patent a mere discovery as in this case.

  19. Someday, the Fed Circuit will wake up and realize that what they intended by the printed matter doctrine was actually one of the canons of statutory interpretation – give full meaning to apparently competing statutes. Where Copyright law squarely addresses certain subject matter that patents only cover tangentially or by inference, Copyright law pre-empts Patent law on that subject matter unless Congress explicitly directs otherwise. Then, the law around PMD will begin to make sense again.
    Still, there will always be a gray area, and content creators will have choices about what type of protection to choose (e.g. patents vis-a-vis trade secrets). But it will be better.
    Professor Collins actionable group-think idea is interesting, but ultimately I think he’s working too hard on that.

  20. I guess you haven’t heard of In re Beauregard, then?

    You mean that Federal Circuit case where the USPTO changed its mind and decided that the printed matter doctrine didn’t apply to the claims and there wasn’t any case or controversy, so the Federal Circuit vacated the Board’s decision? Helluva precedent.

    Malcolm is correct that beauregard claims are ripe for the picking, but I believe they are for a different reason. Some defendant will persuade a judge that those claims don’t recite any corresponding structure and thus should be construed under 112P6. Likely, there won’t be any corresponding algorithm, which is required under Arisocrat, and thus the claims are indefinite.

  21. and have read numerous papers on the subject

    I’ve seen your reading skills 6:

    You’re one of those guys who likes to shine his machine
    You make me take off my shoes before you let me get in
    I can’t believe you kiss your car good night
    C’mon baby tell me-you must be jokin’, right!

  22. “Page 6 was talking about how the court was applying common usage to importatnt terms – including terms of art you merely show a passing aquintenance with.”

    HAH. That I, I, whom has delved into the historical contexts of the words at issue, and have read numerous papers on the subject of, show a passing “aquintenance” with?

    LOLOLOLOLOLOLOLOLOLOLOLOL.

    You crack me up. You really do.

    If you bothered to read what they wrote, in this and many other opinions, they state that they take into account the “common usage” at the time the laws were passed, that is, the contemporary meaning (not contemporary as in “modern day”). Not the “common usage” as the terms have been redefined over the years.

    “Have you ever noticed that the more clueless you are on something, the more compelled you are to keep on typing, and the longer your crrp answers become?”

    Have you ever noticed how short and without backing the nonsense you spew is? Maybe you’ve even gone a step further and noticed how contrary your nonsense is to the explicitly written words on the subject?

  23. 6 – look too hard and you miss the obvious.

    Page 6 was talking about how the court was applying common usage to importatnt terms – including terms of art you merely show a passing aquintenance with.

    Have you ever noticed that the more clueless you are on something, the more compelled you are to keep on typing, and the longer your crrp answers become?

  24. We’re still talking about “useful arts” right?

    Page 6:

    Under the Court of Appeals’ formulation, an invention isa “process” only if: “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” 545 F. 3d, at 954. This Court has “more than once cautioned that courts ‘should not read into the patent laws limitations and conditions which the legislature has not expressed.’” Diamond v. Diehr, 450
    U. S. 175, 182 (1981) (quoting Chakrabarty, supra, at 308; some internal quotation marks omitted). In patent law, asin all statutory construction, “[u]nless otherwise defined, ‘words will be interpreted as taking their ordinary, contemporary, common meaning.’” Diehr, supra, at 182 (quoting Perrin v. United States, 444 U. S. 37, 42 (1979)). The Court has read the §101 term “manufacture” in accordance with dictionary definitions, see Chakrabarty, supra, at 308 (citing American Fruit Growers, Inc. v. Brogdex Co., 283 U. S. 1, 11 (1931)), and approved a construction of the term “composition of matter” consistent with common usage, see Chakrabarty, supra, at 308 (citing Shell Development Co. v. Watson, 149 F. Supp. 279, 280 (DC 1957)).
    Any suggestion in this Court’s case law that the Patent Act’s terms deviate from their ordinary meaning has only been an explanation for the exceptions for laws of nature,physical phenomena, and abstract ideas. See Parker v. Flook, 437 U. S. 584, 588–589 (1978). This Court has not indicated that the existence of these well-established exceptions gives the Judiciary carte blanche to imposeother limitations that are inconsistent with the text and the statute’s purpose and design. Concerns about attempts to call any form of human activity a “process” can be met by making sure the claim meets the requirementsof §101.
    Adopting the machine-or-transformation test as the sole

    Hmmmm no “Useful Arts” there.

    Page 7:

    test for what constitutes a “process” (as opposed to just animportant and useful clue) violates these statutory interpretation principles. Section 100(b) provides that “[t]heterm ‘process’ means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” The Court is unaware of any “‘ordinary, contemporary, common meaning,’” Diehr, supra, at 182, of the definitional terms “process, art or method” that would require these terms to be tied to a machine or to transform an article. Respondent urges theCourt to look to the other patentable categories in §101—machines, manufactures, and compositions of matter—toconfine the meaning of “process” to a machine or transformation, under the doctrine of noscitur a sociis. Under this canon, “an ambiguous term may be given more precise content by the neighboring words with which it is associated.” United States v. Stevens, 559 U. S. ___, ___ (2010) (slip op., at 12) (internal quotation marks omitted). This canon is inapplicable here, for §100(b) already explicitlydefines the term “process.” See Burgess v. United States, 553 U. S. 124, 130 (2008) (“When a statute includes an explicit definition, we must follow that definition” (internal quotation marks omitted)).
    The Court of Appeals incorrectly concluded that thisCourt has endorsed the machine-or-transformation test as the exclusive test. It is true that Cochrane v. Deener, 94
    U. S. 780, 788 (1877), explained that a “process” is “an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.”More recent cases, however, have rejected the broad implications of this dictum; and, in all events, later authorityshows that it was not intended to be an exhaustive or exclusive test. Gottschalk v. Benson, 409 U. S. 63, 70 (1972), noted that “[t]ransformation and reduction of anarticle ‘to a different state or thing’ is the clue to the pat

    Hmmmm, no “Useful Arts” there.

    Face it tardface, you just keep on wishing that a majority backed your nonsense when plainly Scalia wanted no part in it. The only part you want to hang on to was on page 8 you tard. And that is the section which the 5th man Scalia went out of his way to cut out of his opinion.

    Also, why are you prattling on about Stevens supposedly referring back to that? What Stevens refers back to doesn’t change what the plurality of 4 said in places and what the 5 of them said in other places.

    “”Any suggestion in this Court’s case law that the Patent Act’s terms deviate from their ordinary meaning has only been an explanation for the exceptions for laws of nature,physical phenomena, and abstract ideas. This Court has not indicated that the existence of these well-established exceptions gives the Judiciary carte blanche to imposeother limitations that are inconsistent with the text and the statute’s purpose and design.”””

    That paragraph is dedicated to “the patent act”, presumptively the one of the 1950’s. Not the constitution itself tardface. Congress does not determine what the words of the constitution i.e. “useful arts”, as currently written, mean through mere statutes as you well know.

    You are so re tarded, we went over this the week of the decision and you’re still deluding yourself.

  25. 6,

    See generally Pages 6 and 7 of the Majority Opinion, as that is the section that the loser Stevens referred to.

    And Specifically:

    Any suggestion in this Court’s case law that the Patent Act’s terms deviate from their ordinary meaning has only been an explanation for the exceptions for laws of nature,physical phenomena, and abstract ideas. This Court has not indicated that the existence of these well-established exceptions gives the Judiciary carte blanche to imposeother limitations that are inconsistent with the text and the statute’s purpose and design.”

  26. “The problem, sir, is that the PTO took a long walk away from objectivity in evaluating patent applications and decided to conduct witch trials. ”

    I support the current witch trials since they are apparently sanctioned by congress.

    “(as explained by the majority in Bilski)?”

    On which page did such a thing occur? I think you’re referring to a plurality of 4 judges bucko.

    And btw, I’m not just talking about Hawk’s site, I’m talking about his case against Mircrosoft. Or perhaps I should say “caselol”. Microsoft delievered a world-class beatdown before trial even got underway.

  27. what’s up: Malcolm, you may be right, the beauregard claims that recite a medium containing instructions appear to be the same as paper containing instructions. Yet neither the federal circuit nor the bpai has ever gone this far.

    I guess you haven’t heard of In re Beauregard, then? The BPAI went that far, and if the Circuit didn’t see as far it was only because giants were standing on their shoulders.

    Max: I was talking about a particular method, that is the subject matter of a particular valid claim, that is infringed every time any person who happens to be suffering from a particular disease Y takes by mouth a particular bog-standard, off-patent, over the counter pill.

    What’s the problem? That it was patented as an analgesic but infringed by taking orally? I mean, umm… it’s a new use for an existing product. Why should it be any less patentable or infringe-able than medicament-for-the-treatment-of-Y? It’s not like swallowing a pill restricts the skill or practice of a surgeon. The patent covers the molecule and its biochemistry.

    I’d feel a lot better about this particular patent if it had at least one of the following: (1) drug is surprisingly found to treat a second condition, (2) drug is found to treat the second condition in a new dosage/delivery form, (3) drug is surprisingly found to work better in a new delivery form, (4) surprising higher bioavailability means lower dosage is needed, with some benefit ensuing.

    As it stands, it’s just “oh, this drug works better than we thought when you take it in the old way for its known use”. That’s right up there with “water is more refreshing when you drink it from a sports bottle”. Good to know, but not really an invention since we were already doing it that way to treat that same condition.

  28. Maxie,

    Actually it was just a quick dig at 6, who tends to attach importance to phrases that he seems to have little actual grasp on.

    I would tend to view “business methods”, in particular, as evidence of the wide open approach to patenting that I believe the fore-fathers of our great country intended, rather than the uncharacteristic approach of locking something in time (especially when that something is so integrally intertwined with innovation, no less). To wit, the rationale, nigh engineering, approach applied to so many business concepts to me evidences that the term “useful art”, like the beckoning open wide gates of the patent call itself, was meant to be (at least in the gold standard US tradition) geared to the inclusive, rather than the exclusive.

    And its not so much that I groan that you prefer the European way (in fact, as a competititor, I wlecome you to such a second class vehicle), its more that you in your insiduous way, you generally seek to taint the US gold standard and want us (striking me as painfully obvious in your selfish manner) to change to be more like you and less the gold standard we are.

  29. ping, when you assert that “useful arts” was one thing prior to computers and another thing after the arrival of the internet, are you asserting that innovation in ways of doing business was unknown when the framers wrote the Constitution, or that the patent-eligible aspect of innovation in ways of doing business is the doing of it on the internet?

    I prefer (you groan) the European way, that the “useful arts” remain the same, now as then, but innovations in computer architecture are patent-eligible, then as now.

  30. >>The problem, sir, is that the patent system >>took a walk away from the Useful Arts a long >>time ago due to incompetence of epic >>proportions.

    The problem, sir, is that the PTO took a long walk away from objectivity in evaluating patent applications and decided to conduct witch trials. Get thee to TSM.

  31. The Hawk seems to strike a nice story once in awhile, but mostly his stuff is just too long. My ADA fix be much more soothed here, where I can count on chuckles from at least half a dozen sources on any particular thread.

    As for the Useful Arts 6, would that be the Useful Arts of the 18th century, or the useful arts of the modern era (as explained by the majority in Bilski)?

  32. ” Do you see the problem? ”

    The problem, sir, is that the patent system took a walk away from the Useful Arts a long time ago due to incompetence of epic proportions.

  33. “I’ve heard of some weak excuses – and seen some for weaker cases make it up the judicial ladder.”

    All things in good time sir. I wonder whatever happened to that case where the judge warned the plaintiff that although the PTO may have conceded the point in one case that hardly meant that such claims complied with the law. Perhaps the plaintiff already withdrew? I wouldn’t be a bit surprised. I would however be very let down, I was so looking forward to that case.

    What would have also have been nice would have been to see Patent Hawk’s trial on his “toolbar” claims. You guys know he already got beatdown before the trial went down right? I posted links to those docs right? I loled most heartily. Still surprised D didn’t post an article.

  34. Malcolm,

    Don’t be listenin to Anon. If you stop and figure out that the functional relationship thingy makes the difference between just words (like a kit claim) and words that do somethin (like the computer stuff), this blog would sorely miss your whale-in adventures.

    Egad, what would be next? Maxie stoppin his advertising for the EPO?

  35. Malcolm Mooney is wrong when he claims the law is a certain way

    Please be more specific, anon. Maybe quote the exact statement you believe is “wrong” and I can explain it you in even more simple terms.

    the law is clearly not on your side. It is this difficulty, not some trumped up other excuse, that has maintained proper functional claiming in the patent world.

    You are rambling incoherently, anon. A “difficulty” has “maintained” “proper functional claiming”? Huh?

    If you are aware of case law that says you can distinguish an old composition or an old method merely be the recitation of a new function (without corresponding structure) or a new result (without an additional step) of that composition or method, respectively, please let me see it. I am aware of one glaring exception to this fundamental rule and that is Beauregard claims and those types of claims have never been properly challenged and upheld by the Federal Circuit, for the reasons I’ve alluded to above.

    Returning to the King Pharmaceuticals situation, the law is that the inclusion of “new” information about how to use an old composition does not render the old composition patentable. Likewise, the mere communication of an “interpretation” of an old method does not turn the old method into a new method. The reason for this is that allowing such claims would essentially be allowing discoverers of facts (as opposed to discoverers of new compositions or new methods) to claim ownership of the facts.

    Consider the scenario where I have performed the method (the old method) before reading the patent. I have the result in hand. I decide no further treatment is needed, because the result implies Y. Then I read the patent. The patent says that if one finds the result I found, no more treatment is necessary because the result implies Z, and the patent claims the old steps plus a step of communicating the information about Z. So even though I’m performing the same old steps, I am suddenly an infringer if I merely communicate to the patient that the result suggests no further treatment, because of scientific facts Y and Z — facts that are not owned by anyone (because they it’s public information). Do you see the problem?

  36. I agree with your perspective SKR, although I must correct you and point out that the US patent law does match the ethical law you describe.

    Do not be confused by some of the posts here. Specifically, Malcolm Mooney is wrong when he claims the law is a certain way, and he engenders ignorance on the very key of the relationship of functionality, driven by his blind obsession.

    Funny how a non attorney can get the gist of PMD, realizing that in such circumstances — specifically when there is no functional relationship — and can see right to the crux of the matter.

    Again, Mr. Mooney, no matter how many times you proclaim your bias, the law is clearly not on your side. It is this difficulty, not some trumped up other excuse, that has maintained proper functional claiming in the patent world.

    SKR must not be a mate on the Pequod.

  37. While I agree with a lot of people on the board, I think, on a ethical level (not the US patent law), this was a non patentable claim.

    Thse drug was known, the use was the same, the dose strengths were the same – the only change was telling some thing to the patient (which really did not help him recover better/ faster)… how does writing any such information on the box/ leaflet make it patentable?

    I am not a US attorney but work in the field of pharmaceuticals and want to know your perspective.

  38. Ya telling me the last time this “difficult” trifecta came around was Beauregard?

    Oh wait – it was the USPTO itself that turned tail and said “Our bad – that way is OK”, wasn’t it?

    I’ve heard of some weak excuses – and seen some for weaker cases make it up the judicial ladder. And typically it takes two sides to have a court dispute, and Iza bet that at least one side would be willing to risk creating the precedent that destroys the rest of a portfolio.

  39. In general, nothing Malcolm.

    But I wasn’t talking about just any old method claim under the sun, Malcolm.

    I was talking about a particular method, that is the subject matter of a particular valid claim, that is infringed every time any person who happens to be suffering from a particular disease Y takes by mouth a particular bog-standard, off-patent, over the counter pill.

    That’s the particular idea that I still find weird.

    And I think it does nothing to foster the public’s respect for our patent system.

  40. “I mean a defendant who has the money and is willing to appeal after they lose and risk creating the precedent that destroys the rest of their portfolio.”

    That is the real problem. Too easy for them to keep filing and getting patents whilst avoiding the CAFC.

  41. With all the angst and bad sentiments towards these types of patents, doncha think that somebody woulda taken this easy path by now?

    Never said it would be “easy.” You have to find the right defendant and the right claim and a district court judge who is willing to take reason where it leads and isn’t worried about potential political blowback (Judge Patel would seem to fit the bill). By the right defendant, I mean a defendant who has the money and is willing to appeal after they lose and risk creating the precedent that destroys the rest of their portfolio.

  42. MD But you say that, in your jurisdiction, when he uses a molecule that is a well-known, off the shelf, off patent medicament, he can be a direct infringer. Now, if you don’t mind my saying, that really is weird.

    What’s weird about calling someone who practices all the steps of a method claim a direct infringer, Max?

  43. With respect to inducement, how about these types of claims?

    1. A bicycle rim comprising a flared edge that reduces bicycle wear by 50%.

    2. A method to prevent bicycle tire manufacturers from teaching the bicycle rim improvement recited in claim 1 to sell their own brand of bicycle tires, the method comprising the active steps of:

    creating or copying drawings, models, pictures, or text that depict or describe, in a tangible medium of expression, a bicycle rim comprising all of the elements recited in apparatus claim 1 and any bicycle tire that is configured to attach to the bicycle rim recited in apparatus claim 1;

    communicating the drawings, models, pictures, or text that depict or describe the bicycle rim recited in apparatus claim 1, and any bicycle tire configured to attach to the bicycle rim, to a third party;

    communicating to the third party at least one commercial advantage of the combination of the bicycle rim and any bicycle tire configured to attach to the bicycle rim; and

    supplying any bicycle tire to the third party that is attached to the bicycle rim.

  44. “where is the focus on “functionally related?” There is no function being performed by a medium that stores instructions.”

    I try to tell them that but they come up with a bs answer or ignore it altogether. They want it to be functionally related and therefore it is.

    Don’t sweat it man, eventually the courts will snap out of their stupor.

  45. What’s Up: in Europe, statutory exceptions are construed narrowly. The statutory exceptions to patent-eligibility are the things recited in Art 52 EPC. The prohibition is of each of them “as such”. They include mathematical methods, methods of doing business, the presentation of information, and programs for computers. There are 38 Member States of the European patent system. Each has a Supreme Court. Each has its own jurisprudence. The EPO routinely allows Beauregard-type claims, claims to signals etc, when they are not caught by the statutory bar.

    For the EPO, the only subject matter that qualifies for issue is that which corresponds to the solution by technical means of a technical problem. Accountants aren’t technical.

    I do not understand the PMD, so I can’t answer your questions. Sorry.

  46. what’s up?

    Did you just fall off the turnip truck?

    Malcolm,

    Is your entire fan base made up of such well-versed individuals?

  47. Max,

    is there any difference between “presentation of information” and PMD? what types of presentations are barred by your statute?

  48. ping,

    where is the focus on “functionally related?” There is no function being performed by a medium that stores instructions. Malcolm is right on this one.

  49. In Europe, instead of the Printed Matter Doctrine, we have a bar in our statute on claims that amount to “the presentation of information”.

    So, I think I can understand Malcolm’s being keen on the PMD.

  50. appear to be the same

    what’s up – only if you squint your eyes and lose focus on the words “functionally related”.

    But hey – look on the bright side – you have the same logic problem as 6.

  51. Max,
    I don’t really see what the harm is in allowing the “printed matter” claims either. In the US, a claim for a computer readable medium that comprises instructions for causing a processor to do something is considered patentable subject matter. Yet, a claim for instructions to cause a person to use an old product in a new way is considered unpatentable printed matter.

    Malcolm, you may be right, the beauregard claims that recite a medium containing instructions appear to be the same as paper containing instructions. Yet neither the federal circuit nor the bpai has ever gone this far.

    The printed matter doctrine, taken at face value, also appears to apply to claims where the novelty is causing a computer monitor to display, or “print,” information, which covers a lot of technology from image processing to graphical interfaces.

    I really don’t know much about the European approach, but if the Europeans have been allowing these types of claims for decades, then maybe we should take a look at their approach over here.

  52. first decent lawyer to mount a credible challenge to such claims up to the Federal Circuit will win

    And to think it woulda been that easy. Malcolm, Iza suprised that you being the decent lawyer that you be, and believing as strongly as you do, that you haven’t taken a Pro Bonor case just to prove how easy it would be.

    With all the angst and bad sentiments towards these types of patents, doncha think that somebody woulda taken this easy path by now?

    ‘sides, if you took Anon’s advice, ita spoil my Christmas gift for you (Iza got ya a brand new harpoon set, with extra strong line, and a computer brain for locating Moby).

  53. Malcolm in Europe, patents can’t cover methods of therapy, so the self-treater cannot be an infringer. But you say that, in your jurisdiction, when he uses a molecule that is a well-known, off the shelf, off patent medicament, he can be a direct infringer. Now, if you don’t mind my saying, that really is weird.

    You are free to carry on thinking Europe is weird but, over here, the battle was fought nearly 30 years ago and the sky hasn’t fallen yet. If you can monopolise a new pharmaceutical, you effectively deny people treating themselves with it. Is that weird? If you discover, to your amazement, that molecule X, no longer itself new, indeed cures disease Y then what is so weird about getting a patent on that new use?

  54. Direct infringement in Europe but only an inducement in the USA?

    Who’s the direct infringer of the use claim in the EP? In the US you can’t get a composition claim on an old composition. You can get a new method claim however for a new method of using the old composition. The direct infringer is the person treating himself according to the label instructions; the inducer is the seller of the labeled medicine.

    What’s really strange is that in the EP you can get a “use” claim that prevents people from using the composition in a method of treatment, even though patents on methods of treating people are illegal in Europe. That’s weird. Even weirder than Beauregard claims because the end-around with Beauregard claims is a tad less transparent.

  55. The courts, the law and even the Office have all said that claiming using such functional style is a definitive way

    If so, in each case, they contradicted pre-existing law and did so without the proper authority. You simply cannot claim an old composition or method with a new property (i.e., function or result) without articulating in definite structural or step form how the composition or method differs from the prior art.

    Period. That is the law. Any dicta or PTO proclamations to the contrary are simply incorrect, for quite simple reasons. You can believe in Beauregard claims and yes the PTO grants them but the first decent lawyer to mount a credible challenge to such claims up to the Federal Circuit will win. There is simply no way to justify them other than creating an exception out of thin air. Is that what courts are supposed to do?

  56. Malcolm Mooney,

    There is not a thread on any topic that you cannot fit your Moby Dick into, is there?

    Regarding your “and — most importantly — that step or structure has to be claimed in a definite fashion (i.e., not functionally)“, that is where the Ahab in you goes to the bottom of the ocean. Quite bluntly, you are simply wrong.

    I get that you want the law to be a certain way. It just is not that way. No matter how many times you say it and no matter how many threads you say it on, it just isn’t so.

    Functionality. It is this critical aspect of the Printed Matter Doctrine that destroys you. I cannot tell if you just don’t get it, or if you just don’t want to get it, because it is really not a difficult concept to understand. The courts, the law and even the Office have all said that claiming using such functional style is a definitive way – a perfectly legal way.

    It’s time to stop chasing the white whale.

  57. Malcolm, as to “information content”, suppose you make and sell drug X as an analgesic. Then you find out (to your total surprise) that it cures unrelated disease Y. You patent your discovery. You get authorisation from the FDA. You put new labels on the old bottles coming off the end of the production line. You package the bottles in a new package with a new trademark and inside are User Instructions like the old ones except that now they state that the pills are for treating disease Y.

    Direct infringement in Europe but only an inducement in the USA?

  58. What if instead they added a step of “and assessing whether there is an increase in Cmax and AUC” instead of just informing that it would occur?

    Let’s say I do the method and I “assess” that there is no change. Do I infringe?

    What if there is, in fact, a change but I “assess” that there is no change. Do I infringe?

    The issue is: what is the fxxxing invention? You can’t patent information. You can’t turn an unpatentable invention into a patentable invention merely by changing the information content that is transmitted to or from the practitioner. There has to be a new step or a new structure and — most importantly — that step or structure has to be claimed in a definite fashion (i.e., not functionally).

  59. What if instead they added a step of “and assessing whether there is an increase in Cmax and AUC” instead of just informing that it would occur?

  60. Would those instructions be functionally related to the human-readable medium?

    Insert the medium in a human and see if the method is performed as a result.

  61. You want to claim information?

    Claim a human-readable medium comprising molecule X and instructions which when executed by the human cause the human to perform the method of claim 1.

  62. Emeritus Intellectually bankrupt essay. Why? The author premises his argument on an “inferring” step – a mental process – in the Prometheus patent claims. That didn’t fit my recollection of the case and for some reason the author didn’t put any representative claim in his text. So I quickly checked for myself and there is no such step, just two activity steps: (a) “administering” the drug, and (b) “determining” the metabolite level.

    Both these steps were old in the art. The “invention” in the Prometheus case is the discovery of a fact, embodied in the “wherein the measurement means this” clause of the claims. That’s the inferring step.

  63. EG Alternatively, the Federal Circuit panel could have (and should have) simply remanded this case back to the district court for what “evidence” (including expert opinion) there was that this “informing” step was known or would have been considered obvious.

    Except that’s why we have the printed matter doctrine: to preclude wasting time on crap like that. You want to claim a method? File a method claim. You want to claim information? Go hose yourself.

    EG As for your “One day I scribble the words “Place widget in hamster cage” on the side of the box” which “Nobody has ever done this before” hypo, patentability will only matter if someone is alleged to infringe that claim.

    Now you’re sounding like a patent teebxgger: “Patent everything and if nobody infringes who cares.” That’s a registration system. Different universe.

    I was just pointing out that there are others up through this week who still view those types of claims as something to include.

    Right. Such people are ignorant and they are wasting their clients’ money. I’m sure you can find prosecutors out there wasting money drafting product-by-process claims for their clients.

  64. Isn’t this “thinking outside the box”?

    At the very least, it’s thinking along the outer surface of the box.

    PharmCo would do well to get a patent on the formulation with “look at what we don’t infringe” labeling, as well as the formulation with labeling that it is identical to the same formulation that happens to have the new instruction. Oh, and the formulation with instructions to the retailer to display it for sale alongside the identical formulation with the original patented instruction. Including spoken instructions, because crafty infringers probably won’t put such damning evidence in writing.

    Wow, patenting is hard.

  65. Malcolm,

    I wasn’t changing the “hypo,” just allowing for whether or not the composition was “old.”

    As for your “One day I scribble the words “Place widget in hamster cage” on the side of the box” which “Nobody has ever done this before” hypo, patentability will only matter if someone is alleged to infringe that claim. Remember that the scope of an “instruction for use” claim is limited to what that “instruction” describes. Again, we’re not talking about a claim that precludes the width and breadth of potential uses of that “widget.”

    As far as your comment about “thinking” let’s just agree to disagree. I’m not going to change your view and you aren’t going to change my view (or others) on this subject.

    I also didn’t say that the patentability of Claim 23 of U.S. Pat. No. 7,771,946 “hinged” on the “instructions for use.” That’s your take on this Claim, not mine. I was just pointing out that there are others up through this week who still view those types of claims as something to include.

    IANAE,

    I certainly won’t disagree with you that the “informing” step in Claim 21 of the ‘128 patent is pretty feeble. I just wish the Federal Circuit panel here would have addressed the more pressing issue of what Bilski means in this context and which was squarely raised at the district court level. Alternatively, the Federal Circuit panel could have (and should have) simply remanded this case back to the district court for what “evidence” (including expert opinion) there was that this “informing” step was known or would have been considered obvious. This newly enunciated doctrine simply highlights what appears to be a gap in the “evidence” on the novelty/obviousness of the “informing” step in Claim 21 that shouldn’t be filled in ad hoc by the Federal Circuit by resort to a newly created “doctrine,” especially when that wasn’t the reason Claim 21 was invalidated at the district court level.

  66. IANAE Whether you like kit claims or not, this is certainly the worst kit claim ever.

    You’re right. People appeal the darndest things.

  67. While we’re changing hypos, what if you sold your old kit with a label saying “This product does not infringe PharmCo Patent No. X,XXX,XXX (copy of Figure 1 attached) because while we do instruct you to take this product with food, we do not so instruct because of the increased bioavailability that will result”? Adapt as required to any other kit claim.

    LOL. I don’t want to veer off into a discussion about inducement, but I’ve wondered the same thing about labeling. Say something gets a patent on a method of a new use for an old compound. You can’t sell the compound with the label describing that use without inducing. But why not advertise it and sell it with the label that says “Other companies, e.g., recommend using this for this purpose, administered at this dose. We are not permitted to make that recommendation but we guarantee that our compound is identical to theirs in all substantial respects.”

    What do you think, EG? Isn’t this “thinking outside the box”?

  68. I am struck by the symmetry of the CAFC’s apparently emerging position that functional elements will not be considered in a 102 analysis for design patents, and that non-functional elements will not be considered in a 102 analysis for utility patents. Does anyone else see this parallel forming?

    In the case of design patents, I think there is certainly room to argue that the optional, non-optimal, arrangement of functional elements in an article might be considered as ornamental. I’m wondering if there might be a complementary consideration for non-functional elements in a utility patent.

  69. One day I scribble the words “Place widget in hamster cage” on the side of the box.

    Don’t change the hypo.

    The old composition was sold with instructions saying “take with food”. The patent claimed selling the composition with instructions saying “take with food, it’ll work better”.

    Whether you like kit claims or not, this is certainly the worst kit claim ever.

    While we’re changing hypos, what if you sold your old kit with a label saying “This product does not infringe PharmCo Patent No. X,XXX,XXX (copy of Figure 1 attached) because while we do instruct you to take this product with food, we do not so instruct because of the increased bioavailability that will result”? Adapt as required to any other kit claim.

  70. EG First, you’re not getting “new patents on identical compositions of matter” but on a product that combines what may be an allegedly “old composition”

    Allegedly? Don’t change the hypo. It is old. It’s an old composition. It’s a widget. It was sold in the box for fifty years.

    One day I scribble the words “Place widget in hamster cage” on the side of the box. Nobody has ever done this before.

    You think that’s a patentable invention?

    That’s thinking outside the box, thinking that other patent prosecutors endorsed before I did.

    Yes, prosecutors with desperate clients who didn’t have an invention. I’m not impressed.

    It certainly reflects more “thinking” than was expressed by the statement I noted above by the Federal Circuit in Ngai.

    No it doesn’t.

    You don’t have to agree with that thought, but I’m not alone in thinking it, even today. See Claim 23 of U.S. Pat. No. 7,771,946 which issued this week.

    Why do you think the patentability of those claims hinges on pieces of matter with instructional writing on it?

  71. “There’s really nothing about that proposition strikes you as problematic, EG?”

    Malcolm,

    Not to me. First, you’re not getting “new patents on identical compositions of matter” but on a product that combines what may be an allegedly “old composition” with “instructions for use” that describe a new and unobvious method/process for using that “old composition.” That’s thinking outside the box, thinking that other patent prosecutors endorsed before I did. It certainly reflects more “thinking” than was expressed by the statement I noted above by the Federal Circuit in Ngai. You don’t have to agree with that thought, but I’m not alone in thinking it, even today. See Claim 23 of U.S. Pat. No. 7,771,946 which issued this week.

  72. Those “instructions for use” described a method which was itself deemed patentable under 35 USC 103. What particularly offends me about the Federal Circuit’s reliance on the “printed matter” doctrine in Ngai is the following statement: “If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.” So what?

    LOL. There’s really nothing about that proposition strikes you as problematic, EG? Getting new patents on identical compositions of matter simply because one feature of the composition comprises a bit of information that isn’t on the previous composition)?

    Take a breath and think about it, man.

  73. Intellectually bankrupt essay. Why? The author premises his argument on an “inferring” step – a mental process – in the Prometheus patent claims. That didn’t fit my recollection of the case and for some reason the author didn’t put any representative claim in his text. So I quickly checked for myself and there is no such step, just two activity steps: (a) “administering” the drug, and (b) “determining” the metabolite level. Professor, if you worked in the field you write about, you’d know that is usually an active measurement step, not a mental step. This is the type of sloppy patent analysis one expects from a first year associate or a Supreme Court justice with an agenda.

    Based on the author’s “inferring” without explanation a claim limitation that didn’t exist, I took the “mental step” of “inferring” the rest of the essay was worthless and saved some time.

    Apropos of another case at the Fed. Cir., since the omission of the actual claim language and the advancing of a premise that is *at least* arguably wrong is so material to any reasonable reader, I am inferring deceptive intent.

  74. We may have to “agree to disagree” on the validity of “instructions for use” in “kit claims.”

    Sounds good to me.

    Can I just point out, though, that in Ngai as in King v. Eon the “kit” was a single known article plus instructions. Not a terrific set of facts for establishing a precedent for kit claims.

  75. IANAE,

    I hear you and respect you well articulated viewpoint. We may have to “agree to disagree” on the validity of “instructions for use” in “kit claims.” That happens sometimes. Peace.

  76. These “kit claims with instructions for use” address the very concern you raise IANAE, namely how to sue the maker of the kit that includes those “instructions” for direct infringement, not inducing or contributory infringement. Ngai simply bars in a manner illogical to my thinking a way to protect an admittedly patentable method so as to be able to sue for direct infringement, not contributory or inducing infringement. Put differently, the maker of the kit need only leave out those “instructions” and there is no infringment issue.

    Yes, kit claims do address the exact concern I raised. We seem to agree on what that concern is, too. It’s something along the lines of “I’ve invented a new method of putting together old parts to make a new thing, but I’d rather sue someone with more liability than the guy who practices that method at home on his one kit”.

    It’s a valid business concern, to be sure, but merely because the patentee wants more money more easily is not a reason to capture inducers of what he actually invented within a direct infringement theory. Claiming the kit with instructions is tantamount to claiming “a method comprising: (a) providing to a person the set of parts of claim 1; and (b) inducing the person to carry out the method of claim 2”.

    I’d have a little more sympathy for the patentees if they didn’t already have a good cause of action against the kit sellers for infringement of the method, and really the instructions are pretty clear evidence of inducement. The maker of the kit is still free to leave out the instructions, and thereby avoid any inducement issue.

  77. Ned/IANAE/Hans Blix,

    I figured there would be disagreement with what I said. I just find it curious that the Federal Circuit would duck the issue directly raised for why Claim 21 was invalid (lack of patent-eligibility under 35 USC 101) and then reach out to create a new doctrine to invalidate Claim 21 as anticipated.

    The Ngai case to me is the most troublesome of the “printed matter” doctrine cases. The statement by the Federal Circuit that “anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product” doesn’t address whether those “new” instructions do add some functionality to the claimed kit. BTW, there is functionality in those “instructions for use” as they tell you what to do with all those components in the kit.

    These “kit claims with instructions for use” address the very concern you raise IANAE, namely how to sue the maker of the kit that includes those “instructions” for direct infringement, not inducing or contributory infringement. Ngai simply bars in a manner illogical to my thinking a way to protect an admittedly patentable method so as to be able to sue for direct infringement, not contributory or inducing infringement. Put differently, the maker of the kit need only leave out those “instructions” and there is no infringment issue.

    Again, I don’t expect agreement with my views, but that’s how I see it.

  78. So, which is it?

    Both, of course.

    The court generally chooses one over the other because it is easier to formulate its reasoning or get consensus among the panel or shield the decision from reversal on appeal, or some other pragmatic reason. In so doing, the court leaves us wishing they’d tackled the other, more interesting or contentious ground.

  79. Ned, I’m with you. Too strained an analysis. EG’s last comment is curious. Most people on this board seem to get irritated by courts invaliding claims under 101 when 102 or 103 could (in their mind) do the same thing. Now it’s the reverse situation. So, which is it?

  80. Those “instructions for use” described a method which was itself deemed patentable under 35 USC 103.

    Yes, but instructions to perform a method are not the method. If they were, having a copy of the patent would infringe the patent. Incidentally, that’s also why the PTO (rightly or wrongly) insists that instructions for a computer to perform a method be recorded on a statutory article of manufacture.

    If you want to claim a statutory class other than a method, you should define the invention in terms of structure, or function that implies structure. If the parts are connectible in a certain new way to make a new assembled device, that’s what you should be claiming. If the parts are old, you can still claim the method and go after people who sell the kit with instructions as contributory infringers or inducers, but your new idea for putting together a box of old parts doesn’t make the box of old parts new.

    Kits with instructions can be claimed. That they can’t be claimed to capture the party you want as a direct infringer is not necessarily a flaw in the system. After all, who are you to stop people selling boxes of old parts?

  81. EG, do you or do you not support the idea that the words in a claim must have some functional relationship to the subject matter claimed in order for there to be novelty? (A green computer, where computer is old and green is non functional?)

    And, if the subject matter is not novel, why is there any issue of non obviousness at all? That issue is reserved ONLY for novel subject matter.

  82. Professor Collins,

    With all due respect, I find the Federal Circuit’s handling of Claim 21 in this case bizarre. They simply ducked a troublesome patent-eligibility issue under 35 USC 101 that was clearly presented. Instead, the Federal Circuit reached out to create (and I do mean “create”) the new “an anticipated method claim doesn’t become patentable if it simply includes an informing step about an inherent property of that method” doctrine.

    Why did they have to create this new doctrine? Because there was no evidence showing the “informing” feature of Claim 21 was disclosed in the prior art. That makes application of 35 USC 102 and even 35 USC 103 to Claim 21 difficult to justify. Instead, the they concoct this new doctrine that is as illogical as Justice Stevens saying in Parker v. Flook that an otherwise unknown algorithm is prior art under 35 U.S.C. § 103.

    I frankly am not a fan of the “printed matter” doctrine. My poster child for this view is the Ngai case cited to support this new doctrine. The Federal Circuit in Ngai rejected “kit claims” which included “instructions for use” as either anticipated under 35 U.S.C. § 102 or unpatentable under 35 U.S.C. § 103 (isn’t clear which basis the Federal Circuit relied upon) under the “printed matter” doctrine. Those “instructions for use” described a method which was itself deemed patentable under 35 USC 103. What particularly offends me about the Federal Circuit’s reliance on the “printed matter” doctrine in Ngai is the following statement: “If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.” So what? The logic of that statement for supporting the invalidity of “kit claims” in Ngai as anticipated/obvious still escapes me.

    The creaton of new doctrines like those enunciated in this case to replace the absence of evidence to otherwise show the claimed invention is anticipated or obvious does not make for consistent rulings. And to completely duck the patent-eligibility issue under 35 USC 101 that was clearly presented in favor of creating this new doctrine for anticipation just boggles my mind.

  83. Agreed that the Prometheus claims are not novel for the same reason as the King Pharma claims are not novel. However, the author struggles unduly for my tastes in attempting to come up with a theory that knowledge (of the need to increase or decrease dosages) is functional.

    Ugh.

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